Healthy Skepticism Library item: 8313

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Coombes R
FDA tightens its grip on drug regulation
BMJ 2007 Feb 10; 334:(7588):290-291
http://www.bmj.com/cgi/content/full/334/7588/290

Abstract:

Criticised for being too close to the drug industry, the US drug regulator is trying to fix its image as the guardian of drug safety

What’s happened?
Dogged by controversy in recent years, the US Food and Drug Administration has announced moves to tighten up regulations on the safety of drugs-including reviewing the safety of new drugs after 18 months on the market.

The FDA has a growing reputation for weakness, and in particular it faced flak over the withdrawal in 2004 of the painkiller rofecoxib (Vioxx). Two months after Merck withdrew the previously approved drug when it was shown that the drug increased the risk of heart attack, a member of the agency’s drug safety team told the US Senate that the agency was “virtually defenceless” against another “tragedy and a profound regulatory failure” like that concerning rofecoxib.

In September 2006 the Institute of Medicine issued a report decrying the big imbalance between pre-marketing and post-marketing drug surveillance. The report made 25 recommendations for strengthening the agency.

Last week the FDA finally announced several initiatives designed . . .

How was the announcement received?

What next?