Health and Human Services Secretary Kathleen Sebelius overruled the Food and Drug Administration’s decision Wednesday that emergency contraceptives be sold freely over the counter, including to teenagers 16 years old and younger.
The pill, called Plan B One-Step, has been available without a prescription to women 17 and older, but those 16 and younger have needed a prescription — and still will because of Ms. Sibelius’s decision. In some states, pharmacists can write the prescription on the spot for teenagers. But the restrictions have meant the pills were only dispensed from behind the counter — making them more difficult for everyone to get. The pill, if taken after unprotected sex, halves the risk of a pregnancy.
Under the law, Ms. Sebelius has the authority to overrule the agency, but no health secretary has ever done so, according to an F.D.A. spokeswoman. Her decision on an emotional issue that touches on parental involvement in birth control for teenaged children is likely to have powerful political reverberations in a presidential election season.
If this was a political decision (and there's zero doubt about that, frankly, because the science supported making this medication available) then it's a completely moronic one. There's no benefit politically for doing this. It overrules the available science. It's frankly a stupid move you would expect from a red state governor. The FDA said: "Hey, we see no scientific reason this should be done." Kathleen Sebelius and President Obama disagreed.
In a statement, Ms. Sebelius said that the drug’s manufacturer had failed to study whether girls as young as 11 years old could use Plan B safely. And since about 10 percent of girls are capable of bearing children as early as 11, those girls need to be studied as well, she wrote.
“After careful consideration of the F.D.A. summary review, I have concluded that the data submitted by Teva do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age,” Ms. Sebelius wrote.
It's an election-year punt, period. It's insulting, it's wrong, and it's cowardly.
Bad, bad call.
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