Rx-to-OTC Switch

More than a year after the FDA created a new rule allowing hearing aids to be sold over the counter and directly to consumers, a government report finds the category has not yet made the impact many were expecting.

Aspirin is celebrating its 125^th anniversary this year. To find out what brand owner Bayer Consumer Health is doing to celebrate this occasion, and what it is doing to take the brand into the next 125 years, HBW Insight chats with the company’s senior vice president, Global Head Allergy, Cough/Cold, Pain and Heart Health, Reese Fitzpatrick, and head of R&D, North America and Therapeutics, Rachel Koontz.

UK medical devices manufacturer Owen Mumford moves into consumer health with umbrella brand Clariti and OTC relaunch of at-home vaginismus and dyspareunia treatment Amielle Comfort.

Many positions are vacant or filled by individuals with ties to academia, industry or patient groups, representatives from public interest and consumer groups say during an FDA listening session on advisory committee reforms.

Emergent BioSolutions, Harm Reduction Therapetuics, Hikma, Teva and other drug manufacturers commit to increased supply of naloxone and nalmefene in meeting with ]White House Office of National Drug Control.

FDA asks for nominations for voting or non-voting consumer members of its advisory committees. Also wants to hear from consumer organizations interested in participating in selecting consumer representatives for its advisory committees or panels.

Real-world data and evidence, for example generated by digital consumer health technology like apps and wearables, could provide crucial support for Rx-to-OTC switch applications, argues Sanofi Consumer Healthcare’s Penny Glover at the Association of the European Self-Care Industry's 60th Annual Meeting in Brussels, Belgium. Recent research by Sanofi indicates that regulators are actually already using RWD and RWE in many cases when assessing switch applications, even if they do not call it that. 

Failing to take sufficient action on climate change could be a costly business for consumer health companies. However, the good news from the AESGP's 60th Annual Meeting in Brussels, Belgium, is that at least half of the cost of decarbonizing will be balanced by savings, according to Boston Consulting Group. And climate change adaption will present firms with a wide variety of opportunities for product innovation, IQVIA Consumer Health's Volker Spitzer tells delegates.

The Association of the European Self-Care Industry's 60th Annual Meeting in Brussels, Belgium, opens with a rousing call to action from president Jonathan Workman. Looking to the upcoming EU elections, Workman urges industry to push for widening access to OTC medicines through switch, digital and sustainable investment, improved health literacy and regulatory flexibility.

Around 800 pharmacies across Poland have signed up to offer women and girls access to the emergency contraceptive pill without the need to visit their doctor.

Amphastar plans in 2024 to submit application to FDA to move its Rextovy 4mg naloxone hydrochloride intranasal formulation from Rx to OTC. Advertising to drive Primatene Mist awareness planned.

Perrigo spares little about Opill’s launch, advertising and outlook in Q1 earnings briefing, but management also makes clear it’s a large firm and some other segments of its global consumer health products business are holding back overall results.

FDA’s drug center has all but stopped holding meetings at this point, which begs the question: why do they want advice on how to make them better?

FDA seeks feedback at 13 June virtual hearing on three general topics related to advisory committees: panel composition, barriers to service for Special Government Employees, and public perception and understanding of the process.

Canadian firm received approval from FDA for NDA submitted in May 2023 for Lumify Preservative Free. A month earlier, FDA approved Dr. Reddy's ANDA submitted in July 2021 for an equivalent of Lumify’s formulation, brimonidine tartrate 0.025% ophthalmic solution.

UK switch specialist Maxwellia delivers two “me too” reclassifications in the area of women's health: Evana Heavy Period Relief and Ultravana Period Pain Relief.