On Thursday, Senior United States District Judge Edward Korman ruled the federal Food and Drug Administration (FDA) must remove age restrictions on purchases of the so-called morning after pill, a form of emergency contraception.
“The decisions of the Secretary with respect to Plan B One-Step [the contraception pill] and that of the FDA with respect to the Citizen Petition, which it had no choice to deny, were arbitrary, capricious and unreasonable,” Judge Korman wrote in the order of Tummino v. Hamburg.
The ruling bars the FDA from placing restrictions on the sale of Plan B and Plan B One-Step, the two most popular forms of emergency contraception in the U.S., vacating a 2011 directive issued by Department of Health and Human Services Secretary Kathleen Sebelius denying over-the-counter sales of Plan B One-Step to individuals under the age of 17.
In overturning the directive, Judge Korman called Secretary Sebelius’ actions “politically motivated, scientifically unjustified and contrary to agency precedent.”
The ruling instructs the FDA to grant a Citizen Petition that would make morning after pills available without prescription or age restrictions. The order, however, leaves room for the FDA to limit over-the-counter sales, because, according to the FDA, there may be a “significant difference” between one- and two-pill contraceptives.
In his order, Judge Korman said the FDA had engaged in an “administrative agency filibuster” to prevent processing the petition by seeking public comments on the prospects of the administration adopting age-restricted marketing.
“After eating up 11 months, 47,000 public comments and hundreds of thousands, if not millions of dollars, it decided that it did not need rulemaking after all,” Judge Korman wrote. “The plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction.”
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