FDA Advisory Panel Strongly Backs Perrigo’s OTC Birth Control Pill

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2. The joint committee deemed that the benefits of allowing non-prescription use of the drug outweigh its risks.

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3. If approved, Opill would become the first daily birth control pill available without a doctor’s prescription.

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4. Perrigo submitted data from its OTC development program, which showed that patients could understand Opill’s OTC label, and the drug was taken correctly.

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6. Several major medical organizations across the country support making oral contraceptives available without prescriptions.

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7. The FDA is set to decide on Opill’s over-the-counter bid later this year.

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8. Opill, a non-estrogen birth control pill containing 0.075 mg of norgestrel, was first approved in 1973 and has since collected some 50 years’ worth of scientific evidence backing its safety and efficacy.

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9. Making the drug available without prescription will also reduce unintended pregnancies and its associated health risks, as well as improve “reproductive autonomy,” especially for women.

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10. The vote in support of Opill’s OTC bid follows an April ruling from a Texas federal judge that sought to block the sale of the abortion pill mifepristone.

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