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.”
Despite the potential for further legal wrangling over the drug, some reproductive rights advocates hailed the decision as a step forward, even as they pushed for expanding access to Plan B further.
“This is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy,” said Planned Parenthood Federation of America President Cecile Richards. “While we fully support this expansion of access to birth control, we continue to believe that the administration should lift all unnecessary restrictions to emergency contraception.”
The conservative Susan B. Anthony List criticized the decision late Tuesday. “The FDA is recklessly positioning itself as a parent to our children,” Marjorie Dannenfelser, the group’s president, said in a statement. “Fifteen year old girls need the protection that comes with the involvement of real parents and doctors in their lives.”
Plan B has attracted controversy since it was approved as a prescription emergency contraceptive in 1999. Four years later, its manufacturer asked the FDA to make the drug available over the counter. The agency rejected that request, citing a lack of data on how it affects females younger than 16.
Two FDA officials resigned in 2005 after the agency announced it would indefinitely postpone any further review of providing Plan B over the counter. Just a year later, the agency decided it would allow women older than 18 to purchase the drug over the counter.
Teva Pharmaceuticals, which manufacturers Plan B One-Step, applied in February 2011 to sell the emergency contraceptive over the counter without any restriction on age. In December 2011, the FDA recommended that Teva’s application be approved and Plan B One-Step be made available for nonprescription use.
At the time, President Obama said he was not involved in Sebelius’s decision to limit the over-the-counter sales. But he sympathized with it, saying that “as the 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.” HHS officials cited concerns about a lack of safety data for 12-year-old girls who might use the product.
Teva subsequently submitted a new application to sell the emergency contraceptive to females 15 and older, FDA spokeswoman Stephanie Yao said. The FDA said its decision Tuesday was in response to that application and was unrelated to the existing litigation.
Plan B is classified by the FDA as an emergency contraceptive and greatly reduces the chance of pregnancy if taken within 72 hours after intercourse. It differs from abortion drugs such as RU486, which are intended to terminate a pregnancy that has been established.