The Food and Drug Law Institute (FDLI) hosted a program and reception to celebrate the 1962 Amendments to the federal Food, Drug, and Cosmetic Act, more commonly referred to as the Kefauver-Harris Drug Amendments. These Amendments introduced the requirement that product sponsors provide substantial evidence of effectiveness for the product's intended use. Further background information.
Peter Barton Hutt, Senior Counsel with Covington and Burling and former FDA Chief Counsel, and Dr. Robert Temple, Deputy Center Director for Clinical Science, Center for Drug Evaluation and Research, discussed how the Amendments changed modern medicine from both the legal and scientific perspectives. A networking reception followed their remarks.
We plan to transcribe the event and publish the remarks in an upcoming issue of FDLI's Food and Drug Law Journal.
October 17, 2012
Remarks and Reception