Obama administration overrules FDA on Plan B

THURSDAY, DEC. 8, 2011

WASHINGTON – The Obama administration, in an unexpected move, overruled a Food and Drug Administration decision that would have allowed anyone, regardless of age, to buy emergency contraceptives without a prescription.

The pill, called Plan B One-Step, currently is available to women 17 and older without a doctor’s order, though it is kept behind the counter. Teva Pharmaceuticals asked the FDA to make the drug available to teenagers 16 and younger without a prescription.

When taken within 72 hours of unprotected sex, the pill is effective in preventing pregnancy by restricting ovulation or blocking the implantation of a fertilized egg.

Health and Human Services Secretary Kathleen Sebelius said in a statement she was rejecting the company’s request because Teva hadn’t proved girls as young as 11 would be able to use Plan B safely. An FDA spokeswoman said it was the first time that HHS had used its statutory authority to overrule an agency decision.

The move stunned abortion rights advocates. “The decision is a huge step back,” said Dr. Susan Wood, a former FDA assistant commissioner for women’s health. She criticized the administration for “abandoning its scientific integrity principles, and blocking a safe and effective contraceptive.”

Also denouncing the decision were groups representing pediatricians, obstetrician-gynecologists and other physicians involved in adolescent health.

Anti-abortion groups were delighted by the HHS decision. “It would be outrageous to put a drug like Plan B on the shelf next to condoms,” said Rita Diller, head of the American Life League’s Stop Planned Parenthood project. “It’s not meant to be ongoing birth control, and that’s how they would use it if it was available like condoms.”

FDA commissioner Margaret Hamburg, in a statement Wednesday, said she agreed with her agency’s staffers that there was adequate “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.”

But she said she was informed Wednesday that Sebelius disagreed with the FDA’s conclusion and was invoking her authority to overrule the agency.

Sebelius, in her statement, said that Teva’s “label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.” Teva said it was “disappointed” by the decision.

While angering abortion rights groups, the HHS action likely averted a firestorm that could have been touched off by making Plan B more widely available. President Barack Obama’s re-election formula depends on winning swing states where white working-class and Catholic voters will play a critical role.

Administration officials said the decision was based on the merits, and that Sebelius wants to see more data before approving easier access to the drug.

Lanae Erickson, director of the social policy and politics program at Third Way, a centrist think tank, said that Sebelius was taking a “nuanced” approach to a complicated issue. “We need to be sure teens are using the drug effectively and safely, because it has higher hormone levels than other contraceptives,” she said.

But Wood, who left the FDA in 2005 in protest over the agency’s foot-dragging in approving the drug’s original over-the-counter application, said that the FDA, not Sebelius, has the expertise to analyze the data. She said the secretary was holding Plan B to a higher standard than other drugs sold without a prescription.

“The FDA has never asked for age-specific data on any of its over-the-counter products,” said Wood, who teaches at George Washington University’s School of Public Health. “So what we have is a very safe product. … You cannot overdose” – a risk, she said, that exists with other widely used drugs such as acetaminophen.


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