On Regulation and Writing

Professor Fran Miller’s Seminar on Food, Drug, and Cosmetic Law emphasizes writing—to the benefit of students and alumni.

Talented teachers attract talented students—students eager to explore unknown topics and unafraid of taking on a challenge. Like many Boston University School of Law students, the ones who enroll in Professor Fran Miller’s seminar on Food, Drug, and Cosmetic Law are just that type. They may be intimidated by the 40-page paper required to pass, but go ahead anyway, led in part by the experience and enthusiasm of the professor.

Fran Miller began teaching her FDA seminar in 2003, and continues to teach it as a professor of law emerita. She redesigned the course shortly after it was introduced to help students “see the FDA forest through the administrative-law trees.” She explains that since the agency 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.” The seminar has become a staple of BU Law’s Health Law Program, and has helped a number of alumni land jobs with the FDA.

After learning about the bigger areas of regulation, Miller has her students drill down into very specific subjects with their research papers. She provides a list of topics and encourages her students to write about a subject outside their comfort zones. 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.

The sixteen students present their papers throughout the last four meetings of the course. Often, they decide to submit them for writing contests or publication at the end of the seminar. Of her Class of 2015 students, examples include Jamie Flaherty, who received an honorable mention in a prestigious writing competition, and Christine Donovan and Nick Falcone, who have successfully published their papers in the American Journal of Law & Medicine.

Stepping outside the comfort zone

Throughout the semester, Miller meets with each student individually to guide the research, organization, and style of each paper. “Professor Miller repeatedly emphasized that we had to produce a paper of publishable quality.” Flaherty says. “She has a way of clearly and emphatically expressing things that she is passionate about, and one of those things is writing well.” Flaherty, originally a wait-list student, was one of the last in her class to choose a topic. With few options left, she took Miller’s advice and stepped out of her comfort zone to write about the FDA’s move to regulate laboratory-developed tests. “As I began to wrestle with the complexities of the subject,” she says, “I remember thinking, ‘why did I choose this topic again?’ What I failed to appreciate at the time was that, thanks to Professor Miller, I had chosen a topic that is still an extremely important issue in health care today, and one that has been relevant to my practice after law school.”

With Professor Miller’s encouragement, Flaherty submitted her final paper, entitled “Testing Tests: FDA’s Proposed Regulation of Laboratory-Developed Tests,” to the Food and Drug Law Institute’s H. Thomas Austern Memorial Writing Competition. Her paper received an honorable mention in the competition.

Now an associate in the health care and intellectual property transaction groups at Ropes & Gray, Flaherty is grateful to Miller and the FDA seminar for “shaping and fine-tuning” her research and writing skills. Beyond that, “the FDA seminar exposed me to an agency and area of law that I had absolutely no familiarity with going in to law school,” she says, “the class provided me with background knowledge and confidence that continues to shape my health law practice today.”

Driven by interest

Some students enter Miller’s class with a clear idea for their paper. That was the case for Christine Donovan, who became interested in health law after learning about the field’s similarities with environmental law. “It is definitely a competitive advantage to have some working knowledge of the field,” she says. “And BU Law’s health law program is so strong, between the class offerings and the highly regarded health law journal, that I wanted to take advantage of it.”

Donovan enrolled in the FDA law seminar to pursue her interest in regulatory law, particularly the convergence of health law, environmental law, and animal law. With this in mind, she chose a topic to reflect her interests. Her paper, entitled “If FDA Does Not Regulate Food, Who Will?: A Study of Hormones and Antibiotics in Meat Production,” argues that the FDA fails to regulate food appropriately. Donovan’s comparative analysis points to the regulation of hormones and antibiotics in meat production in the United States and other countries to demonstrate her argument. “This is one of my favorite topics—how ineffectively regulating animal and environmental issues can end up impacting human health,” she says. “It was published in the spring 2015 American Journal of Law & Medicine, which was really exciting.”

As an attorney practicing general litigation with Phillips Lytle LLP in Buffalo, New York, Donovan credits Miller’s seminar with helping her become a better writer and researcher, but also to become more comfortable thinking creatively. “All of these skills will be useful for me regardless of what kind of law I’m practicing,” she says.

A longstanding pursuit

Nick Falcone (LAW’15, SPH’16) was well on his way to earning a dual JD/MPH in Law & Public Health, having decided as an undergraduate that he wanted to pursue a career in health law, when he began the seminar. “I took the seminar primarily because I wanted to learn more about the pharmaceutical industry and how the United States regulates it,” he says. “Drugs are such a significant part of the health care system and I hadn’t learned much about them. I had also heard great things about Professor Miller.”

When it came time to choose a paper topic, Falcone picked one that intrigued him, but that he knew nothing about. In 2013, the FDA proposed a rule that, if passed, would permit generic drug manufacturers to revise drug labels to include new information about patient safety risks. “In 2011, the Supreme Court he

ld that because the existing labeling regulation does not permit generics manufacturers to change their labels, it preempts state law ‘failure-to-warn’ suits against the manufacturers,” Falcone says. “I explain in the paper that the FDA’s proposal would likely eliminate the preemption defense that generics manufacturers currently enjoy in state law actions for failure to warn.” His paper, “Repositioning Generics: The Comparative Value of Liability in FDA’s Proposed Rule on Labeling,” was published in the American Journal of Law & Medicine in spring 2015.

After graduating with his JD in May 2015, Falcone is now finishing his MPH as the health law and bioethics fellow with BU’s School of Public Health. Starting in August, he will clerk for Hon. Stuart Rabner, chief justice of the Supreme Court of New Jersey, a position he secured with a letter of recommendation from Professor Miller. Until then, he continues to research and write about issues at the intersection of law and public health, and teaches law to other MPH students. He is also a volunteer attorney with the Antitrust Division of the Massachusetts Attorney General’s Office. “I rely on things I learned in the FDA seminar in both of my positions,” he says. “The law curriculum at the School of Public Health includes some material on pharmaceuticals and preemption, which I’ve been able to teach confidently thanks to my experience writing the paper (and Fran’s guidance). In addition, most of my work at the AG’s office involves pharmaceutical companies, so understanding the basics of the regulatory structure (for example, how the FDA approves generic drugs) has been invaluable.”

Miller’s expertise and enthusiasm has had a lasting impact on those who have passed through her seminar. Graduates have noted improvement in their research and writing, as well as a deeper understanding of a particularly complicated area of the law. “Professor Miller is an exceptional teacher,” Falcone says. “She taught with energy and inspired genuine interest in the subject matter, as well as the law and legal argument in general. She has been very influential for me, both during school and at the beginning of my career.”