Biotech Stock Picking for Charity - 2007 Message Board

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Biotech / Medical : Biotech Stock Picking for Charity - 2007

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To: BulbaMan who wrote (324)	11/25/2007 1:51:11 AM
From: technetium	of 397

Leading the pack is great, but it feels more like a death march than a victory parade. :-( The FDA seems hard to please these days. Pick a reason. The Vioxx withdrawal was blamed in part on lax oversight. Heavy direct to consumer marketing (TV ads, etc.) prompted people to ask their doctor for brand name drugs they never heard of before and might not need. Lack of leadership at FDA? Mark McClellan tried to streamline the drug approval process and make it more efficient. Some companies might have submitted not-quite-ready for prime time applications as a result. McClellan's departure was followed by years of uncertainty and lack of clear direction. The FDA always faces pressure from both sides -- those who want any drug with a chance to get approval, and those who will cast blame and file lawsuits the moment something goes wrong. Limiting approval to drugs demonstrated to be superior to existing drugs maintains the status quo and avoids risk. However, some drugs work better than others for specific patients, so effective drugs may not reach the market if the FDA demands superiority rather than efficacy.

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