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PDUFA law renewal draws consumer protest
Declaring that the Food & Drug Administration "should be ashamed" of the terms it negotiated for renewing the Prescription Drug User Fee Act (PDUFA), which expires Sept. 30, a coalition of patient and consumer groups is urging Congress to scrap the renewal proposal.
The renewal proposal was agreed upon by the FDA, the Pharmaceutical Research & Manufacturers of America, and the Biotechnology Industry Organization. Warning that the proposal favors speed of drug approval over safety, Public Citizen, the United Auto Workers Union, the National Women's Health Network, and the National Center for Policy Research for Women and Families are asking Congress to hold hearings on drug safety before reauthorizing PDUFA.
Passed in 1992 and renewed in 1997, PDUFA requires drug companies to pay fees to the FDA in return for faster review of New Drug Applications. PDUFA has enabled the FDA to hire 1,004 additional drug reviewers and reduce the average time for review from 30 months to about 15 months. According to PhRMA spokesman Jeff Trewhitt, the proposal recommended to Congress will increase user fees by $500 million over the next five years, to a total of about $1.2 billion. The FDA will hire hundreds more drug reviewers and commit itself to cut the final average review time for standard drugs from 12 months to 10 months. The goal for priority drugs will remain six months.
If Congress goes along, it will once again shortchange safety, claims the coalition. In its opinion, review timetables are already overly ambitious, rushing drug reviewers into bad decisions. "We can't point to a smoking gun," said Ben Peck, legislative representative of Public Citizen, but he is alarmed that nine drugs have been withdrawn from the market since PDUFA was approved. To Peck, the "unprecedented" number points to problems in the drug approval process. He said five drugs had safety problems at the time they were approved. Yet there has been no internal FDA review of the withdrawals, no Congressional hearing.
Trewhitt sees the numbers differently: The withdrawal rate in the 1990s was essentially the same as in the 1980s, he said. Further, "for the first time there is going to be a postmarketing surveillance element to PDUFA." The FDA suggests using some of the fees to double the number of drug safety officers over five years, to about 200.
That is entirely inadequate, say the groups, who advocate spending not $10 million on drug safety, but $100 million. They also want money for increased monitoring of drug advertising to consumers. In addition, medical devices ought to be brought into the user fee program.
Deploring that the FDA negotiated "in secret," the coalition hopes a publicity campaign can persuade Congress to alter the bill. The groups worry that W. J. "Billy" Tauzin (R, La.), chairman of the House Energy and Commerce Committee, will attach PDUFA as a rider to a major bioterrorism bill now moving through Congress. They need to head Tauzin off, because no one may be willing to "upset the apple cart" of urgently needed bioterrorism legislation by proposing changes to a PDUFA rider.
Susan Winckler, director of policy and advocacy at the American Pharmaceutical Association, agreed that the groups have "a legitimate concern" that Congress is not holding hearings, but added that the PDUFA money is too paltry to address everyone's concerns. The real problem is that Congress needs to recognize that the FDA budget is inadequate and do something about it, she said.
Tom Hollon. Consumer coalition denounces user fee drug law renewal.