Left ‘speechless’ as Sebelius overrules FDA on access to morning-after pill

In a decision steeped in 2012 politics, President Obama’s top health official on Wednesday overruled government scientists to block wider access to the so-called “morning-after pill.”

The decision to leave in place a requirement that women younger than 17 get a prescription for the drug was a huge surprise to liberal groups and advocates for the Plan B contraceptive, some of whom said they were left “speechless” by Health and Human Services Secretary Kathleen Sebelius’s involvement.

{mosads}It came a day after Sebelius traveled to Kansas on Air Force One with the president, but it is unclear whether the two discussed the decision. An administration official was not aware of any conversations about the pill between the two, and said the decision was Sebelius’s alone.

Wednesday was the deadline for the Food and Drug Administration to make a decision about the drug, and the agency’s scientists recommended broader over-the-counter access.

FDA Commissioner Margaret Hamburg made clear in a statement Wednesday that she agreed with the agency’s scientific reviewers that Plan B should be provided over the counter.

In quashing the decision, Sebelius acted quickly in a letter to the FDA Wednesday morning that said she was not convinced about the evidence supported expanding over-the-counter access to Plan B.

“It is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe are relevant to making this determination as to non-prescription availability of this product for all ages,” Sebelius wrote.

It is highly unusual for the HHS secretary to publicly overrule the decisions made by FDA reviewers. Even major steps such as pulling drugs completely off the market have almost always come from the agency’s career staff.

Plan B is legal and FDA-approved, without a prescription, for women 17 and older. The FDA concluded that there was no medical or scientific basis for requiring 16-year-olds to get a prescription but letting 17-year-olds buy the drug directly from a pharmacist.

“The fact that Secretary Sebelius overruled Commissioner Hamburg and the FDA professional staff is unbelievable,” said Susan Wood, who resigned from the FDA because of the Bush administration’s handling of Plan B. “I cannot understand it, and I have no idea why this happened.”

She was one of several critics who accused Sebelius of bowing to political pressure rather than letting the FDA’s scientists do their jobs.

“We expected this kind of action from the Bush administration, so it’s doubly disheartening and unacceptable that this administration chose to follow this path,” NARAL Pro-Choice America said in a statement.

Rep. Henry Waxman (D-Calif.) also said Sebelius should have stayed out of the Plan B decision.

{mossecondads}“I think it’s very unfortunate the secretary made the decision that she did,” Waxman said. “The FDA is a scientific agency, and they gave her their recommendation based on the science, and I think she should have followed it.”

Republicans believe Plan B causes abortions, and have pressed hard to restrict access to the drug. If the FDA decision had gone forward, it is possible Obama could have come under criticism from the Republican field of presidential candidates for making abortion more accessible.

Some Republicans had threatened to cut the FDA’s budget if it allowed women younger than 17 to get Plan B without a prescription. During the Bush administration, senior HHS and White House officials stepped in multiple times to slow the FDA’s consideration of Plan B.

That political involvement infuriated liberal groups and some scientific advocates, who were stunned to see what they viewed as a similar action by the Obama administration.

Wood said Sebelius’s intervention left her “speechless.”

“I don’t know where it comes from but it is not the FDA,” Wood said. “It is way too reminiscent … this is appalling.”

This story was posted at 12:49 p.m. and last updated at 6:28 p.m.

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