Why Do Some People Dislike FDA?

Yesterday, I received separate posts from three organizations that are anti-industry, one of which dislikes FDA and one of which hates FDA. They are not alone in these feelings. There are many groups and individuals who believe that industry and physician professional societies run FDA. I don't accept their premise or the "facts" from which they launch attacks.

On the same day, I got an update from Americans for Medical Progress (AMP), an organization that educates media and the public about the importance of animal testing in advancing human health. FDA could not do its job without animal studies, both their own and those submitted by sponsors. AMP is among the "good guys" and can always use more support for their work, www.amprogress.org.

I would like to say that all the advocates, such as AMP, are realists and advance the common good by advocating for NIH and FDA….and that all the extreme critics and haters are irrational and inflammatory. It isn't that simple.

The FDA I know is a regulatory agency staffed by smart people trying to do their best. Given its mission, FDA is inherently imperfect and always vulnerable to criticism. The agency has been chronically understaffed and hasn't been able to give every decision the attention it might deserve.

I am on my tenth FDA commissioner. Bad decisions were made during each of their tenures and they all experienced bad days when nothing seemed to work the way it should. Meantime, hundreds of drugs and devices have been approved without subsequent mishap. Our food supply is vulnerable because of globalization, yet it is the safest in the world.

Those who dislike or hate FDA focus almost exclusively on those bad decisions and on the agency's most difficult days. In their minds, that is the FDA. They don't see the rest of the days where things went well: public health improved, patients received new FDA-approved therapies and more than 300 million Americans ate food without an outbreak of foodborne disease.

Because they ignore the good days and focus only on the bad, the haters feel justified in concluding that the agency is corrupt and deserving of vilification. I disagree vehemently with this premise.

I see some of the same problems they do, but recognize the problems are only a small part of FDA's mission and accomplishments. Given this wider perspective, it is misguided to impugn FDA and its staff. Bad days occur, but not because of impure motives or because agency officials blindly listened to the industry's views.

Those who dislike and even hate FDA serve a purpose. Scrutiny makes everyone think and work a little harder to make good decisions. Companies with safe manufacturing plants can still get in trouble with FDA if they haven't documented their safety-related activities. So, too, FDA needs to be able to show it has listened carefully and decided wisely. It can't just assert its decisions are good ones. Better documented and more predictable decisions are needed.

All of this can be taken too far….so that over-cautious decisions become a source of delay or failure in meeting the needs of patient and consumers. The haters would certainly like it that way. The extreme critics serve some useful purposes in a narrow sense, but they are wrong about the big picture of FDA's mission, intent and accomplishments. It is critical that we act civilly in the face of this hatred. That said, we must act to counter their arguments and make sure that the extreme version of FDA-bashing has no reputable standing in Congressional, media and public discourse.

Steven

More predictable decisionmaking at FDA was discussed in an earlier column.

In Praise of Predictability September 3rd, 2009

FDA has always found it challenging to make its actions predictable. This problem will worsen for a number of months while Dr. Hamburg redefines the agency's mission, policies, actions and working assumptions. Once this has been accomplished, the agency will become dramatically more predictable to stakeholders, including Congress. Read the rest of this entry »

In Praise of Predictability

FDA has always found it challenging to make its actions predictable. This problem will worsen for a number of months while Dr. Hamburg redefines the agency's mission, policies, actions and working assumptions. Once this has been accomplished, the agency will become dramatically more predictable to stakeholders, including Congress.

I have written how Drs. Hamburg and Sharfstein's public health backgrounds make them different from their predecessor over the last 35 years--who were mostly researchers, teachers and clinicians from academic health centers. "Public health" as practiced in a big city health department has a gritty immediacy that shapes every activity. In contrast, academic health centers are devoted to providing clinical services to patients and educating students and house staff. Public health is a valuable by-product, but rarely a primary mission.

"Predictability" also means something different in city government than it does at a university. Public health departments are on the frontlines for all public health decisions--from the availability of flu vaccine to monitoring restaurants for sanitary conditions. Leadership must persevere in the chaotic environment of a big city. Every day brings unpredictable events generated by external forces. Success is achieved by having a tight organizational structure and "standard operating procedures" (SOPs) that cover nearly every potential challenge. In most situations, employees, stakeholders, mayors, and councilmen know what to expect. .

Unpredictable external events play a much smaller role in the life of an academic medical center. The combination of a medical school, a teaching hospital, and biomedical research labs is considered one of the most complex systems in our society. Leadership is more inwardly focused, trying to make the different components work together….and work well. Organizational predictability almost always take a backseat to people management, work flow and revenue generation.

My point is that Drs. Hamburg and Sharfstein have been schooled in the value of creating predictability. Generally speaking, their predecessors were not.

Predictability is in short supply at FDA currently--because the new leadership team is identifying the agency's internal and external problems and constructing appropriate solutions. The "new normal" that eventually emerges will be: more focused in the face of a broadening mission; more committed to serious enforcement; and more dedicated to innovation that is consistent with public health and science.

In the process, agency policies and actions will be increasingly based on SOPs, public and industry guidances, and clear articulation of scientific and legal positions. These will be implemented by a larger, tighter organization that will be more consistent in its decisions.

Although some of this evolution will be painful for FDA-regulated industries….they will eventually benefit from greater predictability and less ad hoc decisionmaking at FDA. And all stakeholders benefit from the increased public credibility that FDA will earn when its decisions are easier to understand, better grounded in science and public health and more predictable.

Steven

Hot Town, Summer in the City

Thirty years ago, Washington closed down every August. The heat and humidity were beastly and Congress was gone. Over the intervening years, DC has become a 12-month town, with August one of the busier times.

For FDA, there has been so much August-action that this column had to fit my analysis of two developments: the appointment of the new tobacco center director; and the reorganization of the Commissioner's office.

Appointment of the first Director of the Center for Tobacco Products. In an earlier column (http://www.fdamatters.com/?p=303), I identified the ideal credentials for the new director of the tobacco center:

• broad government experience,
  
• close-up familiarity with FDA,
  
• public health and regulatory perspective, and
  
• the gravitas and presence to handle the heat from Congress and stakeholders.
  

Commissioner Hamburg's choice, Dr. Lawrence Deyton, is a near-perfect match. He is scientifically-grounded, policy savvy, has strong managerial experience and has worked at VA, NIH, HHS and as a staffer in Congress. He is currently the chief public health and environmental hazards officer at the Veterans' Administration.

Based on news accounts, Dr. Deyton has experience with tobacco policy and cessation programs, but it is a very small part of his resume. He had no role in the long effort to create the new Center. None of the stakeholders appear to know him or to have worked with him. All of these are to FDA's advantage and underscore the political shrewdness of the choice.

Passage of the new tobacco law was anti-climactic. The appointment of the new director begins the part that is fresh and exciting. Government regulation of tobacco is finally a reality, with the mandate to turn rhetoric into action.

To Dr. Hamburg, I say "well done." To Dr. Deyton, I say: "never forget the enormity of cigarette-related disease and the need for the strongest possible public health regulations to combat it."

Re-organization of the Commissioner's Office. It is very seductive to imagine that moving boxes around on an organization chart solves problems. It doesn't.

Nonetheless, there is much to ponder in the newly-announced reorganization of the Commissioner's Office. It offers substantive changes that make sense. Here are the three most important:

• Creation of a new Office of Foods, headed by a deputy commissioner for foods. The food center and the veterinary medicine center will report directly to this new office, adding management responsibilities to what was previously a staff function. Creation of the new office ends confusion about who is in charge of food. These changes will take pressure off the commissioner. It creates the optimum structure for making foods more effective within FDA. Ultimately, this may decrease the perceived benefit of creating a separate food agency.
  

• Combining policy and planning with budget. These functions are closely related and need to provide similar visions of FDA's future. Reporting to different people has been an impediment.
  

• Elevating the Office of the Chief Scientist to deputy commissioner status, with more programmatic responsibilities. This provides renewed credibility to the oft-repeated message that FDA needs to elevate its scientific mission. It also increases the responsibilities of Dr. Jesse Goodman, one of the agency's most respected leaders.
  

Although this is still moving boxes around on an organization chart…these changes should make it easier for talented leadership to deliver optimum results. I like it.

Steven

A Resignation and an Allegation at FDA

Several reporters called me last week to ask if I had heard about Dan Schultz's resignation as head of the Center for Device and Radiological Health (CDRH). Had I also heard about conflict-of-interest (COI) allegations against Janet Woodcock, head of the Center for Drug Evaluation and Research (CDER)? Some of the reporters wanted to connect the two events. They wanted me tell them, pundit-like, what this said about Commissioner Hamburg's approach to integrity in decisionmaking and to allegations of wrong-doing.

I disappointed them.

I see no connections between the Schultz resignation and the leak of the Woodcock allegation. One was between Dr. Hamburg and Dr. Schultz and relates to the best interests of the agency going forward. The other is between an unhappy company and Dr. Woodcock and is being handled, appropriately, by the Inspector General. The Commissioner's role, if any, would come later.

There are other important reasons to think the stories are unrelated. Over the past year, Dr. Schultz has faced a series of attacks on his stewardship of CDRH, including calls for his resignation. Whether innocent or guilty, he has been forced to operate in a beleaguered environment.

We do not know what Dr. Hamburg believes. We are told that the resignation was a joint decision. In any case, it falls within the discretionary authority of the Commissioner. They may have discussed the various charges when they met. More likely, the bulk of the conversation was about whether Dr. Schultz's ability to lead has been compromised….or whether, under the circumstances, he is the right leader for a product area slated for intense review that may become a heated public and Congressional debate.

Dr. Hamburg has said that there will be changes in the leadership team. Several have already occurred. One or two of the departures may be a result of her commitment to high ethical standards. It is more likely that people will be replaced because:

• Dr. Hamburg wants her own team, or
  
• there are policy or personality conflicts, or
  
• she has concerns about FDA being caught up in side-issues and personalities.
  

While there may have been more involved, this last reason is sufficient for Dr. Hamburg to want a change at the top of CDRH.

Dr. Woodcock's situation is totally different. There is a single public complaint made by a company that fears it is losing a high-stakes competition for market entry. They are asking only that she recuse herself in the specific matter in which the two companies are involved.

The Inspector General's investigation of Dr. Woodcock appears to be a routine response to these conflict-of-interest allegations. No one should pre-judge the situation until OIG has completed its report. I would expect Dr. Hamburg to do just that---wait for the report before deciding whether any action is needed.

The Schultz and Woodcock stories are interesting, albeit unfortunate. They are totally unrelated and tell us nothing about Dr. Hamburg's approach to leading FDA.

I am sure we will hear more from Dr. Hamburg on FDA integrity and the FDA decisionmaking process. But that wasn't this past week's story….no matter how hard anyone tried to make it so.

Steven

Transparency at FDA: A Work in Progress

A mantra of the new Administration is that government needs to be transparent. While the goal is laudable, the scope of the task is often ill-defined and everyone has their own ideas about what transparency means. FDA's efforts must be viewed as a work in progress that may stretch over years.

The agency has gotten off to a good start with a transparency task force, chaired by Principal Deputy Commissioner, Dr. Joshua Sharfstein. In an earlier post, I addressed some of the likely outcomes of the task force's work: http://www.fdamatters.com/?p=285.

What I didn't discuss at the time were some key issues the Task Force needs to address. Here are my thoughts:

Information is not transparent if it is available, but can't be found. There are hundreds of thousands of pages of information that are publicly accessible from the FDA website. This number will grow steadily as additional archival documents and newly generated materials are posted.

It can be very hard to find what you want in this mass of information. The new FDA website is an improvement. Yet, the homepages for the FDA and the Centers are too cluttered….and not organized to easily get the link you want. Until the agency home pages deliver information effectively, FDA needs to highlight the search functions on the site.

Information is not transparent if it cannot be accessed in a timely fashion. Freedom of Information Act (FOIA) requests often take months to be settled. Expanding the range and depth of materials on the website will help. Still, FOIA requests should be acknowledged within 10 days and a very high percentage fulfilled within 30 days.

Information is not transparent if it isn't readily available to the media. There is robust coverage of FDA in general circulation and trade publications and in new media (such as this blog). However, veteran FDA reporters, such as Jim Dickinson, tell me that access to agency information and FDA subject matter experts has narrowed considerably over the last 15 to 20 years. FDA needs to remove barriers to access by journalists. For most people on most topics, the media is their source of information on agency activities.

Some of FDA's transparency policies should be based on "lessons learned" by other government agencies. In particular, state governments have already converted to a more open, user-friendly approach. There are dozens of organizations that have comparable amounts of information stretched across hundreds of topics, yet have confronted and conquered the website clutter problem.

Other policies need to recognize FDA's uniqueness. It is a public health agency, a scientific agency and a regulator. It oversees products that represent a quarter of consumer spending. It is a repository of confidential business information with a collective value that probably exceeds $100B. Balancing these proprietary concerns with public health needs is likely to be the most difficult part of the task force's mission and may not be finalized any time soon. While this is being resolved, FDA could improve agency transparency by addressing the three issues I have raised above.

Transparency is a state of mind. It may take considerable time before "open" and "available" become the default choice of federal government agencies. It is certainly not in FDA's cultural or institutional DNA to be transparent. FDA's progress can be measured in days and months, but comprehensive policies may still take years.

Steven

Save the Critical Path—Part 2

Transforming FDA into a first-class, 21st-century regulatory agency will not be easy. It requires planning, commitment and a broad vision. Science-based decisionmaking is a central part of the transformation, but it doesn't just happen by itself. Regulatory science needs to provide the tools, standards and knowledge for FDA to handle an ever-more complex world of science and commerce.

To meet this challenge and provide a broad vision, FDA Matters has proposed the creation of the Center for the Advancement of Regulatory Sciences (CARS). It puts FDA's science and FDA's future at the heart of the agency, where the commitment can be constant and everyone won't be running off to meet the next crisis.

"Save the Critical Path-Part 1" appeared ten days ago: http://www.fdamatters.com/?p=317. Here are some questions I have been asked since then.

What is regulatory science?

There is no standard definition for "regulatory science," although the term is widely used and generally understood. It 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" extends to every aspect of the FDA's responsibilities, including manufacturing, product tracking, laboratory procedures, post-market standards, sentinel monitoring, etc.

What are the key characteristics of CARS?

The purpose of CARS is to build the science-based decisionmaking capacity at FDA by creating and validating new scientific knowledge, tests and standards. It should produce greater consistency and predictability in the agency's regulatory activities.

CARS must be FDA-driven and funded with public monies. It must be an FDA initiative with stakeholder input, not an agency-stakeholder partnership. These characteristics are essential to obtaining and retaining Congressional support. There can be no ambiguity: this is FDA's initiative and the program's direction is coming from within FDA.

Consumers and industry benefit from an FDA that is more sophisticated in its approach, more capable in its actions, and more confident that its decisions are scientifically-derived.

Why can't Critical Path and the Reagan-Udall Foundation achieve CARS' purposes?

In Europe it has. The EU's Innovative Medicines Initiative (IMI) is multi-hundred million dollar program designed to address the main causes of delay in pharmaceutical R&D and encourage more rapid discovery and development of better medicines. In Europe, it is acceptable that this is done through a public-private partnership and it contributes to the strengthening of EMEA and national drug regulatory agencies.

If this approach were viable in the US, the Critical Path would be more deeply funded by Congress and the Reagan-Udall Foundation would be ready to accept private funding on a par with the IMI.

Neither has happened. Despite the good intentions of their advocates, there is little evidence it will. A public-private partnership of this type, heavily dependent on private support, will always make the activities and the results suspect in the US. Maybe it shouldn't be that way, but it is the reality we face as friends of the FDA.

CARS is an attempt to redefine these efforts and make them into wholly public activities that can draw broader acceptance and achieve quicker results. The goals of the Critical Path and the Reagan-Udall Foundation are a stronger, more future-oriented FDA based on improved regulatory science. If we can keep it public and FDA-centric, then this becomes possible again.

Many Facets to the Transparency Task Force

FDA's disclosure policies are intended to be a balance between "public right to know" and "company right to protect intellectual property that supports innovations." As such, every FDA policy has a risk-benefit to society, which evolves over time. Seen in this light, the new FDA task force on agency transparency is a legitimate inquiry. It probably should be repeated every 3 to 5 years.

Compared to products, it is much trickier to figure out when policies need to be changed and based on what criteria. Yet, it is possible, even now, to predict the broad outline of the task force report, due in early December:

Low-hanging fruit: There are policies and procedures whose revision is obvious when subjected to examination. For example, more of the senior people at FDA should be required to keep a public log of meetings with external stakeholders. This is fair as long as it includes contact with any interest group, not just industry.

More substantive changes requiring more work of FDA, but public interest clearly weighs in favor of disclosure: FOIA immediately comes to mind. My experience is to get a call from FDA asking if I want the information —12 to 18 months after a FOIA request. I never have gotten anything in a timeframe where I could use it.

Large changes requiring new policies or major re-working of existing policies: These are likely to invoke heated exchange now, but a year hence, everyone will wonder what the fuss was about. An example from the past: the policy of FDA and company briefing books being posted online two-days prior to an advisory committee meeting.

Major changes requiring legislation: These are the ones widely predicted by media, much feared by industry and least likely to happen. One such
proposal, advocated in a NY Times editorial, would substantially increase the amount of company data made available to the public before and after approval of medical products. Some change in this area will happen, but not much. The legislative barriers are too high, the lack of consensus too great, and caution will prevail because no one can be certain where the proper balance lies.

Hanging over all of this is the need for the agency to communicate better. As Dr. Sharfstein observed, sometimes the agency has a good explanation, but it "doesn't break through because of FDA's reputation for being uncooperative."

As a footnote: the task force exercise itself is going to prove instructive, if only because old habits die hard. A tip of the hat to fellow blogger Mark Senak for pointing out that the transparency task force blog: neither identifies who will be writing and posting blogs nor who will be responsible for accepting and rejecting public comments intended for the blog site. No doubt this will be remedied quickly, but the point is still significant: transparency and accountability are not part of FDA's DNA. New habits will take time, energy and experience to develop.

The June 3 Federal Register notice for the June 24^th public hearing of the Transparency Task Force:

http://edocket.access.gpo.gov/2009/pdf/E9-12902.pdf

The original NY Times article by Gardiner Harris on June 2:

http://www.nytimes.com/2009/06/02/health/policy/02fda.html?_r=1&scp=1&sq=gardiner%20and%20heartburn&st=cse

NY Times editorial on transparency and FDA on June 3:

http://www.nytimes.com/2009/06/03/opinion/03weds2.html?tntemail1=y&emc=tnt&pagewanted=print

Mark Senak's comments: http://www.eyeonfda.com/eye_on_fda

Reported in the June 4, Drug Daily Bulletin (free): enewsletters@fdanews.com