Peter Barton Hutt
Covington & Burling LLP
¾ Food & Drug
· Dietary Supplements
· Food & Beverage Law Practice
· Human Pharmaceuticals
· Medical Devices & Diagnostics
¾ Public Policy & Government Affairs
· Congressional & Federal Agency Advocacy
¾ Strategic Risk & Crisis Management
¾ New York University School of Law, LL.M.
¾ Harvard Law School, LL.B.
¾ Yale University, B.A.
Peter Barton Hutt is a senior counsel in the Washington, DC law firm of Covington & Burling, specializing in Food and Drug Law. He began his law practice with the firm in 1960 and, except for his four years in the government, has continued at the firm ever since. From 1971 to 1975 he was Chief Counsel for the Food and Drug Administration.
Since 1994, Mr. Hutt has taught a full course on Food and Drug Law during Winter Term at Harvard Law School. Harvard Law School held a symposium on January 17, 2013, “Celebrating Peter Barton Hutt’s 20 Years (thus far) at HLS.” Mr. Hutt has collected all of the papers on Food and Drug Law prepared by his students in an electronic book that is available on his Harvard Law School faculty website: http://www.law.harvard.edu/faculty/hutt. He taught the same course at Stanford Law School during Spring Term in 1998. Mr. Hutt is the co-author of Food and Drug Law: Cases and Materials (Foundation Press, 1st edition 1980, 2d edition 1991, 3d edition 2007) and has published more than 175 book chapters and articles on Food and Drug Law and on health policy.
Mr. Hutt has represented the national trade associations for the food, prescription drug, nonprescription drug, dietary supplement, and cosmetic industries. While at FDA he drafted the legislation that became the Medical Device Amendments of 1976, and beginning in 1962 he has participated in the drafting of most of the major legislation amending the Federal Food, Drug, and Cosmetic Act. He has testified before the House and Senate more than 100 times either as a witness or as counsel accompanying a witness.
Mr. Hutt has been a member of the Institute of Medicine of the National Academy of Sciences since it was formed in 1971. He has served on the IOM Executive Committee and other NAS and IOM committees. He recently served as a member of the Working Group on Innovation in Drug Development and Evaluation for President Obama's Council of Advisors on Science and Technology (PCAST). Mr. Hutt served on the Science Review Subcommittee of the FDA Science Board to review the FDA science needs in order to perform its regulatory mission, and published a major analysis that resulted in Congress doubling FDA appropriations. He also recently served on the Panel on the Administrative Restructuring of the National Institutes of Health, and on the Working Group to Review Regulatory Activities Within the Division of AIDS of the National Institute of Allergy and Infectious Diseases. He is a member of the Board of Directors of the AERAS Global TB Vaccine Foundation, the Foundation for Biomedical Research, the California Healthcare Institute, the Institute of Health Policy Analysis, and the Keck Graduate Institute of Applied Life Sciences, one of the Claremont Colleges. Mr. Hutt serves on a wide variety of other academic and scientific advisory boards, on the Board of Directors of venture capital startup companies, and on the Advisory Boards of six venture capital firms.
Mr. Hutt has served on the IOM Roundtable for the Development of Drugs and Vaccines Against AIDS, the Advisory Committee to the Director of the National Institutes of Health, the NAS Committee on Research Training in the Biomedical and Behavioral Sciences, the NIH Advisory Committee to Review the Guidelines for Recombinant DNA Research, the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS established by the President's Cancer Panel of the National Cancer Institute at the request of President Bush, and five Office of Technology Assessment advisory panels. He was a member of the New Foods Panel of the White House Conference on Food, Nutrition and Health and authored the panel report. Mr. Hutt has twice been a councilor of the Society for Risk Analysis and has served as Legal Counsel to the Society as well as the American College of Toxicology.
During the 1960s, Mr. Hutt litigated pro bono cases on behalf of homeless alcoholics and drug addicts. He argued the only alcoholism case ever heard in the United States Supreme Court, Powell v. Texas, and then drafted the legislation that created the National Institute of Alcohol Abuse and Alcoholism and the National Institute of Drug Abuse. Based on this work, two-thirds of the States have repealed their statutes that had made public intoxication a criminal offense.
Mr. Hutt was named by The Washingtonian magazine as one of Washington's 50 best lawyers (out of more than 40,000) and as one of Washington's 100 most influential people; by the National Law Journal as one the 40 best health care lawyers in the United States; and by Global Counsel as the best FDA regulatory specialist in Washington, DC. Business Week referred to Mr. Hutt in June 2003 as the "unofficial dean of Washington food and drug lawyers." In naming Mr. Hutt in September 2005 as one of the eleven best food and drug lawyers, the Legal Times also referred to him as "the dean of the food-and-drug bar." In April 2005, he was presented the Distinguished Alumni Award by FDA. In May 2005, he was given the Lifetime Achievement Award for research advocacy by the Foundation for Biomedical Research. The Best Lawyers in America selected Mr. Hutt as the 2013 FDA Lawyer of the Year for Washington, DC.
Honors and Rankings
¾ Chambers USA - America's Leading Business Lawyers, Food & Beverages: Regulatory & Litigation (2014), Healthcare: Pharmaceutical/Medical Products Regulatory (2014)
¾ Washington DC Super Lawyers, FDA (2014)
¾ "FDA Finalizes the Rule Prohibiting Most Omega-3 Nutrient Content Claims," Covington E-Alert (4/28/2014), Co-Author
¾ "The Statutory Authority of FDA to Regulate Cosmetics: A Response to Thomas Cluderay and Jason Rano’s Should Congress Expand FDA Authority Over Cosmetics and If So, How?," Food & Drug Policy Forum (Volume 2) (11/16/2012), Author
¾ "The State of Science at the Food and Drug Administration," 60 Admin.L.Rev. 431 (Spring 2008), Author
¾ "Food and Drug Law: Cases and Materials," Foundation Press (2007), Co-Author
¾ "The Regulation of Drug Products by the United States Food and Drug Administration," chapter 20 in The Textbook of Pharmaceutical Medicine, 5th ed. (2006), Author
¾ "FDA Comes of Age: A Century of Change," chapter 3 in FDA: A Century of Consumer Protection (2006), Author
¾ "The Legal Distinction in the United States Between a Cosmetic and a Drug," chapter 37 in Cosmeceuticals and Active Cosmetics: Drugs Versus Cosmetics, 2nd. ed (2005), Author
¾ "FDA Statutory Authority to Regulate the Safety of Dietary Supplements," 31 American Journal of Law & Medicine 155 (2005), Author
¾ "U.S. Government Regulation of Food with Claims for Special Physiological Value," chapter 16 in Essentials of Functional Foods (2001), Author
¾ "Regulation of Food Additives in the United States," chapter 8 in Food Additives, 2d ed. (2001), Author
¾ "A History of Government Regulation of Adulteration and Misbranding of Cosmetics," chapter 1 in Cosmetic Regulation in a Competitive Environment (2000), Author
¾ "The Food and Drug Administration Modernization Act of 1997," 52 Food Technology, No. 5 (May 1998), Author
¾ "The Transformation of United States Food and Drug Law," 60 Journal of the Association of Food and Drug Officials (September 1996), Author
¾ "A Brief History of FDA Regulation Relating to the Nutrient Content of Food," chapter 1 in Nutrition Labeling Handbook (1995), Author
¾ "A History of Government Regulation of Adulteration and Misbranding of Medical Devices," 44 Food Drug Cosmetic L.J. 99 (March 1989), Author
¾ "Government Regulation of Health Claims in Food Labeling and Advertising," 41 Food Drug Cosmetic L.J. 3 (January 1986), Author
¾ "A History of Government Regulation of Adulteration and Misbranding of Food," 39 Food Drug Cosmetic L.J. 2 (January 1984), Author