Food & Drug Law: How One Seminar Helps Launch Careers at the FDA
Professor Fran Miller’s Food, Drug and Cosmetic Law seminar has helped a number of BU Law alumni land at the US’s chief federal agency protecting public health
Chris Fanelli (’11) didn’t come to BU Law with a background in health law, much less FDA law. Yet after taking Professor Fran Miller’s Health Law course and interning at a small pharmaceutical company, he wanted to explore this area more. Miller’s Food & Drug Law Seminar not only allowed him dive into FDA law, it also led to his current position as associate chief counsel for enforcement at the FDA in White Oak, Maryland.
There are more than a dozen BU Law alumni like Fanelli working at the FDA; the majority took Miller’s Food & Drug Law Seminar. How does one course inspire so many students to pursue such a specific practice area?
Alumni say it’s a combination of Miller’s enthusiasm about the topic and practical approach to the law.
Sparking Interests
Karen Marcus (’12), assistant chief counsel at the FDA, recalls how Miller brought a newspaper to each class so that students could discuss the day’s relevant articles. “That was the first time most of us had a sense for the scope of the FDA’s work and the impact it has on the country in terms of patients and consumers as well as the economy,” she says. “Her passion really sparked an interest among students.”
As for the practical approach, Miller, who has taught the FDA seminar since 2003 and still teaches it as a professor of law emerita, notes that she redesigned the course shortly after it was introduced to help students “see the forest through the trees.” She explains that since the FDA regulates more than a quarter of the economy with its oversight of food, drugs, cosmetics, dietary supplements biologics, medical devices, etc., the traditional theoretical class model didn’t work. “I wanted students to understand how much commerce is governed by the FDA, so I opted for a seminar focus. Now, we cover a specific area of regulation each week.” She also uses A Practical Guide to Food & Drug Law and Regulation, which is published by the Food and Drug Law Institute, as the casebook, eschewing more theoretical textbooks.
After learning about the bigger areas of regulation, Miller has students drill down into very specific subjects with 40-page research papers. Examples of recent topics include personalized medicine, speech rights for drug representatives, e-cigarette regulation, biotech food labeling controversies, and comparative regulation of pesticides in food. Those papers are presented by students throughout the last four meetings of the course. The seminar has proven to be very popular among students, quickly reaching its cap of 16 participants each year.
Opening Eyes
Mary Alice Hiatt (’10), regulatory counsel at the FDA, says she took the course because of an interest in working in health law policy. “The seminar was amazing because Fran—we called her Fran in class—taught us how to think like general counsel. She showed us what we would be doing as lawyers in this area.”
Hiatt adds that Miller encouraged students to consider business issues as well as the law. “She could stump us with those business questions. I remember once she asked why a company would take a prescription drug and make it over-the-counter. After a lot of guesses among students, she explained how the answer involved the business motivations of the drug company when patents are about to expire. That was eye-opening.”
The seminar is so inspiring for many students that it leads them to apply for internships and jobs at the FDA. When this happens, Hiatt notes, Miller supports her students with encouragement, references, and suggestions of BU Law alumni in the agency to contact.
A Growing Network
Fanelli points out that BU Law students have an advantage over other applicants at the FDA because of the School’s well-established and well-respected Health Law Program, which Miller helped found. “The Health Law Program and this seminar set you apart because you can show a demonstrated interest in this area of law,” he says, noting that in the Office of Chief Counsel at the FDA there are approximately nine BU Law alumni out of 95 or so attorneys.
Hiatt agrees: “The Health Law Program and its impressive breadth of classes gave me a background in regulatory and health law that I could show my employer, as I hadn’t directly practiced in this area before. It helped show that I could be an asset.”
Despite the high numbers of BU Law alumni at the FDA, Marcus notes that there is no relationship in place between the federal agency and BU Law. “It’s possible that they could have seen Fran’s name plenty of times as a reference, but the real driver is her ability to interest students in working there. It’s one of the few health law areas where it’s possible to do public interest work and make a living wage. And with more laws going into effect, there is always work to be done. Fran shows us this career path, and her excitement about it is contagious.”
Reported by Meghan Laska