Monday, November 14, 2005

GAO issues report on FDA's Plan B Actions

The Government Accountability Office issued a report today titled, "Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual." That is the most humorous title I've ever seen on a government report. Aside from that, the report describes the GAO's findings after the Office was asked to examine "1) how the decision was made to not approve the switch of Plan B from prescription to OTC, 2) how the Plan B decision compares to other proposed prescription-to-OTC switches from 1994 through 2004, and 3) whether there are age-related marketing restrictions for prescription Plan B and other prescritpion and OTC contraceptives." Questions about the process were raised because "the not-approvable decision for the Plan B OTC switch application was contrary to the recommendations of FDA's joint and advisory committe and FDA review staff." The GAO reviewed the FDA's actions prior to the 5/6/04 non-approvable letter for the initial application. The full text of the report is available here as a PDF.

I haven't had time to read all 62(!) pages of the report, but here are a few direct excerpts from the "What GAO Found" section:

  • The Plan B decision was not typical of the other 67 proposed prescription-to-OTC switch decisions made by FDA from 1994 through 2004
  • The Plan B OTC switch application was the only one during this period that was not approved after the advisory committees recommended approval
  • The Plan B action letter was the only one signed by someone other than the officials who would normally sign the letter
  • Further, there are no age-related marketing restrictions for any prescription or OTC contraceptives that FDA has approved, and FDA has not required pediatric studies for them
  • FDA identified no issues that would require age-related restrictions in the review of the original prescription Plan B new drug application
  • GAO found that high-level management’s involvement for the Plan B decision was unusual for an OTC switch application and FDA officials gave GAO conflicting accounts about when they believed the decision was made
  • The Acting Director acknowledged to GAO that considering adolescents’ cognitive development as a rationale for a not-approvable decision was unprecedented for an OTC application, and other FDA officials told GAO that the rationale differed from FDA’s traditional practices.

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    MeSH Tags: Contraception, Postcoital; Levonorgestrel; Health Policy: Politics; Women's Health
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