{"id":22932,"date":"2016-01-25T15:18:17","date_gmt":"2016-01-25T20:18:17","guid":{"rendered":"http:\/\/www.bu.edu\/law\/?p=22932"},"modified":"2021-12-06T13:42:59","modified_gmt":"2021-12-06T18:42:59","slug":"on-regulation-and-writing","status":"publish","type":"bu-article","link":"https:\/\/www.bu.edu\/law\/record\/articles\/2016\/on-regulation-and-writing\/","title":{"rendered":"On Regulation and Writing"},"content":{"rendered":"

Professor Fran Miller\u2019s Seminar on Food, Drug, and Cosmetic Law emphasizes writing\u2014to the benefit of students and alumni.<\/h2>\n
\"f-miller\"
Professor Fran Miller<\/figcaption><\/figure>\n

Talented teachers attract talented students\u2014students 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\u2019s<\/a> seminar on Food, Drug, and Cosmetic Law<\/a> 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.<\/p>\n

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 \u201csee the FDA forest through the administrative-law trees.\u201d 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\u2019t work. \u201cI 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.\u201d The seminar has become a staple of BU Law’s Health Law Program<\/a>, and has helped a number of\u00a0alumni land jobs with the FDA<\/a>.<\/p>\n

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.<\/p>\n

The sixteen students present their papers throughout the last four meetings of the course. Often, they decide to submit them\u00a0for 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<\/em><\/a>.<\/p>\n

Stepping outside the comfort zone<\/h3>\n
\"flaherty-jamie\"
Jamie Flaherty (’15)<\/figcaption><\/figure>\n

Throughout the semester, Miller meets with each student individually to guide the research, organization, and style of each paper. \u201cProfessor Miller repeatedly emphasized that we had to produce a paper of publishable<\/em> quality.\u201d Flaherty says. \u201cShe has a way of clearly and emphatically expressing things that she is passionate about, and one of those things is writing well.\u201d 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\u2019s advice and stepped out of her comfort zone to write about the FDA\u2019s move to regulate laboratory-developed tests. \u201cAs I began to wrestle with the complexities of the subject,\u201d she says, \u201cI remember thinking, \u2018why did I choose this topic again?\u2019 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.\u201d<\/p>\n

With Professor Miller\u2019s encouragement, Flaherty submitted her final paper, entitled \u201cTesting Tests: FDA\u2019s Proposed Regulation of Laboratory-Developed Tests,\u201d to the Food and Drug Law Institute\u2019s H. Thomas Austern Memorial Writing Competition<\/a>. Her paper received an honorable mention in the competition.<\/p>\n

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 \u201cshaping and fine-tuning\u201d her research and writing skills. Beyond that, \u201cthe FDA seminar exposed me to an agency and area of law that I had absolutely no familiarity with going in to law school,\u201d she says, \u201cthe class provided me with background knowledge and confidence that continues to shape my health law practice today.\u201d<\/p>\n

Driven by interest<\/h3>\n
\"Christine
Christine Donovan (’15)<\/figcaption><\/figure>\n

Some students enter Miller\u2019s 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\u2019s similarities with environmental law. \u201cIt is definitely a competitive advantage to have some working knowledge of the field,\u201d she says. \u201cAnd BU Law\u2019s 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.\u201d<\/p>\n

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\u00a0\u201c<\/span>If FDA Does Not Regulate Food, Who Will?: A Study of Hormones and Antibiotics in Meat Production<\/a>,\u201d<\/span>\u00a0argues that the FDA fails to regulate food appropriately. Donovan\u2019s comparative analysis points to the regulation of hormones and antibiotics in meat production in the United States and other countries to demonstrate her argument. \u201cThis is one of my favorite topics\u2014how ineffectively regulating animal and environmental issues can end up impacting human health,\u201d she says. \u201cIt was published in the spring 2015 American Journal of Law & Medicine<\/em>, which was really exciting.\u201d<\/p>\n

As an attorney practicing general litigation with Phillips Lytle LLP in Buffalo, New York, Donovan credits Miller\u2019s seminar with helping her become a better writer and researcher, but also to become more comfortable thinking creatively. \u201cAll of these skills will be useful for me regardless of what kind of law I\u2019m practicing,\u201d she says.<\/p>\n

A longstanding pursuit<\/h3>\n
\"Nick
Nick Falcone (’15)<\/figcaption><\/figure>\n

Nick Falcone (LAW\u201915, SPH\u201916) 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. \u201cI took the seminar primarily because I wanted to learn more about the pharmaceutical industry and how the United States regulates it,\u201d he says. \u201cDrugs are such a significant part of the health care system and I hadn\u2019t learned much about them. I had also heard great things about Professor Miller.\u201d<\/p>\n

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. \u201cIn 2011, the Supreme Court he<\/p>\n

ld that because the existing labeling regulation does not permit generics manufacturers to change their labels, it preempts state law \u2018failure-to-warn\u2019 suits against the manufacturers,\u201d Falcone says. \u201cI explain in the paper that the FDA\u2019s proposal would likely eliminate the preemption defense that generics manufacturers currently enjoy in state law actions for failure to warn.\u201d His paper, \u201cRepositioning Generics: The Comparative Value of Liability in FDA\u2019s Proposed Rule on Labeling<\/a>,\u201d was published in the American Journal of Law & Medicine<\/em> in spring 2015.<\/p>\n

After graduating with his JD in May 2015, Falcone is now finishing his MPH as the health law and bioethics fellow with BU\u2019s 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\u2019s Office. \u201cI rely on things I learned in the FDA seminar in both of my positions,\u201d he says. \u201cThe law curriculum at the School of Public Health includes some material on pharmaceuticals and preemption, which I\u2019ve been able to teach confidently thanks to my experience writing the paper (and Fran\u2019s guidance). In addition, most of my work at the AG\u2019s office involves pharmaceutical companies, so understanding the basics of the regulatory structure (for example, how the FDA approves generic drugs) has been invaluable.\u201d<\/p>\n

Miller\u2019s 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. \u201cProfessor Miller is an exceptional teacher,\u201d Falcone says. \u201cShe 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.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

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