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More Than a Third of Drug Safety Reports Missing in Action

Remember all those promises the FDA made to improve drug safety, especially those that were blasted by the Pharmaceutical Research and Manufacturers of America, to protect the health of Americans? Those promises ring very hollow, based on the recent findings of a Department of Health and Human Services report.

The safety status of postmarket drugs is, in a word, abysmal. Drug companies aren't reporting the status of safety studies they promised, and the FDA has been lax at best about monitoring that lack of progress.

Almost half of the applications for new drugs approved by the FDA from 1990-2004 required at least one postmarket safety study. An amazing 35 percent of the time, however, those reports either contained no information or were completely missing. And, no surprise, the reports that were filed often lacked the useful data regulators could use to monitor how these studies are progressing.

Of course, the FDA's newest commissioner in the hot seat, Andrew von Eschenbach, denies any ignorance of the facts or wrongdoing, no matter how damning the evidence. More proof than ever, you can't count on the FDA, as it's currently configured, to protect your health.

FDA's Monitoring of Postmarketing Study Commitments Free Full PDF Report

Yahoo News July 7, 2006

Reuters.com July 10, 2006

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