WASHINGTON – The government’s drug safety system is seriously out of balance, devoting too much attention to approving new medications and not enough follow-up to uncovering risky side effects, a blue-ribbon scientific panel concluded in a major report released Friday.
Convened at the request of the Food and Drug Administration after a popular painkiller was linked to heart attacks, the panel of experts in medicine, pharmacology, law and other fields issued a sweeping call for reform. Its 25 recommendations include establishing a fixed term for the FDA commissioner, restricting ubiquitous drug commercials and placing a special cautionary symbol on the packaging for newly approved medications.
The panel urged greater legal authority for FDA regulators to compel drug companies to carry out safety monitoring and called for significant increases in agency funding – although it failed to spell out exactly how much and where it would come from.
Consumer groups and advocates of overhauling the FDA hailed the report, while the drug industry issued a cautionary reaction. “Though there is always room for improvements, it would be a mistake to accept the notion that the FDA drug safety system is seriously flawed,” said Caroline Loew, vice president of the Pharmaceutical Research and Manufacturers of America.
The recommendations will frame a legislative debate over the future of the FDA, expected to be joined in earnest next year when Congress must renew user-fee legislation that provides much of the agency’s funding.
The FDA requested the drug safety review after the sudden withdrawal of Vioxx in 2004 generated a firestorm of criticism over its drug safety program. The widely used drug was pulled from the market by manufacturer Merck after a company-sponsored study confirmed that patients taking Vioxx were more likely to suffer heart attacks than those who did not.