Levonorgestrel-based emergency contraceptives now will be able to be placed on pharmacy shelves, with no age restrictions on who can purchase the products over-the-counter, as a result of a U.S. District Court judge’s ruling on April 5.
Restrictions must be lifted within 30 days, according to the ruling.
The ruling addresses a controversial decision made in 2011 by Health and Human Services Secretary Kathleen Sebelius. Ms. Sebelius overruled a Food and Drug Administration decision to extend approval of the levonorgestrel-based Plan B One-Step emergency contraceptive as an over-the-counter product for women of all ages; she cited a lack of data on women of all age groups in studies submitted to the FDA for approval.
As a result, products have been kept behind pharmacy counters, and a prescription has been required for teenagers under age 17 – limiting access to ECs, particularly when pharmacies are closed.
The court’s "decision was a long time coming and is based on sound scientific evidence" and represents "a major victory for women’s health, removing barriers to teens’ and other women’s access to a needed medication by making it truly over-the-counter," Dr. Eve Espey, professor of obstetrics and gynecology, University of New Mexico, Albuquerque, said in an interview. Emergency contraception "will be on the shelf instead of behind-the-counter, where it’s easier for all women to get, and emergency contraception may be available in stores other than pharmacies since it’s over-the-counter."
For more than a decade, women’s health advocacy groups have been working to make emergency contraception available without restrictions. The effort dates back to 2001, when several groups including the Center for Reproductive Rights filed a citizen’s petition with the FDA to make emergency contraceptives available over-the-counter. In 2006, the FDA approved Plan B as an OTC product for women aged 17 years and older, who could provide proof of their age with a government-issued ID, and as a prescription product for younger women.
That approval came several years after an FDA advisory panel recommended OTC approval for women of all age groups.
In a December 2011 statement, FDA Commissioner Margaret Hamburg said that the agency’s review had concluded that there was "adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of childbearing potential." But she announced that she had been directed by Ms. Sebelius, who disagreed, to notify the manufacturer, Teva Pharmaceuticals, that a prescription would still be required for women under age 17.
In the April 5 ruling, Federal District Judge Edward Korman, of the Eastern District of New York, lifted the age restrictions, and in his opinion he referred to Ms. Sebelius’ decision and the FDA decision to deny the citizen’s petition, as "arbitrary, capricious, and unreasonable."
"The obstructions in the path of those adolescents in obtaining levonorgestrel-based emergency contraceptives under the current behind-the-counter regime have the practical effect of making the contraceptives unavailable without a doctor’s prescription," the ruling said. The ruling reverses the FDA’s decision to deny the citizen’s petition and remanded the case to the FDA "with the instruction to grant the citizen’s petition and make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within 30 days."
During a press briefing April 5, lawyers and representatives of women’s health advocacy groups lauded the ruling as an example of science prevailing over politics.
Nancy Northrup, president and CEO of the Center for Reproductive Rights, said that "despite mountains of evidence that emergency contraception is safe and effective for all ages, the FDA has kept it locked behind the pharmacy counter, subject to ID checks, doctors’ prescriptions for younger women, and the pharmacy hours of operation."
Because of the court order, emergency contraception will no longer be denied to women who do not have a government-issued ID, young women will no longer have to get a prescription, "and no longer will any woman rush into an all-night drugstore only to find the pharmacy gates closed and emergency contraception, which is most effective when taken immediately, just out of her reach," she said.
Speaking on behalf of the American Academy of Pediatrics during the briefing, Dr. Cora Collette Breuner, professor of adolescent medicine and pediatrics at Seattle Children’s Hospital and the University of Washington, Seattle, said that the ruling was long overdue and that it was welcomed by the AAP, which issued a policy statement in December 2012 supporting teen use of emergency contraception as an important backup contraceptive method. Dr. Breuner, a coauthor of that statement, said that even with the lifted restrictions, it was important to ensure that the OTC ECs would remain available to all women of all income levels, and that the cost not be prohibitive for younger teens. The current retail cost is about $40-$50.