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.”
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