November 14, 2005 -- GAO Report Cites ‘Unusual’ FDA Process in Plan B Denial

The then-acting director of the Center for Drug Evaluation and Research in the federal Food and Drug Administration, who issued a “not approvable” decision barring over-the-counter sale of the emergency contraception drug known as “Plan B,” did so over the protests of an advisory council of FDA scientists who had reviewed the drug and recommended it for OTC status, the Government Accountability Office (GAO) said in a report issued today. The acting director’s action was the first time in 67 cases in which a shift from prescription to OTC status had been denied after an advisory committee recommended approval. In a lengthy 62-page report that describes the usual route of a drug through FDA’s procedures, the GAO got conflicting estimates from FDA officials on when the decision to deny OTC was made—whether the decision was reached even before the reviews were completed-- and whether it involved pressure on the acting director from other government officials. The report also notes that the FDA’s announced reason for disapproving OTC status for Plan B—that the FDA feared “the potential behavioral implications” for adolescents under the age of 16, “because of their level of cognitive development” was unique. The full text of the GAO report is available at http://www.gao.gov/docsearch/abstract.php?rptno=GAO-06-109.