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

To: aknahow who wrote (2173)	11/30/2000 3:15:15 PM
From: Biomaven	Respond to of 52153

If you made me drug Czar (not that sort of drugs - those I'd probably legalize <g>) here's what I think I would do: I'd have three classes of drugs - unapproved, safety approved and safety & efficacy approved. I'd have rigorous monitoring for adverse effects, decreasing over time for the latter two classes. There would still be some problems with this system. First, insurance would likely only pay for drugs in the third class. Second, it would be harder to enroll efficacy trials - we saw that with the early Aids drugs. Finally, litigation for side-effects would be a problem. Maybe the best way to handle this is compulsory insurance (purchased by the manufacturer) with regulated payouts - sort of like the current workers compensation system. Payouts would be limited (or perhaps zero) for known, disclosed side effects. But if I had to bet, I'd say the FDA system ten years from now will look very much like it does now. Changes are likely to be some pharmacogenomics tox stuff required and better post-approval monitoring. Peter