The FDA would be able to demand further clinical studies even years after a drug receives approval, enabling it to pull a drug off the market if pharmaceutical companies fail to comply, suspend multimillion-dollar ad campaigns and halt sales of blockbuster drugs-an unsettling development to drug marketers. The FDA did not return a call for comment by press time.
The push comes in the wake of a scathing report last month from the Government Accountability Office that found the "FDA lacks clear and effective processes for making decisions about, and providing management oversight of, post-market safety issues." The report also found that while the FDA "sometimes" requests pharma companies to conduct post-market studies, only about 25% of those studies were completed between 1991 and 2003.
The FDA has never withdrawn a drug from market because a company has not complied with a post-market study. The Washington-based advocacy group Public Citizen is asking Congress to give the FDA authority to impose financial penalties on drug companies that fail to submit post-market studies on time. The GAO report concluded that the FDA "needs greater authority to require such studies."
That authority could have been granted last week, if not for the sharp eye of one lawmaker. An amendment to the Agricultural Appropriations bill offered by Rep. Rosa DeLauro, D-Conn., would have given the FDA authority to mandate post-market studies of prescription drugs. But Rep. Nathan Deal, R-Ga., raised a point of order and said that, procedurally, any authority granted the FDA could not come in the Appropriations Committee.
Ms. DeLauro criticized the move, saying "Just [last week] we learned of a new study showing patients taking Vioxx began to have cardiovascular problems after only four months of taking the medication-much sooner than the 18 months shown in initial studies. This alone is evidence of why post-market studies are needed."
But the issue appears to be shelved only for the moment. "It's definitely coming back," said Peter Pitts, former associate FDA commissioner for external relations and now part of the health-care practice at public relations firm Manning, Selvage & Lee. "This has broad, bipartisan support."