Latest from Malcolm Spicer
Final rule’s requirement that ACNU formulations also remain available as Rx generics could limit revenues for marketers of the nonprescription drugs while approvals of ACNU applications from studies with participants having drugs delivered to their homes may require marketers to limit distribution to direct-to-consumer without clearance for sales in retail stores.
Study completed in 2024 showed consumers using an online application accurately self-selected and safely used an Rx statin drug. An “ACNU” switch NDA would have to first show conventional OTC labeling won’t support proper self-selection and use.
Agency’s proposal for targeting making more formulations available nonprescription through “novel switches” went through changes on its path from idea in 2012 to proposed rule in 2022 and final rule published in December.
FDA’s ‘ACNU’ rule went through numerous twists and turns from agency’s “new paradigm” idea of OTC switches in 2012 to publication.
National Advertising Division found multiple faults with Oral Essentials’ evidence for claim, including that an in vitro study the firm conducted on “mouse cells is not dispositive of whether the same product would have any adverse effects on humans under real world conditions.”
Hiya has more than 200,000 customers in the direct-to-consumer channel, all using subscriptions ordered on the brand’s website, and plans to expand into online marketplaces and retail chains. The startup “offers a compelling subscription model with attractive margins, profitability, and strong cash flow generation,” says USANA CEO Jim Brown.