POLITICS MAY 3, 2013
In President Obama's first term, when the Department of Health and Human Services overrode consensus in the medical community and made the "morning-after pill" available over-the-counter only to women 17 and over, liberals were angry but also somewhat understanding: It was 2011, and the election cycle was underway. In a second term, it seemed, President Obama would no longer feel the need to play politics with women's reproductive health.
No such luck.
This Wednesday, Obama's Justice Department announced that it would appeal a New York district court’s ruling that the drug Plan B must be available over-the-counter for all ages. This came a day after the FDA announced a new policy making it available without a prescription to girls 15 and older. Yesterday, Obama pronounced himself "very comfortable" with the FDA's decision, but defended the DOJ appeal by claiming the judge had overreached. "Part of it has to do with the precedent and the way the judge handled the case," he said, emphasizing that the White House has not been involved in any of the decision-making at the FDA or DOJ. Earlier that day, Press Secretary Jay Carney made a similar point: "The Court’s Order interferes with and thereby undermines the regulatory procedures governing FDA’s drug approval process."
The irony, as anyone who remembers 2011 knows, is that the administration has shown no qualms about undermining the FDA, and Commissioner Margaret Hamburg, when it comes to Plan B. In 2011, the FDA tried to make Plan B over-the-counter for "all females of child-bearing potential" (something its scientists had actually been recommending since 2003), but HHS Secretary Kathleen Sebelius overruled its decision. The affair sparked outcry in the medical community. “The decision to continue restricting access to this safe and effective product is medically inexplicable,” the president of the American Academy of Pediatrics said at the time. Obama defended Sebelius with a knee-jerk reference to Being A Dad. “The reason Kathleen made this decision is that she could not be confident that a 10-year-old or an 11-year-old going to a drugstore should be able—alongside bubble gum or batteries—be able to buy a medication that potentially, if not used properly, could have an adverse effect. … And I think most parents would probably feel the same way.”
The administration's Plan B actions epitomize the unfair double standards that govern women's health: They face barriers to reproductive care that aren’t imposed elsewhere in medicine. This is true in the case of abortion clinics, which must work under strict regulations unheard of at other low-risk outpatient centers. And true, to a much lesser extent, of Obamacare, which has been forced to provide a workaround for birth control coverage to avoid the ire of religious groups. And it's true of the gross disparity between the laws surrounding Plan B and those that govern any other drug in the country. Sebelius' 2011 imposition is a perfect example of the procedural inconsistency that plagues women’s health, since it was the first time in history that a secretary had ever interfered with the FDA’s decision-making process.
Judge Edward Korman’s ruling on April 4 makes clear the strangeness of Sebelius’s decision. Sebelius wrote at the time, “the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately,” adding, “the label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.” But the studies submitted for her review were designed to include a “representative population” of the drug’s likely users, in accordance with FDA requirements, and included some adolescents (not many, because not many teens take Plan B). As for “label comprehension,” countless over-the-counter drugs contain dire prohibitions in small print on their bottles. As three scientists wrote in the New England Journal of Medicine that year: “A 12-year-old can purchase a lethal dose of acetaminophen in any pharmacy for about $11, no questions asked. The only documented adverse effects of a $50 dose of levonorgestrel are nausea and delay of menses by several days. Any objective review makes it clear that Plan B is more dangerous to politicians than to adolescent girls.”
Korman also ruled on the issue in 2009, writing of what was then already a nearly decade-old tangle of political interests, “the record is clear that the FDA’s course of conduct regarding Plan B departed in significant ways from the agency’s normal procedures.” He called the FDA’s policies regarding Plan B “arbitrary and capricious” and said its justification for the age cutoff “lacks all credibility.”
Susan Wood, the former Assistant Commissioner for Women's Health at the FDA, quit in 2005 when politics stalled the provision of access to Plan B, but she said she had hopes the Obama administration would differ from its predecessors. “There’s a policy on the books that says there’s a way the FDA does business, and it’s never followed” in this case, she told me. “I was hoping [Obama] would go back to the normal practice of letting the FDA do business.”
“No other drug is treated this way,” says Julie Rikelman, litigation director at the Center for Reproductive Rights, which brought the lawsuit demanding universal access to the pill. “Drugs are over the counter or they’re not. There’s no sort of hybrid.”
By putting Plan B in its own shadow category, the government further stigmatizes it, and makes it tougher to get ahold of. Korman’s ruling cites a study in which adult female researchers posed as 17-year-olds who had just had unprotected sex and called pharmacies for the drug. In 19 percent of cases, they were told they were too young to legally purchase it, even though 17-year-olds didn’t even need a prescription to buy Plan B at the time.
Yesterday, Obama seemed to leave open the possibility that his second term will see Plan B move, at long last, in front of the counter—with the "bubble gum" and "batteries." "My suspicion is that the FDA may now be called upon to make further decisions about whether there’s sufficient scientific evidence for girls younger than 15," he said. "That’s the FDA’s decision to make. That’s Secretary Sebelius’s decision to review." But it's angering that this resolution has once again been deferred. This isn't a debate about safety, or about sex. It's a question of process. Law is supposed to emerge from the same balanced, methodical practices every time, no matter how contentious the subject. The administration has ditched precedent for politics, treating women as a separate category, to keep Plan B off the shelves.
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