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. .

GAO Hits a Home Run

On July 20, the GAO released its study, "FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of its Resource Needs."

FDA's world has changed considerably since the report was requested. Some aspects of the report describe problems that are known and already being addressed. In other important regards, the report is extremely valuable. It will be widely cited and may be instrumental in creating positive changes at FDA.

The GAO started its research using the FY 2008 funding levels as the latest available figures. Subsequently, FDA received a $150M supplemental appropriation in FY 08 and a $325M increase in FY 09. It looks like the agency will get another $295M increase for FY 10. Over this period, the FDA will also have benefitted from a significant increase in user fees.

Therefore, using FY 08 funding levels gives a distorted picture of the FDA situation today.

Further, the new Administration has joined Congress in acknowledging the critical importance of FDA. They have committed to addressing the agency's many management and programmatic needs. When Congress requested the report, it was looking for GAO to build the case for better management, stronger fiscal controls and higher productivity in the medical product area. In 2009, neither FDA nor Congress need to be persuaded.

If increased funding has changed FDA's financial and programmatic situation....and the new Administration is already undertaking management initiatives, why is the GAO report so important?

The report's primary value is that the GAO has:

• developed the issues list,
  
• compiled the data,
  
• done the analysis,
  
• drawn the conclusions and
  
• made the recommendations.
  

They have been thorough in their work. Their views represent neither an ideological Congress nor a self-serving agency. Never mind that Congress has not been ideological in its concerns about FDA management. And that FDA has not done a good job at being self-serving. To the question "who says," there is a better, highly credible answer: "GAO does."

In the process, GAO has boosted some important FDA program needs and inched forward on some more difficult items. For example, FDA needs a major infusion of monies—well beyond what it's getting—to upgrade and disseminate information technology. The agency may not have enough people to review adverse events reports, but merely hiring more people cannot solve this problem. Only an IT solution can make this labor-intensive work more productive and valuable. Also, the report documents the growing demands on the agency from new legislative mandates and the difficulties in retaining staff.

At the same time, GAO "damns" user fees with faint praise about how it has given the agency flexibility and prevented it from falling further behind. In effect, GAO re-raises the difficult issue of public funding versus user fees. Nothing more is needed to start a debate…if someone wants to have one.

In sum, FDA and Congress are already working on many of the issues and recommendations contained in the new report. GAO's credibility and thorough analysis will make these efforts more productive and contribute to a stronger and better FDA.

Steven

The GAO report can be found at: http://www.gao.gov/new.items/d09581.pdf.

Unfunded Mandates Threaten FDA

FDA is finally moving toward a funding level that will strengthen the agency's core functions. In FY 08 and 09, the agency received more than $600M in new funds. FY10 is on track for another $295M. The FDA can use all this, and more. It is a vast improvement over a string of years where annual increases were closer to $50M, far less than the amount needed to break even with inflation.

With all this good news, there are still a few storm clouds that could rain on FDA's parade. The darkest of those clouds is the threat of unfunded mandates that could result from current Congressional initiatives.

Congress has already passed new tobacco legislation, which will be funded by user fees. Also under consideration are food safety reform (likely), follow-on biologics (probable), and drug reimportation (possible). Each of these three will require funds from FDA's budget.

I don't know how much it will cost to implement food safety legislation or to bring an entire new approval process into existence (follow-on biologics). Both will be expensive. Reimportation is less likely to become law, but will be very costly if we are to preserve a safe drug supply. Commenting on the overall situation, Chairman Waxman has said: FDA should not be set up to fail by being given new responsibilities without new monies for implementation.

The simple but hard question is: will Congress back new FDA responsibilities by giving the agency substantial additional funding? If not, FDA's improved budget situation will evaporate in the face of these unfunded mandates.

If new responsibilities add $250M to FDA's costs and the Agency gets a $300M increase, then that leaves only $50M for strengthening FDA's core programs and responsibilities.  The agency would be back where it was 3 years ago, when it was consistently receiving appropriations that were less than the 6% annual increase in agency costs.

The threat of unfunded mandates is real, but the time for Congress to act has not arrived. The appropriations bills are not supposed to fund legislation before it becomes law.

If any of the proposed legislation passes quickly, then there may be time for House-Senate conferees to add monies into the FY 10 agriculture appropriations bill. More likely, the vehicle would be supplemental appropriations bills for FY10. The first of these is likely to be late this year or the beginning of next year, making the absence of action at this point understandable.

Still, it would be nice to know that authorizers and appropriators appreciate the problem of unfunded mandates and are talking with each other about it. The key chairs--Representatives Waxman and DeLauro and Senators Kennedy and Kohl—need to see the emerging situation as critical to FDA's future.

Otherwise, unfunded mandates threaten and may destroy the successful effort to rebuild and strengthen FDA.

Steven

PS: Two important footnotes:

• I have taken no position on the merits of any of the legislation being considered by Congress. My sole purpose in this column is to make sure that funding keeps up with responsibilities.
  
• The opinions expressed in FDA Matters are my own. However, readers should know about the Alliance for a Stronger FDA, which has been the leading advocate for increased FDA funding. It is a 180-member, multi-stakeholder group that includes patient groups, consumer advocates, health professions organizations, trade associations and companies. It is also backed by three former HHS secretaries and six former FDA commissioners. I am one of the founders and serve as the deputy executive director. For more information about the Alliance, contact me at sgrossman@strengthenfda.org
  

Save the Critical Path—Part 1

The American public and the global marketplace wish to have access to innovation—whether in medical products or foods. Simultaneously, there are strong countervailing concerns about product safety. Both occur within an environment in which FDA's knowledge and tools are inadequate and failing.

The Critical Path program and related initiatives in CFSAN and other centers are designed to meet this challenge. Unfortunately, there has never been a sustained agency-wide commitment to these efforts. Further, most of Congress has not embraced the Critical Path, either conceptually or with substantial funding.

Only a strong, well-resourced FDA will have the time and manpower to address the future and give sponsors and other stakeholders the guidance they need. This can only be accomplished with monies that are specifically set aside for advancing regulatory science. It must be a major function of FDA, organized and funded separately from the divisions with every-day product responsibilities. In short, FDA needs to have an organizational home to promote knowledge and create standards in the regulatory sciences.

FDA Matters proposes the creation of a new entity at FDA: the Center for the Advancement of Regulatory Sciences (CARS). It will work with all centers (food, vet med, biologics, devices, drugs) to meet their existing, ongoing and future needs for knowledge, tools and standards.

Functionally, CARS should operate with the center directors as the primary clients and with the goal of helping each Center achieve its mission. CARS must be FDA-driven with stakeholder input, not an agency-stakeholder partnership. This is essential to obtaining and retaining Congressional support

The new Center should be closely aligned (through grants, contracts and strategic partnerships) with knowledge and expertise in academic medicine and other government agencies. The benefit to FDA of creating such relationships was an important part of the FDA Science Board report (December 2007). The Science Board found that external collaborations were underdeveloped and were particularly crucial for FDA in dealing with emerging sciences and technologies.

An initial funding level of $200 million per year would emphasize the importance of advancing regulatory science. It is vitally important that these funds be appropriated; none of the funds should come from user fees. There should be no ambiguity: this is FDA's initiative and the program's direction is coming from within FDA. This amount is about 10% of FDA's current appropriated budget and far more than the current investment in Critical Path and related initiatives.

There are a number of barriers---not least the bias toward current results, rather than future development. Yet, there are good reasons why Congress, FDA and all FDA stakeholders should support advancement in the regulatory sciences. Food and medical academia should also be supportive: CARS makes them into an FDA partner and stakeholder.

CARS is about the future of FDA. Let's embrace that future and show why it is worth such a large investment.

Notes:

Part 2 will appear next week and provide additional supporting arguments for CARS.

If you have questions about CARS that you would like answered in next week's column, please send them to me or post them below as a comment.

Readers are encouraged to register on the site to receive regular updates. Registering also provides the opportunity to post comments.

Steven

sgrosssman@fdamatters.com

FDA Faces Critical Juncture with FY 2010 Appropriations

On Thursday afternoon, June 11, the House Appropriations Subcommittee on Agriculture will have a mark-up that includes FDA appropriations for FY 2010 (starts October 1, 2009). This mark-up, and the one that will follow in the Senate, will be critical events in the capabilities and effectiveness of FDA for the next 5 to 10 years.

After years of drought for FDA, Congress has invested substantial new monies in the agency in FY 08 and FY 09. There are a number of reasons: strong Congressional champions, widespread media coverage of FDA problems, and the education and lobbying efforts of the Alliance for a Stronger FDA.

President Obama has started the FY 10 cycle with a request for a $295M increase for FDA. Given the long, bipartisan history of miniscule presidential requests for FDA, this was an important break with the past. While supporting the President's request, the Alliance is advocating for about $100M more.

Thursday's mark-up is the first time we will see how Congress intends to respond to the President's request. In addition, the mark-up may provide insight into the appropriations committee's view of new legislation that may give FDA significant new responsibilities in 2009.

Tobacco legislation—likely to pass the Senate this week—will be funded by user fees. After that, Congress is likely to pass a major expansion of food safety inspection capacity. Commissioner Hamburg has already stated that the agency does not have the resources to implement the House bill unless it receives new monies. Reimportation of drugs and follow-on biologics are less likely to be adopted than food safety, but are genuine possibilities this year. Each will be expensive.

The risk is that the gains of the last two years and another $300M for FY 10 will wind up paying for new responsibilities, rather than strengthening the agency. Hopefully, Chair Rosa DeLauro (D-CT) will reference these additional needs in her opening remarks. Or there might be committee language acknowledging the need for additional funds if Congress passes new laws that give FDA more responsibility.

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For those not familiar with the Alliance for a Stronger FDA, its 180 members represent the full range of agency stakeholders. They are strong advocates for increased appropriations for FDA and united in the belief that "a stronger FDA benefits everyone."

In the interest of full disclosure, I was one of the founders of a predecessor organization and now serve as deputy executive director of the Alliance. FDA Matters is not affiliated in any way with the Alliance.

The more members the Alliance has, the stronger its voice on Capitol Hill and in the media. If you want more information about the Alliance, write me at: sgrossman@strengthenFDA.org.