A Tribute to William H. Goodrich: Legal Counsel Extraordinaire -- Left The FDA To Help
Start The Master Plan to Sell Margarine Instead of Butter!
This article originally appeared in the "Making History" column of the March-April 1998 issue of Update, the bimonthly publication of the Food and Drug Law Institute.
A Tribute to William H. Goodrich: Legal Counsel Extraordinaire
Suzanne White Junod, Ph.D.
FDA Historian
On March 10, 1998, the Food and Drug community lost one of its most respected and admired attorneys, William H. Goodrich. A remarkable man in both his public and private life, Goodrich pursued legal and administrative strategies which extended the reach of the 1938 Food, Drug, and Cosmetic Act and its amendments far beyond the literal wording of the statute.
During his years as Assistant General Counsel (now known as Chief Counsel) of the Food and Drug Division from 1952 to 1971, the Division was extraordinarily successful in its legal endeavors.
[Peter Barton Hutt became the new Chief Counsel in 1971. Click here.]
A former FDA colleague recalls that Goodrich used to quip during these years that there were only three kinds of food and drug law cases: ones the agency won; ones on appeal; and ones decided incorrectly. A student in one of his famous food and drug law classes at New York University, an attorney from a large pharmaceutical company, was once quoted as saying, "Now I know how the Indian boy must have felt during a Western." Goodrich himself described the FDA during that period as a "can do" organization, willing to take on new consumer issues avoided by other agencies.
Goodrich came to Washington at age 23, after he had graduated from the University of Texas Law School and had spent a year in private practice. According to his son, he secured quarters when he arrived in 1939 in the old Dodge hotel downtown where both Lyndon Johnson and John Connelly were also among the Washington newcomers. Goodrich went to work in the Solicitor's office of the USDA, which was implementing the 1938 Food, Drug, and Cosmetic Act. Goodrich began by working with the newly created Federal Register to implement and publish administrative procedures under the new law. By 1940, he was transferred to the Food and Drug Division full time and assigned to help implement the food standards provisions of the 1938 Act. When the agency established standards for enriched flours and cereals, the decision was appealed by Quaker Oats all the way to the Supreme Court, by the agency's strategy was upheld.
Goodrich gained legislative experience working with the Insulin Amendment, the Durham Humphrey Amendment in 1951, the Oleomargarine Act of 1950, and the Factory Inspection Amendment of 1953. His most cherished accomplishments, however, came during the 1960's in anticipating, drafting, and implementing changes in the new drug approval process, strengthening drug labeling regulations for all drugs, and later in fighting against false and misleading drug advertising. In 1970, he helped win an important appellate court ruling that paved the way for regulations defining "adequate and well controlled" drug testing.
The FDA History Office is now collecting papers, reminiscences, and anecdotes about Mr. Goodrich and his career to add to our files and to share with Mr. Goodrich's family.
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Ed Basile (Partner: Deputy General Counsel, Health Industry Manufacturers Association, 1985-1987; former Associate Chief Counsel, U.S. Food and Drug Administration, 1975-1985; Managing Attorney, Neighborhood Legal Services Program, District of Columbia, 1973-1975; Lafayette College B.S.M.E., 1969; George Washington University, J.D., 1972); SOURCE
Mr. Bozeman began his government career in 1971, when he joined the Food and Drug Administration’s (FDA) Office of the Chief Counsel as a General Trial Attorney. Mr. Bozeman was the first legal advisor to the Division of Biologics Standards after it was transferred to FDA from the National Institutes of Health in 1972 and renamed the Bureau of Biologics. In 1973 he was appointed the Director of the Office of Compliance for the Bureau. He rejoined the FDA Chief Counsel’s office in 1975 as the Deputy Chief Counsel for Administration, where he was responsible for the administrative management of a staff of approximately 40 attorneys.
In 1976, Mr. Bozeman left government service to return to California as the Director of Legal Services for Alza Pharmaceuticals in Palo Alto, California. In 1978, Mr. Bozeman joined a former FDA colleague to found the Los Angeles firm of Geller & Bozeman, which handled all aspects of FDA law. He continued his FDA practice as a sole practitioner beginning in 1987. SOURCE
Richard Merrill, the FDA's chief counsel, [1975 - 1977 per below] petitioned Samuel K. Skinner U.S. Attorney for the northern district of Illinois, for a grand jury investigation of Searle's "willful and knowing failure" to submit required test reports, and for "concealing material facts and making false statements" in reports on aspartame submitted to the agency.52 Yet industry analysts, interviewed by the _Wall Street Journal_ six months after Rumsfeld's appointment as chairman, noted a rapid turnabout in Searle's fortunes as a result of his direction.53
Searle denies that Chairman Rumsfeld ever had any contact with the FDA, or the Carter and Reagan administrations, to lobby for aspartame.54 But the _Wall Street Journal_ article reported in 1977 that Rumsfeld "keenly understands the importance of a public image. So he has been mending fences with the FDA by personally asking top agency officials what Searle should do to straighten out its reputation." Westley M. Dixon, Searle's vice chairman, told the _Journal_ that without Rumsfeld "we wouldn't have gotten approSOURCEval for Norpace," a drug investigated by the FDA in 1975. 55The grand jury investigation of Searle disintegrated in January, 1977 when the FDA formally requested that Samuel Skinner, U.S. attorney and a protege of Illinois Governor James Thompson, investigate the firm for falsifying and withholding aspartame test data. A month later, Skinner met with attorneys from Searle's Chicago law firm, Sidley & Austin. Jimmy Carter ascended to The presidency a few weeks later. He announced that Skinner would not be asked to remain in office, but the outgoing Republican wasn't found wanting for employment. He informed reporters that he had already begun "preliminary discussions" with Sidley & Austin. 56 SOURCE
Richard Merrill:
.....An expert in administrative, environmental, and food and drug law, Richard A. Merrill joined the law faculty in 1969 after four years of practice with the Washington, D.C., firm Covington & Burling. In 1975 he took a leave from the Law School to serve for two years as chief counsel to the U.S. Food and Drug Administration, where he received the FDA Commissioner's Special Citation and the agency's Award of Merit. He was dean of the Law School from 1980 to 1988. During the fall of 1988, he was scholar-in-residence at the National Wildlife Federation in Washington, and in the spring of 1989, he was a visiting fellow at the Centre for Socio-Legal Studies at Oxford University. He was a member of the faculty of the American law session of the Salzburg Seminar in 1981 and 1986. SOURCEThe prime mover back then was Peter Barton Hutt, who left private practice in 1971 to become chief counsel for FDA, a position he held until 1975. One of the primary charges given Hutt at that time was to draft this legislation. In this interview with MD&DI, Hutt, now a partner in the law firm of Covington & Burling (Washington, DC) and an instructor of food and drug law at Harvard Law School, describes the effort and intent behind the amendments and assesses how well their current implementation reflects the spirit in which they were created. SOURCE
PETER BARTON HUTT
has broad experience in all aspects of food and drug law. From 1971-1975, he was Chief Counsel for FDA. He is a lecturer on law at Harvard Law School, teaching a course on food and drug law. He is a member of the Institute of Medicine, National Academy of Sciences, and serves on academic and scientific advisory boards and on the boards of directors of venture capital start-up companies. He has served on government advisory committees relating to biomedical research, recombinant DNA research, and approval procedures for cancer and AIDS drugs; Office of Technology Assessment Advisory Panels; and as a Councilor of the Society for Risk Analysis. He is coauthor of Food and Drug Law: Cases and Materials (1991), and has published numerous papers on food and drug law and health policy. Mr. Hutt earned his B.A., magna cum laude, from Yale University, his LL.B. from Harvard University, and his LL.M. from New York University under a Fellowship from The Food and Drug Law Institute. SOURCE
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