Insider: Drug Safety Not FDA Priority
Does Agency Serve the Public -- or the Drug Industry?
Sept. 12, 2002 -- A former senior consultant to the FDA says the agency neglects drug safety in its rush to speed the drug-approval process.
Why? Because current laws and policies let the drug industry influence FDA decisions, says Paul Stolley, MD, MPH. Stolley, formerly chairman of preventive medicine at the University of Maryland, served on a number of FDA advisory committees. In 2000-2001, he took a temporary safety-consultant position with the FDA. He now works part-time for the independent watchdog group Public Citizen, which has been strongly critical of the FDA's drug-approval process.
An article in the Sept. 14 issue of the British Medical Journal highlights Stolley's charges. Similar arguments appeared in the May 19, 2001, issue of The Lancet.
"The FDA has a philosophy that innovation is to be worshipped and drugs are to be speeded through as quickly as possible," Stolley tells WebMD. "This philosophy holds that people who worry about safety and risk are holding up new ideas and keeping medicine from a needy public."
That's not so, says Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research. What most people don't understand, Woodcock says, is that clinical drug development is a six-year process during which it is crucial for the FDA to work with drug companies.
"The agency reviews [applications to investigate new drugs] and provides oversight on human trials," Woodcock tells WebMD. "There is quite a bit of interchange with industry, and most parties believe that is quite important. We talk about how many and what kind of patients should be studied, what the study endpoints should be, and safety issues. Once that process is done, the industry writes up everything and puts it into an application and sends it to the FDA. ... We, the scientists and others at FDA, review all the data. During that time we may ask questions of industry, and may arrive at a decision, or may take questions to an advisory committee. At that time industry may be invited to present their views -- at public meetings. And then the FDA makes [a final] decision and communicates to industry what may be put on the drug label."
Not everyone agrees that this process works as it should. Karen E. Lasser, MD, MPH, is instructor of medicine at Harvard medical school. She's the lead researcher of a recent study of adverse drug reactions to FDA-approved drugs.
"I believe the pharmaceutical industry has more influence than it ought to in getting drugs approved and keeping them on the market," Lasser tells WebMD. "It is not always in the patients' best interest what gets approved. Our study found examples of drugs getting approved despite being known to cause adverse events."
A major issue is a 1993 law -- the Prescription Drug User Fee Act (PDUFA). Recently renewed by Congress, PDUFA lets the FDA charge drug companies for reviewing their products. These fees pay about half the cost of product review. In exchange, the FDA promises to promptly process new drug applications. Critics charge that this pressure to complete the approval process sacrifices patient safety.