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Biotech / Medical : T/FIF, a New Plateau
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To: Biomaven who wrote (1240)7/5/2002 12:27:04 PM
From: Czechsinthemail  Read Replies (2) of 2243
 
It has been interesting to read discussions of the FDA and possible changes in their selection/rejection criteria. It is a bit reminiscent of Kremlinologists back in the 20th century, who made a career out of inferring the inner workings of the Soviet government from limited visible data.

I would agree that the FDA should be upfront and forthright in communicating what their standards are, though I suspect FDA people might argue they have been doing that all along: new drugs must be safe and show efficacy. My beef is not so much that they have tough criteria or even that they raise the bar, but rather that it seems hypocritical to raise the bar and then not review drugs that made it over an earlier low bar. If the real issue is patient safety, drugs that can't demonstrate it shouldn't be on the market.

Here the political predicament of the FDA may come into play. The cardinal sin is not having failed but "appearing" to have failed in their regulatory function. I think this is the main reason for stealth shifts in policy without retroactive reviews of previously approved drugs that would likely not pass muster using more rigorous criteria.

I would also agree that finding the balance that best serves patient needs is important and at times difficult. You mentioned long-acting Risperdal. One has to wonder how big the picture those reviewing it are looking at in making their determination. Is it simply a specific thumbs up/down on this particular application or is there also consideration given to other drugs waiting in the wings (e.g. NVS/TTP's iloperidone) that might offer better solutions? I'm not sure what the reasons were for declining the JNJ/ALKS application, but after receiving a baptism by bath in DepoTech many moons ago, I learned not to assume that long-acting formulations of already approved drugs would be a slam dunk.
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