Business
Brazil has approved legislation permitting pharmacies to operate within supermarkets, expanding consumer access to OTC medicines while maintaining strict pharmacist oversight and existing safety standards.
Futura Medical is seeking OTC medical device approval for ED treatment Eroxon Intense, designed for men who prefer a stronger sensation to the original Eroxon product.
“Four or five major acquisitions over the last few years repositioned it, a 140-year-old company, from being a B-to-B company to B-to B-to-C company. That is a major enterprise strategy shift,” says CEO Patrick Lockwood-Taylor.
“In a very siloed organization made up of a jigsaw of different companies, no one was thinking enterprise first,” says Perrigo CEO Patrick Lockwood-Taylor. “The fundamentals of running operations, brand-building, innovation, they are now as they were.”
Innovation & IP
Futura Medical is seeking OTC medical device approval for ED treatment Eroxon Intense, designed for men who prefer a stronger sensation to the original Eroxon product.
In a foreword to a blog post by PAGB CEO Michelle Riddalls, the UK medicines regulator MHRA has signalled strong support for expanding Rx‑to‑OTC reclassification as a safe way to ease pressure on the NHS, strengthen the role of pharmacists and improve access to medicines.
In this episode of HBW Insight’s Over the Counter podcast, we speak with probiotic expert David Pineda Ereño about Europe’s fragmented regulatory landscape, the future of the “probiotic” definition, and how companies can navigate diverging EU Member State positions.
Despite 2025 volume stagnation in France and Italy, structural opportunities in category penetration, wellness premiumization, pharmacy expansion, and Rx-to-OTC switch suggest the self-care market still has clear levers for growth.
Policy & Regulation
Brazil has approved legislation permitting pharmacies to operate within supermarkets, expanding consumer access to OTC medicines while maintaining strict pharmacist oversight and existing safety standards.
Agency offered to drop annual IND fees for sponsors not conducting Phase I trials in US, but industry still raised several concerns about fee incentives for onshoring clinical development.
Context of use, human biological relevance, technical characterization and fitness for purpose are the key elements in validating novel methods to replace animal testing, the FDA said in a new draft guidance.
FY 2026 OMUFA facility fees are $19,188 for OTC monograph drug manufacturers and $12,792 for contract manufacturing organizations also making the products. FY 2025 fees were $37,556 and $25,037.
Rx-to-OTC Switch
In a foreword to a blog post by PAGB CEO Michelle Riddalls, the UK medicines regulator MHRA has signalled strong support for expanding Rx‑to‑OTC reclassification as a safe way to ease pressure on the NHS, strengthen the role of pharmacists and improve access to medicines.
The agency offered to commission a third-party study of efficiency, workload and other factors to determine whether the base PDUFA revenue should be lowered mid-program cycle.
“New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers” draft guidance discusses statutory and regulatory criteria for three-year exclusivity eligibility and provides recommendations on content and format of requests.
Despite 2025 volume stagnation in France and Italy, structural opportunities in category penetration, wellness premiumization, pharmacy expansion, and Rx-to-OTC switch suggest the self-care market still has clear levers for growth.