GAO investigation calls FDA review of abortion pill 'unusual'

[JURIST] In a report [PDF text; summary] released Monday, the US Governmental Accountability Office (GAO) [official website] characterized the Federal Drug Administration's review of the birth control drug Plan B [product website; FDA backgrounder] for over-the-counter sale as "unusual" in procedure. The GAO report alleges that FDA management was more involved in Plan B approval than usual; that the decision not to approve the drug may have been made before the review was completed; and that the reasoning for not switching the prescription drug to an over-the-counter product was "novel and did not follow the FDA's traditional practices." An FDA spokesperson denied the allegations of improper conduct, saying that "the report mischaracterizes facts and does not appear to take into consideration the input provided by the FDA." In August, the agency indefinitely postponed a decision [FDA news release] on whether to approve the drug for over-the-counter sale, prompting an FDA official to resign in protest [JURIST report]; the official later accused the FDA of political maneuvering [JURIST report] during the approval process. A bipartisan group of US representatives introduced a bill [JURIST report] earlier this month that would automatically approve Plan B for over-the-counter sale 30 days after bill approval if the FDA fails to make a decision on the drug by that time. Reuters has more.



 

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