Revising the nonRx drug category

May 15, 2012

Healthcare industry experts discuss the pros and cons.

As the Food and Drug Administration (FDA) considers a new concept that would expand the definition of nonprescription drugs, healthcare experts say the proposed change could offer the healthcare industry both benefits and challenges.

The general idea

For some medications that usually require a prescription, FDA is considering a new paradigm that would allow those products to be distributed over the counter (OTC) if certain special conditions are met.

"It's all still to be determined, because anything that might fall into the potential new paradigm would be driven by the manufacturer or sponsor of that drug," said Marcie Bough, PharmD, senior director of government affairs for the American Pharmacists Association.

Possible benefits

"The primary benefit that we see is rechanneling poorly treated individuals with chronic conditions back into the healthcare system," said Brian Gallagher, RPh, JD, senior vice president of government affairs for the American Pharmacists Association.