After 14 years, the legal battle over access to Plan B – emergency contraception – has ended. The Obama administration announced late Monday that it is dropping its effort to limit sales of the most common morning-after pill, in the face of judicial opposition.
Soon, women and girls of all ages – not just those age 15 and older – will be able to buy the drug over the counter without restrictions. The drug is designed to prevent pregnancy up to 72 hours after unprotected sex.
The decision came after a string of legal defeats, most recently last Wednesday, when the US Court of Appeals for the Second Circuit refused to delay part of a lower-court judge’s order to make the pill available over the counter to people of all ages.
The handwriting was on the wall, and the Justice Department apparently concluded that it would be an uphill climb in court to limit access to the controversial pills. The issue could well have ended up in the US Supreme Court, putting the Obama administration in the uncomfortable position of arguing for restrictions strongly opposed by a core constituency – groups that support broad reproductive rights.
“There was no imaginable possible political gain for them in continuing to fight this,” says David Garrow, a law professor at the University of Pittsburgh and expert on reproductive issues. “Anybody who would agree with them in opposing this already opposes them on everything else.”
In December 2011, Health and Human Services Secretary Kathleen Sebelius took the unprecedented step of blocking the Food and Drug Administration’s plan to approve the sale of Plan B One-Step over the counter without age restrictions. In public remarks, President Obama supported Secretary Sebelius’s decision, citing his perspective “as a father of two daughters.”
"I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine," Mr. Obama told reporters at the White House.
Liberals slammed the president for, as they saw it, putting politics over science, since the FDA had concluded that the morning-after pill was safe for use by women and girls of all ages. But Obama was running for reelection, and not interested in giving Republicans an easy talking point that would read something like this: “President supports morning-after pill for 11-year-olds.”
Now safely reelected, Obama can let social conservatives have that press release.
Opponents of emergency contraception object to the pills on the grounds that they can cause an early abortion (a point that supporters of the pills dispute). But their use by underage girls is especially troubling, opponents say, because they make it easy for men to take advantage of girls without the risk of pregnancy. Girls need access to supportive adults and medical care, not a pill, say abortion foes.
“Irresponsibly removing the important opportunity for a health-care provider to identify and intervene in cases of abuse, and giving a potentially life-ending drug to young girls without any understanding of the medical implications, unnecessarily exposes them to risk,” says Charmaine Yoest, president and CEO of Americans United for Life.
Cecile Richards, president of the Planned Parenthood Federation of America, hailed Monday’s announcement.
“This is a huge breakthrough for access to birth control and a historic moment for women’s health and equity,” Ms. Richards said. “The FDA’s decision will make emergency contraception available on store shelves, just like condoms, and women of all ages will be able to get it quickly in order to prevent unintended pregnancy.”
The battle for public access to Plan B started in 1999, when the FDA approved it for prescription use. In February 2001, the Center for Reproductive Rights filed a “citizen petition” with the FDA on behalf of more than 70 medical and public health organizations to make Plan B available over the counter.
The ensuing decade, under both Presidents Bush and Obama, was marked by internal struggles at the FDA over the drug, as well as accusations of politicization.
In April of this year, federal Judge Edward Korman – a Reagan appointee – ordered the FDA to make Plan B available to women and girls of all ages without a prescription, calling efforts to prevent that action “arbitrary, capricious, and unreasonable.”
In his ruling, Judge Korman expressed disappointment in Sebelius, saying the availability of a drug should be determined by the FDA, not a federal judge.
“The motivation for the secretary’s action was obviously political,” the judge wrote, referring to her December 2011 decision. “It was an election year decision that many public health experts saw as a politically motivated effort to avoid riling religious groups and others opposed to making birth control available to girls.”
In its press release Monday night announcing the change of stance toward Korman’s April 5 order, the FDA said it has asked the maker of Plan B One-Step to submit a “supplemental application” seeking approval of the one-pill product to be made available over the counter without any restrictions.
“Once FDA receives that supplemental application, the FDA intends to approve it promptly,” the agency said.
Eventually, generic versions are expected to be available, also without restrictions.