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Andrew C. von Eschenbach, M.D., Food and Drug Law Institute

This text contains Dr. von Eschenbachs prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

The FDA Amendments Act: Reauthorization of the FDA
Remarks by

Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs

Annual Conference
Food and Drug Law Institute
Washington, D.C.
March 26, 2008



I am very pleased to address the Annual Conference of the Food and Drug Law Institute.

You are very important supporters of the Food and Drug Administration, with great knowledge and insight into the very intricate structure of laws and regulations that govern the conduct of business required to carry out our regulatory mission to protect and promote the public health.

Many Commissioners have used this forum to report on the status of FDA and reflect on accomplishments and issues from the past year.

I much prefer using these opportunities to look ahead and discuss the future of the FDA. At times I do this in a very visionary way, describing lofty ideas that will shape that future and define the mission of the FDA of the 21st Century – ideas that emanate from my belief that (because of advances in science) we are today immersed in the most profound transformation to ever occur in the history of medicine. I call it "The Molecular Metamorphosis in Medicine."

I speak often of the great promise of those changes which are harbingers of healthier lives for us and our children and grandchildren.

Of the future when people will live with but not die of cancer – when the threat of Alzheimer's will be conquered, and diabetes, AIDS, and all other diseases are controlled by the drugs and devices we'll create. And when even our food becomes therapeutic because nutrition can be as personalized and preventive as medicine.

But today I wish to focus my remarks not on the Promise of the Future but the Peril of the Present – the risk that the FDA you have known and in many ways have helped make what it is – that this FDA that during the 20th Century has been the world's gold standard – will in the 21st Century fail in its mission to protect and promote the health of every American.

I wish to spend my time sharing with you why that peril exists, what FDA is doing to address it, and most important what yet must be done: by FDA, by you, and by others.

When I first spoke to you, nearly two years ago, it was soon after my arrival as Acting Commissioner. What I observed about the Agency is what now almost everyone interested in FDA is discussing and what the Science Board report has highlighted. FDA is an agency burdened with a portfolio of enormous responsibilities that have grown over time in a manner somewhat akin to children dressing a Christmas tree – each ornament has been important but was added on without planning, precision, or prioritization.

Growth alone would be a daunting challenge to manage, but FDA's problems have been and are further accentuated by an increasing complex and rapidly and radically changing world whose transformation is captured in such every-day terms as "globalization," "just-in-time delivery from production to consumption," "ready-to-eat," and "fresh every day" – not to mention words like "bioterrorism" and "pandemic."

Let me be specific.

A workforce that was seemingly adequate for the task in terms of performance but was aging, volatile, overextended, and equipped with inefficient tools.

An information technology whose infrastructure was adequately funded at $200 million a year, but which remained antiquated, unreliable, and beset by high-cost maintenance -- a quilt of patched-together hardware, and fragmented software packages.

No systematic programs for career development, fellowship training, and recruitment and retention. A budget divided into appropriated sums with numerous congressional constraints imposed on their expenditure.

User fees that resulted in inefficient allocation of resources across FDA product centers.

I could go on – and on.

But as a wise surgical mentor once taught me, upon arriving to take charge of a patient in crisis, it is far more important to focus not on how the patient got to that crisis – but rather focus on getting out it.

So today, I want to discuss our plan for the Modernization of the FDA. I want to tell you at the outset, the challenge is formidable – and current interventions are vital. The road to recovery will be longer rather than short, but it must be traveled.

And it important to know that if we do the right things and do them in the right way, the prognosis for overcoming the peril is good. The potential remedies are many – but today, I wish to focus only on one major element in this treatment plan: The Full Implementation of the Food and Drug Administration Amendments Act of 2007.

This is worthy of our attention because of FDAAA's many important provisions, its timely passage, and the care and effort that will be required to make its many provisions operational.

Let me begin by expressing my sincere appreciation to so many people who worked extremely hard to develop and refine this legislation.

Among all those who supported FDAAA on Capitol Hill, I would like especially to recognize Senators Enzi and Kennedy, and Representatives Barton and Dingell – but in singling them out I acknowledge that nearly every Member of Congress and their staff worked on some component of the law, and some of them did day and night.

Many FDA employees as well were involved in the creation of FDAAA, and it would not be possible to name them all. But the sustained efforts of Jane Axelrad, Jarilyn Dupont, Randy Lutter, Ann Wion, Jeff Shuren, Theresa Mullin, and Stephen Mason – among others – must not go unacknowledged.

FDAAA is an extraordinarily complex piece of legislation. It consists of eleven titles and contains some 125 separate clauses or provisions that require action. They are obviously of varying "grain size," so first let me tell you about the implementation strategy that the FDA has created in order to cope with the vast inventory.

This strategy is necessary because implementing this law is a highly challenging and complex process, requiring much time, many resources, and painstaking attention to details.

In fact, six months after passage of the Amendments Act, we are still defining many of the implications its provisions will have for FDA's future performance.

The roughly 125 broad tasks required by the law include reports to Congress, Federal Register notices, new regulations, public meetings, and memoranda of understanding. Moreover, many of these individual items involve complex and resource-intensive studies, consultations, and legal analyses.

The complexity of this process is why we have a detailed implementation plan.

Deputy Commissioner Randall Lutter has overall responsibility for implementing FDAAA. Associate Commissioner for Policy and Planning Jeff Shuren and his colleague Senior Advisor Jarilyn Dupont are his chief lieutenants.

Their colleagues in the Office of Policy and elsewhere have been parsing and dissecting the massive legislation, which runs to over 150 pages, and they have identified the discrete actions to be accomplished – and the deadlines for completion. They have entered these actions and deadlines into a matrix, so that everything can be tracked and accounted for. In the spirit of transparency that informs the Act, we have posted a public version of this matrix on our FDAAA webpage.

As these actions were identified, we've established working groups to determine the scope of the tasks, agree on actions and a timetable, and to get the work done. These groups include members with the appropriate expertise from across the agency. And of course the Office of Chief Counsel is responsible for legal interpretations of the statute that form the basis for our implementation of it.

As you might expect, we have focused initially on those items with the earliest deadlines. Next, in setting priorities, we are emphasizing those provisions of the Act with the greatest implications for the public health.

So, because we recognize the challenge of carrying out this far-reaching law, we have a strategy for getting it done.

Let me review some of the FDAAA provisions that serve as essential components of our plan to modernize the FDA.

First, the Reagan-Udall Foundation for the Food and Drug Administration. According to the Act, "The purpose of the Foundation is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety."

The Reagan-Udall Foundation will have a crucial role to play in FDA's transformation. The Foundation's Board of Directors, chaired by former FDA Commissioner Dr. Mark McClellan, is now in place. But the Foundation is not yet operational, as the process has been somewhat slowed by a Congressional prohibition on spending funds to start the Foundation. With one hand, Congress said "go forth." With the other, it said, "Slow down." But the Foundation is getting started, and it will make a difference.

One initiative that we have asked the Foundation to support is the FDA fellowship program that I mentioned at this annual conference last year. As I said then, once the program is underway we envision having as many as 2,000 FDA fellows at any given time. The Foundation is now considering our proposal.

I know that your organization has also expressed interest in the fellowship program, and we would certainly like to continue discussions about including FDLI's training courses as a required component of a formal fellowship program.

The Reagan-Udall Foundation represents an extremely important part of FDA's transformation, so it needs and deserves your support – as well as the removal of obstacles to it becoming fully functional.

Another important project is FDA's "Sentinel Initiative." Reflecting FDA's life-cycle approach to the safety of medical products, this initiative will enhance our ability to evaluate the performance of medical products in real-life.

Through Sentinel, FDA intends to capitalize on emerging technologies and new sources of data. We will be able to mine claims data and electronic health records to help ensure that medical products are optimally used in post-marketing settings.

You should expect to hear more about Sentinel in the near future.

Naturally, user fees represent another crucial element of FDAAA. The prescription drug and medical device user fee programs account for nearly one-quarter of our budget. For the current fiscal year, the FDAAA authorized and the Consolidated Appropriations Act appropriated $439.4 million in the prescription drug user fees, a $139 million increase over FY 2007.

Notably, PDUFA IV strengthens the protection of patients by eliminating the three-year limit to support for post-marketing oversight. In addition, Congress authorized in FDAAA the FDA to collect $6 million in user fees for the agency's first year of voluntary review of direct-to-consumer (DTC) advertising. In the Consolidated Appropriations Act, however, Congress replaced these user fees with increased FDA's appropriations for the same purpose by the same amount of $6 million.

On the medical device side, the reauthorized Medical Device User Fee Act provides more than $48 million for the current fiscal year, an amount that will enable our Center for Devices and Radiological Health to maintain its current staff level while setting streamlined and more aggressive goals for FDA marketing decisions.

Over the past 15 years, user fees have played an essential role in FDA's ability to make safe and effective medical products available promptly to patients who need them. I want to thank everyone who worked on the user fee provisions in FDAAA, including representatives of PhRMA, BIO, and the device associations.

The Amendments Act also places increased emphasis on post-marketing surveillance – another significant advance. We are committed to evaluating the risk-benefit equation of products throughout their entire life cycle. The Act also provides FDA with new regulatory tools and authorities to ensure the safe and appropriate use of drugs. For example, under FDAAA we can require drug sponsors to make certain safety-related labeling changes, instead of relying on voluntary actions.

This emphasis on a product's total life cycle is essential for protecting patients and consumers in our rapidly changing world. Everyone with a stake in patient and consumer safety must recognize the importance of collaborating and sharing information as we seek to minimize the risk of products – and maximize their risks – throughout their life cycle.

I've focused so far on what must be done under FDAAA, and now I'd like to highlight a few of our accomplishments.

As of today, we have already published 20 Federal Register notices required by the Amendments Act. Several are essential for putting FDAAA into effect. For example, three of them specified the amounts of user fees. Five others announced the availability of guidances on such subjects as interactive review for medical device submissions and the development of treatments for acute bacterial diseases.

The Agency has announced early steps in implementing a Risk Evaluation and Mitigation Strategy (REMS). In today's Federal Register, we are listing those manufacturers of prescription drug and biological license applications with an existing risk management program who are required by statute to submit a proposed REMS by September 21, 2008.

These plans are designed to ensure that the benefits of a drug outweigh its risk, and they may be required when the drug is first marketed, or later if FDA becomes aware of new safety data about the drug.

Although it is not related to FDAAA, I have another announcement this morning. Today, we are issuing a draft guidance that provides recommendations for clinical investigations and marketing submissions for drug-eluting stents.

Publication of this guidance is significant for two reasons: first, we are striving to recommend measures that will minimize the risks of drug-eluting stents while preserving their benefits. In addition, it shows how we are willing to work across traditional product boundaries – something we will have to do increasingly as science and technology advance.

We are planning a public workshop on drug-eluting stents, in part to solicit comments on this guidance, so if you're interested please keep an eye on the Federal Register.

I've spent most of my time discussing what we are doing to make FDAAA a reality. But I must close with a cautionary note about obstacles in the path to full implementation.

First is the sheer magnitude of the task itself. Six months into the process, we are still plumbing the depths of this vast legal document.

Second, there is the occasional ambiguity of the law itself. We know that the legislation was carefully crafted, but in any law of this scope there will invariably be provisions that are not easy to interpret.

Most important, though, is the question of resources. It's one thing to have new authorities and functions, but for everything to work we need corresponding resources.

Here is an example.

FDAAA sets a 180-day deadline for the FDA to take a final action following the submission of certain citizen petitions related to the approval of a generic drug. This directive, which seeks to prevent delays in the marketing of these products, substantially reduces the time we currently need to respond to these types of petitions.

Meeting the new deadline will require new efforts, but the provision came with no additional resources. As a result, FDA has to reprioritize its existing resources, which may imply not meeting other existing or new responsibilities under FDAAA.

Let me conclude.

Full implementation of the FDAAA is only one element of the overall treatment plan for the FDA – but it is a crucial element.

Accomplishing the desired and agreed-upon goals of this landmark legislation will require a sustained effort, over time, from many parties – not just the FDA.

Part of FDAAA – and all of FDA's oversight – relies on corporate responsibility and compliance with our standards. The challenges the Agency faces are the same challenges the industry faces – society's questions about the safety of the food we eat, the medical products we use, and the cosmetics we apply are addressed to both of us.

Only together can we improve product safety – and protect Americans.

Some on Capitol Hill are increasingly recognizing this joint future – where regulator and regulated industry must work together, but with the guardrails established by FDA.

I am here today to state that FDA has a plan for putting this law into effect. Our plan for implementing FDAAA is part of our blueprint for the future of the FDA, and it includes the Strategic Action Plan we published last November.

We are hard at work, not only on implementing FDAAA but also internally on a number of fronts, to transform the FDA. Whether it's investing in our IT infrastructure, our continued consolidation at the new White Oak campus, or the Critical Path Initiative, FDA is totally committed to getting ready for the challenges of the future.

We are doing this so that we can continue to protect and promote the health of Americans, and to set the standard for the 21st Century.

Thank you.