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Jane E. Henney, M.D. - PDUFA Public Meeting

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

Remarks by:
Jane E. Henney, M.D.
Commissioner of Food and Drugs
U.S. Food and Drug Administration

Prescription Drug User Fee Act (PDUFA) Public Meeting

Washington, D.C.
September 15, 2000

Good morning. On behalf of the Food and Drug Administration I want to thank each of you for taking the time from your busy lives to join us today--to hear about the agency's experience, and to share your views regarding the Prescription Drug User Fee Program.

The origin of the Prescription Drug User Fee Act, or PDUFA, began in 1992. Congress authorized a five-year program that provided FDA with additional resources to hire more medical and scientific reviewers to conduct premarket reviews, as well as support staff and field investigators.

The increased funding also enabled FDA to actively upgrade the agency's information system. All these changes were intended to accelerate the application review process for certain human prescription drugs and biological products.... a process that had become slow and unpredictable.

FDA was bound by the 1992 legislation to meet a set of review goals under PDUFA I that would become more stringent each year but it enabled FDA to collect user fee resources from the industry to make achievement of these goals possible. FDA agreed to meet drug review performance goals that emphasized timeliness and predictability. There was not then, and never has been, a guarantee of approval.

FDA was and is expected to apply the same high standards-indeed, the gold standard for the world-for safety and efficacy evaluation for those products that would enter the marketplace.

The results of this initial experiment were reviewed in 1997. The results demonstrated clearly that when adequately resourced, FDA is capable of meeting the most demanding of performance standards. Thus, Congress renewed the Prescription Drug User Fee Act for another five years.

With this renewal came additional resources, but higher expectations for reviews, and additional goals related to FDA's responsiveness to industry during the early periods of drug development. Once again, in the first three years of PDUFA II, the agency has met, with rare exception, all of the performance goals expected.

We can now confidently state that these results provide evidence that we're far beyond the experimental testing phase. Nevertheless, under the sunset provisions of the Congressional authorization, further legislative action will be necessary if FDA is to maintain the authority to collect user fee revenue beyond 2002.

We've set this time aside to pause and reflect on the benefits and accomplishments of this effort, but also to raise some fundamental issues and questions.

It's clear that user fees have brought many benefits. Patients and health care providers are able to obtain drugs faster. PDUFA's goals specify review times-or the time it takes FDA to make a decision--and not approval times. Nevertheless, we've seen both review and approval times decrease dramatically.

Approval time has dropped from a pre-PDUFA median of 23 months to 12 months. Approval time for priority products has dropped from a median of more than 12 months in the early PDUFA years, to 6 months. The quality of submissions has improved too. Now, approximately 80% of applications submitted are ultimately approved. Before PDUFA, only about 60% were eventually approved.

At FDA, drugs and biologics are now being reviewed as fast or faster than anywhere in the world, without compromising the very stringent standards Americans have come to expect.

This high quality performance by the agency and predictability in its review function has been an asset for industry as well. Because our reviews are more timely nearly 18 months has been shaved off industry drug development time - resulting in a savings of nearly 2 billion dollars per year. Predictability by the agency also means industry can better plan and manage its own internal affairs. However, from the agency's perspective, while the premarket review is a critical piece in the risk assessment and management of medical products, it cannot, and should not, be seen in isolation.

FDA is expected to be, and is, committed to the lifetime of the product-not just from the early stages of drug development, to the review and approval, but also to monitoring the products once they reach the marketplace. The public expects and deserves to have safety assurance throughout a product's lifetime, including the time it reaches the marketplace and is used by the health professional and the patient.

While the results of PDUFA have generally been positive in our premarket review function for drugs and biologics, there's been a significant impact on the agency's other functions.

The post-approval areas are just as critical to assuring the safety of a product over its lifetime of use. One such area is adverse event reporting--a process that allows us to discover previously undetected, and unexpected, adverse reactions to products after marketing. This is a key area since, prior to approval for marketing, most drugs are exposed only to a relatively small population in a controlled environment.

Another area involves our surveillance and investigative work in the field. FDA maintains its presence in inspectional programs by taking samples and conducting tests to assure that drugs continue to be manufactured with adequate quality control. The inspection process is a critical part of our risk management strategy, ensuring that products are manufactured according to appropriate standards to assure their reliability. When this function is not adequately funded, one of the critical safeguards for American consumers who need and want these medications is undermined.

These postmarket functions and other important premarket programs, such as over-the-counter drugs, medical devices, and blood are becoming seriously underfunded. Because these components are outside the user fee supported drug review process, the "additive provisions" of the user fee legislation have forced them to absorb over $200 million of mandatory pay raise and inflation costs since 1992. These equally vital programs are lacking in terms of staff and operating dollars, while drug review activities have grown substantially. What has emerged is a system of "haves" and "have-nots."

I'd be remiss if I didn't also mention another issue we hear on occasion about the PDUFA program. There's a perception by some that having the regulated industry provide funding for review may compromise the agency's independence and objectivity. We have no evidence for this but even the perception of a conflict of interest is a worrisome issue that must be addressed, for it threatens the confidence of consumers in the integrity of FDA's reviews.

As we began the user fee program in 1993, seven percent of drug review funding came from user fees. This percentage has increased each year. In this fiscal year drug review funding from user fees will nearly equal the funding received from appropriations. Dr. Suydam will address this in more detail shortly.

Our country isn't the only one that has experience with industry funding for drug review. Other countries use industry funding to pay for the review function, and in some cases, for the entire drug regulation process.

We'd like to take the opportunity today to hear your opinions and perspectives about our current funding arrangement and deal with concerns both real and perceived.

What you'll hear from our panelists this morning are FDA's experiences with PDUFA...our lessons learned. And we'll hear from our stakeholder groups that are affected by user fees. What works? What doesn't work? Which aspects of PDUFA should be kept, and which should be changed or eliminated? This is your chance to tell us what you think. Help us design the best possible program for the future--one that will be of most benefit to all concerned, but maintain the support and confidence of the American people. We're here to listen.

Thank you again for your interest and your attendance here today. I look forward to sharing our views with you and listening to your concerns and perspectives.