Rx-to-OTC Switch

A published article from AESGP argues for the increased acceptability, application and use of real-world evidence in the OTC sector where it “may present a more intuitive or efficient way of generating data” compared to randomized controlled trials.

The MHRA has approved the switch of Consilient Health's Calci-D, which will offer UK consumers the highest dose of vitamin D3 available in combination with calcium as an OTC medicine.

Jim Dillard, chief scientific officer for Perrigo since 2019, moves to head the North American business with research and development experience as well as a regulatory background from his work at the FDA.

Viatris' marketing director Rob Elliott speaks to HBW Insight about how the company is investing in flagship OTC erectile dysfunction treatment Viagra Connect to ensure the brand keeps ahead of the growing competition. 

OTC switches are more challenging for sponsors as concerns over label communication, drug interactions and consumers understanding increase, says FDA official Francis Becker. Rx label precautions and warnings must go on OTC labels, too.

COVID-19 pushed Rx-to-OTC switch sponsors into digital research to collect data on consumer usage, and many are unlikely to revert to in-person methods, said an OTC switch expert at the Consumer Healthcare Products Association regulatory conference on 9 September.

OTC drugs’ quick treatment of acute conditions outweighs risks from absence of physician oversight, says OTC switch consultant Bernie Simone.  At CHPA regulatory conference, he discussed other drug categories during his presentation on the downside of keeping some drug ingredients Rx-only.

Acting commissioner's comment on supplement industry regulation was her most definitive statement about the agency’s work in consumer health sector at CHPA's regulatory conference. Pandemic, she says, heightened consumer interest in self-care along with demand for OTC drugs and supplements.