POLITICS JUNE 11, 2013
Last night, after being upbraided for more than a month by women’s rights groups, the legal community, and the press, the Obama administration announced that it’s willing to ditch its legal appeal to keep emergency contraception behind the counter. “U.S. Drops Bid to Limit Sales of Morning-After Pill,” proclaimed The New York Times. But that's not quite right: The White House is far from done meddling in women’s access to Plan B—and, by extension, in the scientific analysis on which the credibility of the Food and Drug Administration depends.1 Rather, Obama and his Justice Department have proposed an odd trade in which one version of the drug (which splits the dosage between two pills) goes behind the counter while the other (all in one pill) hits the shelves.
Those who want to understand the complicated legal distinction between the two versions of the pill should read this great piece of reporting from Sarah Kliff at The Washington Post. But the medical distinction is nil, and the president’s argument—that we should be especially concerned about younger girls getting their hands on the two-pill version without a prescription because they won’t understand how to take it (two steps! so complicated!)—is roundly contradicted by clinical trials. It also violates the FDA’s findings and the federal judge’s ruling that the two versions of the pill are medically identical, and that both are safe, effective, and easy to use enough that they shouldn’t require a prescription. To say otherwise is to continue inserting politics into a process where it doesn’t belong, and to subject women’s healthcare to an absurd game of hoop-jumping that other kinds of medicine would never have to endure.
As far as where the Plan B rigmarole travels from here: Edward Korman, the judge who lambasted the administration for its “strong showing of bad faith and improper political influence,” would have to agree that the administration’s workaround satisfies his order. If he does, then Teva, the manufacturer of the brand name Plan B One Step, would send an application to the FDA, a formality that would be approved, most likely, this summer.
If he doesn’t, the administration may not drop its legal fight after all. In short, it’s far too early to pop the champagne.
Either way, women’s groups will keep fighting the government’s discriminatory approach to regulating Plan B.
“It would be a big step forward to have Plan B One-Step available over the counter, and a great help to women of all ages,” said Julie Rikelman, litigation director of the Center for Reproductive Rights, which has represented the plaintiffs in the ongoing case against the government since it was filed in 2005. “But we do we absolutely feel it’s important for women to have access to generic version of the drug,” including the two-pill version.
Emergency contraception usually costs around $50, but Rikelman said generic versions often cost as much as 20 percent less. This includes the two-step pill, which Teva no longer manufactures, and which is solely available in generic form. The administration hasn’t yet indicated how it would handle generics of the one-dose pill, but its memo to Korman said it is considering granting Teva “market exclusivity” and leaving its competitors behind the counter. Exclusivity is normally proffered, for a limited time, to innovative new drugs to reward their developers for the time and energy that went into the finished product; Teva’s original two-pill version went on the market in 1999, and the one-pill version got FDA approval in 2009.
This continued hemming and hawing isn’t acceptable to women’s rights groups. On a practical level, “there is a price difference. It can make a difference to some women,” Rikelman said. And on the level of ethics and good governance, “What the FDA’s own scientists have been saying for years still has not been fully implemented.”
If Korman approves the administration's compromise and Plan B One-Step is available without a prescription, that alone will help women. But it won't solve the underlying issue, which is the way the Obama administration abandoned liberal values and legal precedent on the issue—and has yet to do the right thing. So let's not celebrate as if they had.
Nora Caplan-Bricker is an assistant editor at The New Republic. Follow her on Twitter @ncaplanbricker.