Cross-posted on Stanford’s Law and the Biosciences Blog
Yesterday, FDA announced a new draft guidance “Innovative Approaches for Nonprescription Drug Products” intended to expand the range of drugs available over-the-counter (OTC). Specifically, the agency’s proposal indicates a willingness to make available OTC drugs for certain historically prescription-only therapeutic categories—such as overdose reversal drugs, like naloxone, or cholesterol-lowering drugs. As I told a journalist yesterday, overall I see this as a positive step—and one that is consistent with long-standing interest in making more drugs available without a visit to a physician, including interest at the state and local level.
Continue reading “Opening Up the OTC Market”
Continuing with FDA-related scholarship posted on SSRN in February and March: Professor Noah explores the possibility of “reverse switches” from over-the-counter (OTC) status back to prescription status (or perhaps, he suggests “behind the counter” status) in response to new safety information. Professor Paradise explains the provisions of the 21st Century Cures Act that contemplate greater patient involvement in medical product development, and Professors Evans and Ossorio evaluate the 21st Century Cures Act exclusion of clinical decision software from the agency’s medical device authority.
Continue reading “FDA Law SSRN Reading List – February and March 2018, 2/3”