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

Dr. Hamburg’s Speech to the Alliance for a Stronger FDA

The Alliance for a Stronger FDA is the primary advocate for strengthening FDA through increased appropriations. It is a multi-stakeholder group that represents consumers, patient groups, health professionals, research advocacy organizations, trade associations and companies.

The Alliance was privileged to have Commissioner Hamburg address its quarterly member meeting on July 22.

She thanked the Alliance for the important work it is doing. She paid tribute to the Alliance's success in building consensus among a widely diverse group of stakeholders around increased funding for FDA. She specifically mentioned information technology (IT) as one of the areas where the Alliance has given visibility to an important agency need.

Dr. Hamburg spoke at length about the key challenges facing FDA and her priorities.  

Improving the Public Health. FDA is going to measure success in terms of public health outcomes. Because of the agency's unique and critical mission and historic underfunding, the new approach will explicitly link budget requests to achieving public health goals.

Increasing and Strengthening FDA's Regulatory Science Capacity. FDA needs stronger support for regulatory science and its science base. Investment and improvement must go together in regulatory science. This requires the agency to hire more expert regulatory scientists and collaborate more broadly with the scientific community outside the agency.

Meeting the demands that globalization places on the FDA mission to ensure the safety of food, drugs and devices. Not only must FDA develop a stronger scientific base, but scientific expertise must be available on a global basis.

Implementing the new tobacco regulation.  FDA is currently planning a tobacco center and in the process of hiring 600 staff. No other FDA components will be forced to make cuts as a result of the added tobacco responsibilities.

Creating readiness against a global pandemic. FDA is working on the lab tests, drugs and vaccines needed to respond to H1/NI and other strains of influenza. FDA will need significant resources to be successful because the job is both complex and unpredictable.

Dr. Hamburg made a number of other observations:

• FDA is trying to recreate its capacity to react and prevent crises, but is constrained by resources.
  
• The recent GAO report documenting resource and management problem has the full attention of the agency.
  
• Food safety legislation would help to close the gaps in the current systems and create more preventive controls. This also creates resource concerns, although a safer food supply is a job that must be done.
  
• FDA has to hire a large number of people and this is a lengthy process.  Human resources at FDA is central to putting new resources to work.
  
• FDA must rethink how it is doing many of its activities, including inspections. There is a need for more specialization within a more specialized workforce.
  

Although this is a report on an Alliance meeting, FDA Matters and the Alliance for a Stronger FDA are not affiliated. This blog represents my personal views and insights as a regulatory consultant and long-term FDA watcher. It is a product of my company, HPS Group, LLC.

Steven

DISCLOSURE: I was one of the founders of the Alliance and serve as its Deputy Executive Director. It is a multi-stakeholder group that represents consumers, patient groups, health professionals, research advocacy organizations, trade associations and companies.

If you are concerned about the future of FDA, I urge you or your organization to join the Alliance for a Stronger FDA. Please contact me about membership at sgrossman@StrengthenFDA.org. .

Dr. Hamburg Meet Dr. Collins

FDA and NIH are natural allies, with closely-related purposes as public health agencies. They share a similar worldview that "medical and scientific knowledge derived from random clinical trials" is superior to all other sources. I explored this in an earlier column at: http://www.fdamatters.com/?p=299.

Last week's announcement of Dr. Francis Collins to be NIH director provides a unique opportunity for FDA. Dr. Hamburg needs to meet Dr. Collins….and create a shared vision.

Government agencies are no different than corporate divisions: they crave positive attention, fight to accumulate bigger budgets and more personnel, and resist any attempts to lessen their autonomy. Tribal rules apply. Outsiders---no matter how well-meaning—cannot be assumed to have your organization's best interests at heart.

One could ask: why should FDA and NIH be different than this grim picture of organizational behavior? The answer is: they aren't. Except in rare cases, having a noble organizational purpose does not suspend the accumulative and suspicious culture that is inherent in any group.

There are countless joint initiatives and working groups that link FDA and NIH. Common purposes and a similar world view often push them together…but I am told that many of these meetings are productive only in a very narrow sense. Although the work gets done, the spirit of common purpose is often weak. Enthusiasm for power-sharing is low. Extending projects to related areas is sometimes never discussed. But opportunity is everywhere.

FDA and CMS relate in a different way. As described in my earlier article, the agencies do not have common purpose and do not have a shared view of what knowledge is important. Because of these fundamental differences, opportunities for shared initiative are limited and relations will always be strained. For FDA and CMS, good will and occasional joint successes can never overcome the distance between them.

Not so FDA and NIH. The two agencies working together are powerfully synergistic….and boundless in the benefits it could bring to Americans. The interest of NIH Institute and FDA Center directors is essential to building a better, more productive relationship. But it will never happen if it rests on their ability to overcome the cultural and tribal impediments.

Only Dr. Hamburg and Dr. Collins can set the proper tone, provide guidance and break down the barriers. Dr. Hamburg, meet Dr. Collins. Please.

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.

Seven Challenges for FDA--revisited

Most current readers of FDA Matters were not receiving these posts during the first week when we examined seven long-term challenges for FDA. Today's column updates this topic. It underscores the need to plan for FDA's future and not let the day-to-day demands consume all the available time.

Each of these challenges requires substantial effort. Two or three years from now, these are the items that everyone will say: "glad we started early."

Here is an updated version of the seven challenges:

Integrating new science into traditional clinical trials. Constructing real-world clinical trials has never been more difficult. In many clinical areas, we are moving from targeting disease symptomology toward a new paradigm of altering fundamental biological processes. These issues need a broader, more systemic examination, as well as more resources applied to Critical Path and other clinical trial improvement initiatives.

Balancing safety with patient risk and need. All FDA approvals represent a balance between risk and benefit. There is a lot of variability in what the agency views as acceptable risk for patients with life-threatening conditions. FDA often undervalues the needs of patients with disabling conditions that are not life-threatening. In most FDA activities, medical and scientific expertise and insight is the key to decisions. Creating better risk-benefit judgments is different: patients are the experts on what they feel and believe and on what risks they would accept for what benefit. Meaningful dialogue requires that patients lead this process, not be an afterthought.

Sifting valuable information from background noise. Through statute and directive, FDA has been asked to collect, analyze, interpret and utilize massive amounts of data. This includes biological, clinical, adverse event, production and distribution data, and medical and food product tracking. FDA lacks the sophisticated systems it needs. Once these systems are developed, it is still a difficult, highly iterative process to distinguish meaningful patterns from background noise and to create actionable intelligence.

Managing globalization, rather than just responding to it. There needs to be a comprehensive, multi-year plan for managing globalization, including a budget for Congress to consider and fund. Tomorrow's problems need to be identified and addressed before they become even bigger issues. Food and drug tracking, recall authorities and overseas offices are necessary, but they are not sufficient to meet this challenge.

Resisting the bias toward negative decisions. Uncertainty is inherent in all positive decisions. Taken to the extreme, excess caution could force the whole world of food and drugs to slow down, and then stop. The correct balance is not achieved by a memo or a speech, but by day-to-day actions and enhanced communications. Systematic review of all decisionmaking processes could be an important corrective.

Staying focused on priorities. FDA's responsibilities greatly exceed its resources. Some mission creep is inevitable and some new responsibilities may be needed to benefit society and the public health. But sometimes FDA needs to say "no." Such moments are difficult. "No" will never be accepted by policymakers or the public unless FDA is clearer in defining, justifying and explaining its priorities. This must be addressed comprehensively.

Keeping the Best and the Brightest. FDA cannot succeed without a high-quality and committed workforce. Public service is an important attraction of working at FDA. It cannot be allowed to go out of style. Increased appropriations provide the opportunity to rationalize workloads, reduce burn-out, and build morale.

Do you have items you would add to this list? If so, post comments with your suggestions or e-mail me at sgrossman@fdamatters.com.

Note: Each of these challenges will be explored individually in separate posts.

The first of these: "Turning Data into Knowledge" was posted on June 2 and can be found at: http://www.fdamatters.com/?p=275.

The second: "Save the Critical Path-Part 1" was posted on June 17 and can be found at: http://www.fdamatters.com/?p=317.

Steven

“The Principal Makes the School” and Other Thoughts for the New Tobacco Center

My experience has been that "the principal," not the teachers, is the key to having a great school. Outstanding principals attract the best teachers and get maximum performance from everyone. The point for Dr. Hamburg: picking the right director for the new tobacco center is your only mission-critical job. All the other details can be handled by your staff and the new center director.

Here are some of the keys to successfully implementing the new tobacco legislation:

Minimize transfers from other parts of FDA. This probably violates some important management principle about letting people bring their talents to the job that interests them most. Still, FDA's budget is growing quickly and its responsibilities even quicker. There are dangers to FDA's overall mission if existing teams are diluted by a large number of transfers to the new center.

Manage the new tobacco center as if it were a separate agency. There will be crises and hearings, complaints and campaigns aimed at the tobacco center. FDA needs to create a self-sufficient center that minimizes the distractions for the rest of FDA. There is one reality that cannot be avoided: the Commissioner has only 24 hours per day.

Audit-proof the accounting for the tobacco user fees. It is 100% certain that there will be challenges as to whether the user fees are accurately paying for all the costs. FDA should bring in someone from outside (maybe from GAO or a big accounting firm) to create a cost accounting system that is parallel to, but separate from, the rest of FDA

Let's return briefly to the question of picking the best "principal" to head the new tobacco center. Ideally, the person would have broad governmental experience, close-up familiarity with FDA, a public health and regulatory perspective and the presence and stature not to dissolve during a critical press conference or a heated Congressional hearing.

The inclination may be to hire a public health leader who has led the fight against smoking. Unfortunately, most of these leaders lack experience as regulators.

Kate Rawson of the RPM Report floated a name in March that should be given serious consideration: Dr. Steven Galson, the acting surgeon general. She cites his experiences at CDC, EPA and as head of CDER at FDA.

I don't know whether he is interested and this is not an endorsement. Dr. Galson does have the ideal credentials I have suggested: broad government experience, close-up familiarity with FDA, public health and regulatory perspective and the gravitas and presence to handle the heat. He has the added advantage of not depriving FDA of existing leadership in order to staff the tobacco center. Another name being discussed: Mitchell Zeller, a former associate commissioner and director of the FDA's Office of Tobacco Programs. While not a physician, he also has many of the characteristics that Dr. Hamburg should be looking for.

Kate's RPM column can be found here:

http://therpmreport.com/Free/cdb495e7-06f4-4dbe-b265-41b0227d9381.aspx?u

Turning Data into Knowledge

Through statute and directive, FDA has been asked to collect, analyze, interpret and utilize massive amounts of data. This includes biological, clinical, adverse event, production and distribution data, medical and food product tracking, and the Sentinel system for early discovery of potential drug safety problems. The systems are not in place to do any of this, at least not at the required level of sophistication. Even if they were, sifting valuable information from background noise is extraordinarily hard. As a result, FDA needs to manage Congressional and public expectations as to "what is possible and when."

Above and beyond its day-to-day information technology needs, FDA will require substantial monies to develop these new databases. Further, the agency lacks the data-mining experts needed to make sense of the data that is received. Such individuals are few and in high demand. Even were the agency given the funds to hire 100 of them this year, it would probably not come close to reaching this goal. Even when the required expertise is on-board, it is a difficult, iterative process to turn data into usable knowledge.

FDA must take account of the littered field of others' past failures and limited successes. Even programs that work well may have limited applicability to FDA's daunting task. The VA system operates with electronic medical records, a finite number of known participants and a partially closed system of care. The Drug Abuse Warning Network (DAWN) tracks only drug-related hospital emergency department visits and drug-related deaths reported by coroners and medical examiners. Each has key characteristics that are not present in tracking food and product use--and consequences--in a real world setting.

FDA has been told that the Medicare claims data set (provided by CMS) gives them a fast start along this difficult path. Perhaps not. I often use the following equation to explain:

Real world data sets = uncontrolled variables + inconsistent data collection + questionable data accuracy.

FDA is used to the type of knowledge derived from controlled clinical trials. In contrast, claims data is notoriously unreliable with few tools to identify and correct for systemic bias.

With very limited staff, FDA has done yeoman work on the initial phases of developing its Sentinel initiative. The goal is a nation-wide electronic safety monitoring system for post-market surveillance. It will use existing data from health systems, hospitals and insurers. An operational system will be a challenge. Creating one that minimizes false positives is more than just a challenge.

There are also some larger issues that will need to be addressed. Even with new hires throughout the agency, medical knowledge and food surveillance needs are growing faster than FDA expertise. Not every "cluster" leads to a medically or scientifically valuable insight. The consequences of premature responses and over-reactions are substantial and often severe. Nonetheless, the tendency in our society, even sometimes at FDA, is to forget that the association of data points often tells us nothing about causality. Finally, it is hard to know the implications of studies that show that more information often does not produce better decisions. This runs counter to FDA culture and is counter-intuitive to the way most of us think.

In sum, FDA has a large job in the area of information technology, data collection and data interpretation. In addition to the need for monies and expertise, there are inherent, as well as institutional barriers to success. Managing expectations will be a test for the new FDA leadership and the senior staff.

Welcome to FDA, Dr. Hamburg

Dr. Hamburg, you have advantages that previous Commissioners did not enjoy. For the first time in decades, there will be extra money to spend, granted by a Congress that will continue to invest in FDA if they see a pay-off. You will be working in the first two years of an administration, when bold plans have the best chance of being realized. You are working for a president interested in public health, a rare event in the last 70 years.

It is not hard to predict that emergencies and crises will take up a lot of your time. So will the care and feeding of the Secretary, OMB, the President and Congress. FDA staff also needs attention, which you and Dr. Sharfstein have appropriately emphasized. There is likely to be tobacco legislation to implement and maybe a new food safety law.

In Long-term Challenges for New FDA Leadership, http://www.fdamatters.com/?p=171, I discussed some issues that may take years to complete, but should be started this year. I hope you will get to them.

Before you can do much long-term planning, you will have to deal with a backlog of policy issues and enforcement actions. This is to be expected when you are preceded by the end of an administration and by "acting" agency heads. Certain decisions just cannot be made until "permanent" leadership is in place.

More than any other activities, you will be judged in the short-term by how you handle the policy and enforcement backlog. These are the decisions that are most likely to animate external stakeholders. As a result, you may have to deal with misperceptions about your approach and your intentions.

Dealing with the back-log—perhaps as many as two or three major policy and enforcement decisions every week for several months—will strike many as hyperactive. They will extrapolate these actions into believing that you intend to govern that way. Eventually the pace will lessen into (merely) frenetic, but not before hard feelings may have set in.

You should communicate that you are dealing with a backlog, rather than planning to make so many major decisions on a regular basis. Emphasize, too, that most of the backlog was generated before you arrived, by FDA staffers operating under statutory or other imperatives. You agree with what staff proposed, but did not initiate it.

During Dr. Sharfstein's first two weeks, he signed the Internet advertising enforcement letters and committed to a review of class III medical devices. Neither was a new issue. The public-released packages reveal upwards of a year or more of FDA staff work behind each. Nonetheless, some saw this as evidence of Dr. Sharfstein's intent to be aggressive in confronting industry. A much better interpretation: these two issues waited for leadership that would be at FDA long enough to defend them.

Many of us hope that this is the start of a golden age at FDA. You are starting with a lot of good will and high expectations. To keep that momentum going, you and Dr. Sharfstein will need to act judiciously and communicate well as you work down the backlog.

Drs. Hamburg and Sharfstein: “The FDA as a Public Health Agency”

Wasting no time, Drs. Hamburg and Sharfstein have written an essay, entitled "The FDA as a Public Health Agency." (Available on-line at: http://content.nejm.org/cgi/content/full/NEJMp0903764). Noteworthy in the new essay is the "big tent" approach they plan to use. They repeatedly refer to consultation with regulated industries, consumers, patients, and the public. They describe specific areas for working more with CDC, NIH, CMS, and the Department of Agriculture.

Drs. Hamburg and Sharfstein touch upon a potpourri of agency issues:

• FDA should be judged by its success in assuring a safe and nutritious food supply and innovative, safe and effective medical products. This must go "beyond such intermediate measures as the number of facilities inspected or drugs approved."
  

• The potential good of a medical product or policy should be balanced against its potential harm. They add: "Some benefits are not worth the risk; some risks are worth taking."
  

• The focus of increased work with NIH should be on accelerating the development of cures. The focus of increased work with CMS should be the exploration of ways to shorten the time from approval to reimbursement.
  

• The focus of increased work with CDC should be on infectious-disease emergencies, outbreaks of foodborne illness, enhanced safety systems, and nutrition.
  

• A new approach to external affairs is foreshadowed by discussion of risk communication, more focus on the scientific basis of agency decisions, and greater transparency.
  

Both by words and tone, the overriding message of the Hamburg/Sharfstein article is that the FDA is a public health agency and will be run by the principles of public health as applied to the issues and opportunities facing the FDA. My May 15 commentary, "Public Health Leadership Comes to FDA," (http://www.fdamatters.com/?p=211) puts some additional texture on this:

It is a perfect time to put the agency in the hands of experienced public health leaders with real world experience. The answer to every question and pressing issue: we will explore what is right from a public health perspective, and then act accordingly. Public health does not require safety to be an absolute value that cannot be offset by other considerations. Innovation to restore health is just as much a public health value as safety.

Dr. Hamburg and Dr. Sharfstein have limited track records on FDA issues. This uncertainty breeds anxiety. Six months from now, everyone will see that the agency is being run by steady, pragmatic leaders. Indeed, it is quite difficult to run the public health department of a large city without these virtues.

This NEJM essay demonstrates that having "limited track records on FDA issues" has not stopped Drs. Hamburg and Sharfstein from having a good sense of the issues and well-developed ideas about how to improve FDA. Ultimately, we, as readers, learn from the essay that Drs. Hamburg and Sharfstein have the knowledge and commitment to address the challenges faced by FDA.

Public Health Leadership Comes to FDA

The world will soon realize that the new FDA leadership--Dr. Hamburg and Dr. Sharfstein-- come from an entirely different mold than their predecessors. When Dr. Hamburg is sworn in, she will formally begin an era of public health leadership at the agency. FDA staff and agency stakeholders will eventually come to appreciate that this difference is good for FDA.

It is a perfect time to put the agency in the hands of experienced public health leaders with real world experience. The shift will be both interesting and salutary. Notably, there will be a consistent standard in decisionmaking. The answer to every question and pressing issue will be: we will explore what is right from a public health perspective, and then act accordingly.

FDA staff and agency stakeholders argue for their position by saying they are advancing the public health, while secretly believing that other factors will drive the final decision. It is disarming, then, for the Commissioner to actually treat "public health benefit" as the agency's North Star.  Of course there will be many disputes, but everyone will have to build their rationale on public health grounds, knowing that it is the real basis of decisionmaking.

Several misunderstandings drive concerns about public health leadership at FDA. Public health is about helping people and communities to get healthy and stay healthy. Prevention is preferred because it preserves health, while therapies "only" restore health. Preferring prevention is not the same as being against therapy. Public health is not anti-therapeutic nor could any FDA commissioner be anti-therapeutic.

Public health does not require safety to be an absolute value that cannot be offset by other considerations. Innovation to restore health is just as much a public health value as safety. Dr. Hamburg has affirmed this.

What it means to run a big city health department has also been misunderstood. The imperative to act is immediate and real, but you learn that "what appears to be real" has to be examined before any decisions are made. Nothing you're told can be relied upon until it had been rechecked and sometimes double and triple re-checked. An over-simple example: reports about unsanitary conditions in a restaurant might just be from the eatery across the street that has lost business.

Dr. Hamburg and Dr. Sharfstein have limited track records on FDA issues. This uncertainty breeds anxiety. Six months from now, everyone will see that the agency is being run by steady, pragmatic leaders. Indeed, it is quite difficult to run the public health department of a large city without these virtues.