Letter to Congress Regarding Prescription Drug User Fee Act (PDUFA) (HRG Publication #1810)
May 4, 2007
Dear Member of Congress,
We are writing to express our opposition to the reauthorization of the Prescription Drug User Fee Act (PDUFA). User fees have created an untenable conflict of interest in which the Food and Drug Administration (FDA) is literally in hock to the industry it is supposed to be regulating. The result has been a decline in safety standards at the FDA, with a resultant record number of drug withdrawals for safety reasons. This should not preclude the passage of various amendments currently under consideration in Congress that would strengthen the agency’s drug safety functions.
Federal Agencies Should be Funded by the Federal Government
The FDA has the intimidating task of reviewing all prescription drug applications. A poor review can result in patients being denied effective medicines or in the release of needlessly dangerous products. Such a delicate balancing act should be performed only by an agency that is totally objective – one that has the public’s interest at heart and is not swayed by the business concerns of companies seeking product approval.
Yet the user fees do just that: the agency has become dependent for its funding upon the very industry over which it has regulatory authority. This is an unacceptable conflict of interest, with the predictable consequences we describe below. Protecting the integrity of drug approvals is a legitimate federal function, and one that should therefore be wholly funded from federal coffers.
User Fees have been Associated with an Unprecedented Number of Drug Withdrawals
With the agency continually looking over its shoulder so as not to endanger its funding stream (fully one-fifth of the overall FDA budget in current proposals would come from user fees), there has been a fundamental change in the atmosphere within the agency such that pharmaceutical companies are increasingly seen as stakeholders, customers or even clients. This has been followed by a rash of drug withdrawals; over a dozen drugs have been withdrawn from the market since 1997.
In 2002, the General Accounting Office (GAO) found that “a higher percentage of drugs has been withdrawn from the market for safety reasons since [PDUFA] was enacted.” And this was before the Vioxx and Bextra bans, before the disclosures of antidepressant data withholding by the industry and the agency itself, before the agency cited Ketek data it knew to be fraudulent, and before this past month’s bans on Tigan suppositories and Zelnorm. User fees have left behind a trail of banned drugs – and patients who have been needlessly killed or injured by them.
User Fees have Undermined Working Conditions at the FDA
The strict review deadlines imposed by PDUFA have had a deleterious effect upon staff morale. The 2002 GAO report cited above also documented that staff turnover is higher among FDA scientists than among scientists in other government agencies. Indeed, the former head of the agency’s drug center has conceded that PDUFA has “create[d] a sweatshop environment that’s causing high staffing turnover.”
The user fee program has demonstrably failed. In a recent open letter, 22 drug regulatory experts, including six former senior FDA staff and four authors of the Institute of Medicine’s drug safety review, opposed the continuation of user fees and concluded that “User fees may appear to save taxpayers money, but at an unacceptable cost to public health.” Although the almost-$400 million in user fees now sought in some PDUFA reauthorization bills is critical to the agency, it is not a sum that would make much of a dent in the federal budget. We urge you to return the agency’s funding source to those to whom the agency is supposed to be accountable: the American taxpayer.
Peter Lurie, MD, MPH
Sidney M. Wolfe, MD