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Biotech / Medical : T/FIF, a New Plateau -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (1234)	7/3/2002 1:58:11 PM
From: Biomaven	Read Replies (3) \| Respond to of 2243

Miljenko, I agree with Rick that by-and-large the FDA has done a good job over the last few years. I have no trouble with them raising the safety bar, at least for non-essential drugs. However, if they want to raise the safety bar they need to communicate this to the companies early in the drug approval process, rather than by means of a "Not Approvable" letter at the end of the process. I also question whether they properly balance the risk-reward ratio for some drugs, as has been pointed out to me by some friends. Not approving the JNJ/ALKS long acting Risperdal immediately will definitely cause significant morbidity and perhaps even mortality (via suicides). Their delay in approving TKTX's Fabry treatment (already on the European market) also causes significant suffering. Peter