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.

 

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