December 14, 2011 — A federal judge on Tuesday rejected a request by the Center for Reproductive Rights to hold FDA in contempt for delaying a decision on nonprescription sales of the emergency contraceptive Plan B, the Washington Post reports. However, the judge agreed to hear arguments over whether the government should allow people younger than age 17 to purchase the drug without a prescription (Stein, Washington Post, 12/13).
Judge Edward Korman said he agreed with the government that the request to hold FDA in contempt was rendered moot after the agency on Monday issued a last-minute response to CRR's petition to allow Plan B to be sold without a prescription.
Korman invited CRR to file the appropriate legal motions to proceed with the other elements of the case. HHS Secretary Kathleen Sebelius could be added as a defendant, he said (Wetzstein, Washington Times, 12/13).
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, 12/13).
CRR said it would follow Korman's instructions. "We intend to take every legal step necessary to hold the FDA and this administration accountable for its extraordinary actions to block women from safe, effective emergency contraception," Nancy Northup, president and CEO of CRR, said (Washington Post, 12/13).
Northup noted that the fight over nonprescription access to EC has lasted a decade. "The FDA cannot simply continue moving the goal posts down the field for women's reproductive health care," Northup said (Washington Times, 12/13). 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. The agency in 2009 lowered the age limit to 17 after Korman ordered it to do so (Women's Health Policy Report, 12/13).
Senate Democrats Question HHS' Plan B Decision
Separately on Tuesday, 14 members of the Senate Democratic Caucus sent a letter to Sebelius requesting the "specific rationale and the scientific data" behind her decision to maintain age restrictions on Plan B One-Step, the AP/Miami Herald reports (AP/Miami Herald, 12/13).
"On behalf of the millions of women we represent, we want to be assured that this and future decisions affecting women's health will be based on medical and scientific evidence," the senators wrote (Baker, "Healthwatch," The Hill, 12/13).
The senators -- led by Sen. Patty Murray (D-Wash.) -- noted that "numerous medical societies and patient advocates have argued [that] improved access to birth control, including emergency contraception, has been proven to reduce unintended pregnancies." They added, "Keeping Plan B behind the counter makes it harder for all women to obtain a safe and effective product they may need to prevent an unintended pregnancy" (Sonmez, "2chambers," Washington Post, 12/14).