Amendment Introduced to Facilitate Over-the-Counter EC

An amendment to the agricultural appropriations bill (HR 4766) that would facilitate over-the-counter (OTC) status to emergency contraception was introduced today by Representatives Carolyn Maloney (D-NY) and Henry Waxman (D-CA). The amendment 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.

In introducing her amendment, Rep. Maloney argued that the FDA’s decision to deny OTC status to emergency contraception was the result of “politics and ideology [influencing] science, endangering the reputation of the FDA and having a direct and irreversible effect on the health and well-being of thousands of women.” 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: Representative Maloney’s office 7/12/04; Amendment text

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