A Collaboration with the University of Pittsburgh

Federal judge dismisses challenge to over-the-counter sale of 'morning after' pill

[JURIST] A federal judge Tuesday dismissed [opinion, PDF] a lawsuit brought by the Association of American Physicians and Surgeons (AAPS) [group website] against the US Food and Drug Administration (FDA) [official website] and Barr Pharmaceuticals [corporate website] seeking to overturn the FDA's 2006 decision to approve the over-the-counter sale [JURIST report] of so-called "morning after" Plan B emergency contraceptive pill [product backgrounder] to women 18 and over. The plaintiffs had challenged the FDA's decision on the grounds that administering the drug without a prescription violates FDA regulations, asserting that the drug has not been proven to be safe for over-the-counter use. Judge John Bates of the US District Court for the District of Columbia [official website] granted the FDA's motion to dismiss, ruling that the plaintiffs had no standing to bring suit because they "lack[ed] a sufficient personal stake in the outcome of the litigation so as to warrant the invocation of federal-court jurisdiction." Bates also ruled that plaintiffs had "failed to exhaust the administrative process mandated by regulation."

The FDA approved Plan B for prescription sales in 1999 and under the FDA's 2006 decision, a woman under the age of 18 must still obtain a doctor's prescription before receiving the pill. Many critics argued that the FDA's delay in approving over-the-counter sales of the drug was politically motivated [JURIST report]. Reuters has more.

About Paper Chase

Paper Chase is JURIST's real-time legal news service, powered by a team of 30 law student reporters and editors led by law professor Bernard Hibbitts at the University of Pittsburgh School of Law. As an educational service, Paper Chase is dedicated to presenting important legal news and materials rapidly, objectively and intelligibly in an accessible format.

© Copyright JURIST Legal News and Research Services, Inc., 2013.