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Fast Track Is for the Fittest

Posted on January 11th, 2008 by Patrick Clinton

The award for goofiest attack on the FDA this week has to go to Senator Sherrod Brown (D-OH), who has asked the Congressional Research Service to look into the possibility of changing or eliminating FDA’s Fast Track designation, according to the Cleveland Plain Dealer.

The Plain Dealer no doubt thinks this makes sense. Last December, the paper published a series of articles revealing that (a) Fast Track designation doesn’t really seem to get drugs to market that much faster, and that most of what it provides can also be provided under the older Priority Review programs, (b) the announcement of Fast Track designation pumps up both stock price and trading volume for biotechs, and (c) there’s pretty persuasive evidence that some execs are playing such announcements to enhance the value of their stock options.

(You can read the series here, here, here, here, and here.)

The Fast Track may indeed not speed up approval that much. When the program began, the Tufts Center for the Study of Drug Development found that it cut almost three years off development time. A more recent Tufts study found no real difference. According the the Plain Dealer, Tufts argued that this was still an improvement, since Fast Track drugs tend to pose complex problems and would otherwise be slower. The paper seemed to doubt that explanation. Me, I simply don’t know.

But as for the rest of it, let’s grow up. The paper complains that investors and patients alike are misled into thinking that Fast Track designation means a drug is a sure thing and coming soon, which, of course, it doesn’t mean at all. If companies are issuing inappropriately worded press releases, the Securities and Exchange Commission should nail them. And if investors are dumb enough to bid up a stock without first finding out what “Fast Track” means, well, Darwin suggests a reason why we might just want to let them suffer.

Tags: R&D · Regulatory

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