Moving the BCS Into the 21st Century
Gordon Amidon, PhD, is renowned for the role his research played in undergirding the Biopharmaceutics Classification System (BCS). But the road to success covered a lot of miles.
“The BCS took 10 years to become U.S. Food and Drug Administration policy, in part because governments like to launder things and vet things in public long enough to be sure there are no problems,” says the Charles R. Walgreen Jr. Professor of Pharmacy and Professor of Pharmaceutical Sciences.
So he presented perhaps 50 lectures on the BCS system to scientific audiences around the world. Cultivating scientific opinion was an essential step, he explains.
“My experience is that when a scientific consensus develops, eventually the regulatory bodies go along,” states Dr. Amidon. “It may take some time, but when the underlying strength of a scientific argument becomes consensus, the conclusion becomes irrefutable.”
Amidon wasn’t going to leave that job to somebody else, not because of his ego, but because he’s passionate about the societal value of his work. “FDA standards are so important to the health and well-being of the public,” he says. “This is the government organization that ensures that pharmaceutical products do what the label says. Caveat emptor doesn’t really work because the patient has no choice. The product has to work.”
As the pharmaceutical industry has become increasingly global, so has the reach of the BCS, which is now an important standard in Europe and Japan, and has been adopted by the World Health Organization (WHO). The WHO is not an enforcement body, however, it does recommend standards that countries can use to make sure their products are safe and effective.
At a time in life when many scientists would be writing their memoirs, Dr. Amidon was instrumental in the College receiving millions in funding from the FDA’s Office of Generic Drugs. His portion is a long-term interdisciplinary project aimed at updating the BCS standards, and then applying them to a growing universe of generic drug products.
“I’ve promoted science-based regulatory standards as both important and as a significant contribution to social good,” notes Dr. Amidon. “The BCS standards are based on scientific measurements which have evolved and improved over the past 20 years. This new FDA-funded research project will incorporate recent scientific knowledge into existing standards.”
Amidon’s zeal for learning and his dedication to the public interest goes back even farther. He grew up in a small town in upstate New York, the oldest of three sons of a single mom who worked two jobs to support the family. “At an early age, I perceived that getting an education was very important to my mother,” he recalls. “So I stopped fighting with my brothers and started working on my education.”
His brothers apparently came to a similar conclusion. Gregory Amidon, PhD, is a research professor of pharmaceutical sciences at the College of Pharmacy, and co-director of the Masters of Pharmaceutical Engineering Program. Thomas Amidon, PhD, is a professor at the State University of New York College of Environmental Science and Forestry in Syracuse.
Equally unforgettable was his introduction to the University of Michigan.
“Two things stand out from my early days as a graduate student,” says Dr. Amidon. “One was going to an evening seminar and realizing that I had a lot to learn. The other was walking into Michigan Stadium on game day. I had come from a university which had an athletic department not much bigger than that of my high school. U-M was big-time. That motivated me. I was going big-time and I had work to do.”
Both the motivation and the work are still going strong.