• FDA Considers A New Prescription Drug Paradigm
  • March 6, 2012 | Author: Sheldon T. Bradshaw
  • Law Firm: Hunton & Williams LLP - Washington Office
  • Under Section 503(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act, a drug must be dispensed by prescription if safe use of the drug requires supervision by a licensed health care professional. The need for professional supervision can be due to the drug’s toxicity or other potential harmful effects, its method of use or collateral measures necessary to its use. But on February 28, 2012, the U.S. Food and Drug Administration (“FDA” or “the Agency”), announced that it believes the prescription drug paradigm has contributed to the undertreatment of certain common diseases, and it therefore is considering a new paradigm under which it would approve certain drugs that ordinarily would require a prescription to be sold over the counter under “conditions of safe use.” On March 22-23, 2012, the Agency will hold a public hearing to obtain comments about the new paradigm’s feasibility, as well as its potential costs and benefits.