June 11, 2013 — The Department of Justice on Monday said it would comply with a judge's April ruling that the emergency contraceptive Plan B One-Step be made available without age or point-of-sale restrictions, the Washington Post reports.
A senior White House official said that President Obama remains opposed to over-the-counter EC access but that DOJ decided to drop the case after recent setbacks in federal court (Dennis/Kliff, Washington Post, 6/10).
According to the Wall Street Journal, it is unclear when Plan B will be available OTC. Plan B's manufacturer -- Teva Pharmaceuticals -- declined to comment on Monday, and the process of relabeling the product could take several weeks (Corbett Dooren, Wall Street Journal, 6/10).
Last week, the 2nd U.S. Circuit Court of Appeals ruled that FDA must make two-pill versions of EC available without age or point-of-sale restrictions while the court considered the government's appeal of a judge's order to drop restrictions on all EC products. The appeals court's ruling did not address age limits on Plan B One-Step -- the more widely used, single-dose version of EC -- thereby leaving in place FDA's recent decision to lower the age limit for nonprescription sales from 17 to 15.
The appeals case results from U.S. District Judge Edward Korman's ruling in April that FDA must end age and point-of-sale restrictions on all EC products. In May, Korman refused to stay his ruling while the federal government appealed the decision. DOJ then took the case to the appeals court (Women's Health Policy Report, 6/6).
Details of DOJ's Plan of Compliance
In a letter to Korman on Monday, DOJ said FDA "has asked the manufacturer of Plan B One-Step to submit a supplemental application seeking approval of the one-pill product to be made available O.T.C. without any such restrictions," which the agency promised "to approve ... promptly."
According to the Times, FDA expects to also receive similar applications from generic EC manufacturers. FDA will consider those applications based on whether it decides to grant Teva market exclusivity.
DOJ said it would not remove restrictions on two-dose EC products, citing concerns about whether young women would know how to use the drug properly. The two-pill versions are a diminishing portion of the market, the Times notes (Shear/Belluck, New York Times, 6/10).
DOJ will officially drop its appeal of Korman's order if he accepts the proposed plan of compliance (AP/USA Today, 6/11).
Supporters Urge Quick Action
Mara Verheyden-Hilliard -- an attorney and executive director of the Partnership for Civil Justice Fund, which represents the plaintiffs in the case -- praised the decision but noted, "We will not rest in this fight until the morning-after pill is made available without delay and obstruction" (New York Times, 6/10).
Planned Parenthood Federation of America President Cecile Richards in a statement urged "manufacturers of [EC] to request new labeling quickly" and for "FDA to approve all such applications immediately to finally make this birth control option available without restrictions" (Epstein/Haberkorn, Politico, 6/10).
NARAL Pro-Choice America President Ilyse Hogue said in a statement that FDA "is taking an important step to reduce unintended pregnancies and put women in control of their futures" (Hays, AP/Miami Herald, 6/10).
Nancy Northup -- president of the Center for Reproductive Rights -- said in a statement that she is "pleased" the administration finally removed "the arbitrary restrictions that kept [EC] locked behind the pharmacy counter when [women] needed it most urgently."
Opponents Express Concerns
Anna Higgins -- director of the Center for Human Dignity at the Family Research Council -- expressed concern that the "government is not putting the health and safety of girls before political pressure." She said the decision could cause young women to "bypas[s] essential screenings at doctors' offices" and "avoi[d] getting guidance from parents on these very important issues."
Susan B. Anthony List President Marjorie Dannenfelser cited similar concerns, adding that the "decision endangers young girls by removing the protection that comes along with doctors and parents" (Politico, 6/10).