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Report Details F.D.A. Rejection of Next-Day Pill
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| Contributor | ArmyDem |
| Last Edited | ArmyDem Nov 15, 2005 12:14am |
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| Category | News |
| Media | Newspaper - New York Times |
| News Date | Tuesday, November 15, 2005 06:00:00 AM UTC0:0 |
| Description | By GARDINER HARRIS
Published: November 15, 2005
WASHINGTON, Nov. 14 - Top federal drug officials decided to reject an application to allow over-the-counter sales of the morning-after pill months before a government scientific review of the application was completed, according to accounts given to Congressional investigators.
The Government Accountability Office, a nonpartisan investigative arm of Congress, concluded in a report released Monday that the Food and Drug Administration's May 2004 rejection of the morning-after pill, or emergency contraceptive, application was 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.
The pill, called Plan B, is a flashpoint in the debate over abortion, in part because some abortion opponents consider the pill tantamount to ending a pregnancy. In scientific reviews, the F.D.A. has concluded that it is a contraceptive.
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." |
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