Rx-to-OTC Switch

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. 

Decisions by “big three” PBMs suggest they’re taking proactive steps to comply with potential HRSA rulemaking to require most health plans, under Affordable Care Act regulations, to cover Opill and other types of OTC birth control without cost sharing.

Citing a will to protect children's health, Poland's president has blocked a bill which would have restored OTC access to the morning after pill to those aged 15 and above. In response, the health ministry has drawn up a proposal to allow pharmacists to issue prescriptions for emergency contraception.

Less than a month into launching sales of first oral contraceptive approved for US OTC sales, Perrigo announces multi-year partnership with WNBA focused on building confidence, strength and health equity for women.

“FDA is seeking to encourage competition for new drugs by proposing to amend the Hatch-Waxman 3-year exclusivity provisions to ensure that this exclusivity is limited to situations where the new drug applicant is actually seeking such exclusivity,” according to legislative proposals document.

The EU Parliament's Environment, Public Health and Food Safety committee proposes a “compromise amendment” to the new pharmaceutical directive that would include only antimicrobials for which there is an “identified risk of antimicrobial resistance” to the prescription requirement. 

Skepticism about the need for widening access to the progestogen-only contraceptive pill, fears of associated thrombosis risk with use and the potential cost barriers were among the many reasons for the unanimous rejection of Perrigo's Rx-to-OTC switch application for desogestrel (75μg) for oral use.

Opioid antagonist naloxone will soon be available without prescription in Sweden following a successful Rx-to-OTC application from Norway's DNE Pharma.

As Poland is ranked the worst country in Europe for contraception access by a group of EU parliamentarians, the country's government has voted through a bill which would make the morning after pill available without a prescription for the first time in more than six years.

VeriSIM uses generative AI for questions such as changing a drug molecule’s chemistry and machine learning to better predict potential biological implications. “When a child is learning a language, you're teaching a child starting from A-to-Z structures, and then suddenly they start speaking. Then they start learning different things, and then they get into problem solving. That's really what AI is getting really good at now,” says CEO Jo Varshney.

“It's a very expensive process for an OTC drug because you don't make significantly high margins compared to a blockbuster cancer drug. For pharma companies utilizing our platform, you can reduce that efficiency challenge and increase the probability of success,” says VeriSIM CEO Jo Varshney.

First US OTC daily oral contraceptive shipped to major retailers and pharmacies and will be available on shelves nationwide and online later in March. Perrigo says pre-orders for Opill are available currently from select online retailers.