“Take Out the Trash Day” was an episode of the White House drama “The West Wing.” It’s a reference to the real-world practice of releasing unpleasant or unpopular information on Friday afternoons to blunt media coverage and reactions as people head into their weekends.
Last Friday, the Food and Drug Administration suddenly called a press conference to announce that it would be delaying a decision on allowing Plan B, a morning-after pill, to be sold over the counter. The agency’s self-imposed deadline for the decision was today.
Plan B works within 72 hours of intercourse by either blocking the fertilization of an egg or stopping the egg from being implanted in the uterus. It’s the second time the agency has postponed approval of the drug, which is opposed by some groups who feel that it is a form of abortion. The agency denies that was a consideration, but when its other reasons are stripped away, all that remains is politics.
In May 2004, acting FDA Director Dr. Steve Galson, blocked over-the-counter sales, claiming that the manufacturer, Barr Pharmaceuticals, did not supply enough information on how the drug would affect young teens. This despite the fact that the FDA’s advisory panel of scientists recommended over-the-counter sales by a 23-4 vote.
At the behest of the FDA, Barr amended its application and sought over-the-counter sales for women older than 17. In the meantime, Galson moved on and Lester Crawford was named acting director and then was formally nominated for the job. In confirmation hearings, he promised senators, including Washington state’s Patty Murray, that he would resolve the Plan B issue by Sept. 1.
But last Friday he broke that promise by saying there might be legal problems with selling a drug over the counter to one set of women (older than 17) and by prescription to another (17 and younger).
Apparently, this didn’t occur to the agency’s leaders when it recommended that Barr resubmit the application with this purported legal defect.
Sorry, but this looks like another maneuver to postone a decision. There was never a reason for age-specific guidelines in the first place, according to the FDA’s scientists. There’s no way to stop young girls from misusing aspirin or cough syrup, but they don’t need a prescription to buy them.
Associate FDA Commissioner Susan Wood was so outraged by Crawford’s decision that she resigned on Wednesday, saying: “I have spent the last 15 years working to ensure that science informs good health-policy decisions. I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended by the professional staff here, has been overruled.”
In Washington state, Plan B and other morning-after pills are sold over the counter. The deleterious effects have yet to arise. There’s no reason to think the situation would be any different if women everywhere could purchase the drug the same way.
The FDA is trashing its reputation as a neutral arbiter by allowing politics to trump science.
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