Thursday, November 17, 2005

 

FDA Trots Out Galileo Defense Again


Dr. Galson, acting director of the FDA's drug center, said last year that he decided on non-approvable for the morning after pill Plan B because a only 29 of 585 participants in a supporting study were between the ages of 14 and 16, and none were under 14. The issue was whether teenagers might be more likely to engage in sex if they knew an emergency contraceptive was available. In the study, teens laughed off that suggestion. Dr. Galson said that younger teens might act differently than older ones. He suggested to the company that approval could be gained if another study included more young adolescents, or if the sale was kept "behind the counter", available without a prescription only to women 16 and over.

The company, Barr, elected to go behind the counter due to the huge expense of the suggested second study. Think about it. How much would they have to pay you to hang around playgrounds asking 12 or 13 year old girls whether they would be more likely to engage in sex if the pill was available? But anyway, the FDA, after thinking about it for another year, said the application would be delayed indefinitely while it thought about it some more.

When the GAO report issued last week pointed out that it was "unusual" for the agency to suggest a means for approval and then later take it back, the agency said "unusual, persmusal", stating that it was an everyday practice going back over 400 years, again referencing the Galileo trial. In that earlier situation, after looking over some instruments of torture, Galileo copped a plea under which he could go free if he did "abjure, curse and detest" his work. A lot of us do that, of course, but Leo didn't have what you call a regular job. Be that as it may, the inquisition later changed its mind, convicted him of "grave suspicion of heresy", and sentenced him to an indefinite delay of freedom.

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