GAO report details dogma, politics at the FDA
Tuesday, November 15th, 2005The New Yok Times tells of a report by the Government Acountability Office on the unusual, political treatment given to the “morning-after” pill by the FDA:
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….
The report suggested that it quickly became apparent that the agency was not going to follow its usual path when it came to the pill. “For example,” it said, “F.D.A. review staff told us that they were told early in the review process that the decision would be made by high-level management.”
It gets better:
Congressional investigators had been unable to uncover the role in the Plan B decision played by the former agency commissioner, Dr. Mark B. McClellan, because agency officials told investigators that all of his e-mail messages and written correspondence on the subject had been deleted or thrown out. The Democrats charged that these acts contravened federal records laws.
And how does the extreme right feel about dogma overruling science and politics overruling protocol? Gee, surprise:
Wendy Wright, executive vice president of Concerned Women for America, a conservative women’s advocacy group in Washington, said that the report’s finding that top agency officials had overruled staffers was comforting. “The F.D.A. has been making some pretty serious mistakes lately,” Ms. Wright said.
