FDA’s Oversight Fails Remarkably–Two-Thirds of Required Drug Studies Never Done

Yet another story about regulatory failure at the FDA appeared in the March 4 New York Times. Frequently, when the FDA approves news drugs for sale it requires manufacturers to conduct follow-up studies to determine whether the drugs are working as claimed and whether any adverse side effects are reported.

Hundreds of studies are still pending, some dating back to 1955, the story notes, prompting new legislation that would require drug manufacturers to follow through on their obligations.

In order to meet demands from patient advocacy groups, the FDA often releases drugs quickly, requiring follow-up studies. Regardless of the role of patient advocacy groups in the quick approval of new drugs clearly the FDA mandate to monitor safety and efficacy is lacking, something notably odd to supplement manufacturers who have born the brunt of much FDA scrutiny. Additionally, as noted by Greg Critter, in the startling new book Generation RX notes, frequently these groups are formed by drug companies looking to impact agency decisions with the power of patients demanding new treatments. .

The Times story notes that as of September 30, 2005, of the 1,231 drug trials promised the huge majority have not even begun. A total of 797, or 65%, have not started. Furthermore, only 172 trials were reported complete to the agency. Pharmaceutical industry officials dispute these figures, adding that trials are often difficult to monitor, especially given the fact that they require some patients to take placebos, in lieu of a known medicine.

While the FDA can withdraw a drug from the market for failure to complete a trial, the agency has never taken this step in response to a manufacturer’s failure to complete a study.

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