Potential OTC Contraception Market Could Attract Switch
This article was originally published in The Pink Sheet Daily
A report showed 62.2% of 2,046 women surveyed favor OTC sales of contraception pills, representing a potential U.S. market of around 11 million. The results also could reflect consumer interest in making the drugs available OTC under conditions of safe use.
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The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics recommend OTC availability of hormonal contraception, but pharmaceutical industry Rx-to-OTC switch sponsors remain elusive.
Leaders at FDA’s drug center appear more closely aligned with the OTC industry than with medical professionals’ groups on consumer access to innovative switches. CDER Director Woodcock says the clinical community has resisted switches – and been proven wrong – before.
A new paradigm for nonprescription approvals could eliminate the risk of self-selecting a birth control drug, with some contraindications might likely not apparent, by having pharmacists provide counseling and screening or having women use a self-assessment tool with a standard algorithm.