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Plan B delayed 'indefinitely'
The FDA Friday announced it will postpone a ruling to approve the Plan B "morning-after" pill for OTC status indefinitely, drawing criticism from Democrats and abortion-rights groups. Officials at the agency are denying charges that its slow review process is politically motivated. Critics say the delay breaks a promise made by Health and Human Services Secretary Mike Leavitt that the agency would rule on the issue by September 1. It was that promise that persuaded three key Democrats to allow the appointment of FDA commissioner Lester Crawford.
In a press conference announcing news of the delay, Crawford said the agency has found "that the science supports giving women 17 and older over the counter" access to the contraceptive, but that planners are unsure how to enforce the age restrictions. Labeling requirements for the drug remain a key issue -- critics want to know if users under the age of 17 will be able to understand them. Democrats say such questions are a diversionary tactic.
- see this story from The New York Times
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