Sex, teenagers, and the morning-after pill. It’s a combination that has scared two presidential administrations out of allowing regular over-the-counter sales of the emergency contraceptive Plan B, despite plenty of evidence showing that it’s safe and effective, and that selling it on drugstore shelves won’t endanger teenage girls. Last week, a federal judge put an end to a decade of stonewalling over Plan B sales. In particular, Judge Edward B. Korman, a Reagan appointee, lit into the decision of Kathleen Sebelius, the secretary of the Department of Health and Human Services, to block the Food and Drug Administration from granting over-the-counter access. His biting ruling exposes the hypocrisy of the Obama administration—its sacrifice of science to political expediency. The whole sorry story stands as a lesson in how federal officials should not make decisions.
Here’s the history. In 1999, the FDA approved Plan B as a prescription drug. Lawyers filed what’s called a citizen petition to sell the drug over the counter and without a prescription. The FDA’s own expert advisory panel said those changes to increase access made sense. But in the early Bush administration, FDA officials refused to grant approval. According to the New York Times, “some said later, they worried they would be fired if they approved it.”
In 2006, the Bush FDA made a partial concession, allowing over-the-counter sales for women 18 and older, while keeping the drug prescription-only for girls 17 and younger. In practice, this means that women of all ages have to ask a pharmacist for the drug and show proof of age to buy it. When a citizen petition asking for over-the-counter access for younger teenagers made its way to Judge Korman, he ordered over-the-counter sales to 17-year-olds. He found that the evidence showing that 18-year-olds understand how to use Plan B, which comes with a standard warning label, also applies at 17. Korman stopped short of mandating broader access, however. In his Friday opinion, he explained that at the time, “it was my view that the decision whether to make Plan B available without a prescription regardless of age was one that should be made by the FDA, to which Congress had entrusted the responsibility, and not by a federal district judge.”
Most of the time, that’s the right path for judges to take. Federal agencies are accountable to the president, whom we elect. Judges are not. They’re supposed to defer to officials like Sebelius and the people who run the FDA. The rule is that for a court to overturn an agency’s determination, that decision has to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” In other words, not just possibly wrong, but really out there. That standard comes with an important addition, though: While federal agency decision-making is “unfettered at the outset,” once the government announces and follows “a general policy by which its exercise of discretion will be governed,” the agency can’t irrationally throw out the rule whenever it feels like it.
That’s the problem Korman justifiably has with Sebelius’ move to override the FDA on opening up over-the-counter sales of Plan B. For nearly three years after Korman’s 2009 ruling, the agency did nothing. In the meantime, Plan B’s manufacturer provided more research about the drug’s safety to support the bid for over-the-counter access. Last year, the FDA finally agreed to this. Commissioner Margaret Hamburg cited “a body of scientific findings” showing that the product was safe and effective for teenage girls, and that girls understood that Plan B wasn’t for routine use.
The FDA’s timing was bad, for a reason that’s entirely political: It preceded President Obama’s reelection. In the midst of the campaign, the administration showed no courage. Sebelius swooped in, countermanding Hamburg’s decision for the slimmest of reasons: The studies submitted to the FDA didn’t show that girls of all ages understood the drug’s use, the secretary said. Never mind that the FDA had asked for no such data. Sebelius said that 10 percent of 11-year-old girls have gotten their periods and that this was enough to back up her concerns. Lest anyone fail to connect the children-having-sex dots, Obama issued his own statement, saying Sebelius made her decision because she “could not be confident that a 10-year-old or an 11-year-old go[ing] into a drugstore, should be able—alongside bubble gum or batteries—be able to buy a medication that potentially, if not used properly, could end up having an adverse effect.”
Last Friday, Obama’s press secretary called this “the right, common sense approach.” It’s anything but. Think of all the drugs that wouldn’t be sold over the counter if the measure is whether a 10- or 11-year-old might misuse it. As three scientists wrote in the New England Journal of Medicine (including the journal’s editor), “a 12-year-old can purchase a lethal dose of acetaminophen in any pharmacy for about $11, no questions asked.” The common brand name for acetaminophen is Tylenol—swallow a bottle and you can die. The side effects of Plan B, by comparison, are nausea and delayed menstruation.
Other drugs that would have to be taken off the over-the-counter market if Sebelius actually applied the rule that she set: laxatives, cough suppressants, and analgesics (drugs for pain relief). Korman points out that in 2003, the FDA approved a heartburn medication for over the counter sale even though “safety in adolescents has not been established.” The agency merely required a warning label saying the drug hadn’t been approved for use by children or teenagers. The diet drug Alli is also for sale on the shelves under similar circumstances.
The singling out of Plan B for special restrictions, based on the faint possibly that a young girl will buy the drug with her Lifesavers, is blocking access for older teenagers and women, too. Korman cites a report from researchers for the Journal of the American Medical Association, who called around to pharmacies to ask for Plan B, saying they were 17. One in 5 stores said they didn’t have the drug on hand. And 19 percent said a 17 year old couldn’t buy Plan B at all. The rate of misinformation was highest in poor neighborhoods.
“This case is not about the potential misuse of Plan B by 11-year-olds,” Judge Korman baldly states. “The motivation for the secretary’s action was obviously political.” This was the first time a cabinet member had stepped in to block a decision by the FDA. Though Sebelius didn’t say so, it surely hasn’t helped Plan B (or other morning-after pills, like ella) that anti-abortion advocates claim that it works by preventing an embryo for implanting—in other words, that it’s not birth control, but rather an abortifacient. Again, as Pam Belluck detailed in this important article, the scientific evidence suggests otherwise, though it’s hard to do a study to definitively rule this out, so it’s a claim you’ll keep hearing.
Given the alarmist reaction to Judge Korman’s ruling, it’s not surprising that the Obama administration didn’t want to embrace greater access to Plan B in the middle of an election. That doesn’t make Sebelius’ decision any less disappointing, though. Every time a president sets himself against solid science, he makes it easier for the next administration to do the same. And crying wolf about child safety is especially bad in the realm of teen sex, where adult fears can block all kinds of sensible education and birth control efforts.
Now that the election is over, Judge Korman’s ruling offers the Obama administration an easy way out: All the government has to do is not appeal. That’s wimpy, but it will put Plan B on the drugstore shelves faster. Korman told the FDA to figure out how to do that within 30 days—an extremely unusual direct order that reflects Korman’s frustration level, since judges usually send administrative cases like this back to the agency to sort out next steps. As Amanda Hess pointed out on Slate, Plan B is already freely available in 63 countries, including Britain and France. It’s past time for the United States to put aside its prudishness and get on that list.
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