GAO: FDA politicized Plan B process
NEWS IN BRIEF — Posted Nov. 14, 2005
The Food and Drug Administration's 2004 decision not to approve Barr Pharmaceuticals' application to allow over-the-counter sales of the emergency contraceptive pill Plan B was made months before it was announced, according to a draft of a Government Accountability Office report that at press time was scheduled for release in November.
According to a summary of the leaked report that was published in The Washington Post, the GAO found that the FDA's action was unusual not only because it ignored a 23-4 advisory panel vote in favor of OTC status for Plan B, but also because several high-level officials were involved in the decision.
The "perceived sensitivity of the issue" -- social conservatives believe Plan B would encourage promiscuous sex and some believe it sometimes acts as an abortifacient -- was used to justify deviating from the procedural norm, the GAO reported.
In August 2005, then FDA commissioner Lester Crawford, DVM, PhD, indefinitely delayed a decision on Barr's application for OTC status for women age 16 and older. Dr. Crawford resigned from the FDA in September.
An FDA spokesperson said the agency would review the report. But at press time, the spokesperson said the FDA had no comment.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2005/11/14/prbf1114.htm.