PDUFA DEADLINES MAY UNDERMINE DRUG SAFETY, EXPERT SAYS
The FDA's rush to meet drug review timelines under the Prescription Drug User Fee Act (PDUFA) may lead to more postmarketing safety problems, a Harvard University professor said.
Drugs that the FDA approves before PDUFA deadlines are more likely to be withdrawn or have other postmarket problems, Daniel Carpenter, director of the Center for American Political Studies at Harvard University, told attendees Aug. 24 at the FDA Regulatory and Compliance Symposium at Harvard University, co-sponsored by FDAnews. The agency must approve a certain percentage of drug applications by set deadlines or risk losing the funding it receives under PDUFA.
Carpenter, who is preparing a report titled "Statutory Deadlines, Regulatory Review Cycles, and Postmarketing Drug Experience," compared the agency's current drug approval patterns and the postmarketing fate of these drugs with agency practices before PDUFA became law in 1992. The study shows that since then decisions have become disproportionately tied to the PDUFA requirement that the agency review and take action on 90 percent of standard and priority drugs within 10 months of the date the application was submitted.
Not only is the agency more likely to approve drugs by this deadline, but those drugs are more likely to be withdrawn from the market, get black box warnings and be discontinued than drugs addressed independent of the deadlines, he said. But Carpenter emphasized that his study was a limited one, focusing only on observations of past agency practices, without clinical studies of upcoming FDA reviews.