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FDA Hasn’t Restructured for Drug Safety Since Vioxx – We Need More & Better Monitoring

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After the FDA’s poor handling of the Merck painkiller Vioxx, which the agency approved in 1999 but then pulled from the market in 2004 after it caused thousands of heart attacks and strokes, GAO advisors strongly recommended that the FDA restructure its drug safety monitoring to avoid similar blunders in the future.

Several years after these 2006 recommendations, congressional investigators have found that the FDA still hasn’t changed the way it approves and then monitors new drugs for safety concerns. Just as before, it gives most of the decision-making power to scientists who approve new drugs rather than those who monitor already approved drugs for safety. Notably, its Office of New Drugs is not only several times larger than its Office of Surveillance and Epidemiology (900 vs. 200 employees), but staffs scientists with the best experience and training in the agency.

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 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.

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.

FDA officials last week declined to comment beyond the agency’s response included in the report. -NC Times

This agency needs to get its act together and start demonstrating a legitimate commitment to the health and safety of Americans. Right now, it’s acting more committed to the profits of drug giants.

2 Comments

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  1. Penny Lane says:
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    You can never have effective oversight no matter if D’s or R’s are in power as long as there is a revolving door between the regulators and the industry they are supposed to regulate.

  2. C Lavant says:
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    Doctors remain naive enough to trust the FDA approval of a drug, and foolish enough to ignore the patient who says they think a medication is making them sicker. Until a doctor concludes that a new drug might be causing a particular symptom, “they will prescribe additional medication to fix what is in fact a side effect.” Consequent polypharmacy can rapidly become more devastating to the patient’s health than the original illness. Until the FDA is restructured, doctors need to be informed that drugs newly approved by the FDA are “in fact” in the experimental stage; and patients who take those drugs will be “in fact” experimental subjects.