"Obama’s Plan B: Politics Over Science"
Last week, Food and Drug Administration Commissioner Margaret Hamburg had “reviewed and thoughtfully considered the data, clinical information, and analysis” from the Center for Drug Evaluation and Research and concluded “that there is 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 child-bearing potential.” The decision to expand the availability of emergency contraception to women of all ages was to be the culmination of an eight-year battle that pitted science against ideology. President George W. Bush’s FDA had dragged its feet in allowing the drug to be sold over-the-counter for three years, finally approving access for women 18 and older in August 2006 — but not before Democratic senators pressured administration appointees into action and a top scientist resigned her post in protest of the politicization of scientific research. In 2009, a federal judge found that the Bush FDA acted “arbitrarily” and “capriciously” in restricting over-the-counter access to younger women, and the agency, following court orders, made the medication available without a prescription for women over the age of 16. Given the Obama’s administration commitment to science, once Teva Pharmaceuticals, the drug’s manufacturer, filed an application seeking to expand over-the-counter access in February of 2011, women’s health advocates expected the Obama administration to grant the request. But in an unprecedented move, Health and Human Services Secretary Kathleen Sebelius overruled Hamburg and denied over-the-counter access without an age restriction.
ADMINISTRATION’S REASONING: In explaining her decision, Sebelius wrote that younger women would not “understand the label and use the product appropriately.” “It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” she said in a statement. “If the application were approved, the product would be available, without prescription, for all girls of reproductive age.” But almost “every medical organization with expertise” in the field agreed that it should be. Scientists — including Susan Wood, the assistant commissioner for women’s health at the FDA from 2000 to 2005 — argued that “the science has been solid that the drug is safe and should be available to anyone who needs it.” Wood wondered why Sebelius’ “worries about the use of medicines by teenagers, have not been applied to other products…such as acetaminophen, and others with known and serious risks, over the counter.”
OBAMA’S DEFENSE: While the administration insisted that President Obama had not involved himself in Sebelius’ final decision, during a press conference on Thursday, December 8, Obama joined the Secretary in disregarding the recommendations of FDA scientists and expressed his concerns about young girls improperly using the drug. “As the father of two daughters, I think it is important for us to make sure that we apply some common sense to various rules when it comes to over the counter medicine,” he said. “The reason Kathleen made this decision is that she could not be confident that a 10-year-old or 11-year-old going to a drug store would be able to, alongside bubble gum or batteriers be able to buy a medication that potentially if not used properly can have an adverse effect.” Obama’s comments conflict with a 2009 executive order, in which the president pledged that “Science and the scientific process must inform and guide decisions of my Administration on a wide range of issues, including improvement of public health.” As he said then, his Executive Order was needed “To ensure that in this new Administration, we base our public policies on the soundest science; that we appoint scientific advisors based on their credentials and experience, not their politics or ideology; and that we are open and honest with the American people about the science behind our decisions.” While teens would not be harmed by over the counter access to emergency contraception, adult women are harmed by keeping it off the shelves. “Women do not always know where to find emergency contraception, are embarrassed to ask for it, are told they need a prescription by pharmacists who do not understand the law, or are turned away by pharmacists who disapprove of it.”
WHAT’S NEXT: Yesterday, fourteen Democratic senators announced that they will hold the administration to its self-imposed standard and are asking the HHS Secretary to provide “specific rationale and the scientific data you relied on” to overrule the Food and Drug Administration. Sebelius has hinted that she could change her mind if Teva submits additional data about the drug’s effects on younger girls, despite the existing consensus that on-the-shelf access to Plan B is safe for everyone. Also on Tuesday, U.S. District Judge Edward Korman heard oral arguments on the Center for Reproductive Rights motion for contempt against the FDA and remained highly skeptical of Sebelius’ decision. Korman rejected the organization’s motion, but told the Center “to file the appropriate legal motions” and indicated that he would “consider reviewing the government’s refusal to make it easier for girls and women to get the drug.” During the hearing, Korman pressed the FDA on why Sebelius denied over-the-counter access to women 17 and under if she was only worried about the youngest of teens and added that the administration’s handling of the case raised concerns about “whether the decision was based on politics or science.”
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