For Successful OTC Switch Proposals, A Good Offense Defends Against Doubters
This article was originally published in The Pink Sheet & The Rose Sheet
OTC switch sponsors should identify adversaries early in the application switch process so they can counter arguments that could derail their switch, s consultant advises. Some switches fail because firms target regulatory approval and do little on marketplace performance.
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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.
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.
Through 30 years working in the pharmaceutical industry, George Quesnelle became a leading expert on the Rx-to-OTC switch process. At GlaxoSmithKline, he led the charge in switching Nicorette and NicoDerm CQ smoking cessation products, as well as alli for weight loss.