Rx-to-OTC Switch

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.

Republicans Robert Latta and Dan Crenshaw and Democrat Debbie Dingell are members of House Energy and Commerce Committee’s Health Subcommittee, predominant source of legislation affecting FDA operations.

Germany's Expert Committee for Prescription has once again rejected the OTC switch of sildenafil, as well as tadalafil. The recently published full meeting minutes show key concerns were falsification, misuse and OTC pricing. 

What makes a winning entry for an OTC Marketing Award? HBW Insight speaks to long-standing judge Stephen Mann, an independent consultant and Rx-to-OTC switch expert, who has worked for and with some of the largest consumer healthcare firms in the world. 

New prudent use rules that would make some commonly used medicines prescription-only should be restricted to antibiotics, the AESGP tells the European Commission in its feedback to the proposed revision of the region's pharmaceutical legislation. 

New Zealand's Medicines Classification Committee has recommended expanded the dispensing conditions for AbbVie Inc.'s combination therapy for hepatitis C Maviret to include pharmacists who meet the requirements of the Pharmacy Council.

Futura Medical's MED3000 erectile dysfunction gel gets OTC approval in the Kingdom of Saudi Arabia, where Switzerland's Labatec Pharma has the rights to commercialize the product under the Eroxon brand. 

Firm reports Q2 net sales up 6.4% to $1.2bn while organic measure was 0.8% growth after a 2.7 percentage point drag from SKU prioritization moves. Investment planned over second half to prepare for launch of Opill sales.

Robert Steinbrook, the 50-year-old health group's third director, plans to stay true to organization’s long-held mission of holding FDA drug approvals to high standards, pushing for stronger evidence of benefit, more attention to safety, and advisory committee votes.

Co-founder and CEO Michael Hufford says HRT hopes to distribute first commercial supply in early 2024. Firm is engaging additional funding partners to help make its affordable opioid overdose treatment more accessible.

Making better use of Rx-to-OTC switch and existing OTC drugs could generate an additional £3.1bn a year in cost savings for the UK's National Health System, PAGB argues in a new report. 

Germany’s Expert Committee on Prescription has gone against the wishes of the country's health ministry in rejecting Rx-to-OTC switch applications for sildenafil and tadalafil. The BMG could, in theory, ignore the SVA’s recommendation, however, such a move would be unprecedented. 

Haleon steps into the US OTC erectile dysfunction market with a commercialization deal for Futura's drug-free MED3000 gel, recently approved by the FDA as a de novo medical device. 

Perrigo will note regulatory approval for Opill as first US OTC oral contraceptive in first earnings briefing with Patrick Lockwood-Taylor at helm. Other firsts in sector will be Kenvue’s 20 July results being its first since spin-out from J&J in May and Bausch + Lomb’s first quarterly results under CEO Saunders.

UK consumers may soon lose OTC access to cough syrups containing codeine after MHRA said the products were increasingly being misused as an ingredient in an illegal recreational drink commonly named “Purple Drank.”