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

To: Czechsinthemail who wrote (1246)	7/5/2002 12:55:30 PM
From: scaram(o)uche	Respond to of 2243

>> receiving a baptism by bath in DepoTech << garlic necklace on and approaching you with a large cross, "back, back, foul thing!" :-) FDA needs the flexibility to expose a MAXM or an IMCL. There needs to be a simple signal.... 1. we have no misgivings re. trial design, or 2. we, FDA, believe that the trial doesn't stand a chance in hell.

To: Czechsinthemail who wrote (1246)	7/5/2002 1:22:10 PM
From: Biomaven	Read Replies (1) \| Respond to of 2243

I think the FDA responded to criticism from Wolf et. al. about approving drugs like Rezulin that were subsequently withdrawn. I doubt if there was a conscious, stated decision made to toughen up. As I said before, I don't object to a higher bar. However if you raise the bar while someone is actually jumping, it's not surprising that many jumpers will fail to clear the bar. Iloperidone won't substitute for long-acting Risperdal. Non-compliance is a huge problem with patients on anti-psychotics, and it is this issue, rather than one of mere convenience, that the long-acting version is meant to address. I very much doubt that the FDA looked at competing drugs in their decision here, but I suppose they might not have fully appreciated the seriousness of the problem the long-acting version is meant to treat. From the FDA's perspective, approving an unsafe drug is a much worse error than delaying the approval of a safe and effective drug. However, I'll bet that the total mortality and morbidity from the FDA's slowness in approving Propranolol, the first beta blocker that had been widely used in Europe and other countries for many years, exceeded by a few orders of magnitude all the problems caused by all the approved drugs that were later withdrawn. Peter