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President Obama Backs FDA's Decision on Plan B; Women's Health Advocates Critical of DOJ's Appeal

President Obama Backs FDA's Decision on Plan B; Women's Health Advocates Critical of DOJ's Appeal

May 3, 2013 — President Obama on Thursday voiced his support for FDA's decision to allow over-the-counter sales of the emergency contraceptive Plan B One-Step to people ages 15 and older with proof of age, USA Today reports (Madhani, USA Today, 5/2).

At a news conference during his trip to Latin America, Obama told reporters that he was concerned about FDA's recommendation in 2011 that would have made EC available to people of all ages without a prescription. HHS Secretary Kathleen Sebelius blocked that decision in December 2011, saying there was not enough scientific evidence to prove the drug's safety for younger girls.

Obama said he is "comfortable" with the latest FDA decision, though he added that it is "not [his] decision to make" and emphasized that it is up to FDA to make science-based judgments (Shear, New York Times, 5/2).

Obama also touched on the Department of Justice's decision to appeal a federal court ruling ordering FDA to make EC available without age or point-of-sale restrictions. He said he suspects the case could result in FDA being "called upon to make further decisions about whether there's sufficient scientific evidence for girls younger than 15" but reiterated "[t]hat's the FDA's decision to make" and "Sebelius's decision to review" (Hennessey, Los Angeles Times, 5/2). Obama added, "My understanding is part of [DOJ's decision] has to do with the precedent, and the way in which the judge handled that case" (Epstein, Politico, 5/3).

According to the New York Times, Obama went "out of his way" to say that he supports broad access to contraception. "I think it's very important that women have control over their health care choices," he said (New York Times, 5/2).

Judge Sets Dates for Court Proceedings

Separately Thursday, U.S. District Judge Edward Korman said he will hear oral arguments on Tuesday in DOJ's appeal of his April 5 court order instructing FDA to make EC available OTC to people of all ages. According to CQ HealthBeat, lawyers previously believed FDA had until May 6 to comply with the order, but Korman said the deadline is May 10.

Korman added that if he denies DOJ's request for a stay on the initial order, he will issue another order allowing the government time to seek a stay from the 2nd U.S. Circuit Court of Appeals (Norman, CQ HealthBeat, 5/2).

Women's Health Advocates Critical of DOJ's Actions

Many women's health advocates reacted harshly to DOJ's move to appeal Korman's ruling, which they called politically motivated and a step backwards for women.

Susannah Baruch -- interim president and CEO of the Reproductive Health Technologies Project -- said in a statement, "We are profoundly disappointed" by DOJ's appeal, which is "especially troubling in light of [FDA's] move ... to continue age restrictions and ID requirements" on EC. She added that the pair of announcements "highlight the administration's corner-cutting on women's health."

Advocates recalled that just last week Obama spoke to Planned Parenthood supporters about the importance of reproductive rights (Neergaard/Lederman, AP/Sacramento Bee, 5/2). "We shouldn't have to remind people that when it comes to a woman's health, no politician should get to decide what's best for you," he said.

"It doesn't square and that is what's so disappointing," said Nancy Northup, president of the Center for Reproductive Rights, which brought the suit. She added, "There couldn't be a clearer record than there is in this case that emergency contraception is safe and effective for all ages" (Rovner, "Shots," NPR, 5/2).