Missing in action: An FDA plan for postmarket drug safety

"There have been long-standing concerns regarding the Food and Drug Administration's (FDA) oversight of postmarket drug safety." So begins a Government Accountability Office (GOA) report released on Wednesday that examines the steps the FDA has taken since making its own 2006 recommendations on the matter. In the eyes of many, the GAO's finding may be an understatement.

The GAO's main recommendation was that the FDA separate responsibilities between the Office of New Drugs and the Office of Surveillance and Epidemiology -- the first would approve new drugs, and the second would follow up on postmarket drug safety issues. When those approving the drugs in the first place are also responsible for tracking them postmarket, potential conflicts could arise, the GAO found. Those who approved the drug -- obviously finding it safe enough -- may find themselves in an awkward position if the drug is later found to be lacking.

There were other concerns, too, including limitations in the data FDA relies on to identify postmarket drug safety issues and the systems it uses to track such issues.

So what has the FDA done so far? The "FDA is beginning to address previously identified weaknesses in its oversight of postmarket drug safety issues, but challenges remain," the GAO writes.

Still No Time Frames

Responding to the report, the FDA says it has taken steps to increase the responsibilities to the Office of Surveillance and Epidemiology (OSE), but it cannot fully transfer the responsibility until the unit has the resources and experience to accept it. The agency adds that it doesn't have a time frame for this transfer. The FDA did not immediately return calls from DailyFinance.

The FDA is also revising its program for resolving scientific disputes, plans to implement new data systems in 2010 and is increasing access to external data to assist with drug-safety decisions. But these moves haven't solved many of the problems yet, the GAO says.

The GAO wants the FDA commissioner to develop a comprehensive plan for transferring the additional regulatory authorities to the OSE that includes time frames and steps to ensure resources are properly aligned to allow the OSE to assume these responsibilities.

"No More Time Should Be Wasted"

And the sooner the better. Several cases have illustrated the issue of postmarket safety, the most well known being Merck's (MRK) Vioxx, which was removed from the market five years after it was approved because it was linked to heart attacks. In fact, the FDA later said it found that 27,785 heart attacks and sudden cardiac deaths could have been prevented if Vioxx hadn't been approved. Pfizer's (PFE) drug of the same family, Bextra, was also withdrawn. The situation was so bad The New York Times headlined one story FDA Failing in Drug Safety.

Labeling is another problem. Just in July, Pfizer and GlaxoSmithKline (GSK) were ordered to add a strong black-boxed warning on their antismoking drugs Chantix and Zyban to highlight the risk of serious mental health problems.

Senator Charles Grassley (R-Iowa), who requested the GAO follow-up, tells DailyFinance: "No more time should be wasted at the FDA in establishing independence for its postmarket surveillance. It's a matter of public safety. Just as everything possible should be done to introduce new lifesaving drugs to the marketplace, everything possible also should be done to rigorously review the performance of those drugs after they're on the market. The Government Accountability Office has provided a road map that ought to be followed."
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