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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: aknahow who wrote (2219)12/3/2000 4:06:11 PM
From: Biomaven  Read Replies (1) | Respond to of 52153
 
george,

What kind of changes at the FDA should Bush become president?

I really don't expect anything dramatic. It's kind of like an ocean liner - pretty hard to make any quick changes at all. My sense is that the FDA is currently moving towards a more cautious safety stance. To hear Sidney WOlfe speak though, you would think they were already in the pockets of the drug companies.

One political issue on the horizon is the User Fee act. I think this will get re-enacted in pretty much its current form under either Bush or Gore. (Again, Wolfe thinks this was a terrible law, particularly part that I don't think has ever been actually used allowing private 3rd party approvals for medical devices). Part of the issue that people like Wolfe don't like is that the user fees have made the drug approval branch comparatively better funded than other areas of the agency.

My sense is that Gore is actually pretty centrist on issues like the FDA, despite his recent tack left to shore-up his support among the party faithful. If Bush ends up the winner, I suppose there is a slight chance of a fuss on RU-486 and perhaps some tightening on stem cell from fetuses.

Bottom line though is that I don't see that much impact from either of the possible presidents.

Peter