FDA approves over-the-counter sale of 'morning after' pill after controversy

[JURIST] The US Food and Drug Administration (FDA) [official website] on Thursday approved the over-the-counter sale [press release] of the "morning after" or Plan B emergency contraceptive pill [product backgrounder], to women 18 and over. A controversial provision of the FDA's approval requires a doctor's prescription for women under 18 years old. The drug's manufacturer, Barr Laboratories [corporate website], will be responsible for tracking whether pharmacists are enforcing the age restrictions. Barr has also agreed not to sell the drug in gas stations and convenience stores, as these outlets may be less likely than pharmacies to enforce the age restrictions.

The morning after pill was approved by the FDA for prescription sales in 1999. Since then, critics have argued that the delay in approving over-the-counter sales was politically motivated [JURIST report]. Former FDA chief Lester Crawford [official profile] resigned [JURIST report] after only three months in the position, but during his confirmation hearings [JURIST report] in July 2005, Crawford was criticized for dragging his feet while serving as the FDA's acting commissioner on making a determination about the over-the-counter sale of Plan B. A high-ranking FDA official resigned in protest [JURIST report] last year over the agency's continued delay in deciding whether to approve the contraceptive pills for over-the-counter sale.

The FDA announced last month that it would reconsider allowing some over-the-counter Plan B sales, prompting criticism [JURIST report] from Democrats in the US Senate because the announcement came just before a Senate confirmation hearing [committee materials] for Dr. Andrew von Eschenbach [official profile], the acting FDA commissioner and President Bush's nominee to lead the agency permanently. Sens. Hillary Rodham Clinton (D-NY) and Patty Murray (D-WA) [official websites] had previously threatened to block von Eschenbach's nomination, but said Thursday that they will now drop their opposition [Reuters report] to the nomination. AP has more.

 

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