By James Fallows
Jon Huntsman has been taking flak for apparent wavering from the "I'll listen to scientists about science" stance involving climate change. (Understanding whether climate change is happening, as the overwhelming preponderance of world science says it is, is of course different from agreeing on what can and should be done about it.)
Kathleen Sibelius (Image: Wikipedia)
It's worth giving the Obama Administration flak for today's disheartening decision by the Secretary of Health and Human Services, Kathleen Sebelius, to overrule the scientists in her own Food and Drug Administration who recommended allowing over-the-counter sale of "Plan B" contraceptives. As the New York Times story on the ruling says, the head of the FDA, Dr. Margaret Hamburg, recommended the change:
The agency's scientists, [Hamburg] wrote, "determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted disease."...
After reviewing the scientists' determination, Dr. Hamburg wrote that she agreed "that there is adequate and reasonable, well-supported and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential."
Why did Sebelius take the [apparently unprecedented] step of overruling the FDA? According to the Washington Post's story (emphasis added):
In a separate statement and letter to Hamburg, Sebelius said she overruled the FDA because she had concluded that data submitted by the company that makes the drug did not "conclusively establish" that it could be used safely by girls of all ages. "About 10 percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age," Sebelius said. "If the application were approved, the product would be available, without prescription, for all girls of reproductive age."
This does not pass the straight-face test. The drugstore aisles are full of over-the-counter products that might be dangerous if taken without limit by 11-year-olds. And obviously the FDA scientists' panel would have considered these risks, as they do for any drug.
Scientists do not have the final word on all matters of public policy, but this was an expert panel operating in its area of presumed and assigned competence. The decision to overrule them would look clumsily political and anti-science if it had been made in a Bachmann Administration. Unless Sec. Sibelius has better reasons than she has offered so far, it looks that way in an Obama Administration too.
This post was originally published at The Atlantic.
8 December 2011