FDA lacks power to require drug label changes

Deputy director of the FDA's Office of New Drugs Dr Sandra Kweder, in testimony before the Health, Education, Labor and Pensions Committee earlier this week, said that this was a major issue behind the length of time it took the FDA to secure changes to the label for Merck & Co's painkiller Vioxx (rofecoxib), which withdrawn from the market last September after being linked to cardiovascular side effects.

Kweder said that that Vioxx safety had been under scrutiny since 2001 - when the FDA convened an advisory panel meeting to discuss whether the drug raised the risk of heart attacks and strokes. But despite the panel advising that the label of the drug be changed to reflect this risk, this did not occur for over a year, due to the lengthy negotiation process that must be undertaken between the agency and the manufacturer of a drug.

She told the panel that new legislation to allow the FDA greater powers to force label changes through for medicines would be 'very helpful'. There was also discussion about whether the FDA should be able insist that companies carry out additional post-marketing studies of drugs if safety issues arise. It lacks this ability at present, although Kweder noted that so far in most cases the agency has been able to persuade companies to comply with a request for additional studies.

Another key issue to address in enhancing public safety is that of the current adverse event-reporting scheme, which relies on healthcare professionals to send in side effect reports to the FDA. This will be revamped with an Internet-based version that should make it easier to file reports, she told the meeting.

An FDA advisory panel looking at the safety issues with Vioxx and other drugs in the COX-2 inhibitor class voted on 18 February - albeit by the slimmest of margins - to recommend the drug be put back on the market in limited circumstances. A decision is expected within the next few weeks.