Suppliers, FDA shine spotlight on switches

The recent Food and Drug Administration public meeting on driving future switch potential by way of the pharmacist and/or health technology sparked some discussion on what’s next.


This FDA public hearing is just the first step in what could become a major paradigm shift for companies looking to extend the patent lives of their pharmaceutical properties by engineering an Rx-to-OTC switch. From a pure business perspective, switch is one of the more substantial OTC growth catalysts, noted David Spangler, SVP policy, general counsel and secretary for the Consumer Healthcare Products Association. And there is opportunity to broaden the OTC product pipeline by embracing the technology that exists today, he added.


There already are companies looking into additional, more complex switch applications. Pfizer has discussed publicly its inclination to explore a Lipitor switch, and Somaxon Pharmaceuticals with OTC partner Procter & Gamble late last year reported its pursuit of switching the insomnia medicine Silenor.


“There doesn’t need to be a third class of drugs” for the pharmacist or healthcare practitioner to become more involved, Laura Mahecha, industry manager of healthcare practice and analyst for Kline, shared with DSN earlier this year. “The onus would be on the manufacturer to provide educational programs for [healthcare practitioners] so that they would understand [the protocol].”

The article above is part of the DSN Category Review Series. For the complete Rx-to-OTC Switch Buy-In Report, including extensive charts, data and more analysis, click here.