Dangerous Drugs Remain On Market
Potentially dangerous and ineffective drugs have been allowed to stay on the market by the Food and Drug Administration even when follow-up studies showed they didn't perform as advertised.
In a report released yesterday, the Government Accountability Office shows that the FDA has never pulled a drug off the market due to a lack of required follow-up about its actual benefits, even when such information is more than a decade overdue.
The GAO says the FDA should do more to track whether drugs approved based on preliminary results actually have lived up to their promise. The FDA responded that the report paints an overly negative picture of its so-called "accelerated approval" program, which is only used to approve drugs for the most serious diseases, and said they have no plans to get more aggressive.
In 1992, the FDA began speeding up the approval of novel drugs based on so-called surrogate endpoints, or laboratory measures that suggest the drug will make real improvements in patient health. HIV drugs, for example, are cleared based on their virus-lowering power, a predictor of increased survival.
Drugmakers favor the program because it helps them get products to market sooner, without conducting long-term patient studies that can take years and cost hundreds of millions of dollars. A condition of quicker approvals is that drugmakers conduct follow-up studies to show the drug's benefits actually panned out.
But the GAO report identified several drugs still on the market that never lived up to their initial promise. And in the 16 years that the FDA has used accelerated approval, it has never once pulled a drug off the market due to missing or unimpressive follow-up data.
According to the report, of the 144 studies the FDA has required under the program since 1992, 64 percent have been completed and more than one-third are still pending.
The GAO report cites the case of Shire Laboratories' low blood pressure treatment ProAmatine The GAO found that ProAmatine has generated more than $257 million in sales, even though "the clinical benefit of the drug has never been established." Yet, the the required study has gone incomplete for more than 13 years. The GAO found numerous other instances in which the FDA has failed to act even when company’s own studies show drugs did not improve patient outcomes.
For example, the FDA approved AstraZeneca's lung cancer drug Iressa in 2003 based on early results showing it reduced the size of tumors. But later studies showed the drug did not significantly extend patient lives. The FDA has left the drug on the market, despite hundreds of reports of a sometimes fatal pneumonia.
The GAO concluded that the FDA has no policy for pulling drugs off the market that were approved using surrogate endpoints. When GAO investigators confronted FDA officials about this lack of enforcement, they reportedly said it would be difficult, if not impossible to draft a standard policy for withdrawals, given the unique circumstances of individual drugs.
