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

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

Speech before

Food and Drug Law Institute
Annual Conference
Bethesda, Maryland

"State of the FDA" Address

Remarks by

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

April 12, 2007
Thank you, and good morning.

Members of the Food and Drug Law Institute, it is an honor to make my first appearance before you as a full-fledged, properly confirmed FDA Commissioner.

The promotional materials for this conference promised that my remarks would cover FDA’s priorities as they are being driven by the “new science.” You might therefore expect me to discuss what I’ve termed the “molecular metamorphosis,” how medicine is being transformed by discoveries at the molecular level.

You might also expect to hear about the “four P’s”: how medicine of the future will be personalized, predictive, pre-emptive, and participatory. I love giving that talk, because it is about a realistic expectation for a new reality in health care.

But that’s not the talk I am going to give this morning. Instead, I would like to assess, in rather frank terms, the state of the FDA today. I want to provide you a sense of what it feels like inside this venerable, and potentially vulnerable, guardian of the public health.

I want to do this because, in the past eighteen months at the helm of the FDA, I have come to appreciate a few critical facts:

  • First, the FDA of the past set the world’s gold standard for promoting and protecting the public health

  • Second, the FDA of the past is inadequate for the challenges of the future

  • And third,. nothing good in creating a healthier America through food and medical products will come to pass without the involvement of the FDA

That future is being shaped by the extraordinary changes that have occurred in science and medicine during the past five to ten years.

The changes that are transforming science and medicine place FDA squarely in a new reality, with novel challenges, demands, and expectations.

Let me share with you what this reality looks like by surveying some of the issues we confronted last month. While much of the nation focused on “March Madness,” to close out the college basketball season, we at the FDA had our own special brand of March Madness. Here’s how it went.

Across the various product Centers, the regulatory process was in full swing – approving drugs for high blood pressure, cancer, and clotting disorders, as well as tests for West Nile Virus and viral versus bacterial meningitis.

We issued guidances on communicating drug safety information to the public and on Good Agricultural Practices for the safe production of fresh-cut fruits and vegetables.

We also issued a proposed guidance on advisory committees and managing conflicts of interest among committee members.

But, in addition to this planned work, each day brought new issues and problems requiring a rapid response from FDA.

First were the Congressional hearings. I want to start by saying that I wholeheartedly support and welcome Congressional oversight. It plays an essential part in our system, and it helps FDA do its job well.

During March, FDA officials testified five times. Early in the month, Randy Lutter articulated our position on importing prescription drugs into the U.S. During the last week of March, Dr. Janet Woodcock set forth FDA’s views about follow-on proteins.

Between those occasions, I testified three times: during a Senate Agriculture field hearing in Wisconsin on the safety of produce; before the Senate on renewing the Prescription Drug User Fee Act; and before the House on FDA’s work to ensure the safety of human drugs.

Not surprisingly, FDA’s March Madness included several high-profile product recalls: February’s recall of peanut butter contaminated with Salmonella continued, imported bottled water was recalled because of arsenic contamination, and we also dealt with the recall of millions of cans and pouches of pet food.

At the end of the month, we took action on two approved prescription drugs. As part of our standard practice of monitoring drug products throughout their entire life cycle, we asked manufacturers of pergolide products to remove their products from the market because, in essence, their products had become obsolete. We also requested and secured discontinued marketing of a drug to treat irritable bowel syndrome, because of data that had very recently come to light about increased cardiac risk associated with its use.

One of the important aspects of FDA’s environmental scan, as it considers its future, is that our world is rapidly changing. This change is both vast and diverse in its scale, its scope, and its complexity.

How, then, is FDA going to be able to respond to such an environment and not fail or fall short in carrying out its mission to protect and promote the public health?

There is only one way forward. FDA must do the right thing, and do it in the right way.

To do that, we need the best minds. We need people with the intellects to recognize what is the right thing to do. That means FTE’s, which is government-speak for people. And it means having the right people in the right positions.

Already, I have made several changes. Early this year, I appointed Deputy Commissioner Dr. Janet Woodcock as FDA’s Chief Medical Officer. More recently, I named John Dyer, a seasoned executive with extensive government experience, as Deputy Commissioner for Operations and Chief Operating Officer

A new Chief Information Officer is now in place, with the mandate of modernizing FDA’s information systems. And we are establishing an Office of Integrity and Accountability, whose purpose is to create an organizational environment and culture that fosters robust discussion and diverse points of view.

But the demographics of the FDA’s current workforce present one of the greatest challenges we face.

Make no mistake. FDA is only as good as its workforce, and its current workforce is unsurpassed. Our scientists and medical officers and consumer safety officers are second to none. But there is a cloud on the horizon. The demographics of FDA’s experts and professionals are not encouraging.

Consider these facts about FDA’s workers: they are, on average, 47.2 years old. Nearly 44 percent are at least 50, and fewer than four percent are less than 30 years old. In our business, experience counts for a lot, but the dearth of young talent presents a serious concern in this age when new discoveries and technologies are transforming science and medicine.

Here’s another sobering set of facts: Nearly 15 percent of FDA’s employees are currently eligible for retirement, and some 14 percent are eligible for early retirement. The future is more worrisome than the present, as nearly 30 percent of FDA’s non-supervisors and 47 percent of its managers and supervisors will be eligible for retirement in the next five years.

These demographics raise some stark questions. How can FDA keep up with scientific advances? How will we deal with what seems to be a sort of “double whammy?” We will be losing expert scientists, skilled regulators, and seasoned investigators at the same time we are competing with many other public and private organizations for young talent in such areas as information technology and molecular biology.

To help address this anticipated shortfall, I have asked Dr. Woodcock to spearhead the development of a fully credentialed FDA fellowship program that will include opportunities for developing talent in a wide variety of fields important to FDA. When this program is fully enrolled, I expect there to be as many as 2,000 new FDA fellows at any given time.

We are working closely with the Food and Drug Law Institute on this fellowship program, and we certainly appreciate their interest and support.

As if the changing scientific and medical environment and the need for people were not challenging enough, FDA is also caught up in the scramble for resources.

Consider these facts:

  • Eighty percent of FDA’s budget directly supports our employees. Times of flat-lined budgets and continuing resolutions can have a direct impact on our ability to do the right thing and do it in the right way.
  • On a per capita basis, FDA’s broad public health protection costs every American less than five dollars and fifty cents a year in taxes – a bargain by any measure.
    Our need for adequate resources has fostered the growth of user fees as an increasingly crucial part of FDA’s budget. In an ideal world, perhaps, FDA might be fully funded through appropriated dollars. In the real world of 2007, user fees must continue to play a significant role as a way of adding to FDA’s resource base. To those who question the current reliance on user fees, I would say only that user fees are simply that: a fee for a service.

We recently sent to Congress our proposal for renewing the Prescription Drug User Fee Act, and we stand ready to work with the Hill on this significant legislation.

Serious negotiations on the Medical Device User Fee and Modernization Act are well underway, as well. These must go forward unfettered and unencumbered.

Since I am discussing our changing and complex environment, let me mention another area where FDA faces a major challenge – and where scientific complexities and resource issues meet head on. Capitol Hill is currently focused right now on what to do about follow-on protein products. Much of this debate revolves around cost-savings, ensuring the safety of patients, and protecting the intellectual property of innovator companies.

As Congress wrestles with these important considerations, FDA has gone on the record in support of an abbreviated pathway to the market for follow-on proteins. Although FDA has already approved several relatively simple follow-on proteins, the current state of scientific understanding and technology does not support the approval of more complicated products under an abbreviated process. And even if the science existed, for many products we would still lack the legal pathway to approve them.

So what is needed is a workable and science-based regulatory framework to make follow-on proteins available.

What is often lost in this debate are the severe strains this new legislative pathway would place upon the FDA. Our Office of Generic Drugs currently lacks the capacity to handle a massive influx of new abbreviated pathway applications. Such applications would require FDA to extrapolate mountains of data, a task that would stretch our resources and personnel even further.

In the midst of this conversation about follow-on proteins, recognizing the greater role that small-molecule generic drugs play in the health of Americans, we have called for a Generic Drug User Fee Program. Regrettably, the response from the generic drugs manufacturing lobby has been less than quick. That’s unfortunate, because working together quickly, I believe we could create a program that benefits the public and improves the Agency’s service to the generic drug industry.

Partnerships represent another means of adding to the resource base of the FDA. Through joint projects as the Critical Path Institute with the University of Utah, the Joint Institute for Food Safety and Nutrition with the University of Maryland, and the Interagency Oncology Task Force with the National Cancer Institute, FDA and its partners are able to accomplish more by joining forces than we ever could separately.

Let me be clear about resources. Thus far, FDA has been exceptional in its response to challenges we face because of the great self-sacrifice of its dedicated and faithful employees.

In a way, I am sounding a warning bell. I am saying that FDA is reaching the point where Americans, broadly speaking, will have to decide what kind of Food and Drug Administration they want. The resources and the support must be there, if FDA is going to continue its long run as the world’s premier consumer protection agency. The President’s budget for 2008 continues efforts to strengthen the Agency, and we must build from this base.

Expectations must also be realistic. And FDA’s ability to fulfill Americans’ expectations is directly related to the support the agency receives.

The pet food recall I mentioned earlier provides a textbook example of how the system is being stressed. FDA has been called to Capitol Hill to account for its performance in this matter, and in fact we will testify on our investigation later today.

What we plan to say is that FDA’s work on the contaminated pet food represents the agency at its best. Dealing with this recall has been a highly complicated task with an unprecedented scope. Upon learning of the contaminated pet food, we immediately ramped up a massive investigation. Some 400 FDA employees and experts across the nation have been inspecting manufacturing facilities and warehouses, conducting tracebacks, testing product samples, and responding to complaints from pet owners.

Ten FDA District Offices are inspecting facilities, and all districts are responding to consumer complaints and monitoring the recalls. As of April 6th, we had received more than 12,000 complaints about the recalled pet food. This is an astounding figure, given that FDA averages approximately 5,000 complaints a year for all the products it regulates.

The facts demonstrate that the FDA acted instantaneously, with notification, and did every thing in its power to protect animals. Most likely, we helped save hundreds of thousands of animals’ lives, just as our quick work on the peanut butter contaminated with Salmonella probably saved many lives and kept many more people from becoming ill.

But the high – and perhaps even unrealistic – expectations are part and parcel of the environment in which FDA and other public health authorities must operate.

Perhaps it is time for all of us to pause, and to consider that this Food and Drug Administration is our FDA. We must therefore begin to consider what we all must do to help it and sustain it.

I would ask you to consider this question: What does FDA require to maintain its position at the forefront of public health? I would ask, further, What can you do to help FDA accomplish its public health mission?

To American consumers and patients I would say, please continue to support your Food and Drug Administration. Taxpayer dollars remain the most important component of our budget. This stands in sharp contrast to other nations, which rely to a much greater extent on funding from industry.

To patient advocacy and consumer groups, I say this: we need your voices telling the whole story. We need your advice, your points-of-view, and your support.

To the industries whose products we regulate, help us to build the bridge to the future. We at the FDA will do our best to remove the speed bumps on the road to the marketplace, and to provide the guard rails that keep the development of safe and effective products on track. We share the goal of promptly getting innovative, safe, effective, and wholesome products to patients and consumers. Work with us, as appropriate, on cooperative ventures, such the partnerships I have mentioned, that will further this goal.

Let me close with by acknowledging our host, the Food and Drug Law Institute, at the beginning of its 50th Annual Conference.

I want to thank the leadership the Food and Drug Law Institute for supporting the mission of the FDA in a multitude of ways: through courses, publications, and conferences such as this one.

To build on your fine tradition, I would ask you to become “story-tellers” for our work. The Food and Drug Law Institute is uniquely positioned to spread the word, to explore the answers to important questions.

So, fellow members of the food and drug community, those are my thoughts on the current state of the FDA. It is an exciting time, and it is also a crucial time. For the decisions that we make about nurturing and sustaining this proud agency are decisions whose ramifications will be felt for years, if not decades, to come.

Thank you for your time, and your attention, this morning.