Report: New FDA switch paradigm could bring $36 billion in prescription revenue to the front end

MONMOUTH BEACH, N.J. — A new switch paradigm could open the door to $35.7 billion in OTC opportunity, according to a new report recently released by Francesco International. 

Titled "A New FDA-Driven Rx-to-OTC Switch Initiative: The Expansion of Conditions of Use," the report outlines new potential Rx-to-OTC switch candidates that would qualify under a new switch paradigm under consideration by the Food and Drug Administration, and identifies possible building blocks in developing a switch application. "For example, combining a drug with new smartphone technology could create potentially valuable OTC opportunities in several therapeutic categories," the company stated. Enabling access to OTCs through technology or consults with retail pharmacists and clinicians could bring prescription-only medicines like statins into the mass market, Francesco noted. Other potential switch candidates identified by Francesco in the report include medicines for hypertension, benign prostate hyperplasia, chronic obstructive pulmonary disorder and erectile dysfunction. "Under these new conditions of safe OTC use, the quality of life for the consumer could be significantly enhanced, and overall healthcare costs could be reduced without the need for constant physician involvement," the company added. 

“There is the chance for change as the major stakeholders are now starting to re-think their business models, and some of these new opportunities, especially those from the new healthcare legislation and the contribution of new technology, are becoming apparent and actionable," stated Steve Francesco, CEO of Francesco International. "The FDA sees this as an opportunity. As experts on the subject, we can see some new conditions of safe use having a potentially huge positive impact on both public health, as well as healthcare industry sales and profit."

The FDA last year held a public meeting attempting to identify switch pathways that would expand the class of medications considered appropriate for sale without a prescription today. The FDA is working with Brookings Institute and a number of switch experts, including Francesco International, on the Nonprescription Safe Use Regulatory Expansion initiative. Brookings hosted one meeting in December; the next is planned for May 9.  

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