FDA’s Busy Summer of 2011

Once upon a time, Washington slowed a little over the summer. Those days are long gone…and this was a particularly busy summer. Congress went down to the deadline on the debt limit/deficit reduction legislation, then left town for August. There was a continuous stream of FDA headlines in June, July and August.

FDA Matters focused on a number of the most pressing issues: post-market safety and surveillance; barriers and opportunities for increased drug discovery and approvals; the rising tide of imports; prospects for biosimilars and medical devices; FDA funding; and various crises facing the agency.

Here is a recap of the summer’s stories:

FAQ: How Biosimilars Will Transform the Marketplace      August 21st, 2011

Biosimilars will be a huge success--used by most prescribers at least some of the time. Much of the current negativity about the market for biosimilars is fed by a mismatch of expectations: the Biologics Price Competition and Innovation Act (BPCIA) is barely 18 months old, while the transformation of the marketplace will take a decade or longer. FDA Matters explores the likely evolution of the marketplace in a set of FAQs.  Read the rest of this entry

FDA Funding Prospects Altered by the Budget Control Act     August 14th, 2011

The Budget Control Act of 2011 (BCA) will have a heavy impact on FDA’s future. Under this new law, most discretionary spending programs will shrink—not merely cease to grow. Yet, FDA’s growing responsibilities and resource needs are not diminished because federal spending is being reduced. Our nation is less safe and less healthy if FDA cannot excel at its mission. Read the rest of this entry

People, Not Science, Make Decisions  August 8th, 2011

To FDA Matters, the people making the decisions at FDA are its strength. They are smart, conscientious and committed. Yet, when asked about bottlenecks at FDA, I have to admit that people slow the process down. There are good reasons why this is so. Read the rest of this entry

Medical Device Melodrama: A Great Story With a New Plot Twist  August 1st, 2011

Two years ago, FDA Matters urged FDA and Congress to review the 510(k) approval process for moderate-risk medical devices and predicted meaningful changes that would work for FDA, industry and consumers. FDA and industry have been proceeding along these lines (albeit with some tough negotiating and lots of rhetoric)…until the Institute of Medicine (IOM) declared that the current system is so flawed that a new regulatory framework is needed.  Read the rest of this entry

FDA, Reorganization and the Four Crises    July 24th, 2011

Dr. Hamburg’s reorganization plan addresses four crises that beset the agency: industry discontent with the medical product review process; public concern about import safety; implementation of the Food Safety Modernization Act; and Congressional concerns that the agency is inefficient in its use of resources. The new structure should drive better decisonmaking and greater productivity…. at a time when the agency is struggling to fulfill its growing mission and faces the potential for budget cuts.  Read the rest of this entry

Complexity, Uncertainty, Unpredictability: Not Necessarily Bars to FDA Approvals      July 17th, 2011

In most discussions of science and medicine, there is an implicit assumption that the human body is a complex biological machine. “The human body as a machine” is a metaphor, not a fact. Once we accept this, FDA Matters believes we can become liberated from unrealistic expectations about medical discovery and FDA’s role as a gatekeeper for new products that benefit patients. Read the rest of this entry

Should FDA Have an Independence Day?     July 4th, 2011

FDA Matters thinks that making FDA an independent agency will not make FDA more effective or more efficient. Although the idea is not truly harmful, proposing independent agency status is a seductive distraction from the tough job of improving FDA. Read the rest of this entry

Imports: FDA Issues a Cry for Help   June 26th, 2011

 No challenge to FDA’s mission looms larger than the rapid globalization of the world markets for food, drugs, medical devices and other FDA-regulated products. By way of making this point, the FDA released a special report, entitled “Pathway to Global Product Safety and Quality.”  FDA Matters read the report carefully and heard a cry for help, if not an actual primal scream. Read the rest of this entry

Post-Market Safety: Getting the Most Out of Inferences That Aren’t Proofs   June 21st, 2011

FDA has expanded its post-market efforts, including development of a monitoring system (called Sentinel) that will be able to track drug usage and medical history information on tens of millions of patients. Although such information will be useful, it can only provide post-hoc inferences, not proof of causation. Even with this limitation, FDA Matters thinks developing the system is worthwhile and may provide multiple benefits.  Read the rest of this entry
Steven

FDA Funding Prospects Altered by the Budget Control Act

The just-passed Budget Control Act of 2011 (BCA) will have a heavy impact on FDA’s future.  Under this new law, most discretionary spending programs will shrink—not merely cease to grow.  Yet, FDA’s growing responsibilities and resource needs are not diminished because federal spending is being reduced. Our nation is less safe and less healthy if FDA cannot excel at its mission

FDA Matters urges Congress and the President to see that increased funding of FDA is the only option.  Ultimately, the pressures created by the BCA will test the government’s commitment to FDA’s essential role in our society.  

Appropriations Caps and the Impact on FY 12.  The BCA limits discretionary federal spending for every fiscal year from 2012 through 2021. By capping annual appropriations growth, federal spending will be reduced by more than $900 million over 10 years.

For FY 12, the House and Senate appropriations committees cannot spend more than $1.043 trillion. Within this total, the ceiling for non-security programs (e.g. FDA, NIH, education, etc.) is slightly below the FY 11 appropriations level.

The ceiling is also substantially above the level the House has been using to mark up FY 12 bills. This is particularly encouraging because the House-passed Ag/FDA appropriations bill would cut FDA by $285 million below FY 11 (-11.5%) and $572 million below the President’s FY 12 budget request (-21%).

Senate staffs are currently preparing FY 12 appropriations bills using the aggregate spending levels in the BCA. Subcommittee and then full committee mark-ups are expected to start in early to mid-September.  Advocates, notably the Alliance for a Stronger FDA and its members, have been encouraging the Senate to put more money into FDA. The goal is to provide the agency with an increase in its FY 12 appropriation, not merely undo the cuts proposed in the House bill.

FY 13 Appropriations and Beyond.  A second part of the BCA requires a further reduction of the federal deficit by $1.2 trillion over the next 10 years. This can be achieved by any combination of changes in entitlements, revenues and appropriations.  

To pull together this deficit reduction plan, a so-called “super committee” has been appointed. It is composed of 12 members—3 each from the majority and minority parties in the House and the Senate. The group’s work must be completed by November 23, 2011. Any resulting bill will not be amendable and must pass Congress by December 23, 2011. If no legislation passes or the President fails to sign it, then across-the-board cuts (“a sequester”) will occur during  fiscal year 2013, which starts on October 1, 2012.

The general consensus in Washington is that the super committee appointees are too divided ideologically to pull together the needed deficit package. Democrats will only accept entitlement changes if there are new tax revenues. Republicans are pledged to oppose any tax increase.

Predictions of failure may be premature because the super committee will be under intense public and political pressure to find a compromise. In addition, sequester cuts would fall heavily on defense programs that most of Congress supports.

FDA is vulnerable in the “super committee/sequestration” process in two ways.

• If the super committee produces a plan, it may include further cuts in discretionary spending. There is no guarantee that Congress would allocate those cuts in a way that would protect FDA and other essential programs.
• If the super committee does not produce a plan, then the sequester would go into effect in FY 13.  If the entire 10-year $1.2 trillion in savings must be found through sequestration, then FDA is likely to sustain an across-the-board reduction in FY 13 of at least 8% to 10%.

Conclusion. Over the last five years, FDA has been one of few discretionary programs to receive substantial funding increases. This reflected both Congressional and Executive Branch recognition that the agency was dramatically underfunded for its growing responsibilities in an increasingly complex world. FDA still needs more resources, even though the downward budgetary pressures have become significantly greater.

Steven

Imports: FDA Issues a Cry for Help          June 26th, 2011

No challenge to FDA’s mission looms larger than the rapid globalization of the world markets for food, drugs, medical devices and other FDA-regulated products. By way of making this point, on June 20, the FDA released a special report, entitled “Pathway to Global Product Safety and Quality.” FDA Matters read the report carefully and heard a cry for help, if not an actual primal scream. Read the rest of this entry

FDA “Exceptionalism” at the Funding Crossroads       May 2nd, 2011

Congress returns at the beginning of May to start the FY 12 appropriations process. Downward pressure on federal spending will intensify. If, despite this, the FDA receives another increase, then it will move closer to establishing itself as an exception to the budget cutting process. Thus, FDA Matters sees the coming funding battle as a crossroads for FDA.  Read the rest of this entry

Medical Device Melodrama: A Great Story With a New Plot Twist

Two years ago, FDA Matters urged FDA and Congress to review the 510(k) approval process for moderate-risk medical devices. It was recognition that medical devices are different and that the review process had not been thoroughly re-examined in two decades.

I imagined tweaks, possibly substantial ones, to the 510(k) process. I also predicted that those working with the current system would be comfortable with the changes. FDA and industry have been proceeding along these lines…until last week when the Institute of Medicine (IOM) declared that the current system is so flawed that a new regulatory framework is needed.  

The FDA and industry discussions are being played out on several fronts: industry proposals, FDA proposals, and negotiations over a five-year extension of the Medical Device User Fee Modernization Act. FDA and industry both think the existing system can be improved.

They have different viewpoints. Industry wants a more predictable process that allows applications for moderate-risk devices to be submitted, reviewed and approved more quickly. FDA admits that evolving requirements and standards may be slowing reviews, but also feels the quality of company submissions is a major impediment to faster reviews.

The medical device industry has played its hand well. At their behest, Congress has sent a message to FDA: go slowly as you revise the medical device approval process, avoid mistakes, and do not create any unintended consequences.

FDA has been deft in its responses. It has talked about changes in abbreviated review processes, has proposed a new speedy “high innovation” review track, and been appropriately attentive to Congressional concerns that the process not be rushed. They have been forthright that user fees will need to increase significantly over the next 5-year period for the agency to meet its growing workload and keep pace with 510(k) reviews.

Industry is reluctant to pay increased fees, given their perception that FDA has failed to meet performance targets in the current user fee program. Industry has suggested that maybe a two-year user-fee reauthorization may be preferable to five-years, giving FDA a chance to implement reforms that would, in turn, justify the increased user fee revenue.

The back and forth discussions between industry and FDA have been heated at times, but always mixing disagreement with civility. That is not to minimize the degree of conflict or occasional harsh words. But by government standards, the two sides are working together well and there is reasonable hope of a satisfactory conclusion that will protect the interests of the American public and stimulate innovation in the medical device industry.

Enter the Institute of Medicine. This branch of the National Academy of Sciences had been commissioned by FDA to study the 510(k) approval process. Its long-awaited report was issued on July 29.

Surprisingly, IOM’s report didn’t provide any insights that would help the negotiating process. Instead, they concluded that: FDA should invest in developing a new regulatory framework to replace the flawed 510(k) medical device clearance process. An effective system could not be built on the current framework.

FDA immediately declared: “FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.” Industry, too, has a strong interest in improving, not replacing, the 510(k). They agreed with FDA’s rejection of the IOM report.

FDA and industry will continue working and disagreeing with each other, trying to reach agreement. They now have a common enemy: an IOM that insists that a perfect medical device review system should be created….while FDA and industry know that patching the existing one is the only realistic possibility. 

Steven

All FDA Stakeholders Affected by Medical Device Reforms      October 31st, 2010

There are so many visible, contentious FDA issues right now….that reform of the medical device approval process has received only a fraction of the attention it deserves. Other centers at FDA and non-device stakeholders need to be watching more closely. FDA Matters is. Read the rest of this entry

“No Surprise” That Medical Devices Are Under Scrutiny           October 1st, 2009

Five weeks ago, I wrote a column entitled, “Re-Evaluating the Medical Device Approval Process.” It was not widely-read. I assumed it was because everyone already knew that a review was underway at FDA with more activity coming. Apparently, I was wrong.  Read the rest of this entry

Re-evaluating the Medical Device Approval Process        August 27th, 2009

Earlier this year, a GAO report concluded that many high risk medical devices have not been adequately reviewed. In June, the House Health Subcommittee held the first of what may be a series of hearings on medical devices. The media appears increasingly interested in medical devices and is raising more questions.

All these events are a prelude to FDA and Congress undertaking a major re-evaluation of the product approval process for medical devices. It would be a relief if FDA could diagnose and treat its own medical device problems, leaving the Congress and the media to watch. Read the rest of this entry

FDA, Reorganization and the Four Crises

In previous posts, FDA Matters has expressed its disdain for efforts to solve problems by reorganizing government agencies. So, it may be surprising that I am giving Commissioner Hamburg an “A” for her recent reorganization of FDA’s senior management.

In the reorganization, she is addressing four crises that beset the agency: industry discontent with the medical product review process; public concern about import safety; implementation of the Food Safety Modernization Act; and Congressional concerns that the agency is inefficient in its use of resources. The new structure should drive better decisonmaking and greater productivity…. at a time when the agency is struggling to fulfill its growing mission and faces the potential for budget cuts.  

Until the beginning of this year, Dr. Hamburg has relied upon Dr. Joshua Sharfstein, a trusted deputy and alter-ego, to assist in managing the agency. In addition, he had served as a buffer between the agency and external forces, particularly Congress.  Instead of replacing Dr. Sharfstein, the Commissioner has chosen a new organizational approach that responds to the agency’s most difficult challenges:

Crisis #1: Growing discontent among the medical product industries. They allege that unreasonable FDA requirements and the agency’s overly-cautious approach to potential safety issues are keeping innovative and effective products from becoming available to patients. For more details, see my columns at:  http://www.fdamatters.com/?p=1428 and http://www.fdamatters.com/?p=1401.

Response: Create a new Deputy Commissioner for Medical Products and Tobacco and appoint Stephen P. Spielberg, MD., PhD, a distinguished physician and researcher and former dean of Dartmouth Medical School. He also spent 11 years in industry, working for Merck and then J&J.

In his new role, Dr. Spielberg will oversee the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products.

The intent is for him to serve as a “senior partner” to the four center directors, facilitating decisions that might otherwise wait for the Commissioner. When appropriate, he would also stand-in for the Commissioner on their behalf. Right now, these center directors can’t be getting very much of Dr. Hamburg’s time and they are quite vulnerable on the Congressional side.

In addition to the stature he brings, Dr. Spielberg’s bio describes his research interests as: mechanisms of idiosyncratic adverse drug reactions, human pharmacogenetics and personalized medicine, and pediatric clinical pharmacology. This background is germane to the areas of industry concern about pre- and post-market review of medical products and also positions him to be one of the agency’s chief advocates for improvements in regulatory science.

Crisis # 2: The safety and quality of imported food and medical products.  The American people and Congress want safe products and expect FDA to use its very limited resources to make it so. For more details, see my column at: http://www.fdamatters.com/?p=1408.

Response: Create a new Deputy Commissioner for Global Regulatory Operations and Policy and appoint Deborah Autor, now Director of CDER’s Office of Compliance. Her “directorate” will oversee the Office of Regulatory Affairs (ORA) and the Office of International Programs.

The intent is to increase coordination and greatly reduce the number of decisions that would otherwise wait for the Commissioner’s availability. Just as importantly, the new structure brings together FDA’s overseas relationship and capacity-building successes with a tougher, more regulatory posture to assure that imports meet the same standards for safety and quality as domestic goods.

Crisis #3: Implementation of the new Food Safety Modernization Act to create a sophisticated risk-based food safety system. This is a complex multi-faceted task being made more difficult by inadequate funding.

Response: Continue the existing position of Deputy Commissioner for Foods, which oversees the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. Michael Taylor, who will continue in this post, has already demonstrated the advantages of Dr. Hamburg’s new organizational approach….by his general leadership and his representation of the agency with Congress on food issues.

Crisis #4: FDA’s ability to sustain and grow its FY 2011 funding level is being challenged in the Congressional appropriations process.

Response: Create a new Office of Operations, headed by a Chief Operating Officer (COO) to oversee human resources, facilities, information technology and finance. This will strengthen the agency’s ability to respond to Congress on administrative matters and, in particular, assure Congress that the agency is under tight fiscal management.

Conclusion: FDA has many problems, some of which are reaching crisis-proportion. While more resources are necessary, good leadership is essential.

Regardless of the demands, Commissioner Hamburg can never have more than 24 hours each day to address the agency’s needs. The new organizational arrangement—with four deputy commissioners providing span of control over most of the agency--seems well-suited to address this limitation.

Steven

Here is a link to read the Commissioner’s message to agency employees conveying the new organizational structure:  http://carl1anderson.wordpress.com/2011/07/14/major-reorganization-at-fda/.

I would hope in the future that FDA would post these types of communications directly onto the agency website, rather than relying on the Commissioner’s messages to be reprinted in newsletters and blogs.

Should FDA Have an Independence Day?

Years ago, while helping an incoming administration evaluate the public health service agencies at HHS, I became captivated by the idea that a series of reorganizations would solve many of the problems. I eventually snapped out of my trance and learned a life-long lesson: redrawing organizational boxes and altering reporting relationships are rarely effective solutions.

FDA Matters thinks that making FDA an independent agency will not make FDA more effective or more efficient. Although the idea is not truly harmful, proposing independent agency status is a seductive distraction from the tough job of improving FDA.    

Making FDA an independent agency has been proposed many times before. The issue has come up now because Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), included it last week among a number of proposals in his “state of the industry” speech. The industry is to be applauded for its commitment to new thinking, which focuses on ways to stimulate investment in biosciences, as well as improve FDA. While I think there may be some great ideas in BIO’s proposals, an independent FDA is not one of them.

An” independent agency” is a federal government organization that is not located within one of the 15 executive departments.  While most independent agencies are commission-type organizations run by a board, some are structured in a manner similar to the executive departments.  Examples include the Environmental Protection Agency (EPA), the National Aeronautics and Space Administration (NASA), and the National Science Foundation (NSF).

Being independent sounds great, but would it really help FDA become a more effective or better-resourced agency?

Independent agencies do not run independently of the President and the Executive Branch. Whether part of HHS or independent, FDA’s authority derives from the President, its money comes through the Office of Management and Budget (OMB), its manpower is cleared by the Office of Personnel Management (OPM), and its office space and purchases are controlled by the General Services Administration (GSA).

The chief advantage to FDA of being independent would be the ability to by-pass HHS leadership and bureaucracy. While HHS may be a problem, does anyone want to argue that it is so bad that it requires FDA to be uprooted? Historically, it is OMB that has pushed FDA budget requests downward and objected to FDA regulations. That wouldn’t change.

Being an independent agency does not necessarily improve access to the President. Because only heads of executive departments are cabinet members, the HHS secretary currently speaks for FDA when the cabinet meets.  The head of EPA has the status of “cabinet-rank,” along with OMB. I am not sure whether EPA gets much out of this honor, but similar standing for FDA would seem unlikely.  

Being an independent agency does not move an organization to a different appropriations committee. EPA is funded by the Interior, Environment and Related Agencies subcommittee. NASA and NSF are funded by the Commerce, Justice, Science and Related Agencies subcommittee. Independent or not, FDA will be funded as part of the Agriculture appropriations bill.

Independent agencies haven’t necessarily prospered, either. NASA had a good track record while it embodied a national aspiration, but it is clearly on the decline now. The National Science Foundation has never enjoyed the level of support given the National Institutes of Health.

That leaves us, perhaps, EPA as the embodiment of an independent agency with regulatory and scientific responsibilities. Has science triumphed at the agency because its independent status shields it from politics? It seems unlikely that anyone would make that argument. EPA, too, appears to be an agency on the decline.  

Maybe FDA would benefit from being an independent agency, although I don’t think so. At best, it would take enormous political effort to accomplish….energy that could be applied toward more effective ways to improve the agency.

Steven

Jim Greenwood, President and CEO, 2011 BIO STATE OF THE INDUSTRY ADDRESS. “Unleashing the Promise of Biotechnology to Cure Disease and Save Lives”  http://www.bio.org/news/speeches/2011_greenwood_convention_speech.pdf

A more in-depth description of the BIO proposals is at: http://www.bio.org/aboutbio/promiseofbiotech.pdf

List of independent agencies: http://www.usa.gov/Agencies/Federal/Independent.shtml 

Imports: FDA Issues a Cry for Help

No challenge to FDA’s mission looms larger than the rapid globalization of the world markets for food, drugs, medical devices and other FDA-regulated products.  By way of making this point, on June 20, the FDA released a special report, entitled “Pathway to Global Product Safety and Quality.”  

FDA Matters read the report carefully and heard a cry for help, if not an actual primal scream.

The report provides startling statistics on the recent and future growth of imports. A decade ago, 6 million shipments of FDA-regulated goods passed through our nation’s 300 ports; this year the number will quadruple to 24 million shipments.

The impact is across all areas of FDA responsibility. Currently, 60% of fruits and vegetables and 80% of seafood consumed in the US are imported. About 80% of active ingredients found in pharmaceutical products (not finished products) originated abroad. More than 35% of the US medical equipment market is imported devices.

The world is an unsafe place. Despite that, Americans are not going to restrict themselves to seasonal and locally grown food. Nor will we limit ourselves to the drugs and devices that can be developed and manufactured using only ingredients and parts that come from within the US.

We count on FDA to be sure our foods are safe and medical products safe and effective, regardless of origin.  However, imports inspire less confidence because there are hundreds of thousands of products made under local laws and business practices. We have much to be concerned as these numbers continue to grow.  

Even with additional resources, new legal authorities, international cooperation, improved strategies, complex databases and a bunch of good luck…keeping the American people safe will require the agency to invest several times more effort than it has in the recent past.

FDA’s plan is logical and appropriate:

1) FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.

2) With these coalitions, FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.

3) FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.

4) FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.

In short, FDA’s strategy is: let’s build the food, drug, and device equivalent of Interpol, then “let’s get the bad guys before they get us.”

This seems like a good approach, but it is not enough. In a speech in April, Dr. Murray Lumpkin, Deputy Commissioner for International Programs, referred to FDA-regulated products as coming from “roughly 200 countries, using 825,000 importers through over 300 US ports-of-entry.” How do you possibly manage that?   

I can’t claim to know the answer. Significantly increased funding for import safety is essential. A larger FDA overseas force is necessary to work with other governments and set up international standards. Tougher US laws are needed. We have learned, however, that it is hard to prevent problems when one or two business owners are prepared to willfully neglect standards and heedlessly adulterate food and drug products.

Our only choice is to respect what FDA has accomplished.....and give them the support and funding (and maybe some out-of-the-box ideas) to do an even better job.

Steven

FDA’s Report on Imports: http://www.fda.gov/AboutFDA/CentersOffices/OC/GlobalProductPathway/default.htm

Dr. Lumpkin’s presentation:  Viewing the world through the FDA international lens: Advancing domestic public health through international engagement. Slides from presentation given to membership of the Alliance for a Stronger FDA, April 26, 2011.

FDA Appropriations: Good News for FY 11...A Struggle in FY 12

FDA survived the FY 11 (current year) appropriations process with an increase of about $107 million. The agency was the only account in the agriculture appropriations bill that received more money in FY 11 than it did in FY 10. Very few domestic discretionary programs received increases.

FY 12 will be harder. All the “easy” cuts have been made. In the House, the appropriations subcommittees were given very small allocations for programs under their jurisdiction. As a result, the initial House position for FY 12 has included cuts to FDA.

On May 24, 2011, the House Agriculture Appropriations Subcommittee marked up the FY 2012 appropriations bill. The chairman’s mark—adopted by the subcommittee--proposed cutting the FDA’s budget authority (BA) appropriations by $285 million for Fiscal Year 2012 (starts October 1, 2011). This represents an 11.5% cut from the recently passed FY11 Continuing Resolution, which funds the government until September 30, 2011.

This cut represents a significant decrease and would put FDA’s appropriation below its FY10 number and more than $500 million below what the President requested for the agency in FY12.

FDA	FY 10  Final	FY11  Final  CR	FY 12 House Appropr. S/C  May 24, 2011	FY 12 President’s Request—Feb.14, 2011
Budget Authority appropriations  (no user fees)	$ 2.361 billion	$2.457 billion    includes -0.2% across the board cut of $5 million	$ 2.172 billion $285M below FY 11	$2.744 billion

The House appropriation committee’s press release states that the overall cut in the agriculture appropriations bill is 13.4%. FDA’s 11.5% cut is slightly better, on average, than other agencies within the agriculture appropriations jurisdiction. Every area of FDA activity would sustain cutbacks under the House subcommittee bill. (For exact breakdown by Centers, go to: http://fdaalliance.files.wordpress.com/2009/11/fy-12-fda-approps-house-sc-by-center-5-24-11.pdf)

FDA will have about $288 million more in user fee income in FY 12, about the same amount by which budget authority appropriations have been cut. However, user fees are limited in scope and only pay for specific activities. The Alliance for a Stronger FDA does not consider an increase in user fees as justification--or an offset--for decreases in BA appropriations. I agree.

The Alliance for a Stronger FDA’s press release on the House subcommittee mark-up is at: http://strengthenfda.org/media/media-release-may-24-2011/. The Alliance is the only multi-stakeholder group working to increase FDA’s appropriations. Its 180 members represent consumer, patient and health professions’ groups, as well as companies, associations and individuals.

The Alliance will be working hard to restore funding to FDA when the full House Appropriations Committee marks up the subcommittee bill on May 31 or June 1, 2011. While the FDA’s case is strong, the pool of available monies is so small that there probably won’t be any progress at the full committee mark-up.

It is generally assumed the Senate will be more favorable to domestic discretionary programs. However, the situation is unclear.  The Senate is at an impasse with regard to a FY 12 Budget Resolution…and the appropriations subcommittees have not yet been given allocations on how much they can spend.

The Senate may start to move on appropriations bills in June or early July. More likely there will be no action until the House and Senate reach a deal on raising the debt ceiling, which must be done by August 2.

Advocates for more funding for FDA must continue to stress that the agency provides essential services. There is no fallback—no other agency to do FDA’s work--if there are insufficient monies.

Steven

For purposes of disclosure: I am one of the founders and serve as Deputy Executive Director of the Alliance for a Stronger FDA. For more information about the Alliance, go to www.StrengthenFDA.org or write to me at sgrossman@StrengthenFDA.org.

FDA “Exceptionalism” at the Funding Crossroads

The 15-month long battle over the nation’s fiscal year (FY) 2011 budget was finally resolved on April 16, just before Congress recessed. Despite broad pressures for program cuts and deficit reduction, the FDA received a $107 million increase, one of the few winners among domestic federal agencies.

Congress returns at the beginning of May to start the FY 12 appropriations process. Downward pressure on federal spending will intensify. If, despite this, the FDA receives another increase, then it will move closer to establishing itself as an exception to the budget cutting process. Thus, FDA Matters sees the coming funding battle as a crossroads for FDA.

There are two primary considerations that drive FDA’s fate in the FY 12 funding battles:

• The US government is in a fiscal situation that can’t be resolved without unpopular actions. There is no avoiding the “iron triangle” of deficit reduction: discretionary spending cuts, entitlement changes and net increases in tax revenues. While there is hope that a comprehensive, multi-year resolution can pass Congress this year, it will still take at least a decade before the deficit crisis is fully behind us.

• FDA has been chronically underfunded for more than 25 years. Congress has chosen to give FDA new responsibilities without commensurate increases in appropriations. Even without these mandates, the FDA has needed to grow because of globalization, increasingly complex science, and significant growth in the industries it oversees. After several years of substantial increases, the agency is in better financial shape, but still resource-restricted in fulfilling its mission.

Advocacy by the Alliance for a Stronger FDA and others (especially Commissioner Hamburg) undoubtedly helped in achieving an increase for FDA this year. Also of significant help to FDA was the half-billion dollars in “saving” that the agriculture appropriations subcommittees derived from lower FY 11 cost estimates for the nearly $7 billion Women’s, Infant and Children (WIC) nutrition program. Behind the scenes, we know that Members of Congress spoke on behalf of FDA’s funding needs.  

The FDA budget, along with the rest of federal spending, is going to be under significant pressure for at least the next 10 years. Surviving the first year is an accomplishment, but not a trend. Nor can it be treated as a sign that FDA will have it easier in the FY 12 funding battles.

Yet, FDA has a strong case for why it should be an exception to budget-cutting. Here are a few of the points that should resonate this year:

Congress is interested in creating more jobs and stimulating the US economy. FDA is part of the solution.  FDA-regulated products represent nearly 25 cents out of every consumer dollar spent in the US.  There are millions of jobs in the food, drug, device and cosmetics industries that FDA oversees. These are also industries that are growing and are major exporters of US products.

Congress is concerned that regulatory agencies, in particular, are an impediment to innovation and the growth of US companies. Yet, all the major trade associations favor increased FDA funding. Every company whose products are regulated by FDA probably wishes for at least a few changes in agency rules and regulations. However, they recognize that no federal regulatory agency is more willing to engage in dialogue and consider changes. Further, industry understands that their problems are likely to get worse, not better, if FDA is underfunded.

Congress wants to protect the health and well-being of the American people. FDA has a unique role in achieving this. If FDA cannot do its job, there is no organization or persons to pick up the slack. No one else can assure that our food is safe. No one else can evaluate the safety and efficacy of drugs, devices, biopharmaceuticals, and vaccines prior to market. The agency also has a unique role in preventing agro-terrorism and developing medical countermeasures that will lessen the casualties from a terrorist attack.

There are many more reasons why FDA should be an exception to Congressional budget-cutting. The main advocate for this cause is the Alliance for a Stronger FDA, the only multi-stakeholder group devoted to increasing the appropriated resources available to FDA. I urge you to contact me and consider joining.  

Steven

For purposes of disclosure: I am one of the founders and serve as Deputy Executive Director of the Alliance for a Stronger FDA. Members include patient and consumer groups, professional societies, research advocacy groups, associations, companies, consultants and individuals. For more information about the Alliance, go to www.StrengthenFDA.org or write to me at sgrossman@StrengthenFDA.org.

FDA and Its Regulated Industries: A Cornerstone of America’s Economic Future       March 7th, 2011

On March 7, the Alliance for a Stronger FDA released a white paper on the far-reaching and positive economic impact of a strong FDA and the industries it oversees. The report is intended to provide interested parties, including Congress and Executive Branch policymakers, with information on FDA’s role in economic growth. A number of groups–consumers, patient advocates and industry–provided comments to the Alliance on the impact of FDA on the American economy.

When an Investigator Knocks on Your Door

The last Congress was dominated by the economy, health reform and the election campaign. Congressional oversight and investigations (O&I) never gained much traction. So far this year, appropriations and budget have dominated Washington. Not much other work has been done.

FDA Matters thinks this will change soon. Without money to spend on new programs and no interest in legislating new regulations, most committees have little else to do other than O&I.  As a result, FDA and FDA-regulated industries can expect a lot of attention from Congressional investigators. Even without Congressional prodding, FDA, the Department of Justice, and Inspector Generals are likely to be doing more investigations.

Despite what most FDA-regulated companies will tell you, they are not well-prepared to be investigated.  When an investigator knocks on their door, they either pay too little attention or go instantly into crisis mode. Neither is likely to be appropriate or in the company’s best interest.

To find the best response, companies need to understand who’s doing the investigating and how they view the situation.

If you did something that FDA program staff or inspection/enforcements staffs considers “wrong,” then the best response is to admit it forthrightly (if true) and act quickly to undo your mistake or clarify the situation. FDA is more likely to work with you to resolve a problem if they feel you have been cooperative, honest and contrite. It always amazes me how few companies seem to respond this way and instead take a defensive posture.

It is altogether different if you are under investigation by a Congressional Committee or FDA’s Office of Criminal Investigations, the HHS Inspector General, the Department of Justice, or US Attorneys. Generally, their investigators live in a world of black and white, neatly divided between good guys and bad guys.

Unlike program staff and inspectors at FDA, it rarely occurs to these investigators that intent, extraneous events or misunderstandings might provide reasons to temper their judgments. Dealing with such nuances is not part of their job.

I saw the contrast as a legislative staffer in the Senate who also spent time with investigators. My world was painted in shades of gray; their world in black and white.  Most people in FDA-regulated industries are like me. The constant search for bad guys is not part of their jobs or temperament. Few have insight or experience in dealing with investigators with a different world view.

Because Congressional, civil and criminal investigators see the world in blacks and whites, it is never a positive experience to be sitting across the table from them. All company options are likely to be bad, including public humiliation, civil liability and criminal prosecution. Exoneration is a remote possibility, even if you fervently believe you have done nothing wrong.

FDA-regulated companies can (and should) limit their exposure to such situations through systematic preparations. Companies need to be able to review and monitor their own actions at a very granular level. A level of transparency is required that makes most companies nervous. Even more difficult for corporate culture: prompt action to dismiss any employees who violate company rules and any supervisors who looked the other way. No exceptions can be made, even if it includes someone from the executive suites.

Companies that follow this path are less likely to become the target of an investigation. Even if investigated, a company that can document strict programs–prospectively initiated and rigorously enforced—will usually do much better than one promising “never to do it again.” A pre-existing company commitment to tough enforcement may be the only way to get an investigator to consider your alleged wrongdoing in shades of gray, rather than black and white.

Steven

FDA and Election 2010: Oversight and Investigations        November 13th, 2010

President Obama’s election and the distraction of health reform have distracted us from the disruption that divided government imposes on FDA. With the new Republican majority, the agency will find itself buffeted by political forces that are as concerned about "scoring points" as they are about improving government. FDA Matters thinks this will have a large impact on FDA, as well as the agency’s stakeholders. Read the rest of this entry

Will the New Congress Be Good for FDA-Regulated Industries?   December 19th, 2010

FDA Matters is hearing that FDA-regulated industries will benefit from the 2010 election. It is assumed that a Republican-led House and more Republicans in the Senate will benefit drug, device and food companies. After all, aren’t Republicans more business-friendly and more concerned about perceived regulatory excess?

Those saying and thinking these things may be in for a rude awakening. Even worse, they may find themselves nostalgic for the “good old days” (whenever those were). Everybody—FDA, industry, patients and consumers—is going to have a rough time over the next two years. Industry will be heard more often, but not always have the winning position. Read the rest of this entry

FDA and Its Regulated Industries: A Cornerstone of America's Economic Future

On March 7, the Alliance for a Stronger FDA released a white paper on the far-reaching and positive economic impact of a strong FDA and the industries it oversees.  The report is intended to provide interested parties, including Congress and Executive Branch policymakers, with information on FDA’s role in economic growth. A number of groups--consumers, patient advocates and industry--provided comments to the Alliance on the impact of FDA on the American economy.

“Most policymakers have heard that FDA-regulated industries account for nearly 25% of U.S consumer spending,” said Nancy Bradish Myers, President of the Alliance for a Stronger FDA and President of Catalyst Healthcare Consulting. “However, many have not thought about the major negative economic impact if FDA, the primary regulator of those industries–which employ millions and are net exporters of U.S. products—is not adequately funded by federal dollars.” 

She added: “FDA is a regulatory agency that can help the economy expand. It is one of the reasons that industry, patients and consumers support a strong, appropriately funded FDA that has the resources to assure that our foods are safe and our biopharmaceutical, medical devices and vaccines are safe and effective.”

The Alliance for a Stronger FDA white paper, entitled “The U.S. Food and Drug Administration: A Cornerstone of America’s Economic Future” provides useful information about medical products, the American food supply, and FDA’s role in fighting bio- and agro-terrorism. It also describes some of the advantages of maintaining U.S. leadership role in the global economy and the potential costs to the domestic economy and U.S. exports if FDA falls behind.  

“Food contributes nearly $1.2 trillion to our economy, or 8% of the U.S. gross domestic product. Ensuring the safety of our food supply is as essential as providing for our national defense,” said Caroline Smith DeWaal, an Alliance Board Member and Director of Food Safety at the Center for Science in the Public Interest. “Protecting our food supply is a major part of FDA’s mission, and both the food industry and consumers benefit from a strong FDA and a growing economy.”

“No agency with a critical role like FDA’s should be asked to do more, with less,” said Margaret Anderson, Vice President of the Alliance and Executive Director of FasterCures.  “If we are to advance medical progress and improve patients’ lives--which will significantly bolster the US economy--we need to start making the FDA a national priority.”  

The Alliance’s 180 members--comprised of consumer, patient, professional and research groups, companies, trade associations, and individuals--represent millions of Americans who support increased appropriated funding for FDA.  More information about the Alliance can be found at www.StrengthenFDA.org.

The full report – The U.S. Food and Drug Administration: A Cornerstone of America’s Economic Future -- can be downloaded from the Alliance’s web site.

###

WHAT OTHERS ARE SAYING ABOUT THE IMPACT

OF FDA ON THE AMERICAN ECONOMY

AdvaMed (Advanced Medical Technology Association)

“Everyday, America’s medical technology companies are developing life-saving, life-enhancing advancements in patient care. This progress doesn’t occur in a vacuum. It’s critical to patients, continued innovation and future economic growth that our regulatory processes support the next great leap forward in medical progress. That’s why we support a well-resourced FDA with well-trained reviewers who have appropriate scientific expertise.” Stephen J. Ubl, President and CEO

Alliance for Aging Research

“Over the next 30 years, there will be no greater challenge to the U.S. than dealing with the human and economic consequences of the graying of America.  To improve lives and bend the cost curve of billions of health care dollars, we will need investment and innovation from the medical products industries.  An effective working partnership with the FDA is essential.” Dan Perry, President & CEO

AstraZeneca

“AstraZeneca favors a well-funded and scientifically world-class FDA that has the resources it needs to bring safe, effective and innovative medicines to patients in the United States. Developing and making new medicines available not only helps improve peoples’ health, it helps grow the American economy.” Rich Fante, President, U.S. & CEO North America

Biotechnology Industry Organization (BIO)

“The promise of the life sciences – economic expansion, jobs, and new therapies for unmet medical needs – requires an adequately funded FDA and a strong, reliable regulatory environment.” James C. Greenwood, President & CEO

Center for Science in the Public Interest

“Food contributes nearly $1.2 trillion to our economy, or 8% of the U.S. gross domestic product. Ensuring the safety of our food supply is as essential as providing for our national defense. It is a major part of FDA’s mission. Both the food industry and consumers benefit from a strong FDA and a growing economy.” Caroline Smith DeWaal, Director of Food Safety

FasterCures/The Center for Accelerating Medical Solutions

“No agency with a critical role like FDA’s should be asked to do more, with less. If we are to advance medical progress and improve patients’ lives--which will significantly bolster the US economy--we need to start making the FDA a national priority.” Margaret Anderson, Executive Director

Friends of Cancer Research

“Innovation – in the form of new drugs, vaccines, and medical devices – has vastly improved the health of people around the world and has thus far been a pillar supporting the US economy.  Without further financial investment in the science at FDA, future innovation is put at severe risk.”   Dr. Ellen Sigal, Chair and Founder

Medtronic

"The growth of Medtronic and the medical device industry is truly an American success story. To write the next chapter, we need a business environment that fosters innovation, drives job creation and supports principled collaboration between industry, government and medical professionals.  A strong, fully-funded FDA is vital to creating a more predictable and consistent regulatory system, making it possible for patients to get faster access to novel medical technology." Bill Hawkins, Chairman and CEO

National Research Center for Women and Families

“As public health experts and advocates, we know that Americans depend on a strong FDA to ensure the safety and effectiveness of medical products made by companies that also produce jobs and grow our economy.” Diana Zuckerman, PhD,  President

National Organization for Rare Disorders

"There are innumerable diseases and conditions for which patients are awaiting new therapies. These can only come from viable and vibrant biopharmaceutical and medical devices industries whose investments grow America and move us closer to helping patients with unmet medical needs.” Peter Saltonstall, President

Pharmaceutical Research and Manufacturing Association (PhRMA)

"America’s biopharmaceutical research companies are among the most innovative, research-driven enterprises in the world. Combined, they employ around 650,000 high-skill, high-wage men and women; and, every direct job supports nearly 3.7 additional American jobs. Our industry invests tens of billions annually in research and development. But, without a strong, science-driven, appropriately funded FDA, patients wouldn’t realize any of the benefits of the life-saving and life-enhancing therapies that our companies produce." John J. Castellani, President and CEO.  

FDA Is Fighting on Two Fronts

FDA is still a 20th century agency. It lacks the databases, technologies and tools to do its work. It does not have the depth of manpower to be experts in all the increasingly complex sciences associated with medical products and foods. It lacks the confidence to consistently make decisions based on risk-benefit analysis, rather than leaning toward the highly restrictive Precautionary Principle.

FDA Matters can’t see any downside to the FDA gaining the technology, the manpower and the confidence to transform itself into the 21st century FDA that our nation needs. Yet, Commissioner Hamburg has to fight on two fronts to preserve her ability to make the necessary changes.

The new Congress has a different set of priorities than the previous two. Deficit cutting and government accountability are on everyone’s mind.

Under a House-passed bill that would fund the federal government in Fiscal Year (FY) 11, the FDA would be allotted $241 million below the level at which it was funded in FY 10. Were this to become law, the agency would need to cut new programs, abandon initiatives and probably lay off staff. To reach agreement with the House, the Senate will also have to cut the federal budget, although perhaps not the funds for FDA.

A 21st century FDA requires capacity to meet new challenges. This won’t occur if the FDA’s budget is being cut.

At the same time, Congress is increasing its oversight/investigative activities. Oversight of FDA needs to occur, but it comes at a price. Investigative hearings are a potent reminder to FDA that cautious, risk-adverse decisions are the ones Congress won’t question. Thus, FDA is reinforced in being a 20th Century agency, rather than encouraged to modernize and think more broadly about problem-solving in the 21st century.

Also, there is an ongoing shift from public funding of FDA to industry funding. User fees pay for very specific tasks. Over-reliance on them reduces the flexibility that FDA leadership needs to handle public health challenges, especially modernizing and strengthening the agency.

Prevailing with Congress won’t be easy and must be considered Commissioner Hamburg’s top priority. At the same time, she must deal with growing unhappiness among FDA-regulated medical product companies.

Based on some recent FDA decisions (e.g. on three weight-loss therapies), many in industry believe FDA is erecting an insurmountable wall of trial design and safety requirements, all intended to slow or deny approval for large-population drugs. Yet, the blockbuster drug (rather than personalized medicine) will remain the industry’s primary business model for at least the next 10 years. Further, Americans still need safe and effective drugs that can treat hundreds of thousands of patients.

Similarly, there have been a number of skirmishes about review standards for medical devices. FDA has moved slowly, listened hard and made compromises. However, with some justification, industry still fears that proposed new standards and procedures will be expensive and delay approval of safe and effective medical devices in the US. FDA also finds itself being compared to the European system, where medical devices are approved far more quickly.

Current industry unhappiness might not be such a challenge for the Commissioner, except for its likely impact on user fee negotiations, agency funding, Congressional oversight and the national debate over how to stem the flow of American jobs and capital to Europe and Asia.  

Ultimately, the FDA’s “fight” with Congress and “fight” with industry come down to one issue: the creation of a 21st century FDA.

It won’t happen if Congress doesn’t fund modernization, tears FDA apart with investigations or relies too heavily on user fees. It also won’t happen if industry—which is the natural advocate for a more modern FDA—can’t work with the FDA to synchronize public health and safety concerns…with efficient and effective ways to review and approve new therapies.

 Steven

FDA and Congress: FY 11 Deficit Reduction Could Cut Deep   February 13th, 2011

Based on budget-cutting actions in the House of Representatives, the FDA is now vulnerable to substantial cuts in its current-year programs. This column analyzes the House situation for FY 11, based on analysis I have done for the Alliance for a Stronger FDA, which is the leading voice for increased appropriations for FDA. Read the rest of this entry

Will the New Congress Be Good for FDA-Regulated Industries?     December 19th, 2010

FDA Matters is hearing that FDA-regulated industries will benefit from the 2010 election. It is assumed that a Republican-led House and more Republicans in the Senate will benefit drug, device and food companies. After all, aren’t Republicans more business-friendly and more concerned about perceived regulatory excess?

Those saying and thinking these things may be in for a rude awakening. Everybody—FDA, industry, patients and consumers—is going to have a rough time over the next two years. Industry will be heard more often, but not always have the winning position. Read the rest of this entry

FDA and Election 2010: Oversight and Investigations     November 13th, 2010

The return of a Republican majority in the House of Representatives means an increase in Congressional oversight and investigations. This mirrors 2006, when the Democrats took back Congress and immediately started investigating the Bush administration. Once again, the agency will find itself buffeted by political forces that are as concerned about “scoring points” as they are about improving government. FDA Matters thinks this will have a large impact on FDA, as well as the agency’s stakeholders.  Read the rest of this entry

FDA and Congress: FY 11 Deficit Reduction Could Cut Deep

Two upcoming events this week will set the tone for FDA appropriations for the next two years. On Monday, the President will release his request for FY 12 funding. On Tuesday, the House will begin consideration of HR 1, which provides continuing appropriations for the remainder of FY 11 (through September 30, 2011).

This column analyzes the House situation for FY 11; a separate column will preview the President’s FY 12 request. These are based on analysis I have done for the Alliance for a Stronger FDA, which is the leading voice for increased appropriations for FDA. I urge you to e-mail me at sgrossman@strengthenfda.org for more information about joining.

The current FY 11 Continuing Resolution (CR) expires on March 4. Until then, almost the entire federal government (including FDA) will be funded at the FY 10 enacted level. For FDA that has meant a budget of $2.35 billion.

The new House Republican majority feels committed to immediate passage of sweeping budgetary cutbacks. Compromises were proposed in the House this past week that would have made a substantial cut in FY 11, but not the $100 billion in deficit reduction that many new Representatives felt was promised.  This approach was rejected.

On Thursday and Friday, the House appropriations committees had to find an additional $20+ billion in cuts to reach the target of $100 billion below the President’s FY 11 budget request. In the first (compromise) round, FDA was slated to receive $2.284 billion. This is $220 million below the President FY 11 request and $62 million below the FY 10 enacted level.

The agency was hit harder in the second round of much deeper cuts. The bill that will be debated on the House floor next week would fund FDA at $2.104 billion. This is $400 million below the President’s request level and $242 million below the FY 10 enacted level.

This represents about a 10% decrease in available agency funding in the current fiscal year. Since the cuts would all have to be absorbed in the second half of the fiscal year, the actual cut (in percentage terms) is likely to be larger. The exact magnitude depends on how much money FDA held back (from spending in the first half of the year) as a hedge against cuts later in the year.

Here is the timeframe and process for consideration of HR 1:

·        Next Tuesday (2/15) – floor debate under an open rule (an open rule allows many amendments to be offered). Expect the House to be confronted with proposals that would impose even greater cuts compared to the version of HR 1 that will come to the floor.

·        By next Friday (2/19) – House expects to have passed HR 1

·        House and Senate both recess on 2/19 and return on 2/28

·        When it returns, the Senate has less than five days to act on the CR and reach a compromise by March 4 with the House   

Most commentators expect several short-term CR extensions before the House/Senate finally agree in late March on serious cuts that are, nonetheless, much less than the House levels. This assumes that 53 Senate Democrats will agree upon lesser cuts and outvote the 47 Senate Republicans.

FDA Matters points out that the Senate is rarely that simple. Senate Majority Leader Reid has said he will fight the House cuts. However, he may not have 53 votes to do so, given the views of several fiscally-conservative Democrats up for re-election in 2012.

In contrast, Senate Minority Leader McConnell has said he has 47 Republican votes for whatever FY 11 CR passes the House. While that may not be true, it leaves open the possibility that he would need only a few Democrats to control the Senate with regard to the FY 11 CR.

Steven

For purposes of disclosure: I am one of the founders and Deputy Executive Director of the Alliance for a Stronger FDA. It is the only multi-stakeholder group devoted to education and advocacy to increase the appropriated resources available to FDA. Members include patient and consumer groups, professional societies, research advocacy groups, associations, companies, consultants and individuals. For more information about the Alliance, go to www.StrengthenFDA.org or write to me at sgrossman@StrengthenFDA.org.

FDA and the President’s FY 12 Budget Request: What to Watch For

Two upcoming events this week will set the tone for FDA appropriations for the next two years. On Monday, the President will release his request for FY 12 funding. On Tuesday, the House will begin consideration of HR 1, which provides for continuing appropriations for the remainder of FY 11 (through September 30, 2011).

This column previews the President’s FY 12 request; a separate column will analyze the House situation for FY 11. These are based on analysis I have done for the Alliance for a Stronger FDA, which is the leading advocacy voice for increased appropriations for FDA. I urge you to e-mail me at sgrossman@strengthenfda.org for more information about joining.

The President’s FY 12 budget request is the opening salvo in what is likely to be a long, hard fight over next year’s appropriation. While Congress is unlikely to accept the President’s recommendations, it is critically important to FDA whether the President suggests increases, flat funding or cuts for the agency.

If past years’ patterns repeat, there will be confusion on Monday after the release of the President’s budget request. Many of the numbers being discussed by media and commentators will be inaccurate or out of context.

Here are the most common sources of misunderstanding:

·        What base is being used in the President’s request? A proposed $100 million increase (or decrease) for FY 12 means something different if it is based on the FY 10 funding level (which is also the current FY 11 CR level) or on the President’s FY 11 request.

If the President follows past practice, the FY 12 budget request will be based on his FY 11 budget request. Because Congress never adopted it and never will, it would mean that every number in the President’s request has to be adjusted before determining its impact.   

·        For FDA specifically, are user fees included in any given budget number? If comparisons are made between budget numbers, are they both calculated the same way?

As recently as this past week, the media was confused because the House appropriations committee’s initial FDA numbers for the FY 11 CR referred to the President’s FY 11 funding request. The intended reference was to the budget authority (BA) appropriations request (monies to be drawn from general revenue). However, some analysts attempted to interpret the House position by referencing the President’s FY 11 request that included both BA appropriations and user fees.

·        The President’s budget request for FDA usually appears larger because it includes revenue from user fees that are proposed, but not authorized. In many cases, the proposed user fees have been submitted to Congress year after year, although they will never be adopted.

·        The President’s budget request is distorted by the inclusion of tobacco user fees, which represent $450 million in agency income in FY 11. While BA comparisons are not affected by these monies, they make any increase in total funding for the agency look much greater that it really is. The tobacco program is distinct and self-funded. Its growth in no way helps FDA meet its traditional public health mission.  

In terms of timing, the House and Senate want to resolve FY 11 before devoting much time to FY 12. A fast schedule (probably unrealistic) for FY 12 funding would be: 

·        Hearings in March/April, 2011

·        Subcommittee and full committee mark-ups in April/May

·        Final floor action and House/Senate conference agreements in June and July

·        Under this schedule, no bills (or only conference reports) would require action in September.

More likely, there will continue to be sharp disagreements between the House and the Senate on funding levels, delaying the passage of FY 12 funding bills until summer or September. FDA Matters will continue to keep you posted.

Steven

For purposes of disclosure: I am one of the founders and Deputy Executive Director of the Alliance for a Stronger FDA. It is the only multi-stakeholder group devoted to education and advocacy to increase the appropriated resources available to FDA. Members include patient and consumer groups, professional societies, research advocacy groups, associations, companies, consultants and individuals. For more information about the Alliance, go to www.StrengthenFDA.org or write to me at sgrossman@StrengthenFDA.org.

The State of the FDA—January 2011

FDA's touches the lives of every American at least 6 to 10 times each day. The agency oversees 80% of the nation's food supply, all of human/animal medical products and cosmetics, and almost all radiation-emitting devices. Altogether, the agency is responsible for about 20% of all consumer dollars spent in the United States.

With the President set to deliver his State of the Union address to Congress in 10 days, it seemed a good time for FDA Matters to provide its view of the "State of the FDA." At the beginning of 2011, the agency is doing well, but has a lot of catching-up to do and faces a number of threats.

Strengths: FDA's most important strength is the dedication of the agency's staff and the leadership of Commissioner Hamburg's team. They have made great strides in advancing the public health mission of the FDA, aided by increasing appropriations and the momentum of a new presidency. The renewed emphasis on public health has become a core strength of the FDA.

The agency's commitment to science is another strength. Not every decision can be answered with science (e.g. policy on social media), but a substantial number can. The FDA is successfully building its scientific capabilities, although it is a work in progress. Similarly, the agency's new initiatives to establish an international presence represent a strong response to the challenges of globalization.

Weaknesses: While FDA has been doing better, it is still an organization with workplace issues. Within the agency, barriers still exist to sharing knowledge across offices and divisions. To the broader world, the whole agency seems insular. In particular, the FDA makes inadequate use of expertise that lies outside the agency, particularly in academia.

FDA's information technology (IT) systems are grossly inadequate for an agency with such large, far-flung responsibilities. Some major, badly needed databases aren't going to be available anytime soon, preventing the agency from making the best, most well-supported decisions.It also dooms staff to perform tedious work that could be done in seconds with better tools.

Opportunities: Within FDA, there is the potential for a 21st century regulatory and public health agency that could be the world's benchmark for decades. While such standing is a goal in itself, it is also true that the world-wide use of FDA standards opens up export markets and can contribute to our nation's economic growth.

To realize this opportunity, FDA needs to do a better job in explaining regulatory science to Congress, the media and the public. The tools and standards FDA uses every day are still largely anchored in the last century. Public investment in improving regulatory science is what will bring the agency into the new century.

Another opportunity for the agency is to break the secrecy of how decisions are made. Observers often wonder about the agency's rationale. Industry needs the benefit of understanding the agency's actions. Dr. Hamburg and other senior FDA leaders have taken an important step by publishing more articles in mainstream journals. The handling of internal dissent in FDA's ranks was accomplished deftly in last summer's Avandia decision. In doing so, honestly and forthrightly, FDA increased it credibility and was better able to defend its ultimate decision.

A very different type of opportunity is presented by FDA's ongoing consolidation of personnel at just two locations, White Oak and College Park. This provides the opportunity for a more cohesive workforce, as well as a more efficient one.

Threats: FDA's largest threat relates to its funding and the possibility of being dragged back by budget cutting. Several years of increases have greatly helped the agency, but it is not enough to offset decades of budgetary neglect or carry the agency forward without more money. The gap can widen quickly because FDA's responsibilities keep increasing: more complex science, globalization and two major new laws to implement, food safety and bio-similars.

Another looming threat comes from the ongoing negotiations for re-authorization of pharmaceutical and medical device user fees. FDA needs the funding, but not the likely hit on its public credibility. When Congress considers renewal legislation in 2012, the agency is likely to be caught in the crossfire between those who think FDA is too industry-friendly and those who think the agency impedes FDA-regulated industries in bringing new, sometimes life-saving products to market.

Compounding this threat, user fee re-authorization will probably be the only FDA legislation that must pass Congress over the next two years. Dozens of legislator are going to try to get their FDA-related concerns addressed in the legislation. No one knows how much damage the final legislation might do to FDA.

Steven

Will the New Congress Be Good for FDA-Regulated Industries?

THIS IS THE LAST OF MY 2010 COLUMNS ON FDA AND THE NEW INCOMING CONGRESS. LINKS ARE AT THE BOTTOM OF THIS PAGE.

FDA Matters is hearing that FDA-regulated industries will benefit from the 2010 election. It is assumed that a Republican-led House and more Republicans in the Senate will benefit drug, device and food companies. After all, aren't Republicans more business-friendly and more concerned about perceived regulatory excess?

Those saying and thinking these things may be in for a rude awakening. Even worse, they may find themselves nostalgic for the "good old days" (whenever those were). Everybody—FDA, industry, patients and consumers—is going to have a rough time over the next two years. Industry will be heard more often, but not always have the winning position.

To start with, the Republican House of Representatives is going to be asking lots of questions about policies and programming initiated by the Executive Branch during the last two years, including FDA.  Because of their backgrounds as heads of big-city public health department, Commissioner Hamburg and Principal Deputy Sharfstein are more prepared then most political appointees.

However, they have never experienced the volume or magnitude of these inquiries. Neither FDA nor any stakeholder benefits if FDA is busy answering Congressional letters or preparing for oversight hearings on the Hill…..instead of reviewing products, setting standards and conducting inspections.

Even in the Senate, oversight and investigations are going to make a big comeback. This is a byproduct of budget politics: if there is no money to spend and big divisions over authorizing legislation, then Members turn to investigations to fill the time and command national attention.

Beyond FDA, regulated industries are going to come under increased scrutiny. The incoming chairman of the House Oversight and Government Reform has already announced plans to investigate the over-use of expensive medical devices and probe the way food recalls are handled. Imported food, drugs and raw ingredients from China may be given oversight scrutiny. Current investigations are going to continue on quality manufacturing in drugs, biotech products and OTC drugs.

Senator Grassley, as Ranking Minority on the Senate Finance Committee, has held investigations of tax-exempt hospitals, non-profit advocacy groups, FDA and FDA-regulated industries. Senator Hatch, who will be Grassley's successor in the post, has already indicated his intention to continue many of Grassley's issues and to have a tough investigations staff.

The Alliance for a Stronger FDA has already established that consumer and patient groups, health professional societies, associations and industries have a common interest in a strong FDA through increased appropriations. In the face of the current budget-cutting fervor, it remains to be seen whether industry will be able to convince legislators that FDA needs more resources from general revenue.

Separate, but related: a year from now, the drug, biotech and medical device industries will be trying to limit the amount of new user fees they will be required to pay when user fees legislation is re-authorized in 2012. It is hard to see how business' complaining about excessive fees will prevail against Congress' need to increase FDA funding from sources other than general revenue.

From these examples, it is possible to see a larger theme. Republicans generally believe that industry, without too much government intervention, should be relied upon for job creation in the US. Most of the party rhetoric is focused on achieving these through reducing the federal budget, trimming federal regulations and regulatory agencies, and making sure that "the people" who voted for them in the last election feel they are being heard.

The FDA context is different. Most FDA-regulated companies want simplification of the regulatory requirements and more certainty in their implementation, but are not interested in eliminating FDA's regulatory structure or limiting its ability to assure public health and safety. Thus, industry would not benefit from efforts to starve, roll-back, harass or marginalize the agency. The worst-case for the next two years is that Congress might try all four and not listen to industry concerns about negative outcomes.

Steven

"Must-Pass Legislation" Key to FDA's Future
December 12th, 2010

FDA Matters believes that the 2010 election will profoundly affect the FDA's mission, priorities, funding, standards and work flow. Eighteen months from now, FDA's leadership team will probably be the same, but the agency won't be. At the moment, there is only one "must-pass" item on Congress' FDA agenda: the next round of user fee renewals that will come before Congress in the Spring of 2012. Read the rest of this entry

Two Strategies for FDA Legislation in 2011
December 5th, 2010

The current Congress has two primary FDA-related accomplishments: have been less visible: an abbreviated approval pathway for bio-similar drugs; and a food safety bill that may be enacted before Congress adjourns. FDA Matters believes that any FDA-related legislation will falter in 2011 if it does not follow the strategy behind one or the other of these efforts. Read the rest of this entry

FDA and Election 2010: Oversight and Investigations
November 13th, 2010
 

President Obama's election and the distraction of health reform have distracted us from the disruption that divided government imposes on FDA. With the new Republican majority, the agency will find itself buffeted by political forces that are as concerned about "scoring points" as they are about improving government. FDA Matters thinks this will have a large impact on FDA, as well as the agency's stakeholders. Read the rest of this entry

FDA and Election 2010: Deficit Reduction and Appropriations
November 6th, 2010
 

So-called "wave elections"–where one party overwhelms the other–are particularly hard to judge. The ground rules are going to change dramatically– in ways that no one can fully anticipate. At first, each side refuses to compromise. Then, something happens that sets the pattern for whether people will work together and on what issues. This may take months to resolve or may occur before the new Congress arrives. As things change, FDA Matters thinks there are some key issues for FDA-watchers to monitor. Read the rest of this entry

“Must-Pass Legislation” Key to FDA’s Future

This is the fifth straight column looking at FDA and Congress. This reflects FDA Matters' belief that the 2010 election will profoundly affect the agency's mission, priorities, funding, standards and work flow. Eighteen months from now, FDA's leadership team will probably be the same, but the agency won't be.

Identifying and understanding the likely changes to FDA requires examining the meaning of "must-pass legislation" and its escalating importance as a quarrelsome Congress turns into a divided Congress. At the moment, there is only one "must-pass" item on Congress' FDA agenda: the next round of user fee renewals that will come before Congress in the Spring of 2012. 

"Must-pass" legislation is a bill or resolution that Congress is compelled to pass in order to maintain the functions or functioning of government. The best examples are appropriations bills, Congressional budget resolutions, and legislation to increase the limits on the national debt. Sometimes, "must pass" is defined by the agenda of a political party or the President, as was the case with health care reform.

Looking at this Congress' two FDA-related legislative accomplishments, "must pass" played a role in both. Representative Anna Eshoo (D-CA) had the votes to advance her version of bio-similars in place of the version supported by House Energy and Commerce Committee Chair Henry Waxman (D-CA). Occasionally Committee Chairs don't have the votes to prevail; they re-gain leverage by not scheduling a mark-up. This was not an option for Waxman because Eshoo's bio-similars bill was offered as an amendment to the "must pass" health care reform bill.

Because of the breadth of mostly bi-partisan support for food safety legislation, it was possible for it to advance as regular legislation in both the House and Senate. However, procedural barriers have now stalled the Senate-passed version in the House and it might not become law. The House responded by adding food safety legislation to the FY 11 Continuing Resolution (CR) that will fund the government when the current one runs out at midnight on December 18. This tactic may not ultimately work, but the CR is definitely "must pass legislation."

With some exceptions, it is hard to anticipate what pieces of legislation become "must-pass." In theory, FDA might go an entire Congress without enactment of any major legislation. This can't be the case for the incoming Congress because authority to collect both prescription drug and medical device user fees expires on September 30, 2012. In the months prior to that date, Congress will face a choice: pass re-authorizing legislation or deprive the agency of $700 million in revenue each year. Thus, "user fee legislation" = "must-pass legislation."

User fees need to be renewed every five years. The last round of user fee re-authorizations resulted in the Food and Drug Administration Amendment Act (FDAAA). It is complicated and emerged after extremely tough negotiations. The final legislation was 155 pages long and had 11 separate Titles. It is at: http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf.

Commissioner Hamburg, Members of Congress, and most FDA stakeholders have wish lists of ways they would change FDA and the laws it implements. None of these--at least not any major ones--are likely to pass in 2011 without broad bi-partisan support.

But 2012 will be another story. In the process of adopting the "must pass" user fee reauthorizations, we can anticipate Congress considering dozens of provisions and programs that don't relate to user fees. Lawmakers and stakeholders will all have a chance to put their mark on the FDA in 2012.

Steven

Two Strategies for FDA Legislation in 2011          December 5th, 2010
The current Congress has two primary FDA-related accomplishments: an abbreviated approval pathway for bio-similar drugs; and a food safety bill that may be enacted before Congress adjourns. FDA Matters believes that any FDA-related legislation will falter in 2011 if it does not follow the strategy behind one or the other of these efforts. Read the rest of this entryy

FDA Funding and the Appropriations Drama       November 28th, 2010 
 The process for passing appropriations bills should be similar from one year to the next. After all, it is a one-directional, regimented process. Yet, I have been through 30 or so appropriations cycles and each one seems to have its own unique story to tell. This year's efforts would make a riveting "made for television" movie "based on a true story." FDA Matters doesn't know how it will end, especially for FDA. Read the rest of this entry

FDA and Election 2010: Oversight and Investigations   November 13th, 2010 
President Obama's election and the health reform debate have distracted us from the disruption that "divided government" imposes on FDA. With the new Republican majority, the agency will find itself buffeted by political forces that are as concerned about "scoring points" as they are about improving government. FDA Matters thinks this will have a large impact on FDA, as well as the agency's stakeholders. Read the rest of this entr 

FDA and Election 2010: Deficit Reduction and Appropriations     November 6th, 2010 
 So-called "wave elections"–where one party overwhelms the other–are particularly hard to judge. The ground rules are going to change dramatically– in ways that no one can fully anticipate. At first, each side refuses to compromise. Then, something happens that sets the pattern for whether people will work together and on what issues. This may take months to resolve or may occur before the new Congress arrives. As things change, FDA Matters thinks there are some key issues for FDA-watchers to monitor. Read the rest of this entry  

Two Strategies for FDA Legislation in 2011

The current Congress will be remembered for its 15-month battle to enact health reform legislation. The FDA-related accomplishments have been less visible: an abbreviated approval pathway for bio-similar drugs included in the health reform law; and a food safety bill that may be enacted before Congress adjourns later this month.

In both cases, unanimity was never possible, but working majorities formed and prevailed. FDA Matters believes that any FDA-related legislation will falter in 2011 if it does not follow the strategy behind one or the other of these efforts. 

Bio-similars. The Democrats (Senator Kennedy and Representative Eshoo) leading the bi-partisan effort—and most of the Democratic rank and file who supported the legislation--come from high-tech, life sciences states and districts. Republicans joined the Democrats because of similar home-town support from life sciences companies and interest in promoting a pro-innovation, pro-economic development agenda.

The combination of Democrats with biotech interests and Republicans became a powerful force. It is also an approach that can be duplicated next year with a reasonable chance of success.

Indeed, another such effort is already underway regarding the medical device review process at FDA. Two weeks ago, 8 members of the Minnesota Congressional delegation sent Commissioner Hamburg a letter stating:

We support the FDA's work to improve the process for the approval of safe and effective Class II medical devices but we must work to ensure that we continue to foster life-saving innovation and growth….and a larger goal of saving and improving patients' lives….Changes that may jeopardize that goal should not be made unless there is clear evidence that the changes are necessary to address a public health problem.

The letter was signed by the state's 2 Democratic Senators, 3 of its Republican House members and 3 of its Democratic House members. Elsewhere, the letter mentions that Minnesota has over 500 medical device companies that employ almost 35,000 residents at average pay-levels almost 50% higher than the state average.

Food Safety. As with bio-similars, there was a widespread consensus that food safety reform legislation was needed. The similarities between the two efforts end there.

Hill staff and key constituency groups held extensive discussions about needed changes. After lots of disagreements and some very tough negotiating, most Democrats and Republicans found enough common ground to move forward in the House.

The Senate also evolved a compromise version—somewhat different from the House, but with a similar breadth of support. Action stalled in the Senate because of cost issues and concerns about small food producers. But the core of support never disappeared.

When those concerns were addressed in the Senate, the other extraneous issues and disagreements fell away. Even the House appeared to have signaled that they would accept the Senate bill, rather than face further negotiation that might delay action until next Congress. Such deference has become increasingly uncommon in Congress.

I don't want to minimize the difficulties in establishing and conducting negotiations on food safety. It may still fail. What made agreement possible was the willingness of constituency groups to work together, despite strongly held views that were often opposed. This approach can also work next year for other issues, as a broad-base of constituency groups lead Congress to a bi-partisan agreement on legislation.

---

The current Congress has not been known for its bi-partisanship. Some commentators think bi-partisanship may disappear altogether in the new Congress. Nonetheless, FDA is an area where getting the parties together is possible.

If consumer and patient groups, industry and associations and the Administration or Congress want to get anything done in 2011, they would do well to consider how the bio-similars and food safety strategies might apply to their cause.

Steven

The Minnesota delegation's letter to Commissioner Hamburg about changes in the process of approving medical device. http://www.hpm.com/pdf/MNLegConcerns.pdf

Some relevant past columns:

All FDA Stakeholders Affected by Medical Device Reforms        October 31st, 2010
There are so many visible, contentious FDA issues right now….that reform of the medical device approval process has received only a fraction of the attention it deserves. Other centers at FDA and non-device stakeholders need to be watching more closely. FDA Matters is. Read the rest of this entry

FDA: An Honest Broker on the Slow Path to Bio-similars      October 24th, 2010
FDA Matters enthusiasm for bio-similars is a matter of public record. The market will build slowly, but 10 years from now the new law will be seen as ushering in a new age of biopharmaceutical product development. Read the rest of this entry

Fall Scorecard for Follow-on Biologics        September 11th, 2009
The creation of a regulatory pathway for follow-on biologics (FOB) has become a favorite topic of FDA Matters. The substance of the legislation is important and the politics are fascinating. It should get even better this fall. Read the rest of this entry

FDA Funding and the Appropriations Drama

The process for passing appropriations bills should be similar from one year to the next. After all, it is a one-directional, regimented process. It always starts with "total available funds" and a baseline of current spending programs and concludes when the President signs an appropriations bill into law. And there are only 12 such bills that have to pass each year.

Yet, I have been through 30 or so appropriations cycles and each one seems to have its own unique story to tell. This year's efforts would make a riveting "made for television" movie "based on a true story."  FDA Matters doesn't know how it will end, especially for FDA.

Here is a summary of the plot thus far:

The Democratic-controlled, but still badly divided Congress, failed to pass any of the 12 appropriations bills that fund the entire trillion-dollar federal government. Usually, Congress passes at least the Defense and Homeland Security bills. Past deadlocks have mostly been limited to the other ten bills. 

In addition to disputes over total funding and specific program allocations, Congress has been bedeviled by a continuing fight over appropriations earmarks. In both Houses, there are Democrats and Republicans on both sides of the question. Some argue that earmarks are a wasteful, expensive process that epitomizes Congress' lack of commitment to deficit reduction. Others argue that earmarks are one of the few ways that Congress can reduce the discretionary prerogatives of the Executive Branch.

In late September, Congress passed a Continuing Resolution (CR) to fund government from October 1 (start of the new fiscal year) to December 3. The government will shut down at 12:01 a.m. on December 4 unless Congress passes another CR, an omnibus funding bill or individual appropriations bills. The current CR creates no priorities; virtually the entire government will have spent the first 9 weeks of the FY 11 fiscal year operating under the same ceilings as the FY 10 spending levels. While this postponed difficult decisions until after Election Day, a further short extension of the CR is possible to December 10 or 17.  

Republicans picked up more than 60 seats in the House and will be the majority party starting in January. Democrats maintained control of the Senate for next year, but will go from a 59-41 advantage to a 53-47 margin. Understandably, Democrats want to accomplish as much as possible in the post-election session, while Republicans are inclined to defer most things to the new Congress. However, these do not reflect hard lines—what "might be possible" changes daily, sometimes hourly.

The House and Senate appropriations committees have tried to put together an omnibus FY 11 spending bill (i.e. decide on the content of all 12 funding bills separately, then roll them into one legislative package). Supposedly, they had leadership encouragement to do this, but there doesn't appear to be much enthusiasm outside of the appropriations committees.  However, most of the hard staff work on this seems to be done. A less expensive version of the bill might have a chance to pass.

Where does FDA stand in this drama? Bad scenarios for the agency include a Continuing Resolution set at the FY 10 levels or, worse, a CR that imposes across-the-board cuts. The best scenario is the omnibus bill, on the assumption that this will incorporate decisions about priorities. Any funding bill in which some programs do better than others (which could be a CR as well as an omnibus), gives FDA the best chance to received increased resources for FY 11.

Steven

FDA and Election 2010: Deficit Reduction and Appropriations       November 6th, 2010

So-called "wave elections"–where one party overwhelms the other–are particularly hard to judge. The ground rules are going to change dramatically– in ways that no one can fully anticipate. At first, each side refuses to compromise. Then, something happens that sets the pattern for whether people will work together and on what issues. This may take months to resolve or may occur before the new Congress arrives. As things change, FDA Matters thinks there are some key issues for FDA-watchers to monitor.  Read the rest of this entry

Deficit Hawks in the New Congress Threaten FDA Funding     October 17th, 2010

FDA Matters doesn't know who the majority party in the House and Senate will be next year. There seem to be a very large number of races where incumbents are vulnerable or are too close to call. The fate of FDA will be driven by the post-election tone of Congress, more than by the fates of individual Members or who holds the majority.  Read the rest of this entry

FDA and Election 2010: Oversight and Investigations

The return of a Republican majority in the House of Representatives means an increase in Congressional oversight and investigations. This mirrors 2006, when the Democrats took back Congress and immediately started investigating the Bush administration.

President Obama's election and the distraction of the health reform debate have helped us forget the impact of divided government on FDA. Once again, the agency will find itself buffeted by political forces that are as concerned about "scoring points" as they are about improving government. FDA Matters thinks this will have a large impact on FDA, as well as the agency's stakeholders.

In the House of Representatives, there are three committees that exercise "oversight and investigations" jurisdiction (O&I) over the FDA. The primary ones are the Energy and Commerce Committee and the Oversight and Government Reform Committee. The Appropriations Committee also conducts O&I.

The Energy and Commerce Committee intends to investigate the scope of work and expenditures under FDA's contract with McKinsey & Company, an international management consulting firm that has been asked to improve the productivity of the generic drug review office. Once the Energy and Commerce has reorganized itself for the new Congress and priorities are set, there are sure to be more areas under investigation.

The Oversight and Government Reform Committee is off to a faster start because outgoing chair Representative Edolphus Towns (D-NY) and incoming chair Representative Darrell Issa (R-CA) were already working together on manufacturing problems in the drug industry. This has now become an investigation of whether understaffing in FDA's Puerto Rico office led to inadequate oversight of industry.

FDA is under scrutiny all the time. Congress' watchdog arm, the General Accounting Office (GAO), regularly reports on areas where they believe FDA should do better. Likewise, the HHS Inspector General keeps a watchful eye on the agency. In a more helpful, but often no less critical mode, the Institute of Medicine also oversees many aspects of FDA programs.

What may make 2011 different?

Dr. Hamburg and Dr. Sharfstein can expect to spend countless more days preparing for and testifying at oversight hearings. Their involvement is the tip of the iceberg, with staff at every level being pulled from other work to respond to Congress. Some key staff that were able to focus on big picture issues this year...are likely to be in "damage control" mode most of next year.

FDA's competence will be questioned publicly, then magnified by the media. FDA has a lot of problems. Oversight can contribute to improvements. However, any loss of public confidence in FDA is a serious barrier to the agency doing its job better.

This may also lead to questions about whether the agency should receive more monies….when, in fact, many of the problems (not all of them) cannot be fixed without more resources. For example, unless you believe there are FDA staff sitting idle, how does understaffing in FDA's Puerto Rico office get resolved without a larger appropriation?

Oversight of food safety may lead to more effective use of resources, but cannot obviate the need for more inspectors. Oversight of medical products may lead to more conservative decisions by the agency, further slowing new therapies for patients.

As oversight of FDA ramps up, so too will oversight of industry. FDA Matters has exhorted CEO's to see quality controls, good manufacturing and improved sales and marketing practices to be integral to whether its products represent a public good. O&I is likely to be unflinching in its exposure of those who have not taken this to heart.

In the end, FDA will survive. Hopefully, it will be a better agency, while preserving its needed funding growth. Meantime, it is inevitable that FDA and industry will feel some pain.

Steven

My apologies to readers who may have received more than one mailing last week. The end of daylight savings time caused repeat distribution of several columns. Hopefully, it is now fixed.

 FDA and Election 2010: Deficit Reduction and Appropriations      November 7th, 2010

So--called "wave elections"–where one party overwhelms the other–are particularly hard to judge. The ground rules are going to change dramatically– in ways that no one can fully anticipate. At first, each side refuses to compromise. Then, something happens that sets the pattern for whether people will work together and on what issues. This may take months to resolve or may occur before the new Congress arrives. As things change, FDA Matters thinks there are some key issues for FDA-watchers to monitor. Read the rest of this entry

Quality Control Woes: What's a CEO to Do?    June 2nd, 2010
Medical products companies are struggling to assure FDA and the American people that their products are "safe as manufactured and distributed." We don't know whether quality control has become lax, FDA is discovering more problems or industry has just had a run of bad luck. We do know that quality control relies on a lot of people maintaining tough standards…and that manufacturing is rarely a priority of a drug and device company CEO. FDA Matters asks: "what's a CEO to do?" Read the rest of this entry

Black, White, Shades of Gray      November 13th, 2009
Civil and criminal investigations are becoming a more prominent feature in the world of FDA-regulated industries. People who never gave any thought to this….suddenly find themselves needing to understand how investigations work. Being FDA-regulated means "always worrying that you will have to say you're sorry." But it matters whether you are apologizing to FDA or trying to apologize to investigators. Read the rest of this entry

FDA and Election 2010: Deficit Reduction and Appropriations

As a result of the 2010 Mid-Term election, Republicans have netted more than 60 seats and taken control of the House of Representatives, effective in January.  The Senate will remain in Democratic hands, but with a much slimmer majority.

So-called "wave elections"--where one party overwhelms the other--are particularly hard to judge. The ground rules are going to change dramatically-- in ways that no one can fully anticipate. At first, each side refuses to compromise. Then, something happens that sets the pattern for whether people will work together and on what issues. This may take months to resolve or may occur before the new Congress arrives.

As things change, FDA Matters thinks there are some key issues for FDA-watchers to monitor:  

Regardless of how Democrats, Republicans and the President choose to interact in 2011, there will be a working majority in both House and Senate for significant deficit reduction.

• This is not a good budget environment for FDA or any federal agency with growing responsibilities.
  
• If deficit reduction is based on evaluating each agency and program and identifying national priorities, then the case for increased FDA funding is very strong.
  
• If deficit reduction is accomplished by "across the board" cuts, then FDA may still be treated as an exception. However, it will be far more difficult to make the case for FDA as a budget-cutting exception.
  

The direction of deficit reduction is yet-to-be determined.

• There is a large difference between campaign rhetoric and the realities of reducing the deficit.
  
• Congress has never been able to break "the iron triangle of deficit reduction:"
  
  • Republicans don't want new taxes, making it hard to generate more revenue.  
    
  • Democrats don't want to change entitlement programs, making it hard to significantly decrease expenditures.
    
  • Everyone's favorite punching bag--discretionary spending--isn't large enough or growing fast enough to produce deficit reduction on the scale required.
    
• Budget deficits are not calculated using ordinary math. For example:
  
  • The Bush tax cuts expire at the end of this year. Re-instating them is an additional "cost" that will widen the deficit--even though tax rates will stay the same.
    
  • Similarly, health care reform provided about $800 billion in savings to offset its $800 billion cost. Thus, repealing or defunding any parts of health care reform associated with cost savings….could wind up increasing costs and widening the deficit.  
    

The situation in both House and Senate is fluid with regard to committee assignments, chairmanships and leadership.

• Republicans in the House and Senate will be increasing their numbers on each Committee. A number of current Republican members will be moving up in seniority and may have new opportunities and choices to make.
  
• Democrats in the House and Senate will be decreasing their numbers on each committee. While this would normally tend to freeze committee positions, a number of very senior Democrats will not be back, opening up opportunities. One person's decision could affect the choices available to a dozen other members.
  
• In sum, expect changes in the committees that authorize, appropriate and oversee FDA.
  

The Alliance for a Stronger FDA has been preparing for this much tougher budget environment. The Alliance recognized a year ago that the federal budget situation was likely to deteriorate and has spent the intervening time building the case for FDA to be seen as an exception to budget-cutting. More recently, they have started talking about how a strong, well-resourced FDA is important to jobs and economic growth in the US.  

For those readers who are not members, I strongly recommend joining. The membership includes consumer and patient advocacy groups, health professional societies, research advocacy groups, associations, companies, law firms and consulting firms, and individuals.

Every additional member strengthens the Alliance's position in advocating for increased funding for FDA.  

Steven

For purposes of disclosure: I am one of the founders and Deputy Executive Director of the Alliance for a Stronger FDA. It is the only multi-stakeholder group devoted to education and advocacy to increase the appropriated resources available to FDA. For more information about the Alliance, go to www.StrengthenFDA.org or write to me at sgrossman@StrengthenFDA.org.

Deficit Hawks in the New Congress Threaten FDA Funding

    October 17th, 2010

FDA Matters doesn't know who the majority party in the House and Senate will be next year. There seem to be a very large number of races where incumbents are vulnerable or are too close to call. The fate of FDA will be driven by the post-election tone of Congress, more than by the fates of individual Members or who holds the majority. Read the rest of this entry »

FDA Funding for FY 11: Back to the Future

    October 3rd, 2010

Not so long ago, FDA's appropriation barely budged from year-to-year. A good year was a 2% to 3% increase. This changed four years ago, after the formation of the Alliance for a Stronger FDA. The agency's case for more resources—always a good one—finally had an independent, multi-stakeholder voice. Champions on the Hill and in the Executive Branch emerged.

The agency appropriation has grown 50% in the last three fiscal years. So far, FY 11 looks more like the past than it does the last few years. FDA Matters believes that the consequences could be severe. Read the rest of this entry »