FDA AUTOMATIC APPROVAL DEADLINE FOR DRUG PRODUCTS SUGGESTED AT AMERICAN ENTERPRISE INSTITUTE SEMINAR; Rx-TO-OTC SWITCH "SUNSET LAW" PROPOSED
Executive Summary
FDA should have a legal deadline before which the agency can deny a drug approval and after which the drug would automatically be approved, according to Sam Peltzman, University of Chicago, and Peter Barton Hutt of the D.C. law firm Covington & Burling.