Over The Counter 22 May 2023: What You Need To Know About HRA’s Historic US OTC Pill Switch With HBW’s Malcolm Spicer
Executive Summary
HBW Insight catches up with US executive editor, Malcolm Spicer, to discuss Perrigo subsidiary HRA Pharma’s Rx-to-OTC switch application for its daily contraceptive, Opill. With the switch currently under consideration by the US Food and Drug Administration after a positive recommendation from its advisory committees, Spicer draws on his in depth coverage of the subject, as well as his extensive experience writing about the US consumer health market, to tell listeners what they need to know about this historic switch.
Further Reading
Year After Acquisition, Perrigo Waits For US Decision On HRA’s OTC Oral Contraceptive Switch
FDA May Ask HRA For Another OTC Birth Control Actual Use Study Due To ‘Improbable Dosing’
Advisory Panel Members On Unanimous Vote Recommending US FDA Approve OTC Birth Control
First OTC Oral Contraceptive Has Advisory Panel’s Unanimous Support Despite FDA’s Data Concerns
US Oral Contraceptive OTC Switch Sponsor Says ‘Challenging Target’ Met For Adolescents In Study
Cloud Over FDA Advisory Panel Meeting From ‘Over-Reporting’ In Birth Control OTC Switch Study
Adolescent Access Weighs Heavy In US FDA Decision On First OTC Daily Oral Contraceptive
‘Over-Reporting’ An ‘Inherent Risk’ In Self-Report Study – Oral Contraceptive OTC Switch Sponsor
If Successful, HRA Pharma Acquisition Will Complete Perrigo’s Pivot Towards Self-Care
HRA Raising Game To Promote UK OTC Daily Contraceptive, Hopes US Switch Will Follow
HRA Pharma And Maxwellia To Launch The UK’s First OTC Daily Contraceptives
Further Listening
Podcast Special: The Shifting Landscape For Drugs And Devices Post-Roe v. Wade
Over The Counter Theme Music
Warm Vacuum Tube by Admiral Bob (c)
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