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Published on FierceHealthcare (http://www.fiercehealthcare.com)

FDA emphasizing speed over safety?

By admin
Created Jun 11 2007 - 8:01pm

On the one hand, everyone would like to see potentially beneficial drugs approved as soon as possible. On the other, no one wants to see the FDA speed heedlessly through the approval process either. As scandals blow up on Capitol Hill over Avandia and other drugs, critics are beginning to question whether the FDA is striking the right balance between speed and safety. Evidence increasingly suggests that the FDA has a habit of silencing internal and external critics--and that safety may be too low on its list of concerns, according to a New York Times analysis. With researchers pointing to dangers from antidepressant use in children [1], Ketek [2], Vioxx [3] and now Avandia [4] and Actos prior to the FDA's taking any action, some Congressional players are wondering whether they should crack down on the agency.

To learn more about the ongoing debate:
- read this piece [5] in The New York Times

Related Articles:
Avandia critic: FDA launched smear campaign. Report [6]
FDA boosts reviews for new drugs. Report [7]
IOM slams FDA, calls for major reforms. Report [8]
Report faults FDA's post-marketing vigilance. Report [9]


Source URL:
http://www.fiercehealthcare.com/story/fda-emphasizing-speed-over-safety/2007-06-12