Plan B FDAgate

FDA's decision to block approval of OTC status for the Plan B contraceptive is rapidly becoming the center of an FDA controversy that has all the earmarks of a Watergate conspiracy.

At the center of the controversy is a report by the non-partisan Government Accountability Office (GAO) released yesterday to Congress. The report claims that top officials at the Food and Drug Administration decided to block over-the-counter sales of the Plan B contraceptive months before completing their review of the application in 2004.

Two FDA commissioners appointed by president Bush -- Mark B. McClellan and Lester M. Crawford -- were allegedly involved in the decision to bar Barr's Plan B OTC conversion. Both commissioners resigned after very short terms. According to a story in the NY Times, the FDA deleted or threw out all of McClellan's e-mail and written correspondence on the subject (reminds me of Nixon's lost section of tape) and Crawford has conveniently refused to cooperate with the GAO inquiry. And we all though Lester left town because of financial conflicts of interest! Sure.

According to the Times story, the GAO report called FDA's decision on Plan B unusual in several respects:

Top agency officials were deeply involved in the decision, which was "very, very rare," a top F.D.A. review official told investigators. The officials' decision to ignore the recommendation of an independent advisory committee as well as the agency's own scientific review staff was unprecedented, the report found. And a top official's "novel" rationale for rejecting the application contradicted past agency practices, it concluded.

In the 10 years prior to the rejection of Plan B OTC status, when the FDA reviewed 23 applications to switch drugs from Rx to OTC, the FDA never went against the advice of its own advisory committee as it did with Plan B.

The FDA's "novel" rationale for rejecting Plan B was explained by Dr. Steven Galston, the acting director of the FDA's Center for Drug Evaluation and Research:

Dr. Galston said younger teenagers might act differently than older ones and might engage in riskier sex if they knew an emergency contraceptive was easily available. The company needed more data to ensure that this was not true, he said.

In the rejection letter, Galston suggested Barr could get approval if it would sell the drug "behind-the-counter," making it easily available only to women 16 and older, with younger women still needing a prescription.

Barr chose that option in a new application filed in July 2004. FDA rules required it to issue a decision by January, 2005, but it has delayed doing so indefinitely. Soon after the FDA waffled and opened a 60-day comment period, Susan Wood resigned from her position as FDA assistant commissioner for women's health in protest of the Plan B decision.

"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," said Wood.

Matthew Holt over at The Health Care Blog, claims that Plan B FDAgate "is only one small battle in the war to keep the creationists and fundamentalists loons outside of science. A battle that weÂ’ve lost."

Watch out Matt! Pat Robinson may curse you as he cursed a town in Pennsylvania for exercising their democratic right to vote out creationists on their school board. Or he may call for your assassination.

Regardless of your views on contraception, abortions, and evolution, it's a sad day when government officials subvert the checks and balances built into our system of government that prevent dictatorships. If FDA commissioners can overrule their staffs and later cover up and refuse to account for their actions, then the next step is a system based on Commissars.