Rx-to-OTC Switch

Responding to Sen. Roger Marshall’s question on rulemaking to accelerate OTC switches by allowing NDA sponsors to use extra-label information to guide consumers through self-selection of a drug, Robert Califf said he’d support making progress on a proposal FDA began considering in 2012 in its NSURE initiative.

Sweden's national drugs regulator says environmental contamination risks should be reviewed as part of the overall benefit/risk assessment when reclassifying OTCs for sale outside pharmacies.

JAMA study results could spur additional research with subjects from broader pool of candidates for determining whether ENDS products have potential for approval as NRT products. Studies typically limit participants to consumers who want to quit, but expanding pool to include those not interested could add to research results more instances of successful quitting.

Petros considers switch NDA for Stendra (avanafil), approved for Rx sales in US since 2012 on an NDA by Metuchen. Early indicators showed positive outcomes in a 453-subject label comprehension study for the oral PDE5 inhibitor.

Traditional Chinese Medicine and regulatory reform are driving Rx-to-OTC switch in China, the country's non-prescription medicines industry association says. Furthermore, Alibaba's "new retail" model of blending online and bricks-and-mortar shopping is fostering innovation in the Chinese market, creating opportunities for international OTC players. However, there is still room for improvement, according to the Global Self-Care Federation's recently published Self-Care readiness Index.

In this episode, HBW Insight’s US and EU editors analyse Q3 OTC business trends, including why the biggest pharmaceutical companies in the world are spinning out their consumer health businesses to create new standalone firms and what's causing the supply chain troubles that are driving up OTC product prices.

It was only after prolonged litigation led a federal judge in 2013 to order FDA not to allow political interference with its science-based decisions that Plan B and generic equivalents became available OTC without age restrictions. “Hopefully, all I can say, it won't happen again,” says reproductive rights advocate Kirsten Moore.

Continuing impediments include pharmacists and other staff at drug and grocery stores refusing to sell emergency contraceptives, some stores stocking products in locked display cabinets and prices unaffordable to some consumers, says Kelly Cleland, American Society for Emergency Contraception executive director.