In early April, U.S. District Judge Edward Korman ordered the Food and Drug Administration to make Plan B available over the counter to all women. He gave the Obama administration until May 5 to appeal his decision.
The FDA’s decision Tuesday, coming so close to that deadline and in conflict with Korman’s order, triggered confusion among women’s-health advocates. Some groups interpreted the FDA’s move as a precursor to an appeal. The Justice Department and the White House declined to comment on whether the Obama administration would challenge the ruling.
“This triggers their intention to file an appeal even if they haven’t yet,” said National Women’s Law Center Vice President Judy Waxman. “This decision doesn’t comply with the judge’s ruling.”
If the administration decides against an appeal, the FDA’s move Tuesday would become only symbolic. Women of all ages would soon gain access to the pill, which could be sold next to painkillers and toothpaste, though it could take weeks or months before the drug is on shelves.
A legal fight would reignite a debate over whether young teens should be eligible to obtain emergency contraception without a doctor’s consent. In December 2011, the FDA concluded that the drug was safe for over-the-counter use among all women, but senior Obama administration officials overruled the agency’s scientists.
Tuesday’s decision by the administration was seen by women’s advocates as an attempt to chart a middle ground, offering easy access to the pill to older teens but still restricting it for younger ones.
“Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” FDA Commissioner Margaret A. Hamburg said in a statement. “The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease.”
For more than a decade, Plan B has had a complex and politically divisive path toward obtaining federal approvals, marked by multiple resignations by senior staffers at the FDA and the creation of a complicated web of regulations around the contraceptive.
In a 59-page ruling in April, Korman offered a scathing rebuke of the 2011 decision by Health and Human Services Secretary Kathleen Sebelius to bar over-the-counter sales of the pill to girls younger than 17. Korman called Sebelius’s decision “politically motivated, scientifically unjustified and contrary to agency precedent.”