Amendment to Facilitate Over-the-Counter EC Passes

An amendment to the agricultural appropriations bill (HR 4766) that would facilitate over-the-counter (OTC) status to emergency contraception passed on Tuesday in the House of Representatives by unanimous consent. The amendment, introduced by Representatives Carolyn Maloney (D-NY) and Henry Waxman (D-CA), states that the FDA cannot withhold a drug from OTC use if it finds that drug to be safe and effective for OTC use. The FDA was advised by its expert panels to approve emergency contraception for OTC status last year as a safe and effective drug, yet it decided to deny this status for Plan B emergency contraception.

“It became evident when the FDA turned its back on its own scientific panel to deny over-the-counter status for the morning-after pill that we needed to reaffirm our position that science, not interest groups, should direct the FDA,” said Rep. Maloney in a press statement.

Medical research has overwhelmingly demonstrated the safety, efficacy, and need for emergency contraception over-the-counter. Emergency contraception meets all FDA standards for OTC status: it is ‘safe and effective, not associated with any serious or harmful side effects, easily self-administered, and requires no need for medical supervision.’

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Media Resources: Maloney press release 7/13/04; Amendment text

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