Court Ruling: On April 4, 2013, U.S. District Judge Edward Korman reversed a decision of the U.S. Food and Drug Administration (FDA) and directed the agency to “make levonorgestrel-based emergency contraceptives [such as Plan B or Plan B One-Step] available without a prescription and without point-of-sale or age restrictions within thirty days.” Tummino v. Hamburg, Memorandum and Order No. 12-CV-763 (ERK)(VVP).
This was not Judge Korman’s first involvement in this issue. In 2006, the FDA had approved over-the-counter (OTC) non-prescription distribution of Plan B for women 18 and older, but prescription-only availability for adolescents 17 and younger. In a 2009 ruling, Judge Korman had ordered the FDA to make Plan B available OTC without a prescription to adolescents one year earlier at age 17. The FDA did not appeal that decision.
Deirdre McQuade, spokeswoman for the bishops’ Secretariat for Pro-Life Activities, urged that Judge Korman’s 2013 ruling “be appealed and overturned.” She stated:
Plan B is a large dose of a powerful hormonal drug (levonorgestrel) that is available only by prescription when used in smaller doses for contraception. The court has acted irresponsibly by making this powerful drug available without a prescription to minor children.
Plan B does not prevent or treat any disease, but makes young adolescent girls more available to sexual predators. The court’s action undermines parents’ ability to protect their daughters from such exploitation and from the adverse effects of the drug itself.
Many studies have shown that wider access to “emergency contraception” among young people does not reduce pregnancy or abortion rates, but can contribute to higher rates of sexually transmitted disease. No public health consideration justifies the unregulated distribution of such drugs to children.
On May 1, 2013, the U.S. Department of Justice filed a notice to appeal the April 4, 2013, ruling, and asked Judge Korman to stay his order pending the results. On May 10, 2013, Judge Korman rejected the government’s request to stay his order and gave the government until noon on May 13, 2013, to seek a stay from the Second U.S. Circuit Court of Appeal. The government appealed. On June 5, 2013, a three-judge federal panel of the Court of Appeals ruled that Judge Korman’s order allowing unrestricted access to the one-pill version of Plan B should be lifted temporarily while the case is on appeal but that unrestricted access to the two-pill version should be allowed.
However, on June 10, 2013, the federal government reversed its position. In a court filing the Justice Department stated that the FDA would allow Plan B to be sold without age or point-of-sale restrictions. The government said it would comply with Judge Korman’s April 4, 2013, order and would end its appeals in court on this matter.
The Teva Application: In 2011, Teva Women’s Health had applied to the FDA to make Plan B One-Step (a one pill Plan B regimen) available OTC to all girls of reproductive age. The FDA had approved the application but U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius had overruled the FDA on the grounds that the data “do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.” Judge Korman’s 2013 ruling was directed against the FDA denial of a Citizen Petition to make all emergency contraceptives available OTC without prescription requirements, but Judge Korman linked this denial to the 2011 action by Secretary Sebelius. The 2013 ruling removes not only age restrictions but also the point of sale restrictions that limit availability to pharmacies and health clinics from behind the counter.
After the rejection of its 2011 application, Teva submitted an amended proposal to make Plan B One-Step available without a prescription for women 15 years of age and older. On April 30, 2013, in an action separate from the Korman ruling, the FDA approved the modified Teva proposal. Not only was the age requirement dropped from 17 to 15 years, but the product would be available on the shelf in retail outlets with an onsite pharmacy. The amended proposal does not apply to Plan B (the two pill regimen) or to Ella. Ms. McQuade called the approval a “disappointment” and charged the FDA with “failing in its responsibility to protect children.” For full statement, see: www.usccb.org/news/2013/13-081.cfm.