December 13, 2011 — HHS Secretary Kathleen Sebelius on Tuesday said her decision to maintain age restrictions the emergency contraceptive Plan B One-Step was not "about politics," Bloomberg reports (Frier, Bloomberg, 12/12).
Last Wednesday, FDA was set to eliminate the current requirement that women prove they are at least 17 years old or obtain a prescription to purchase the drug. However, Sebelius issued a memo stating that she was invoking her authority to overrule the decision because the drugmaker did not provide "data on all ages for which the drug would be approved" for nonprescription use. Sebelius cited the "significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age" as a reason for maintaining the current age restrictions (Women's Health Policy Report, 12/9).
Many doctors, medical associations, women's health advocates and lawmakers were surprised and angered by Sebelius' decision, and they accused the Obama administration of being motivated by politics rather than science (Women's Health Policy Report, 12/8).
Sebelius on Tuesday said Teva can submit an application that includes more testing on label comprehension and use among younger girls. "There are always opportunities for the company to come back with additional data," she said (Bloomberg, 12/12).
FDA Denies Center for Reproductive Rights Petition on Eve of Federal Court Hearing
Meanwhile, FDA on Monday denied a petition by the Center for Reproductive Rights that sought to lift age restrictions on an older version of Plan B that includes two pills, the Wall Street Journal reports. In denying the petition, the agency said it would need data from use and label comprehension studies for the two-pill version of the drug. FDA said studies of Plan B One-step "would not be transferable" to the two-pill version of the drug.
CRR and FDA are set to appear in court on Tuesday to argue the group's request that the agency be held in contempt for failing to promptly act on a 2009 court order to reconsider the Plan B decision.
Nancy Northup, president and CEO of CRR, said, "On the eve of a contempt hearing, the FDA has once again come up with an excuse to treat the approval of contraceptives differently from any other drug."
CRR has been pursuing legal action against FDA over Plan B since 2001, when it filed a petition seeking a ruling that would make Plan B available without a prescription. FDA approved nonprescription access in 2006, but only for women ages 18 and older (Corbett Dooren, Wall Street Journal, 12/12).
In March 2009, U.S. District Judge Edward Korman ruled that the 2006 decision was politically motivated and scientifically flawed. Korman ordered FDA to make Plan B available to 17-year-olds and re-examine other restrictions, including if non-prescription access should be available to all ages. FDA announced the following month that it would allow non-prescription sales of the two-pill version of Plan B to individuals ages 17 years and older.
The agency also said it would reconsider making the two-pill version of Plan B available without a prescription to all ages, but it later said it would not address the issue (Women's Health Policy Report, 11/19/10). FDA that year also approved Plan-B One-step and allowed it to be sold without a prescription to women ages 17 and older.
Tuesday's hearing will address whether FDA fully complied with the 2009 court order (Wall Street Journal, 12/12).