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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Remarks at the GDUFA Public Meeting

Remarks as Prepared for Delivery of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
GDUFA Public Meeting
September 17, 2010

Good morning—and welcome to this Generic Drug User Fees Public Meeting. It’s my pleasure to be here today, and I’m heartened to see so many of you come together to discuss an issue of great relevance in this moment of health reform and economic transition.

The simple truth is that generic drugs have carved out a critical public health role in our 21st century society. More than 70 percent of the prescriptions written in this country are generics, and—because reduced drug costs lead to lower costs for consumers—they have come to represent affordable access to treatment for many Americans, as well. In fact, in the past decade, the American public collectively saved $824 billion because of generic drugs. That’s a stunning number.

But, as you know, the approval process for safe, effective, high quality, generic drugs still faces a variety of challenges—challenges that have significant public health repercussions. Among these challenges are the increase in  generics applications, which has the potential to overburden FDA's capacity to conduct a proper review of a generics application. A complete review of an ANDA includes actions by agency components outside the Office of Generic Drugs, such as consults to other divisions within CDER and preapproval inspections by CDER’s Office of Compliance or  FDA’s field inspection force in the Office of Regulatory Affairs. Assuring FDA’s capacity for a timely and complete generic review process must remain our foremost focus. Additional challenges that have contributed to the increase in FDA’s queue of pending applications is the number of new and foreign ANDA applicants and the fact that more complex dosage forms are increasingly becoming the subject of generic applications.

I want to caution the audience however that the queue of pending generics applications is not as simple an issue as it first appears. Under the law, generics cannot be legally marketed in the United States until exclusivities on the innovator products expire. So although there is an increase in the number of applications pending with FDA, the public and industry should be clear that we are not in a situation where, but for FDA inaction, thousands more generic drugs would currently be on the market in the United States. 

But we all can agree that an increasing queue of pending applications has the capacity to strain FDA’s review system. And along with the increase in the median review time for generic applications, we are concerned that FDA is, or soon will be, facing a situation where the agency may not be able to assure that generic versions of drugs are ready to be distributed to American consumers on the first day that they may legally be marketed.

I want to be clear: we are not in crisis now. But we may soon be. We want to avoid a situation where safe and affordable drugs—drugs that could potentially save American lives—cannot reach the people who need them when they need them simply because we lack the resources to approve them quickly enough.

From a public health perspective, that situation would be simply unacceptable. We need the resources to promote the health and well-being of all Americans. And we need them as soon as possible.

That’s where user fees come in. An effective user fee program negotiated between FDA and industry—a model that has seen major successes with other FDA-regulated items, including innovator prescription drugs, medical devices, animal drugs, and generic animal drugs, to name a few—would reduce review time and make funding more flexible.

The fact is that no one benefits from a pending-application queue of 2,000-plus products. Uncertainty and delays are costly to consumers, costly to industry—and hurtful to the public. We are already using the $10 million that Congress allotted to our agency to hire 50 additional scientists to address the generics-application backlog. But without a fair system of user fees, we simply cannot achieve for the public what we otherwise could. We have an essential role to play in providing industry with meaningful benchmarks and performing to those goals, but that requires both parties to come to the table.

Finally, I would be remiss if I did not mention that a generic drug user fee has the capacity to help FDA make significant progress on another issue that is very important to me and to the agency:  advancing regulatory science. With additional capacity provided by a user fee, FDA should be able to provide additional guidance and standards to the generic drug industry. Such information would be a shared resource—a public good—that would be expected to have direct benefits to the public through resulting better quality, more predictable, and easier to review generic drug applications.

The bottom line is that these additional resources will help FDA to fulfill its fundamental public health mission: to promote and protect the public health. Reasonable fees will lead to more rapid review and to better surveillance—both of which are key to getting products out to the people who need them and to strengthening consumer confidence in safe and high-quality products. And with the industry becoming increasingly global, user fees can also address the continuing threat of intentional economic adulteration, and the increasing complexity of supply chains—all of which pose a tremendous challenge in our efforts to prevent or detect problems early.

It is clear that something must change. But it is also clear that we cannot do it alone. For this effort to succeed—as we've seen from past experiences—the process must be transparent and open, which is why meetings like this one, designed to get input from the public, are so important.

Above all, though, there must be commitment and collaboration from both our agency and the generics industry. The truth is, the FDA and the generics industry actually have more in common than we may sometimes think. Ultimately, we both serve the people. We must work together to address important public health needs and to secure the trust and confidence of the public.

We hold a joint stake in moving our respective efforts forward and developing a well-constructed Generic Dr User Fee Program. We have a unique opportunity—a singular responsibility—to demonstrate good faith and help each other usher public health into this second decade of the 21st century.

I’d like to close by recognizing those of you who are working on these issues—and particular, those of you who will be speaking at today’s meeting or submitting comments to the docket. Transparency is a two-way street, and for FDA to do its job well, we need to know what stakeholders are thinking. So your work is critical to the future of public health in this country, and I thank you for your time, your commitment, and your ideas. We have a long road ahead.

I will leave you with a quote from the FDA’s founding father, Teddy Roosevelt, a quote that I have used before and that has special significance today. "In a moment of decision," Roosevelt said, "the best thing you can do is the right thing. The worst thing you can do is nothing."

Let us put our heads together and do the right thing—for the sake of public health and, above all, for the sake of the American people.

Thank you.