FDA Matters Blog

STEVEN GROSSMAN 1/16/11 STEVEN GROSSMAN 1/16/11

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.

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

STEVEN GROSSMAN 12/19/10 STEVEN GROSSMAN 12/19/10

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

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.

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

STEVEN GROSSMAN 11/28/10 STEVEN GROSSMAN 11/28/10

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.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.

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

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

STEVEN GROSSMAN 11/6/10 STEVEN GROSSMAN 11/6/10

FDA and Election 2010: Deficit Reduction and Appropriations

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.

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.

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 Funding for FY 11: Back to the Future

October 3rd, 2010

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 »

STEVEN GROSSMAN 10/17/10 STEVEN GROSSMAN 10/17/10

Deficit Hawks in the New Congress Threaten FDA Funding

Looking around the country, nearly every candidate is running "against Washington." The major themes--among Democrats and Republicans alike--are the need to create more jobs and the need to reduce the burgeoning government deficit and the national debt.

Congress may be stymied in the jobs area, since it is unclear how to intentionally create more jobs in our current economic situation. In any case, Congress will have to work through divergent views about how to approach this task. If creating jobs proves difficult, then Members will be working extra hard to show the electorate that the deficit is being tamed.

This year's first continuing resolution only provides FY 11 funds for the federal government through December 3. It has to be seen for what it is: a placeholder for more severe cutting that might occur later this year or early in the next Congress. Regardless of the outcome of the election, there will be a working majority of Republicans and Democrats in the House and Senate in 2011 that are deeply committed to substantial deficit reduction.

While it may surprise many, President Obama has a strong commitment to deficit reduction and will be working with newly-empowered deficit-cutters in Congress.

The White House clearly sees what the campaigns see: nearly across the political spectrum, voters want the federal government to spend less…or at least dramatically slow the increases that are already built into budget projections. The White House is likely to disagree with Congress on some budget items, but the focus will be on very specific items or on how far and fast to cut. Philsophically, President Obama sees himself as a deficit-cutter.

None of this sounds good for FDA. And it isn't. The Alliance for a Stronger FDA anticipated a year ago that future increases would be harder to get for FDA. Throughout 2010, the Alliance has been building on the theme that FDA needs to be an exception to whatever budget cutting occurs.

The Alliance's focus has been to show how a well-resourced FDA creates jobs in the American economy, which is a particularly potent argument with nearly 10% unemployment. The Alliance has also focused on the extraordinary demands being placed on the agency, be it growing responsibilities for medical product reviews and food imports or unexpected items such as pandemic flu and contaminated eggs.

The case for FDA "exceptionalism" has been effective in at least two recent years when most of the federal government received flat funding and FDA received an increase. No one knows if it will work in 2011 and 2012. FDA Matters does know that the agency will find it hard to function if it is caught in an "across the board" 5% or 10% cut in domestic discretionary spending.

It could be even worse. At least one proposal being discussed would roll the Federal Government's funding levels back to the FY 08 base. For FDA, this would mean reducing funding from $2.345 billion in FY 10 to the FY 08 level of $1.713 billion. A quarter of the agency might disappear.

Can I imagine things going that badly? Frankly, no. But so many things happen that we don't believe possible that I worry for the agency and hope readers will lend their voices to those advocating for increased FDA funding.

Steven

For purposes of disclosure: I am a founder 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 Funding for FY 11: Back to the Future
October 3rd, 2010

Not so long ago, FDA appropriations 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.

STEVEN GROSSMAN 10/10/10 STEVEN GROSSMAN 10/10/10

Success is Uncertain for FDA’s Regulatory Science Initiative

FDA Matters was an early advocate for regulatory science. It has been exciting to see the concept grow from the Commissioner's first public speech to the President's request for $25 million in FY 2011. And now, FDA has released a White Paper describing the Regulatory Science Initiative (RSI).It is an excellent report and I applaud those who worked hard to create it. Still, I have misgivings about the way the White Paper characterizes regulatory science, leading to concerns about whether RSI will develop the necessary political and public support to be a long-term, permanent part of FDA.

It is an excellent report and I applaud those who worked hard to create it. Still, I have misgivings about the way the White Paper characterizes regulatory science, leading to concerns about whether RSI will develop the necessary political and public support to be a long-term, permanent part of FDA.

According to the report:

"Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products." (emphasis added).

I would suggest that:

"Regulatory science is the tools, techniques and knowledge needed by food, medical product and other FDA regulators to carry out their public responsibilities."

FDA's definition makes regulatory science about what FDA develops (new tools, standards, etc.) and about regulated products. Instead, it should be about how regulatory science makes it possible for FDA to carry out its public health mission in an increasingly complex scientific and global environment. It needs to be clear that consumers, patients and regulated industries benefit when regulators have sophisticated, state-of-the-art capabilities and use them transparently, so that no stakeholder has to guess about the agency's approach. These are public purposes for which it is possible to gather broad support.

Most agency funds are spent to carry out applied regulatory science. A smaller, but not insignificant part of the agency budget is already being spent to create and improve regulatory science. For example, much of the budget of the Center for Food Safety and Nutrition that is not spent on inspections and enforcement is focused on better tools and knowledge to create a safer food supply. Most of the work of the National Center for Toxicological Research is devoted to improving regulatory science through the creation of science-based standards.

Regulatory science is not new and is much larger than an agency initiative. Rather, it is a re-conceptualization of who the agency is and what it does. Without this larger and more visionary framework, I fear that RSI is going to be underfunded by Congress and pushed aside when dollars are tight.

What reason is there to think so? The Critical Path Initiative (CPI) was launched with significant fanfare. The original report was one of the most lucid statements I have ever read from a government agency. The projects that Critical Path supported appear to have been well-conceived and responsive to broad, serious regulatory science needs within FDA.

Yet, the Critical Path completely failed to capture Congress' imagination. It received very modest financial support from Congress, even in the last few years when the FDA's budget expanded significantly.

RSI risks the same failure if Congress and other policymakers can neither explain "regulatory science" nor understand why it is fundamental to FDA's mission success. As judged by CPI funding and the limited enthusiasm that it generated, Congress saw it as a nice add-on, but not a necessity.

If RSI can't do better than this, it will not grow and prosper once the initial excitement fades. This would be a great shame because improving regulatory science is essential to making FDA into a 21st century regulatory agency.

That's why it matters what FDA says now about the RSI. Undoubtedly, the agency wants regulatory science to be seen as a better, more holistic way to understand and improve the agency. At the moment, it still looks more like a collection of worthwhile agency improvements that have been bundled into a new initiative.

Steven

The FDA White Paper, Advancing Regulatory Science for Public Health, can be found here, along with the Commissioner's speech on the topic at the National Press Club: http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/default.htm

One of several earlier FDA Matters' columns on regulatory science:

CARS: The Vehicle for FDA's Future October 25th, 2009

Since Labor Day, Commissioner Hamburg has spoken a number of times about the importance of regulatory science. She is right. FDA must have the scientific tools and methodologies to be a 21st century regulatory agency. FDA needs to define regulatory science, develop programs to support it, and package them in a way that will quickly bring recognition and funding. Read the rest of this entry »

STEVEN GROSSMAN 10/3/10 STEVEN GROSSMAN 10/3/10

FDA Funding for FY 11: Back to the Future

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.

For the new fiscal year (FY 11) starting on October 1, Congress passed a Continuing Resolution (CR) that funds the government until December 3. As a result, the government is open, but no agency received new funding. For the next 2 months, government agencies (including FDA) will only be able to spend the amount they were appropriated in fiscal year 2010.

One of this year's Alliance themes has been the need for FDA to be an exception to the overall dismal federal budget situation. The agency must receive funding increases to do its job, which grows larger every day. There is strong support for this in Congress. The Alliance expects FDA to receive serious attention anytime Congress debates funding priorities.

This didn't happen for this first round of the CR for a fairly simple reason: Congress put this CR together without acknowledging any funding priorities. The Alliance believes FDA can win the debate to get increased funding, but only if that debate occurs.

When Congress returns in mid-November and looks at FY 11 funding again, there will be an opportunity to make the case that FDA should receive more funds. However, it is only a guess that this debate will occur before December 3. Congress may decide to pass the same CR to cover the period from December 3 to February 4. If so, the pain of level funding will only become more intense for FDA.

Funding FDA at last year's levels is a particularly acute problem because over 80% of the agency's budget is people-related costs: salary, benefits, rent, IT, travel, support services. FDA cannot delay spending, as NIH might, by waiting a few extra months to disburse grant funds.

FDA management is reviewing contingency plans to preserve its priorities and maximize output. Retaining the fiscal 2010 spending levels will impact FDA's ability to hire medical product reviewers and food inspectors and personnel for other areas of growing need. The agency must use its CR funding to pay for October 1 raises and rent increases, which obviously are not reflected in the FY 10 appropriations level.

The overall situation, as well as these new costs, restricts FDA's ability to make commitments in hiring, new programming, better IT, and contracts. They will also not want to create obligations now that they may not be able to fund later in the year.

Congress will eventually be ready to address the nation's funding priorities, hopefully in November. Regardless of when this debate occurs, all of FDA's supporters will need to rise up as one to convince Congress that more monies are needed.

Steven

FDA's Yearly Appropriations Growth Since FY 2003

FY 03 (base year): $1.390 billion

FY 04 ($11M increase): $1.401 billion

FY 05 ($51M increase): $1.452 billion

FY 06 ($41M increase): $1.493 billion

FY 07 ($77M increase): $1.569 billion (most domestic programs received no increase)

FY 08 ($145M increase): $1.714 billion (plus $150M one-time supplemental, non-add)

FY 09 ($325M increase): $2.039 billion

FY 10 ($306M increase): $2.345 billion

STEVEN GROSSMAN 7/18/10 STEVEN GROSSMAN 7/18/10

Update on FDA’s Appropriation for FY 11

On July 1, the House Appropriations Agriculture/FDA Subcommittee marked up it FY 11 bill. The bottomline was good for FDA: $2.571 billion, a $214 million increase over FY 10, about 9%. No further details will be released until the full committee marks up, possibly later this month.On July 15, the Senate Appropriations Committee marked up its version of the Agriculture/FDA funding bill. The good news is that the Senate agreed that FDA needs better funding….and provided $2.516 billion, a $158 million in new monies. This is a bit more than 6%. Here is FDA Matters' analysis of this critical budget battle.

On July 15, the Senate Appropriations Committee marked up its version of the Agriculture/FDA funding bill. The good news is that the Senate agreed that FDA needs better funding….and provided $2.516 billion, a $158 million in new monies. This is a bit more than 6%. Here is FDA Matters' analysis of this critical budget battle.

The Senate's funding level for FDA is the same as the Administration's request. There was hope that the Senate could find the $55 million more to reach the House level. Even the House's proposed funding is not nearly enough to meet FDA's responsibilities in the coming year and the Senate is clearly even further behind with its number. Even so, the Senate's 6% increase is more than what most domestic federal agencies will receive.

The Senate mark-up proved one important point. Both the Senate and the House agree that FDA needs to be an exception to this year's tough round of budget-cutting.

There is still a ways to go. The House full committee needs to mark up its bill, and then both bodies will need to consider and approve these appropriations bills. This presumably would occur in September, although it may occur in late July. It looks like the Agriculture/FDA legislation might be one of the first appropriations bills to move through the pipeline. Hopefully it will be enacted into law before the Congress has to pass a Continuing Resolution (September 30 in advance of the new fiscal year, which starts on October 1).

The primary advocacy group for FDA resources, the Alliance for a Stronger FDA, continues to work for the House level or higher. It is difficult for any agency in this appropriations cycle. Hill deliberations are already sharply skewed by the upcoming 2010 elections. Despite this environment, the FDA's friends in the Administration, the House and the Senate are still trying hard to get the agency more money for FY 11. The Alliance is working with them to preserve FDA gains and to raise awareness that FDA is still under-resourced relative to the agency's responsibilities.

In past years, it would have been safe to assume FDA would receive an increase of $158 million to $214 million. However, none of the current numbers can be relied upon until the House and the Senate reach some understanding about total spending for FY 11.

The Senate is considering proposals that would reduce domestic discretionary spending by either $4 billion or $20 billion. If it is the latter, a large number of domestic programs will face deeper cuts than currently planned. Those who are doing comparatively better may find their gains wiped away. This macro-budgetary risk means the case for FDA must continue to be made and that numbers being discussed now cannot be relied upon.

Below I have provided links to prior columns that discuss why FDA's needs grow each year and why the agency must be an exception to budget cuts. Also below is a chart comparing FY 10 to the levels proposed by the Alliance, the Administration, the House and the Senate.

For information about adding your voice to those advocating for more FDA resources, go to www.strengthenfda.org or send me a note at sgrossman@strengthenfda.org.

Steven

For purposes of disclosure, I am one of the founders of the Alliance for a Stronger FDA and serve as its deputy executive director. FDA Matters is not affiliated in any way with the Alliance.

FDA: A Bargain at Two Cents Per Day Per American
March 28th, 2010

This is the powerful message that the Alliance for a Stronger FDA has been delivering to Capitol Hill. Even still, it will be a difficult year for any federal agency whose mission and responsibilities are growing. Read the rest of this entry »

FDA Needs at Least a $250 Million Increase in FY 2011
March 7th, 2010

FDA Matters feels strongly that this is not nearly enough. By my calculations, at least a $250 million increase for FDA would be needed, just to achieve the program levels anticipated in the President's budget request. The Alliance for a Stronger FDA has asked for a $495 million increase, which could be put to good use by the agency. Why is 6% not enough? Read the rest of this entry »

-------------------------

Status of FY 11 Appropriations for the FDA

Compared to the Alliance for a Stronger FDA's FY 11 Request

Updated July 16, 2010

Budget Authority Appropriations (does not include user fees)

Function Note: budget authority only, by center	FY 10 Final (October 2009)	FY 11 Alliance Request	FY 11 President's Request Feb. 2010	FY 11 House Subcommittee 7/1/10	FY 11 Senate Committee 7/15/10

Food	$ 784 million	$ 955 million	$ 856 million		$856 million
Human Drugs	$ 465 million	$ 580 million	$ 484 million		$489 million
Biologics	$ 206 million	$ 255 million	$ 215 million		$215 million
Animal Drugs/Feed	$ 135 million	$ 165 million	$ 141 million		$141 million
Devices & Radiological Health	$ 315 million	$ 385 million	$ 326 million		$326 million
Natl. Ctr. For Toxicological Research	$ 59 million	$ 72 million	$ 61 million		$61 million
HQ, Office of Commissioner and Other	$ 144 million	$ 183 million	$ 162 million		$157 million
Rent & Facilities Cost	$ 237 million	$ 250 million	$ 259 million		$259 million
SUBTOTAL, Salaries and Expenses	$ 2.346 billion	$ 2.845 billion	$2.504 billion		$2.504 billion
Building and Facilities Repair	$ 12 million	$ 12 million	$ 12 million		$ 12 million
TOTAL, ALL Budget Authority Appropriations (no user fees)	$ 2.358 billion +$307M over FY 09	$ 2.857 billion Proposes $499 million over FY10	$2.516 billion Proposes $158 million over FY 10	$2.571 billion Proposes $214 million over FY 10	$2.516 billion Proposes $158 million over FY 10

Some columns may not add due to rounding.

The House has released the total for the FDA, but does not release the allocation until full committee mark-up expected later this month.

For more information about the Alliance for a Stronger FDA:

Ladd Wiley, phone: (202) 887-4083 email: lwiley@StrengthenFDA.org

Steven Grossman, phone: 1- (301) 539-9660 email: sgrossman@StrengthenFDA.org

STEVEN GROSSMAN 5/27/10 STEVEN GROSSMAN 5/27/10

Not Too Soon to Consider the Hamburg Legacy

May 18 marked one year since Dr. Margaret Hamburg was sworn in as Commissioner of the US Food and Drug Administration. The challenges are great, the torrent of issues is never-ending and most days you can smile but you can't win. Nonetheless, I think it has been a very good first year for her and for Principal Deputy Commissioner, Dr. Joshua Sharfstein.It may seem premature to be discussing "the Hamburg legacy." But you know that she is thinking about it (all commissioners do), so why can't FDA Matters talk about it?

It may seem premature to be discussing "the Hamburg legacy." But you know that she is thinking about it (all commissioners do), so why can't FDA Matters talk about it?

Top-line: the agency has a renewed energy and sense of purpose, which I attribute to her leadership. She has been aided by something none of her recent predecessors have had: the flow of new monies. This has allowed her to make choices about priorities and invest time and manpower into them.

Dr. Hamburg's most important legacy will be whether she can sustain this momentum. FDA is still severely under-resourced. The FDA commissioner who can reverse this trend for more than a few years will always be remembered for that.

Improving regulatory sciences is apparently quite high on Dr. Hamburg's list and I have written favorably about it a number of times. I also know that a lot of FDA-watchers are puzzled by it. Here is FDA Matter's explanation:

"Regulatory sciences" means the tools, techniques and knowledge needed by food and medical product regulators to carry out their public responsibilities. Fundamental to the concept is that consumers, patients and regulated industries benefit when regulators have sophisticated, state-of-the art capabilities and use them transparently so that no stakeholder has to guess about the agency's approach.

"Regulatory science" is most often thought of in relation to medical product approvals and food safety, but actually extends to every aspect of the FDA's responsibilities, including manufacturing, product tracking, laboratory procedures, post-market standards, sentinel monitoring, etc.

Accomplishing this—even getting it firmly launched—is a legacy item. We will all benefit if she succeeds…and we will certainly remember her for it.

A third area emerging as a legacy item is a new FDA toughness on enforcement. At one point, I had thought that this was a threshold item: Congress wouldn't let Dr. Hamburg address her other priorities unless she proved that she could assure the safety of medical products and food. That may even be how she thought of it a year ago.

This mission turned out to be more than just eliminating some marginal players and confirming that the mainstream regulated industries were playing by the rules. The past year, we have seen a number of established, name-brand companies held accountable for lapses that should not—by their own admission—have occurred.

One important consequence of inspections and enforcement is to keep everyone on their toes. Maybe CEO's of FDA-regulated companies are not asking tough enough questions or don't appreciate how much the company can be hurt by people many levels below them. If the behavior of mainstream industry is markedly improved and the agency is clearer and more predictable in its standards and enforcement actions, then this would be a powerful legacy for Commissioner Hamburg.

With a year in office, it's not too soon to discuss Dr. Hamburg's potential legacy. What do you think of my list? What would you add? Please post your comments or send them to me at sgrossman@fdamatters.com

Steven

Some previous columns that touch on each of these legacy items:

FDA: A Bargain at Two Cents Per Day Per American

March 28th, 2010

CARS: The Vehicle for FDA's Future

October 25th, 2009

Shaken to the Core: What FDA and FDA-Regulated Companies Can Learn from Toyota

February 25th, 2010

I do not believe that Toyota became a global success by cutting corners and ignoring safety concerns. Nonetheless, the company may not survive the investigations, the lawsuits, the civil and criminal fines, the securities litigation, the recalls (8.5 million cars so far), the loss of consumer confidence and the possible criminal indictments.

FDA Matters hopes that the CEO's of FDA-regulated companies are paying attention. They need to understand that their company can be "shaken to the core," as Toyota has. Read the rest of this entry »

STEVEN GROSSMAN 4/25/10 STEVEN GROSSMAN 4/25/10

Center-Envy: Are Foods Doing Better than Drugs?

Several times this year, I have been told: FDA's food activities have been getting most of the new monies at the expense of human drugs (CDER) and biologics (CBER). But is it true that food activities (mostly CFSAN, the Center for Food Science and Applied Nutrition) are receiving preferred treatment? FDA Matters ran the numbers to see. We conclude that center-envy is bad in its own right, but even worse when it is based on misinformation and misperceptions.

FDA Matters ran the numbers to see. We conclude that center-envy is bad in its own right, but even worse when it is based on misinformation and misperceptions.

Here is a chart providing relevant comparisons over nine fiscal years, including the current one.

Center	FY 2002	FY 2007	FY 2010

FOOD--Total	$393 million	$457 million	$784 million
Center	-------$143 million	-------$159 million	-------$237 million
Field activities	-------$250 million	-------$298 million	-------$547 million
User fees	-------none	-------none	-------none

HUMAN DRUGS & BIOLOGICS--Total	$542 million	$746 million	$1.185 billion
Centers	-------$289 million	-------$349 million	-------$503 million
Field activities	-------$104 million	-------$113 million	-------$168 million
User fees	-------$149 million	-------$284 million	-------$514 million

Center, field activities and user fees combined. These are the number across the two rows marked "total." In FY 2002, the FDA's food budget was 72% of the amount allocated to human drugs/biologics received.

In FY 2007, it had declined to 61% and rebounded slightly to 66% in FY 10. Thus, over this 9 year period (8 appropriations cycles), funding for food activities has actually declined slightly compared to CDER/CBER.

Excluding field activities from funding available for Center activities. "Field activities" is FDA-speak for investigations and enforcement. The funds supporting field activities are in each Center's budget, but are transferred to the Office of Regulatory Affairs (ORA). These funds do not support core Center activities.

If field activities in ORA are excluded over the nine year period, CFSAN grew by 60%. CDER and CBER (including user fees) grew by more than 150%. Thus, it is possible to conclude that the core functions of CDER and CBER have done far better than the core functions of CFSAN.

The pace has changed over the last 3 years. During this period, CFSAN grew by 67% compared to CDER and CBER's growth (including user fees) of 62%. Funding for drugs and biologics, which grew enormously through the mid-2000's, is now growing at a rate comparable to foods. However, for foods this means an increase of $78 million, while CDER/CBER grew by $384 million over the three years.

Excluding User Fees, as well as field activities. Core appropriated funding for the centers grew at about the same rate over both the longer and shorter period. For the nine years (eight appropriations cycles), CFSAN grew by 60%, CDER/CBER by 57%. For the last three years, CFSAN has grown by 67% compared to 69% for human drugs and biologics. In effect, the food and drugs centers have been treated almost identically, with user fees tilting the comparison dramatically in favor of CDER and CBER.

Bottom-line: Increases in CFSAN have gotten a lot of attention, but CDER and CBER budgets have grown by far more over the last nine years if user fees are included. If user fees are excluded, then CFSAN and CDER/CBER have grown at comparable rates over the nine year period and also over the last three years.

PS: In the President's FY 11 request, the proposed appropriations increase for CFSAN is larger than for CDER and CBER combined. However, all of the differential is in 87 people and $40 million that is being proposed for new food inspectors. If ORA is excluded, as well as user fees, the food increase and the drug/biologics increases are about equal on a percentage basis.

Steven

Two past columns have discussed the Office of Regulatory Affairs and a recent column urged less reliance on user fees to fund CDER.

The Uncrowned Prince of FDA
September 15th, 2009

Which FDA line manager has the most appropriated resources to work with in FY 09? Is it Janet Woodcock, head of the drug center or Stephen Sundlof, head of the food center? The correct answer: neither. Read the rest of this entry »

Commissioner Hamburg's Most Important Personnel Decision
February 21st, 2010

With due respect to the many fine individuals that Commissioner Hamburg has recruited, FDA Matters thinks the most important appointment so far has been Michael Taylor to be Deputy Commissioner for Foods. An even more important decision needs to be made soon: choosing the right person to be Associate Commissioner for Regulatory Affairs. Read the rest of this entry »

Wrestling for the Soul of FDA
March 17th, 2010

User fees are a bad way to fund FDA, a public health regulatory agency that oversees nearly a quarter of all consumer spending. It's not that user fees are corrupting. FDA is capable of making good and bad decisions without regard to where the money comes from. But user fees have the potential to erode public confidence in the agency. Read the rest of this entry »

STEVEN GROSSMAN 3/28/10 STEVEN GROSSMAN 3/28/10

FDA: A Bargain at Two Cents Per Day Per American

FDA touches every American many times each day. Today's investment (2 cents per day per American) is a pittance compared to the benefit of a strong FDA and the risk of an underfunded FDA. There cannot be many agencies in the US government that have such a vast scope of responsibilities and so few dollars to get the job done. This is the powerful message that the Alliance for a Stronger FDA has been delivering to Capitol Hill. Even still, it will be a difficult year for any federal agency whose mission and responsibilities are growing.

In recent testimony to the House and Senate Appropriations Committees, the Alliance focused on the large gap between FDA's responsibilities and resources. The Alliance also points to ways in which the agency's job becomes tougher each year—notably through increased scientific knowledge and rapid industry globalization.

In the style of David Letterman's Top Ten lists, the Alliance has its own list of 10 things they hope policymakers will know and remember about FDA:

FDA is a comparatively small agency with a small appropriation: just $2.35B in 2010 to regulate products that represent a quarter of all consumer spending.
Twenty-five years ago, FDA and CDC were the same size; today the CDC budget is nearly 2 1/2 times as large.
A strong FDA is good for the US economy and for our balance of trade.
FDA is an integral part of our response to public health emergencies, including defense against bioterrorism.
FDA's appropriation is almost entirely staff costs, requiring nearly 6% increase each year to sustain program levels.
After three years of good increases (thank you, Congress), FDA staffing levels from the 2010 appropriation have only just been restored to the previous high-level achieved in 1994.
User fees serve valuable functions, but they are targeted and support only specific activities. They don't strengthen the FDA in carrying out its overall public health mission.
All FDA stakeholders support a stronger FDA (consumers, patients, health professionals, and industry).
FDA's responsibilities increase each year---through new mandates, globalization, and scientific complexity.

And the single most important reason (and the one raised at the beginning of this column):

FDA touches every American many times each day. Today's investment (2 cents per day per American) is a pittance compared to the benefit of a strong FDA and the risk of an underfunded FDA.

To their credit, the Obama Administration has committed to cutting domestic spending by funding priority programs, rather than relying on across-the-board cuts. This is a challenge FDA can meet: showing that increased funding brings substantial benefits to the American people and is worthy of increases beyond what other agencies are getting.

Going from 2 cents to 3 cents per day doesn't seem like much, but it would add $1 billion to the FDA budget.

Steven

For purposes of disclosure, I am one of the founders of the Alliance for a Stronger FDA and serve as its deputy executive director. FDA Matters is not affiliated in any way with the Alliance.

For more information about the Alliance, send me a note at sgrossman@strengthenfda.org.

The Alliance for a Stronger FDA's House testimony is at:

http://fdaalliance.files.wordpress.com/2009/11/alliance-statement-house-appropriations-committee-fy-11.pdf

STEVEN GROSSMAN 3/7/10 STEVEN GROSSMAN 3/7/10

FDA Needs at Least a $250 Million Increase in FY 2011

The President's proposal to freeze domestic discretionary programs in FY 2011 (and beyond) will force painful cuts across government and in programs that millions of American rely upon. Even some traditionally-favored agencies, such as NIH, are looking at only small increases. With a proposed 6% increase (about $150 million), FDA would seem to be doing far better than most.FDA Matters feels strongly that this is not nearly enough. By my calculations, at least a $250 million increase for FDA would be needed, just to achieve the program levels anticipated in the President's budget request. The Alliance for a Stronger FDA has asked for a $495 million increase, which could be put to good use by the agency. Why is 6% not enough?

Despite three good years of increases for FDA, we are still fighting decades of neglect. Appropriated staffing levels in 2010 are only back to where they were in 1994. Over a 25-year period, CDC has grown from an agency the size of FDA to one that is three times as large. Meantime, FDA has new responsibilities and an ever more-complex environment in which to function.

A 6% increase doesn't go very far. A tad more than $100 million will be taken up by increases in salaries, benefits and rents. Other costs go up also. On a FY 10 base of $2.35 billion, about $40 million is available for new programming in FY 11. It will probably go to hire more food inspectors, which is an important need.

This suggests that the rest of the agency (apart from food inspection) will be able to operate in FY 11 at their FY 10 staffing/program levels. In reality, this won't be the case unless the Congress provides FDA with an appropriation above the President's request.

Here is why the picture is actually quite grim. According to FDA budget documents, the increased cost of salaries in FY 11 is $66 million. As far as I can tell, only about $3 million is actually part of the President's request. So, what we consider as an increase to cover inflation…..actually does nothing of the sort. The President has told Congress: give FDA a $146 million increase in monies and it will provide a $143 million increase in programming.

So, food inspections, patient safety and advancing regulatory science (the President's budgetary priorities) will happen….and parts of the rest of the agency will shrink (because they can't cover inflation) OR vital, existing services will continue, but FDA won't be able to deliver on the President's initiatives. It will take an extra $100M (an increase of $250 million total) to cover inflation in salary, rents, etc. and provide the new programming in the President's request.

To bring this down to specifics, the President has requested $25 million for advancing regulatory sciences. This is a priority of Commissioner Hamburg and much lauded by the stakeholder communities. At an IOM meeting last week on regulatory science, there was palpable excitement that the President had made a great first-year commitment. But follow the logic of this analysis and it is unclear whether there really will be monies to get started in FY 2011.

The bottomline: FDA needs more than the increase proposed in the President's request. The President, by his budget justification, agrees....and envisions an FDA that will require at least a $ 250 million increase.

Steven

Some recent thoughts on the same topic, but with a different focus:

The President's Budget Request: Is 6% Enough for FDA?

February 4th, 2010

The President's FY 11 budget request for FDA includes a $146 million increase in appropriated (non-user fee) funding. This is about 6% of the $2.36 billion appropriation that FDA received in FY 10. With the President's tough talk about deficit reduction, anything above a freeze should be considered good. Why was the Alliance for a Stronger FDA disappointed? Read the rest of this entry »

STEVEN GROSSMAN 2/4/10 STEVEN GROSSMAN 2/4/10

The President’s Budget Request: Is 6% Enough for FDA?

Or to be more precise, the Alliance (www.StrengthenFDA.org) appreciated that FDA got more than most agencies, but felt that an inflation level increase was insufficient for FDA. The Alliance pointed out that the increase will not cover the ever-growing demands on the agency or strengthen the agency's capacity to fulfill its mission. They added: three good appropriations cycles for FDA (FY 08 to FY 10) have not undone more than a decade of budgetary neglect.

Of the $146 million increase for the agency's appropriated budget, CFSAN would get $60 million, about an 8% increase. This is a little more than an inflationary increase and foods programs will be able to grow marginally in FY 11. This is progress…though not nearly what is needed to meet the continued challenge of keeping foods safe and the increasing complexity and international scope of the food supply chain.

Far less was provided for medical products. Drugs and biologics received a combined $28 million increase in the President's request (about 4%). Devices received an $11 million increase (less than 4%), which does not cover the cost of pay increases. Other items that will increase this year (rent, IT, training, and travel) will need to come from existing program dollars.

There is near-universal acceptance that the federal budget needs to be trimmed. Few domestic agencies did better in the President's request than FDA.

But there are differences in the needs of federal agencies. FDA's budget is almost entirely people costs. Salaries are more than 60% of the agency's budget. When you add in benefits, rent, IT services, travel, training, etc., 80% of the budget is devoted to people and the support they need to do their jobs.

If the FDA's appropriated budget does not grow by at least inflation each year, then staff levels decrease. This is what happened in most years from 1994 to 2007.

For example, after 9/11 the agency received significant new monies to hire inspectors to decrease the risks of agro- and bio-terror. Within 5 years, this increase in the FDA field force had disappeared, due to inflation, attrition and a lack of supportive funding. There is nothing hypothetical about the consequences of underfunding FDA.

Undoubtedly, FDA will find ways to be more efficient in FY 11, which will relieve a little of the pressure of doing more without new money. However, the amount to be gained in this manner is not large.

In contrast, there are plenty of areas for additional investment. FDA is operating a 1990's IT system, requiring it to work with databases that are incomplete and do not provide sophisticated support for decision making. Training the FDA workforce is another priority for additional funding.

FDA is still very much in the catch-up mode from past underfunding. Six percent is not enough!

Steven

For purposes of disclosure, I am one of the founders of the Alliance for a Stronger FDA and serve as deputy executive director. FDA Matters is not affiliated in any way with the Alliance.

Chart provided by the Alliance for a Stronger FDA:

President Obama's FY 11 Request for the FDA

Compared to the Alliance for a Stronger FDA's FY 11 Request

Budget Authority Appropriations (does not include user fees)

Function Note: budget authority only, by center	FY 08 Actual (December 2007)	FY 09 Final (March 2009)	FY 10 Final (October 2009)	FY 11 Alliance Request	FY 11 President's Request

Food	$ 510 million	$ 649 million	$ 784 million	$ 955 million	$ 848 million
Human Drugs	$ 353 million	$ 413 million	$ 465 million	$ 580 million	$ 484 million
Biologics	$ 155 million	$ 183 million	$ 206 million	$ 255 million	$ 215 million
Animal Drugs/Feed	$ 97 million	$ 116 million	$ 135 million	$ 165 million	$ 141 million
Devices & Radiological Health	$ 238 million	$ 280 million	$ 315 million	$ 385 million	$ 326 million
Natl. Ctr. For Toxicological Research	$ 44 million	$ 52 million	$ 59 million	$ 72 million	$ 61 million
HQ, Office of Commissioner and Other	$ 97 million	$ 121 million	$ 144 million	$ 183 million	$ 162 million
Rent & Facilities Cost	$ 220 million	$ 223 million	$ 237 million	$ 250 million	$ 259 million
SUBTOTAL, Salaries and Expenses	$ 1.714 billion (+$145M over FY 07)	$ 2.039 billion (+$325M over FY 08)	$ 2.346 billion (+$307M over FY 09)	$ 2.845 billion	$2.496 billion
Building and Facilities Repair	$ 8 million	$ 16 million	$ 16 million	$ 12 million	$ 12 million
TOTAL, ALL Budget Authority Appropriations (no user fees)	$1.722 billion	$2.055 billion	$ 2.362 billion	$ 2.857 billion (Proposes + $495M over FY10)	$2.508 billion (Proposes $146 million over FY 10)

Because OMB includes new and proposed user fees in their totals, these numbers vary considerably from those being discussed by the Administration and reported by many sources. Notably, the President's request includes user fees being collected for the new tobacco center at FDA, monies that exactly match the cost of new responsibilities added this year.

STEVEN GROSSMAN 1/28/10 STEVEN GROSSMAN 1/28/10

FDA, SOTU, and the President’s Budget Request

The President's State of the Union (SOTU) address gave no clues as to the fate of the FDA budget for FY 11 (begins October 1, 2010). Both the general and specific details for the agency await the February 1 release of the President's budget request.While the House and Senate have control over the final amount that FDA receives, the President's request is the baseline against which the Congress works. FDA Matters is pleased to offer a guide to interpreting this first stage of the FY 11 appropriations process.

While the House and Senate have control over the final amount that FDA receives, the President's request is the baseline against which the Congress works. FDA Matters is pleased to offer a guide to interpreting this first stage of the FY 11 appropriations process.

What the State of the Union didn't tell us. There was hope that the President would make reference to FDA or touch upon food safety. This didn't occur and there was almost nothing on public health in the address. Even a reference to cancer research did not lead to a mention of support for NIH.

The President announced a three-year freeze on discretionary domestic spending, followed by inflationary increases for the rest of the decade. Within this, some agencies and programs will continue to grow, while others will need to be cut substantially or eliminated. Other than to exclude defense and veteran's affairs, the President did not give any indication of who would be favored with budget increases.

What to expect when the President's budget request is released. It will be confusing. Increased revenue from existing and new user fees is likely to be included in totals showing that FDA is growing. This will mask whether the non-user fee budget authority (BA) appropriations (public funds) will increase under the President's request.

Media often report straight from the OMB summary sheets, so don't believe any reported numbers unless they recognize the distinction between user fees and BA appropriations. Another potential point of confusion is whether the user fees that fund the new Tobacco Center will be represented as providing more resources to FDA.

The distribution of any new funds among the FDA functions is also important. It is possible, for example, for food safety to receive increases while the rest of FDA is flat-funded.

Looking strictly at BA appropriations, FDA received $2.35 billion for FY 10. Based on year-over-year inflation in FDA costs, the agency needs an increase of $120 to $140 million just to maintain current staffing and program levels. Any less will mean cutbacks within the agency.

It is possible the President's request will include new responsibilities for FDA. Unless separate additional funding is provided, this will also hinder efforts to strengthen the agency.

For comparison purposes, FDA received a $306 million increase in FY 10. The Alliance for a Stronger FDA is recommending a $500 million increase for FY 11.

What Congress does next. Just as the President has weighed FDA against competing priorities, so must Congress. Action will accelerate through the Spring, with hearings, mark-ups and negotiations. Congress will be trying to get appropriations done by September 15, well before the elections.

Why advocacy is essential to funding the FDA. The Alliance for a Stronger FDA has 180 members and represents all FDA stakeholder groups: consumer and patient groups, health professional societies, associations, companies and individuals. Former FDA commissioners and Secretaries of HHS have chosen to be honorary members and support efforts to provide better funding for FDA.

The Alliance has been a potent force over the last 3 years by successfully reversing a decade of budgetary neglect of FDA. The Alliance needs your support to continue its work in what appears to be a very rough year. For information about becoming a member, please write to me at sgrossman@StrengthenFDA.org.

Steven

For purposes of disclosure, I am one of the founders of the Alliance for a Stronger FDA and serve as deputy executive director. The Alliance is not affiliated in any way with FDA Matters or with my consulting practice, HPS Group, LLC.

An earlier column with additional background:

Can FDA Withstand the FY 11 Budget-Cutters?

December 6th, 2009

The President's FY 11 budget request is likely to be deeply constrained. Having advocated successfully for a number of costly initiatives, President Obama will need to show that he can also reduce the deficit. He asked Cabinet secretaries to submit their budget requests at a no-growth level and an alternative budget on the assumption that their Department might be reduced by 5% overall. Read the rest of this entry »

STEVEN GROSSMAN 1/24/10 STEVEN GROSSMAN 1/24/10

Mr. Brown Goes to Washington

The election of Massachusetts' new Senator, Scott Brown, has set off a media frenzy about the fate of health care reform legislation. However, the ramifications of his election reach far beyond health reform.FDA turns out to be a good example. FDA Matters sees at least three consequences of his election that may affect the agency in 2010.

FDA turns out to be a good example. FDA Matters sees at least three consequences of his election that may affect the agency in 2010.

Congressional Focus. Health reform is still alive, but it will require considerable effort to re-start the process and advance new legislation. This could mean yet another year in which the nation's dialogue on health issues will be largely limited to one topic, health reform.

If health reform is re-started, Congress may enact food safety reform and hold scattered hearings on medical devices, drug safety, and medical innovation. However, Congress will lack the time and focus to attend to other important FDA issues.

Regulatory Pathway for Follow-on Biologics. A regulatory pathway for approval of follow-on biologics (FOB) is a probable casualty of the Brown election and the demise of current health reform legislation. Chairman Waxman has never wanted FOB in health reform. In the days before Senator Brown's election, he was reportedly working with the White House and the Democratic leadership to reduce the 12-year data exclusivity that had been in both the House and Senate-passed legislation.

If FOB is to be adopted in 2010, it will probably have to be as stand-alone legislation. This is a mixed blessing for the biopharmaceutical industry. While it gives Chairman Waxman a new opportunity to shape the House version, the strength of the industry has been in the ranks, rather than with leadership. The key to the industry's earlier victory in the House was that the legislation sponsored by Representative Anna Eshoo had 140 bi-partisan co-sponsors from every part of the country.

The time for legislation may also have passed. I believe more companies are going to file full Biological License Applications (BLA), rather than waiting for a generic-oriented pathway. BLA's are more expensive, but there are offsetting proprietary advantages. Some companies may also be able to build their US BLA on clinical data that had been compiled to support abbreviated applications in Europe.

Deficit Reduction. Senator Brown's election may also be a harbinger of another trend that could impact FDA. President Obama had already announced that the Administration's appropriations requests for 2011 (considered in 2010) would focus on deficit reduction.

Congressional enthusiasm for deficit reduction is always strong on rhetoric, but weak on follow-through. Many members of Congress see the Massachusetts special election as reflecting a growing and ugly mood in America about the economy and jobs. Because the federal deficit is an important contributor to this mood, Members of Congress may take deficit reduction more seriously this year.

If the deficit reduction fervor increases further, FDA is at-risk of receiving a very small increase at a time when the agency's needs are growing and it still working to overcome a decade of budgetary neglect.

It is rare for a Congressional special election to affect DC. This one is different and we are likely to see considerable change as Mr. Brown comes to Washington. FDA Matters will continue to watch closely how the election may impact: Congressional attention to FDA, the follow-on-biologics debate and the fate of FDA's appropriation.

Steven

For more background on the battle over FOB's in the House last year:

The Best Little Chess Game in Town

August 3rd, 2009

One of the reigning champions of political chess, Representative Henry Waxman, has found himself in an endgame on follow-on biologics (FOB). His three decades of success have been built on extraordinary mastery of Congressional procedure, artful compromise and strategic alliances. His defeat seems unavoidable, but no one should assume that he can't yet win or draw this game. Read the rest of this entry »

STEVEN GROSSMAN 12/6/09 STEVEN GROSSMAN 12/6/09

Can FDA Withstand the FY 11 Budget-Cutters?

Tradition says nothing happens between Thanksgiving and New Year's Day. People check out mentally and, as often as possible, physically. Not this December, not in Washington, DC.Most attention is on the US Senate, which is working this weekend and remains under threat of "no days off" until healthcare reform legislation passes. Just as intensely, but much less visibly, the Executive Branch is working full-tilt to complete the President's Budget Request for FY 11 prior to the State of the Union speech in late January. Of the two December activities, the President's budget is far more important to FDA.

Tradition says nothing happens between Thanksgiving and New Year's Day. People check out mentally and, as often as possible, physically. Not this December, not in Washington, DC.

Most attention is on the US Senate, which is working this weekend and remains under threat of "no days off" until healthcare reform legislation passes. Just as intensely, but much less visibly, the Executive Branch is working full-tilt to complete the President's Budget Request for FY 11 prior to the State of the Union speech in late January.

Of the two December activities, the President's budget is far more important to FDA.

With Congressional elections less than a year away, Congress will also feel pressure to dramatically reduce government spending. This will be particularly acute for Democrats, because the President's party usually loses a substantial number of seats in the mid-term elections.

Much of the government is likely to be flat-funded in the President's budget request. Even agencies and programs that advance Democratic policy priorities may not get increases.

There are three other reasons why FY 11 may be a rough year for FDA funding:

a number of unfunded mandates (FOB, food safety) in upcoming legislation may consume FDA's budget increases ($300M is not an increase if the agency gets $400M in new responsibilities),
FDA could get lost in the funding and implementation of health care reform, and
increases over the last three years may be seen as sufficient to tide the agency over during a difficult budget year.

FDA's fate on FY 11 appropriations is not sealed. It will require many good arguments and hard work for the agency to get a meaningful increase in the year ahead.

The Alliance for a Stronger FDA will continue to lead the fight to get the agency more funds. Since the Alliance's founding three years ago, FDA's budget has increased by nearly $800M, a 50% increase. (FY 10 compared with FY 07).

The Alliance has 180 members, representing all FDA stakeholders: consumers, patients, associations, companies and individuals. They all agree that the agency needs to be better funded. Three former Secretaries of Health and Human Services and 6 former FDA commissioners support the Alliance's efforts and are honorary members.

If your organization, company, association, law firm or consulting firm are not members of the Alliance, please contact me at sgrossman@StrengthenFDA.org for details about joining. The Alliance also has individual memberships for those not associated with an organization.

The broader and deeper the Alliance membership, the more successful they can be. If FDA matters to you, please act now to help strengthen the agency through increased appropriations.

Steven

In the interests of disclosure, I am one of the founders of the Alliance and serve as its Deputy Executive Director. FDA Matters represents only my own views and is a product of my health policy and regulatory consulting firm, HPS Group, LLC. The Alliance and HPS Group are not affiliated in any way.

My last column on appropriations addressed FY 10's successful efforts…and examined one of the key long-term concerns: FDA's need to show that new monies have been well-spent in ways that support and promote the public heath:

To Whom Much is Given, Much is Expected
October 6th, 2009

This is the third good year for FDA, after years of bad ones. The agency is still severely underfunded, but progress is finally being made. Now the hard work begins: spending the new money wisely and showing that it has been used to accomplish important public health missions. Read the rest of this entry »

STEVEN GROSSMAN 10/6/09 STEVEN GROSSMAN 10/6/09

To Whom Much is Given, Much is Expected

There is good news to report now that House-Senate conferees have finalized work on FDA's FY 10 budget. FDA received $306 million (15%) more to spend this fiscal year. Every center will have more resources to work with. This is the third good year for FDA, after years of bad ones. The agency is still severely underfunded, but progress is finally being made. Now the hard work begins: spending the new money wisely and showing that it has been used to accomplish important public health missions.

Because FDA has been shortchanged for so long, it is almost unfair to expect results in anything less than 3 to 5 years. However, Congress will only be patient for so long. FDA and Dr. Hamburg don't have much time to produce serious improvements.

Even acknowledging that a vastly larger appropriation is still needed, it is understandable why Congress won't wait very long before expecting results:

In the past two fiscal years (since FY 08), the budget for food programs has increased by more than 50%. Much of the extra money is allocated for field activities (inspections and enforcement).
Budgets for CDER, CBER and CDRH have all grown by more than 30% in the last two fiscal years.
The overall agency appropriation has increased by $776 million over the last three fiscal years (since FY 07). The represents a 50% increase in funding.

Dr. Hamburg and Dr. Sharfstein are responsible for moving the agency forward. Congress and the American people will hold them accountable.

They can't do it alone. FDA staff is smart, committed and largely effective. Yet, territorial behavior is fairly common and creates multiple problems. The Commissioner must create a vision of the agency that gives FDA employees a reason to work for the entire agency, not just for their own division or unit.

"To whom much is given, much is expected" applies to all of FDA. It will take a team effort to meet the lofty, but legitimate, expectations that have been created.

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In prior columns, I have focused on other aspects of the appropriation process. Here is an update:

FDA's Office of Regulatory Affairs (ORA) receives more appropriated funding (about 1/3 of the total) than any other part of FDA. For FY 10, appropriated funding directed to ORA increased by 20% to $847 million. This situation led me to dub the head of ORA as The Uncrowned Prince of FDA, at http://www.fdamatters.com/?p=499.

Unfunded mandates are a continuing concern for FDA, threatening the funding progress that has been made over the few years. Pending legislation (e.g. food safety reform) has not advanced since I last wrote on this topic. On a smaller scale, the FY 10 conference report adds $7 million to cover some new program requirements, in effect acknowledging that these would otherwise be unfunded mandates. My column, Unfunded Mandates Threaten FDA, is at: http://www.fdamatters.com/?p=375.

Steven

The House-Senate conference report can be found on pages 210 to 216 at: http://appropriations.house.gov/pdf/Ag_Conf_Rpt_FY2010.pdf.

FY 10 Appropriations for the Food and Drug Administration

Compared to Earlier Years (based on Conference Agreement)

Budget Authority Appropriations (does not include user fees)

(Prepared by the Alliance for a Stronger FDA)

Function Note: budget authority only, by center	FY 08 Actual (December 2007)	FY 09 Final (March 2009)	FY 10 President's Budget Request	FY 10 House-Senate Conf. Final

Food	$ 510 million	$ 649 million	$ 783 million	$ 783 million
Human Drugs	$ 353 million	$ 413 million	$ 458 million	$ 465 million*
Biologics	$ 155 million	$ 183 million	$ 206 million	$ 206 million
Animal Drugs/Feed	$ 97 million	$ 116 million	$ 135 million	$ 135 million
Devices & Radiological Health	$ 238 million	$ 280 million	$ 315 million	$ 315 million
Natl. Ctr. For Toxicological Research	$ 44 million	$ 52 million	$ 59 million	$ 59 million
HQ, Office of Commissioner and Other	$ 97 million	$ 121 million	$ 144 million	$ 144 million
Rent & Facilities Cost	$ 220 million	$ 223 million	$ 237 million	$ 237 million
SUBTOTAL, Salaries and Expenses	$1.714 billion	$2.039 billion	$ 2.338 billion	$ 2.345 billion
Building and Facilities Repair	$ 8 million	$ 16 million	$ 12 million	$ 12 million
TOTAL, ALL Budget Authority Appropriations (no user fees)	$1.722 billion	$2.055 billion	$ 2.350 billion	$ 2.357 billion

* The $7 million increase is intended to pay for some of the additional costs that CDER will bear as a result of Conference report language that contains increased financial commitments to the Critical Path program, generic drug reviews and other CDER programs.

STEVEN GROSSMAN 9/17/09 STEVEN GROSSMAN 9/17/09

It’s Time to Change CDER Funding

I did some crunching of FDA budget numbers for my column earlier this week on the Office of Regulatory Affairs (ORA). A by-product of my efforts was an analysis of how the Center for Drug Evaluation and Research (CDER) is funded. We often hear how dependent CDER is on user fees. The actual numbers are startling and deserve to be well-aired.

As most readers know, bio-pharma companies pay user fees, based on activities (such as submitting a New Drug Application) and on the number of their manufacturing facilities. The amounts are set by law. As part of the arrangement, FDA agrees to certain performance goals, which are also specified in law.

We often hear how dependent CDER is on user fees. The actual numbers are startling and deserve to be well-aired.

In FY 09, CDER received $413 million dollars, of which $111 million goes to ORA for inspections and enforcement. The remaining $302 million is the appropriated amount available for CDER to fulfill its responsibilities. User fees add another $357 million.

Of CDER's $660 million, 45% comes from appropriations and 55% comes from user fees. The split is similar for employees. Nearly 1300 employees are paid from appropriated monies; 1500 employees are paid from user fee funds.

I do not believe that user fees are corrupting, as some have alleged. The oft-heard insinuation that user fees put FDA "in the pocket of industry" is nonsense.

Nonetheless, the appearance is terrible. Everyone in the FDA stakeholder community agrees—patient groups, companies, consumer groups and associations. No one favors more drug user fees…and most would like to roll back or eliminate them in favor of all-public funding. Is this possible?

The current drug user fee program (PDUFA IV) was signed into law on September 27, 2007 and covers five fiscal years. Although Congress won't act to renew the program before 2012, the FDA will be starting its public hearing process in the first quarter of 2010. This is the first step in creating FDA's legislative proposal for PDUFA V.

This seems like a perfect opportunity to build momentum for a rollback of user fees, leading to a much smaller PDUFA V. Except that it will never happen that way.

FDA won't recommend, and industry won't agree to, a smaller user fee program….unless they are assured that the same amount of funds will be replaced by appropriations. Additional appropriated funds above that level would be even better, since CDER has a lot of needs.

That brings the potential for a smaller user fee program back to Congress. It won't be simple. The user fee programs are authorized by the House Energy and Commerce Committee and the Senate HELP Committee. They will determine the size and scope of PDUFA V.

However, the House and Senate Appropriations committees control the amounts of user fees to be collected and made available to the FDA. If there is to be a larger, offsetting appropriation to replace some user fees, these committees will have the find the money.

A smaller PDUFA V could only happen if House E&C Chair Henry Waxman and House Appropriations subcommittee Chair Rosa DeLauro agree. Likewise, Senate HELP Chair Tom Harkin would have to reach agreement with Senate Appropriations subcommittee chair Herb Kohl to implement a smaller user fee program. The Senate may be easier, since Senator Harkin is the #2 Democrat on Senator Kohl's subcommittee.

One person can cut through all of this and lead the way to a smaller user fee program. When President Obama submits his FY 2011 budget to Congress next February, he could include additional appropriated funds to reduce CDER's reliance on user fees. A good start would be to get the proportion of user fees below 50% of CDER funding.

I wouldn't bet on this happening…..but I can dream, can't I?

Steven

STEVEN GROSSMAN 8/30/09 STEVEN GROSSMAN 8/30/09

After Kennedy, Who Will Lead the Senate HELP Committee?

We mourn the passing of Senator Kennedy. He had something others admire, but can rarely duplicate. He was--often simultaneously—a formidable ideologue and the first to create a bipartisan bridge over troubled Senate waters. The health reform debate has suffered greatly from the absence of his commanding personality and his sense of how to make a deal (and make it stick).Sadly, we are already involved in the game of guessing who will be the new chairman of the Senate Health, Education, Labor and Pension (HELP) Committee. I have also started to think about the possible impact on the FDA.

Sadly, we are already involved in the game of guessing who will be the new chairman of the Senate Health, Education, Labor and Pension (HELP) Committee. I have also started to think about the possible impact on the FDA.

No one knows who will be the new chairman, despite a lot of instant analysis. Seniority on the committee is fixed, but every potential successor would have to give up something important.

Senator Chris Dodd has "right of first refusal" and has enjoyed his role leading the HELP committee on health care reform. He would certainly want to be chairman, except he would have to give up his chairmanship of the Senate Banking Committee, of obvious importance to his home state of Connecticut. Facing a very rough re-election campaign, commentators have been divided over whether he benefits from leaving the Banking committee and distancing himself from the near-collapse of the financial industries...or whether he should stay chairman and be the leader on re-regulating them.

Senator Tom Harkin is next in seniority. To take over HELP, he would have to give up the chairmanship of the Senate Agriculture Committee, of obvious importance to his home state of Iowa. He already heads the Appropriations subcommittee responsible for much of the labor and health care programs within the HELP jurisdiction. To have both positions would be incredibly powerful. Some commentators have said that Harkin isn't interested, but the better view is that he will need to assess the political consequences of changing chairmanships.

If Dodd and Harkin say "no," Senator Barbara Mikulski (MD) is next in line. She is also the most senior member of the Democratic Caucus who is not a full committee chair. It is widely assumed that she would happily take over the HELP committee. I think this is right, but at least one commentator has suggested that this might make it more difficult for her to eventually chair the appropriations committee, where she is fifth in seniority.

If this goes past Senator Mikulski, the next most senior member would be Senator Jeff Bingaman (NM), who would have to give up his chairmanship of the Energy and Natural Resources Committee. There are other Senators on the list after that, but the Majority Leader, Senator Harry Reid (NV), might step in first to assure leadership positions for more senior members within the Senate.

Not being discussed at all by commentators is a brokered deal for interim leadership. The chairmanship would then be decided in the next Congress (January 2011).

None of these potential chairs present any problems for FDA. They would all be expected to support the agency. That said, priorities for FDA will eventually change with new leadership of the HELP committee. Before that occurs, the new chair will have to evolve out of Senator Kennedy's enormous shadow and into their own agenda and style. That will happen, but slowly.

Steven

STEVEN GROSSMAN 8/9/09 STEVEN GROSSMAN 8/9/09

A Busy Year for FDA Legislation

With Congress on August recess, it is time to review and comment upon this year's FDA-related legislation, which seems more far-reaching than usual. Matched with an activist agenda from FDA's new leadership team, this could be a watershed year for the FDA.

A new law gives FDA jurisdiction over tobacco products, a massive new responsibility. It will be funded wholly by user fees. FDA is prohibited from using appropriated dollars for any tobacco activity. An announcement of a new center director is expected very soon. I discussed the tobacco center at: http://www.fdamatters.com/?p=303.

Before departing for recess, the Senate passed its version of the FY 10 Agriculture/FDA appropriations bill. Since it is similar to the House version and the President's request, it seems certain that FDA will be getting $295M in additional appropriated funds. For a change, FDA funding should be in place before the new fiscal year starts.

The legislation presages two issues that will need to be addressed during the next two budget cycles:

ever harder questions about how new monies are contributing to improvements in the public health. FDA is conscious that more scrutiny is coming and expects to be ready.
tension between funding new FDA responsibilities and continuing to strengthen the long-underfunded agency core. My recent column exploring the consequences of "unfunded mandates" imposed on the agency is at: http://www.fdamatters.com/?p=375.

Food safety reform is the most likely to pass of the remaining FDA legislation. The House approved its version just before recess. The Senate is likely to respond and final legislation should reach the President within 6 months.

The Congressional Budget Office (CBO) developed an analysis of the House-passed food safety bill. Because the bulk of new mandates are not effective immediately, FDA costs will not increase in FY 10 and FY 11. However, even after subtracting income from new user fees, the cost reaches $368M in FY 12, $749M in FY 13, and about $1B in FY 14. In short, FDA needs to grow by $1 billion in the next 5 years…just to cover new food responsibilities. Because it illustrates the unfunded mandates problem, I recommend the CBO report to those interested in FDA's future: http://www.cbo.gov/ftpdocs/104xx/doc10478/hr2749.pdf.

Legislation creating a regulatory pathway for follow-on biologics (FOB) is the next most likely to pass, probably as part of health reform. While it produces 10-year net savings for governmental and private insurers, the benefit will not go to FDA. I have heard (but can't verify) that it will cost $300M to set up the new program and about $150M per year for ongoing staffing and other costs. As with food, this is not a reason to oppose (or support) legislation, it is just an ongoing concern. My most recent analysis of FOB politics is at: http://www.fdamatters.com/?p=412.

Congress is again looking at drug reimportation. Although included in the Senate version of the Homeland Security Appropriations bill in July, it is likely to be stripped out in conference with the House. The issue will come up again because there are more than 50 Senators from both parties who favor reimportation. Were it to become law, it would have significant impact on FDA operations and funding.

In addition to FOB, health reform bills include other provision that will impact FDA directly. I will devote a later column to these miscellaneous FDA provisions, as well as some thoughts on how health reform itself might impact FDA.

A watershed year for FDA? It could be.

Steven