June 10, 2013; New York Times
The Obama administration has declared it will stop trying to block the over-the-counter availability of Plan B One-Step, commonly known as the “morning-after pill.” The drug prevents a pregnancy if taken within 72 hours after intercourse.
A statement issued by the Food and Drug Administration on Monday night announced that the FDA would drop its appeal of an April 5th court ruling made by U.S. District Court Judge Edward Korman ordering that the drug be made available to women of all ages and without requirement for an ID which the judge wrote placed a disproportionate burden on blacks and the poor. The FDA statement read in part “To comply with the order, the 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,” the statement said. “Once FDA receives that supplemental application, the FDA intends to approve it promptly.”
Plan B was originally approved in 1999, but one required a prescription to get it. In 2001, the Center for Reproductive Rights filed a citizens’ petition to have it made available without one. By many accounts, the medication then for a decade became a political football with the playing field being regulation of age and identification requirements.
Then, in December 2011, when the FDA appeared ready to lift all age restrictions, Health and Human Services Secretary Kathleen Sebelius intervened. Sebelius overruled the agency, saying that the drug had not been tested on girls as young as 11 who might also become pregnant.
In April of this year, Judge Korman ordered that the government make morning-after pills available without age restrictions, a prescription, or need for I.D., calling Sebelius’ intervention “politically motivated, scientifically unjustified, and contrary to agency precedent.”
“The FDA has engaged in intolerable delays in processing the petition,” the judge wrote. “Indeed, it could accurately be described as an administrative agency filibuster.”
Reproductive rights advocates are cautious about celebrating until they watch how the shift will be implemented.—Ruth McCambridge