GAO Report: FDA Strayed With Morning-After Pill Approval Process
GAO report says rejection of contraceptive may have been made before scientific review
Indeed, according to the report, some FDA officials told the GAO that they were told by the FDA commissioner as early as December 2003 that the OTC application would be denied nearly six months before the denial was issued and at least four months before the scientific review was completed. (Although the GAO has redacted the names of the various officials involved, during the period in question Mark McClellan [son of Texas state comptroller Carole Keeton Strayhorn] served as FDA commissioner and Steven Galson was the acting chief of the FDA's Center for Drug Evaluation and Research.) Although the FDA's joint advisory panel agreed the OTC switch should be approved, on May 6, 2004, Glason rejected the committee's finding and instead signed a "non-approval" letter, denying the switch the first time in 10 years that the CDER director had rejected the committee's decision.
The official concern that hastened the denial was incomplete data on whether emergency contraceptives are safe for teens a seemingly pseudo-scientific rationale that the GAO report terms "novel" and contrary to standard agency practice. A second, retooled Plan B OTC application which would market the drug to women over 17 is still pending with the FDA. To view the entire report, go to www.gao.gov/cgi-bin/getrpt?GAO-06-109.