Rx-to-OTC Switch

Upcoming retirement of Janet Woodcock will mean loss of one of agency's FDA’s most experienced and influential drug regulators. However, CDER still has plenty of long-tenured staff peppered across all its key functions.

The trophies have been presented at the OTC Marketing Awards 2023 - but what did the judging panel have to say about the winning and highly-commended entries?

The European Commission responds to questions from HBW Insight regarding its decision to include OTC antivirals and antifungals, including commonly used products like thrush and cold sore creams, in the expanded prescription-only requirements for antimicrobials, as part of proposed measures to combat antimicrobial resistance. 

Smart Women’s Choice agrees to consent decree requiring it to halt production and sales of namesake brand product promoted as being hormone-free and with claims including “immobilizing sperm” and “preventing fertilization.” Related company with similar name, product and claims continues sales.

Reviewing the news that Sanofi will exit the OTC market after setting up its Consumer Healthcare business to go it alone.

Perrigo investing in preparing marketplace for Opill and educating consumers about it and reports trend of sales volumes increasing for private label/store brand consumer health portfolio.

Topicals should not be included in the proposed prescription-only requirement for antimicrobials, including antifungals and antivirals, suggests EU rapporteur Pernille Weiss in her response to the European Commission's planned overhaul of the EU pharmaceutical legislation. 

Perrigo is targeting Germany for its next Rx-to-OTC switch of a daily contraceptive (desogestrel 75μg) after seeing success in the US and UK with Opill and Hana respectively. 

For ED products, “where you have a contraindication for current use of nitrates, this enables you now to leverage technology to help assist the consumer without a physician intermediary to appropriately self-select. Yes, music to our ears, we loved it,” says president Fady Boctor.

In letter to departments of Health and Human Services, Labor and Treasury, 47 of 48 Democrats and one of the three independents say allowing insurers the option “significantly reduces the advantages to consumers of an OTC product.”

Two weeks after announcing strong results from label comprehension study, initiating self-selection study using Drug Facts label tested for nonprescription sales of its ED drug Stendra.

Consumer health products sector’s earnings reports for July-September period are its first since FDA advisory committee unanimously voted that results of research agency presented show oral phenylephrine at OTC monograph doses is ineffective to treat nasal congestion.

Firm reports “significant comprehension” among 480 participants. It also expects DFL technology it’s developing for potential OTC sales of Stendra ED drug could be used for other OTC switch proposals.

Viatris has penned a deal worth $2bn to offload “substantially all” of its OTC assets but has decided to retain select consumer health products and Rx-to-OTC switch candidates, including erectile dysfunction treatment Viagra.

In this episode, HBW Insight catches up with UK switch specialists Maxwellia to find out what’s next for the company that gave to the UK one of the first OTC daily contraceptive pills. Now a disruptive consumer health player in its own right, the company is looking for investors to take it to the next level and help launch two new women’s health products in the pipeline for next year, CEO Anna Maxwell reveals in this exclusive interview.

In the second part of HBW Insight’s exclusive interview with OTC industry veteran Birgit Schuhbauer, we discuss the trends that will shape the future of consumer health. Drawing on her extensive experience in OTC, most recently as global vice president of J&J’s Self Care franchise and president of the AESGP, Schuhbauer gives her views on consumer shifts towards self-care and prevention, digitalization and e-commerce, supply chain resilience and sustainability. Schuhbauer also offers an insiders perspective on moves by companies like Kenvue and Haleon to spin out as independent OTC players, and the implications for Rx-to-OTC switch.