FDA Gets Authority to Monitor Drugs
In September 2007, President Bush signed into law a bill passed by the Congress that gave the Food and Drug Administration (FDA) more power to monitor the safety of prescription drugs. The bill was written because of Congressional concern that too many harmful medications were reaching the public. The law gives the FDA authority to monitor the safety of drug products after they go on the market, not just before, and to order that warnings be added to labels and patient information when new side effects become evident. The Prescription Drug User Fees Act of 2007 (PDUFA) gives the FDA power to take swift, decisive action to protect consumers when new information comes to light about risks and side effects.
Experience with the dangerous side effects of Vioxx (Merck), a drug linked to heart attacks and strokes, Avandia (GlaxoSmithKline) to heart attacks, and Prempro (Wyeth) to breast cancer, heart attacks, strokes, and dementia, as well as other dangerous new drugs, convinced lawmakers that the FDA needed to be able to police drug safety even after products are on the market. PDUFA gives the FDA that responsibility and to help defray costs, provisions are included for $400 million in industry user fees, and the authority to levy more fines if companies fail to comply.
Industry Pays FDA’s Bill
User fees were first put into law by Congress in 1992 in response to complaints from drug companies and patients rights groups about excessively long lag times in drug approvals. The fees allowed the FDA to employ more drug reviewers and bring medicines to market faster. It speeded up approval times for new drugs from an average of 27 months to 14 months, according to the Government Accountability Office (GAO). But critics of the law are far from satisfied.
Critics contend that faster drug approval times have resulted in less attention to drug safety. The same GAO report that studied the impact of user fees on the speed of drug approval, also found that since passage of the user fee law, a higher percentage of prescription drugs have been withdrawn from the market because of patient safety concerns. Critics point out that user fees create a built-in conflict of interest for the agency by making the FDA dependent on the industry it regulates to pay its bills. With user fees, the FDA has two customers, the public and the drug industry, an obvious conflict-of-interest.
User Fees, A Form of Lobbying
In 2009, the FDA is scheduled to collect $626 million in user fees from the drug industry, a quarter of its annual budget. The industry spent $168 million on lobbying in 2007, reports the Center for Public Integrity, based on an analysis of federal lobbying data. Nine out of ten lobbying dollars were spent by just 40 drug and medical equipment companies and three industry trade groups. The oversized budgets of Washington’s largest lobby, the pharmaceutical industry, is credited with passage of the Medicare reform act of 2003 which contained a prescription drug benefit but disallows the government from negotiating for lower drug prices. In this context, user fees amount to another avenue for lobbying Congress and the White House by the pharmaceutical industry.
The reauthorization of the Prescription Drug User Fee Act (PDUFA) of 2007 has kicked up more opposition to the notion of industry-paid user fees to fund the regulatory oversight work of the FDA. Public Citizen’s Health Research Group, a leading health advocacy organization, says user fees create an untenable conflict of interest in which the FDA is in hock to the industry it is supposed to regulate. The results have been a decline in safety standards at the FDA, with a lengthy record of drug withdrawals for safety reasons. They cite the GAO report which documents that a higher proportion of drugs has been withdrawn from the market for safety reasons since the original PDUFA was enacted. The report was published before the Vioxx and Bextra bans, the early termination of the Women’s Health Study, and the disclosures of the witholding of antidepressant drug data by the industry and the FDA.
FDA Called A Sweatshop
Morale at the FDA is low, insiders report, because since the passage of user fees, strict deadlines for drug reviews have created sweatshop conditions at the agency. While user fees may save the government some modest dollars, it is at an unacceptable cost to public health, a former senior staff member at the FDA contends. He and others urge a return to total funding of the FDA by taxpayers at a level commensurate with the job.
Full Public Disclosure
PDUFA, passed in 2007, was prompted, in part, by experiences with the pain medication Vioxx, and the anti-depressant drug Paxil, two cases in which drug companies did not make public their complete clinical trial study results that showed that the drugs had dangerous side effects yet the companies continued to market the drugs intensively, without warning about side effects. Thanks to the lobbying efforts of Consumers Union (CU), the new bill contains a provision that requires results from clinical drug trials be made public on the internet, so consumers can know both what is good and what is bad about medications. CU managed to convince lawmakers that, “We can’t have a fair and safe marketplace if industry keeps this vital information from the public.”
Other groundbreaking provisions of PDUFA include:
- record-monitoring to detect problems with new drugs
- encouraging more accurate drug advertising and heavier fines for misleading ads
- print ads that must include a toll-free number and a website for reporting side effects to the FDA
- limiting conficts of interest because of ties or income from drug companies for FDA advisory committee members
- opening up internal FDA debates on drug approval
- some first steps in food safety reform, including expanding inspections of imported food, seafood, and pet foods
Restoring Public Confidence
Consumers Union, which lobbied for reform of drug safety for three years, was enthusiastic about PDUFA. Drugmakers also were happy with the legislation, according to a lobbyist for Pfizer. They hope it will restore public confidence in the FDA’s oversight of drug safety. Trial lawyers were pleased, too, because of language in the bill that could make it harder for drug manufacturers to win lawsuits filed by plaintiffs who say they’ve been harmed by medications. The new bill requires companies to disclose risks and side effects on package labels as they are discovered. Previously, companies could argue they were not at fault because all the FDA required on the label was published when the drug first entered the marketplace.
On balance, the bill has something for everyone, and the general opinion is that drug safety has been improved. It represents an important addition to FDA authority for keeping the public safe. Only time will tell if the bill results in safer drugs and fewer lawsuits.
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