Peter Barton Hutt, JD

Senior Counsel, Covington & Burling LLP

Peter Barton Hutt has worked at the Washington, DC law firm of Covington & Burling, specializing in Food and Drug Law, for more than five decades. He has represented clients in administrative, legislative, executive, and judicial settings. He began his law practice with the firm in 1960 and is now Senior Counsel; between 1971 and 1975, he was Chief Counsel for the Food and Drug Administration.

During his tenure at the FDA, Peter led the agency's transformation from outdated law enforcement to modern administrative law. He promulgated regulations to implement the review of GRAS food ingredients, require nutrition labeling for half the food supply, define “imitation” food, establish the emergency permit controls for low acid canned food, and modernize food standards; to implement the prescription drug requirements of the Drug Amendments of 1962 following a sweeping victory in four Supreme Court cases and to create the OTC Drug Review for nonprescription drugs; to create a process for reevaluating the safety and effectiveness of all biological products that had been licensed since 1902; to rationalize the application of the Delaney Anticancer Clause to animal drugs; to require ingredient labeling for cosmetics and premarket safety substantiation for all cosmetic ingredients, and to prepare FDA for the enactment of the Medical Device Amendments of 1976. He created the requirement of preambles for all proposed and final FDA regulations, initiated the use of guidelines (later named guidance) to establish informal FDA policy, and established the use of regulatory letters (later named warning letters) as an inexpensive and efficient enforcement approach. Before leaving the FDA, he wrote the comprehensive proposed procedural regulations that govern all FDA administrative action.

The Best Lawyers in America selected Mr. Hutt as the 2013 FDA Lawyer of the Year for Washington, DC. Since 1994, Mr. Hutt has taught Food and Drug Law during Winter Term at Harvard Law School, covering all aspects of government regulation of food and drugs from ancient times to the present. He is the lead co-author of the text used to teach Food and Drug Law at law schools through the country. He has been a member of the National Academy of Medicine since it was formed in 1971.