US Consumer Health Managing Editor
Latest From Malcolm Spicer
Substantially more consumers in 2022 report sleep issues, allergies and skin problems than in 2018 while using quit smoking aids has dropped, according to CHPA’s latest “Value of OTC Medicines” survey. Average annual household spending on OTCs is $645.
FDA “understands that manufacturers expect availability to continue to increase in the near future.” CHPA is working with members “focused on safeguarding the US supply by maximizing capacity to produce and direct product to where it is needed most.”
Proposal for simultaneous Rx and OTC sales of same drug at same dose and indication has CHPA hoping FDA acknowledges Pataday and Voltaren Arthritis Relief are competing with Rx equivalents even though elimination of prescription NDAs was part of approvals for the two switches.
Proposal is counter to fundamental of FDA platform for approving drugs as either Rx or OTC, with a formulation of a drug with a certain indication available in one class, not both. CHPA says the proposal also runs counter to encouraging pharma firms to invest in research needed for OTC switches.
USANA also signals its turning outside nutritional products sector for potential growth driver. One of two firms it’s acquiring, Oola Life Inc., also provides life coach services directly to customers as well as nutritional supplements.
Pharmacist groups’ representatives, in meeting with FDA officials, reiterate argument for greater role in access to OTCs through “additional conditions for nonprescription use.” Group not at meeting, American Society of Health-System Pharmacists, suggests “intermediate approach to nonprescription status.”