Dr. Kenneth Hastings served in the U.S. Peace Corps from 1987-1988 in Fiji as a consultant to the Ministry of Health
Kenneth Hastings
Pharmacology/Toxicology Reviewer, U.S. Food and Drug Administration
B.A., University of North Carolina at Chapel Hill, 1974
M.P.H., University of North Carolina School of Public of Health, 1980
Ph.D. in Parasitology and Laboratory Practice, University of North Carolina School of Public Health, 1987
Dr. Hastings served in the U.S. Peace Corps from 1987-1988 in Fiji as a consultant to the Ministry of Health. In addition, he served on the faculty of the Fiji School of Medicine. From 1988-1991, he completed postdoctoral training under the direction of Dr. A. Jay Gandolfi in the Department of Anesthesiology, College of Medicine, University of Arizona. Dr. Hastings joined the U.S. Food and Drug Administration in 1991 as a pharmacology/toxicology reviewer in the Division of Antiviral Drug Products, Center for Drug Evaluation and Research (CDER). He has served since 1984 as chair of the CDER Immunotoxicology Committee and as the CDER Expert Reviewer in immunotoxicology.
The following is a transcript of Dr. Hastings' presentation at Biology Career Day 1997:
I work for the FDA. My undergraduate degree was in philosophy, which was a long way from science. I had been out doing all kinds of things and finally went back to graduate school. I ended up getting a doctorate in parasitology. After getting my doctorate, I did the Peace Corps tour working for the Ministry of Health for the Republic of Fiji. That was pretty interesting. When I came back to the U.S., I did a postdoctoral here at the University of Arizona in the pharmacology/toxicology program. After three years here in a postdoctoral position, I looked into a job with the FDA. It turned out that the networking I did had a lot to do with my getting the job.
I work in the Center for Drug Evaluation and Research. The FDA is about 9,600 people - not a very big bureaucracy. It's split up into various centers: Center for Veterinary Medicine, Foods - the largest in the FDA - the Center for Drugs, which is the second largest, the Center for Devices, and the Center for Biologics and Veterinary Medicine. Then there's some big research, and there's the regulatory part of the FDA, which is the Office of Regulatory Affairs. They are the FDA's cops.
I work in the Division of Antiviral Products. We review all the drugs that are proposed for use for the treatment of HIV infection and treatment of diseases associated with AIDS. We get all the tuberculosis drugs, drugs for transplant patients, and a smattering of other types of drugs. It's a very interesting job. Basically, what I do is review the information if a sponsor wants to enter a drug into clinical trials and make a recommendation to the staff as to whether or not the proposed clinical trials are safe. That's really the primary job I do, but I also have a lot of other things I do. I have to follow drugs when they go through the drug development process. I have a pretty important role when drugs are finally submitted to market, providing labels, things like this.
I do a fair amount of work as chairman for the Center's Immunotoxicology Committee, writing guidance documents, and doing regulatory policy kinds of things. Right now I'm ona detail for the International Regulatory Issues Staff, which is actually attached to the commissioner's office. We do a lot of policy work, particularly international conference and enforcement policies and mutual recognition agreements. These are instruments to harmonize the drug approval process between the United States and other countries - primarily Europe right now, but other parts of the world, like the Far East.
The FDA is downsizing, but actually we do have jobs. Even though, like so much of the federal government that's downsizing, the kinds of jobs that I have and that will be your type of positions - those will always be there. They are actually funded under user's fees to a certain extent. Basically, we charge a fee to the drug companies when we do drug reviews. Basically, we get a fee for service. So those jobs will always be there.
Questions and Answers
You mentioned working in Fiji. I was wondering about your involvement at the College of Medicine. Would that be a good school to attend?
Well, Fiji is kind of an interesting situation. I was there when the country fell apart - basically, my job was helping out. I was kind of like a triage bureaucrat. I taught at the medical school, but one of the biggest problems we had there was just trying to keep the medical system - the health care system - from going down the tubes. It was a very interesting experience. I do value it. They have a school of medicine. I taught there for a while - really on an emergency basis. The purposes for which that medical school was designed are actually pretty good. The problems are political. It's not the school.
