FDA planned to approve morning-after pill, ex-commissioner testifies

[JURIST] A former commissioner of the US Food and Drug Administration [official website] testified in a deposition [text, PDF] that the agency postponed a decision to allow over-the-counter sales of Plan B emergency contraceptives [product backgrounder] while it considered how to restrict nonprescription access only to females 17 and older. Dr. Lester Crawford [official profile], a veterinarian who led the FDA for three months before resigning [JURIST report] amid charges that the delay was politically motivated [JURIST report], said the announcement last August was not intended to be a denial of over-the-counter sales. Rather, he expected then that the FDA would resolve the enforcement issue within six to nine months. A Government Accountability Office report [PDF] released in November characterized the FDA's review of Plan B as procedurally "unusual" [JURIST report]. The Center for Reproductive Rights [advocacy website] has sued the FDA in US District Court for the Eastern District of New York [official website] to allow over-the-counter sales of Plan B for all ages.

Separately, Crawford is under criminal investigation [JURIST report] by a grand jury for alleged financial wrongdoing and making false statements to Congress. The Center for Reproductive Rights is scheduled to depose [press release] Crawford's predecessor as FDA commissioner, Dr. Mark McClellan [official profile, PDF], on Tuesday. The lawsuit is Tummino v. Von Eschenbach [CRR materials]. AP has more.

 

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