Donald Kennedy served as the FDA Commissioner and the president of Stanford University. He earned a Ph. D. in biological services from Harvard University in 1956 and spent four years teaching at Syracuse University, before moving on to the Department of Biological Services at Stanford in 1960. Kennedy was appointed to head FDA in April 1977. Over his 26-month tenure, Kennedy supervised the overhaul of good manufacturing practices and attem pted to revise the drug provision of the FD&C Act in the proposed Drug Regulation Reform Act of 1978.

Peter Barton Hutt served as the Chief Counsel for the FDA from 1971 to 1975. During his time there, he drafted the legislation that evolved into the Medical Device Amendments of 1976. Hutt has participated in the drafting of most major legislation amending the Federal Food, Drug and Cosmetic Act. He currently serves on the FDA Science Board Working Group.

John Villforth became director of the Bureau of Radiological Health in 1969. His bureau merged with the FDA in 1971, and Villforth took on a role as chief of the Center for Devices and Radiological Health in 1982. After he retired, Villforth continued on to serve as president of the Food & Drug Law Institute and founded the FDA Alumni Association.

Kathryn Zoon started her career at the FDA’s Bureau of Biologics in the 1980s, and soon was recognized with FDA Awards of Merit for her scientific accomplishments, including her work on the cytokine review group, for the review and licensing of AIDS-related cytokine products. She was appointed as director of the FDA’s Center for Biologics Evaluation and Research. Zoon is currently an associate editor of the Journal of Interferon Research.

Suzanne White Junod is a historian for the U.S. Food and Drug Administration. She is also a published author on topics including women’s health issues, food issues and homeopathy. Her articles include “Quacks & Crusaders: The Fabulous Careers of John Brinkley, Norman Baker and Harry Hoxsey” and “Perspectives on the Pill: An Essay Review.”

John Swann is a historian for the U.S. Food and Drug Administration. He has been at the FDA since 1989 and specializes in the history of drugs, biologics, and their regulation.

Philip Hilts is a well-known health and medical journalist. He has written hundreds of stories for the New York Times and The Washington Post on medicine and public health, and garnered three New York Times’ Publishers Awards for his coverage of the tobacco industry, breast implants and birth control. His books include Smokescreen: The Truth Behind the Tobacco Industry Cover-up (1995) and Protecting America’s Health: the FDA, Business and One Hundred Years of Regulation (2003).

Marion Nestle is currently the Paulette Goddard Professor of Nutrition, Food Studies and Health at New York University. She penned both Food Politics: How the Food Industry Influences Nutrition and Health (2002) and Safe Food: Bacteria, Biotechnology and Terrorism (2003). Most recently, North Point Press published her book What to Eat, which was named one of Amazon.com’s top ten books for 2006.

Daniel Carpenter is the Allie S. Freed Professor of Government and Director of the Center for American Political Studies in the Faculty of Arts and Sciences at Harvard University. He is the author of The Forging of Bureaucratic Autonomy: Reputations, Networks, and Policy Innovation in Executive Agencies, 1862–1928, and is currently completing a book on the FDA.

Bill Vaughn is a Senior Policy Analyst at Consumers Union, in Washington, D.C. Consumers Union (CU) is an expert, independent, nonprofit organization, whose mission is to work for a fair, just, and safe marketplace for all consumers. CU publishes Consumer Reports and ConsumersReport.org in addition to two newsletters, Consumer Reports on Health and Consumer Reports Money Adviser

Quotes from FDA: A History

Donald Kennedy on effectiveness of FDA:
“My sense is that except for occasional, sporadic outbursts of worry that FDA is either letting too many drugs on the market that may not be safe, or, alternatively, that FDA is regulating so stringently that good therapies are being kept off the market. I think we’ll never know and the public will never know whether the balance has been drawn at the optimum place in terms of social utility. But FDA is a very good agency. It’s a highly graded agency. People there have had a lot of experience. FDA regulates about 25 cents out of ever consumer dollar spent in the United States, and it does so in a very professional and a very well charted way. There is no mystery about how FDA works.”

Peter Barton Hutt on FDA response to crisis:
“You can take a look at all the crises over the last few years: the issue of Vioxx, the issue of spinach, the issue of adequate regulation of medical devices, the issue of defibrillators. People say ‘Why didn’t FDA do something ahead of time?’  FDA has to run from one issue to the other, they have to put a Band-Aid on these problems because there aren’t enough people and there aren’t enough resources for them to do an adequate job.”

John Villforth on radiological health and FDA:
“When the Environmental Protection Agency was formed in the early 70’s, the public health, air pollution, public health water supply, water pollution and industrial programs were all pulled out of the Public Health Service and became the bolus of people who operated the EPA. The Bureau of Radiological Health in the Public Health Service was left with machine radiation. Then they looked around and said, “But you regulated these machines, and there are not quite 500 of you left--where are we going to put you? Let’s see, there’s one solution. There’s one organization in this Public Health Service that regulates things: Food and Drug Administration. Why don’t we put in the Food and Drug Administration?” And I said, “I don’t think so, Sir. Because we’ll lose all that we have done in the education area because you guys, I think of you as a bunch of cops.” He said, “Well, I think you might was to think about that again.” The next day, I got a message from the department that said ‘Report to the FDA.’ I do think that the culture that [the EPA] had actually helped FDA and I do think FDA’s methodical, regulatory, and disciplined approach to problems, in the compliance area, helped us. I think it was a great marriage."

Kathyrn Zoon on the biologics culture:
“You can look at a lot of paper and you can visualize what happens on the paper, but it isn’t until you go into a facility and actually observe how things are made that it brings another dimension to what you’re actually looking at. So I think for biologics, the tradition that we had back from early 1900s of actually going to look at the site to ensure that the products were being made properly was part of our culture, ingrained in our culture.”

Kathy Zoon on progress:
“I think that without having someone actively engaged in the science, people become risk adverse. They’re not willing. They don’t understand the science enough to make a decision as to whether something can go forward. So what happens is that it’s easier to say no when you don’t understand and protect yourself than to say yes. This makes sense scientifically and I think the risk benefit ratio favors going forward.”

Suzanne White Junod on the development of good manufacturing practices:
“In the modern era there was an increasingly clear understanding that FDA inspectors couldn’t be in all places at all times. In the 60s there was more of an emphasis on getting the industry itself educated so that it could do some of the monitoring of its own affairs, knowing that when an inspector is called in after a problem it is not as effective as preventative measures. So the development of good manufacturing practices, good laboratory practices, good clinical practice regulations--all these things were sort of tools of the modern inspector, both simplifying his investigations when they were necessary, but also creating a blueprint for manufacturers themselves to follow to stay out of trouble with FDA.”

John Swann on the Bureau of Chemistry:
“When the Bureau of Chemistry began in the 1860s, the focus really wasn’t on consumer products, not in the sense of foods or drugs or so on. They were more concerned with commodities of great interest to farmers.”

John Swann on the Federal Food Drug & Cosmetic Act:
“With the 1938 law, devices and cosmetics come under the law, food packaging becomes much stricter, food standards become reality, enforceable food standards, drug labeling takes a vast step forward. “

Philip Hilts on the drug approval process
"The central issue that had arisen, especially between, the contentious issue between those who were against regulation and those where were for regulations turned out to be this issue of drug lag. How long does it take from the time a company puts a drug application in to the time it come out the other end approved?"

Marion Nestle on the removal of FDA resources:
“The secret to compliance is enforcement. If there is nobody minding the store, all kind of things can happen that aren’t in the public interest. The FDA is a public health agency and it should be doing public health. If it’s going to do that it needs to have the resources to do it and the systematic removal of resources from the FDA is a national tragedy, nothing less.”

Marion Nestle on chronic disease prevention:
“For a long time, people were concerned that the food labels didn’t really give information about chronic disease prevention. So again, chronic disease prevention was the guiding issue here and it’s controversial because for the first time people would be healthier if they ate less of something. Eating less is very, very bad for business.”