Saturday, September 26, 2009

FDA rules to suppress competition.

In his op-ed article "The FDA Rejects Another Good Cancer Drug" (Wall Street Journal, Sept. 24), Matt Alsante says that the FDA stipulated that for the drug Yondelis to be approved it would have to show a six-week improvement over the most effective therapy now being used. What awful public policy! Americans don't need the FDA protecting existing drugs from new competition--only Big Pharma needs that. It is especially wrong-headed to block a proven cancer drug, since such drugs typically work for some patients and not for others. More options available to physicians will lead to more remissions. (By the way, even though Yondelis met FDA's demands it was rejected!)  Surely the laws empowering the FDA do not include a mandate to minimize competition for approved drugs. There is reason to question any preemptive FDA role regarding efficacy--how about letting the market work? But suppressing new drugs because they do not out-perform existing drugs is pernicious nonsense, suggestive of corruption. Nearly everyone in America is distressed or outraged about drug costs: It's the FDA's doing. Among our obvious needs is more competition; the FDA sees its role as preventing competition.

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