Changing course on “Plan B” (UPDATED)
on Jun 10, 2013 at 11:20 pm
UPDATED Tuesday 3:01 pm: Groups advocating wider access to Plan B notified the District Court Tuesday that they will file by Wednesday a response to the government’s change of position.
In a sharp shift in government policy, the Obama administration decided on Monday to allow women of all ages to obtain the new one-pill version of the emergency contraceptive “Plan B” without a prescription and without any restrictions at retail stores. If a federal judge in Brooklyn, N.Y., goes along with the switch, the most popular version of Plan B would become far more widely available. And a lengthy legal battle that had seemed likely to go to the Supreme Court could come to an end promptly.
Plan B is considered to be an “emergency” form of birth control because it has been shown to prevent pregnancy if taken soon after engaging in unprotected sexual intercourse. But the availability of this new medical option for women has been surrounded in political controversy for years.
The administration told the judge that it will interpret his April decision on Plan B access as allowing the Food and Drug Administration to continue to require prescriptions for girls under age seventeen who seek access to the older, two-pill version of Plan B, on the premise that government officials are not yet satisfied that it should be openly available to younger girls.
That version is now available only in generic form, but in that form, it is cheaper than the brand-name “Plan B One-Step” that the FDA is now ready to make openly available. The one-pill version is made by Teva Pharmaceutical Products.
Although it is more expensive than the two-pill Plan B, Plan B One-Step is considered to be more convenient because it involves only a single dose. In fact, the one-pill version has gained so much popularity with women who have access to it that it now claims some eighty-five percent of the overall Plan B market.
The Obama administration, like the Bush administration before it, has fought energetically to limit access to Plan B for younger females, but the resistance has been met with energetic challenges by women’s rights groups and, for the most part, those groups have had the Brooklyn federal judge — Senior Judge Edward R. Korman — on their side.
It was a decision by Judge Korman on April 5 that the Obama administration had sought to undo. at least partly, by filing a recent appeal to the Second Circuit Court. Now, in Monday’s letter to Judge Korman, the Justice Department said the government would abandon that appeal if the approach FDA now plans to take is permitted. The Second Circuit just last week, in a preliminary order, had told FDA to start making the two-pill version available without age or retail restrictions and without prescriptions.
The FDA plans, as outlined in the letter, would not keep the two-pill version available without restrictions, because the FDA is interpreting Judge Korman’s April order as giving it permission to choose between Plan B One-Step and the two-pill version so that just one of them would be open without restrictions to women of all ages.
The actual timing of the switch in policy depends in part upon Judge Korman’s reaction, and on the reaction of the advocacy groups that have been battling FDA for years over the Plan B issue. But another factor affecting timing is that, as outlined in Monday’s letter, the FDA would have to go through several administrative steps to get Plan B One-Step on the market without restrictions, but probably with new labeling requirements. The letter promised that FDA would go through those steps “without delay.”
While clearing the way for the one-pill version, the government letter said, “FDA will not at this time take steps to change the approval status of the two-pill Plan B or its generic equivalents.”
One of the women’s rights groups that has been pursuing completely open access to all versions of Plan B — the Center for Reproductive Rights — said in a statement Monday that it welcomed the new initiative by FDA, but added that “we will continue to fight for fair treatment for women who want and need more affordable options…The Obama administration continues to unjustifiably deny the same wide availability for generic, more affordable brands of emergency contraception.”