Federal judge orders FDA to review limits on over-the-counter sale of ‘morning after’ pill

Federal judge orders FDA to review limits on over-the-counter sale of ‘morning after’ pill

[JURIST] A judge for the US District Court for the Eastern District of New York [official website] overturned [memorandum and order, PDF] Monday a US Food and Drug Administration (FDA) [official website] decision to limit the over-the-counter (OTC) availability of the Plan B emergency contraceptive pill [product backgrounder] to women over the age of 18. In 2006, the FDA approved [JURIST report] the OTC sale of the Plan B contraceptive to women 18 years old and older, but included a controversial provision that required a doctor's prescription for women under 18 years old. The court agreed with the plaintiffs' assertions that the FDA's decisions regarding limiting the OTC sale to women over 18 "were arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making." In overturning the FDA's decision and remanding the matter to the agency for further deliberation on OTC usage of the medication, Judge Edward Korman wrote:

When a court reviewing an agency decision rules in favor of the plaintiff, it generally remands to the agency rather than granting affirmative relief. Certain circumstances, however, warrant exception to this general remand rule. Where a court has found that an agency decision is not supported by the record, but "the record has been fully developed," remand would fail to "serve a useful purpose." …

A remand would serve no purpose with respect to one aspect of the FDA’s decision – requiring that 17 year olds obtain a prescription for Plan B. The record is clear: the FDA’s justification for the denial of OTC access to Plan B for women over the age of 17 – rather than 18 – "runs counter to the evidence" and "is so implausible that it could not be ascribed to a difference in view or the product of agency expertise."

The court ordered the FDA to make Plan B available to 17-year-olds without a prescription and remanded for further consideration on whether the contraceptive should be available OTC to women under the age of 17.

The Plan B contraceptive has been the subject of considerable legislative and judicial activity since winning approval from the FDA in 2006. In March 2008, a federal judge in the US District Court of the District of Columbia dismissed [JURIST report] a lawsuit brought by a physicians' group against the FDA seeking to overturn approval of the OTC sale of Plan B. In November 2007, a federal judge suspended [JURIST report] a Washington state law that would have required pharmacists to dispense the Plan B pill. In October 2007, Illinois pharmacists considered a settlement [JURIST report] to a dispute over a state law that would have required them to dispense the Plan B pill regardless of their moral objections to the contraception.