In reversal, Obama to end effort to restrict morning-after pill


Published Jun 11, 2013 at 05:00AM / Updated Nov 19, 2013 at 12:31AM

WASHINGTON — The Obama administration has decided to stop trying to block over-the-counter availability of the most popular morning-after contraceptive pill for all women and girls, a move fraught with political repercussions for President Barack Obama.

The reversal by the government means that anyone will soon be able to walk into a drugstore and buy the pill, Plan B One-Step, without a prescription.

The Justice Department had been fighting to prevent that outcome, but said late Monday afternoon that it would drop its appeal of a judge’s order to make the drug more widely available. In a letter to Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York, the administration said it would comply with his demands that the Food and Drug Administration be allowed to certify the drug for nonprescription use.

The Justice Department appears to have concluded that it might lose its case with the appeals court and would have to decide whether to appeal to the Supreme Court. That would drastically elevate the debate over the politically delicate issue for Obama.

Women’s rights groups, who had sued the government to clear the way for broader distribution of the drug cautiously hailed the decision as a significant moment in the battle over reproductive rights but said they remained skeptical until they saw details about how the change will be put into practice.

The drug prevents conception if taken within 72 hours after sexual intercourse.

“We will not rest in this fight until the morning-after pill is made available without delay and obstruction,” said Mara Verheyden-Hilliard, a lawyer and the executive director of the Partnership for Civil Justice Fund, which represented the plaintiffs in the case.

The FDA issued a statement Monday night saying that it planned to drop its appeal. “To comply with the order, the FDA has asked the manufacturer of Plan B One-Step to submit a supplemental application seeking approval of the one-pill product to be made available OTC without any such restrictions,” the statement said. “Once FDA receives that supplemental application, the FDA intends to approve it promptly.”

The decision is certain to anger anti-abortion advocates, who oppose letting young girls have access to the drug without the involvement of a parent or a doctor. For Obama, the decision could rekindle a high-intensity, politically turbulent debate about contraceptives even as he is already dealing with a series of distracting scandals and national security leaks.

Obama had expressed personal concern about making the drug more broadly available last year and offered support to Kathleen Sebelius, his secretary of health and human services, when she blocked a decision by the FDA that would have cleared the way for nonprescription distribution to all girls and women regardless of age. The president said that as the father of two young girls, the idea of making the drug available to them without a prescription made him uncomfortable.

But a federal judge angrily accused the administration of blocking the drug because of politics, not science, and ordered Sebelius to reverse her decision. Last week the Court of Appeals for the 2nd Circuit in New York City partially refused the Justice Department’s request for a delay in the judge’s order while the government appealed.

The fight to make emergency contraceptives universally available without a prescription is more than a decade old. Plan B, the trade name for the morning-after pill, was approved in 1999 as a prescription-only product. In 2001 the Center for Reproductive Rights filed a citizens petition for it to be made available over the counter or without a prescription.

Scientists, including an expert advisory panel to the FDA, gave early support to that request. But top agency officials rejected the application because, some said later, they worried they would be fired if they approved it. A lawsuit was filed in 2005.

In 2006 President George W. Bush’s administration allowed over-the-counter sales of Plan B to women 18 and older but required a prescription for those 17 and younger. In 2009, in an effort to expand access to the drug incrementally, Korman directed that the pill be made available without a prescription for those 17 and older.

In April, Korman once again ordered the government to make all morning-after pills available without a prescription and without any sales restrictions. In a stridently worded ruling, Korman wrote that Sebelius’ decision to overrule the FDA “was politically motivated, scientifically unjustified, and contrary to agency precedent.”