The U.S. Food and Drug Administration really only regulates two things—a wide variety of products used by the public and words, Peter Hutt, a former Chief General Counsel to this federal agency, told a gathering of students and faculty Thursday at the Yale School of Public Health.
Throughout the Agency’s long history, the landscape between ensuring safety of foods, drugs and cosmetics and controlling what manufacturers can say about them, has been in constant flux. Many times, changes have been made only in response to public health crises.
Prior to the modern era of scientific drug trials, the agency focused on safety since it had no means to evaluate effectiveness of drugs. But, it was also tough on preventing producers from making “false and misleading” claims. The agency became extremely effective, beginning in the early 1900s, in cleaning up the drug supply, claims Hutt.
Hutt is a senior counsel in the Washington, D.C., law firm of Covington & Burling, specializing in food and drug law. He has represented the national trade associations for the food, prescription drug, nonprescription drug, dietary supplement and cosmetic industries and is also a member of the Institute of Medicine, a former Chief General Counsel to the FDA and co-author of Food and Drug Law. He is a Yale College graduate.
Hutt’s lecture was the first in a series this semester offered by the school’s Regulatory Affairs Track that features leading experts in the area of food and drug regulation.
Since a 1976 U.S. Supreme Court ruling that gave corporations greater freedom of speech, Hutt said the agency has often had to soften the language used on product labels and ferret out “misleading” words. Disagreements with industry arise frequently.
Robert Makuch, Ph.D., professor of biostatistics and director of the Regulatory Affairs Track at the School of Public Health, said that restrictions on free speech and what appears on the FDA’s warning label is “a slippery path, as we now closely debate what is scientifically valid evidence.”
Careful design and evaluation of clinical trial protocols, meanwhile, are more important than ever, said Hutt, as there is a precise 1:1 correspondence of every word between study protocols and FDA labels.
Four other experts in food and drug policy will speak as part of the Regulatory Affairs seminar series this month. The speakers include:
Nathan Schactman, April 7, noon, Winslow Auditorium, Laboratory of Epidemiology and Public Health.
Schactman's practice in New York has over 30 years of experience in the defense of product liability suits, with an emphasis on scientific, medical and legal issues that often dominate such cases. His trials, hearings, and appeals have involved prescription and over-the-counter medications, medical devices and exposure to toxic substances from products and environmental sources.
Dr. Lee Simon, April 14, noon, Winslow Auditorium, Laboratory of Epidemiology and Public Health.
Simon served as the FDA’s Division Director of Analgesic, Antiinflammatory and Opthalmologic Drug Products from 2001 to 2003. He also served on multiple FDA advisory committees and has extensive experience in drug development as a senior investigator for Celecoxib, an anti-inflammatory drug, in the United States.
Dr. Joseph Scheeren, April 21, noon, Winslow Auditorium, Laboratory of Epidemiology and Public Health.
Scheeren is the head of global regulatory affairs for the Pharmaceuticals and Consumer Care division at Bayer Healthcare. He has more than 20 years of global industry experience and will discuss China’s dynamic regulatory environment.
Dr. Yu-te Wu, April 28 (by invitation only).
Wu, Yale M.P.H. ’00, Yale Ph.D. ’05, is the FDA’s Division Director for generic drugs.