FDA Has Failed To Make Safety Changes: GAO
6 CommentsBy Ed Silverman // December 9th, 2009 // 9:02 am
In 2004, Merck withdrew its Vioxx painkiller, prompting intense scrutinty of the FDA’s review process. But the agency has not yet restructured its staff to better monitor drug safety, even though experts recommended several key changes back in 2006, the Associated Press reports.
Although FDA officials have made some changes to drug oversight, a Government Accountability Office report finds the agency FDA continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market. “It is not yet clear if or when FDA’s decision-making process will be substantially improved as a result of its efforts,” according to the GAO report (here it is).
Within the FDA bureaucracy, scientists tasked with reviewing new drug applications have traditionally had the most say over questions of safety, even after drugs are approved. But outside experts say leaving such key decisions to the scientists who first cleared the drugs could lead to inadequate safety actions, putting prescription drug users at risk, the AP writes. They say such decisions should be made with equal input from the FDA’s office for monitoring reports of side effects.
The GAO, the Institute of Medicine and other experts have long recommended that the so-called Office of Surveillance and Epidemiology be given equal authority on drug safety with the agency’s Office of New Drugs. But GAO investigators report that FDA leaders still have not transferred key responsibilities to surveillance officials.
The GAO report calls on the FDA to set a timetable for transferring new responsibilities to the surveillance office. But citing the report, the AP writes that, despite a formal memo between the offices designed to put them on equal footing, the new drug office still retains nearly all the power over regulatory decisions.
In a response to the report, the FDA said major decisions about drug safety are delegated to the new drugs division because that is “where staff with the broadest expertise and experience” on product safety issues reside. The FDA said it intends to give the surveillance office more responsibilities, but only after its nearly 200 employees gain the experience and resources needed to take on those tasks. The Office of New Drugs has more than 900 employees.
According to the GAO, the number of surveillance staffers would have to double in coming years to accommodate the additional work being assigned to the unit.
Congressional investigators did note that the FDA is making progress on other safety initiatives, including revamping the computer system used to track and sort reports of drug side effects; gathering more reports about possible drug safety issues from federal agencies and private medical systems and developing a system to resolve drug safety disagreements between staffers.
Lisa Van Syckel
i would like to see Senator Grassley try a second time to get a bill passed that will allow an Independent Office of drug Safety. It appears that the efforts of drug safety through PDUFA ha failed
patrons99
Yes, Lisa. You’ve nailed it. That’s exactly what the public needs. Whose drug safety is it, anyway? Drug safety belongs to the people, not pharma. Data entry and control over the worldwide drug safety database must be completely independent of pharma and FDA. Anything less than that will be bound to fail. Ever since initial enactment of the PDUFA in 1992, FDA has been a client of pharma, not the public.
Jaynesday
A Federally recognized (but unattached) Drug and Device “Consumers Report” with bite is in order. And the bite only needs to be real time, unbiased reporting on the actual safety, cost and performance of products. By and for the consumer only, unattached to industry, politics and big money.
Producers will have to fight for a thumbs up or suffer the consequences. May the best company win.
Justice in MI
The need for an independent Office of Drug Safety (by whatever name) has been recommended by high-level government studies since the 1970s–whether via the NHS, IOM, GAO, etc. The administrative details have differed, but the core proposal has not.
What’s being discussed here is a very conservative version of the separation. It would all still be inside CDER, but people like David Graham would not still be reporting up the chain to the OND, which calls the ultimate shots.
So what others are suggesting up the thread goes far, far beyond anything Grassley has endorsed.
patrons99
FDA has been a pharma-shill. Drug Safety should be taken away from FDA. Drug Safety should be completely independent of both FDA and pharma. FDA has failed miserably at ensuring Drug Safety.
Karen fisher
Hair dye chemical manufacture of PPD says to
use gloves and a cap but only gloves are included
and cancer levels are highest ever.
Is the lucrative cancer drug industry at work?