Tuesday, November 15, 2005

"Review of 'Plan B' Pill Is Faulted: Report Calls FDA Actions 'Unusual'"

Read the full article by Marc Kaufman in the Washington Post online.

Excerpts from the article"

"Senior Food and Drug Administration officials were told that the application to sell the 'morning-after pill' without prescription was going to be rejected before the staff completed its scientific review and months before the decision was made public, government investigators reported yesterday.

"A report by the independent Government Accountability Office also said senior FDA officials, including then-Commissioner Mark B. McClellan, were actively involved in the politically sensitive decision -- one of four aspects of the agency's actions that the investigators called 'unusual.'

"The GAO report, requested by Congress more than 16 months ago, said the agency did not follow its normal procedures in making the scientific assessment of the Plan B proposal and in having a top official sign off on the eventual decision after lower-ranking scientists refused.

"Critics of the FDA's handling of the issue said the report confirmed their view that the agency had allowed politics to trump science."

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