OTC Switches Face Tougher FDA Evaluations, Less Predictable Process
This article was originally published in The Pink Sheet & The Rose Sheet
Executive Summary
OTC switch sponsors bear more responsibility than in previous years to convince FDA a product would be safely used and has a strong risk/benefit profile, say Pinney Associates consultants. FDA currently is more conservative on risk/benefit decisions and the advisory committee process isn't productive, they say.
You may also be interested in...
OTC Switch Interest Cooled By Study Costs To Update Safety Data
Firms often are hesitant to prepare Rx-to-OTC switch applications because safety and efficacy data for their products are over a decade old, notes health care consultant Laura Mahecha.
‘Emotional’ NDACs Stymie OTC Switches – Former Chairman Wood
OTC industry stakeholders must prepare better for FDA Nonprescription Drug Advisory Committee meetings and argue against members’ “emotional” objections to switches based on retail price or loss of doctor-patient visits, says former NDAC chair Alistair Wood.
Chronic Conditions Data Emphasize Need For Additional, Innovative OTCs
An NIH-funded study shows 92% of older consumers have chronic conditions, the primary target of FDA’s Nonprescription Safe Use Regulatory Expansion initiative to facilitate more Rx-to-OTC switches. The agency also extends the comment period for its initiative on making more ingredients available through the OTC monograph process.