Food & Drug Law Certificate
The Food and Drug Law certificate examines the regulation of food, tobacco, cosmetics, and medical products, including dietary supplements, drugs, biologics, and medical devices. Students enrich their understanding of food and drug law from both a U.S. and global perspective. Our faculty experts come to us from a range of institutions, including the U.S. Food and Drug Administration, the National Institutes of Health, non-governmental organizations, and the private sector.
Student learning goes beyond the classroom with Food and Drug Law Journal, a partnership between Georgetown Law’s O’Neill Institute for National and Global Health Law and the Food and Drug Law Institute (FDLI).
The Food and Drug Law certificate is offered in conjunction with the O’Neill Institute for National and Global Health Law.
This certificate may be completed as a stand-alone program or students can further their studies with an LL.M. in Global Health Law.
|Requirement||U.S.-Trained Students||Foreign-Trained Students|
|Prerequisite Course Requirements||Successful completion of a basic course in Administrative Law||Students must enroll in Administrative Law in the fall semester|
|Specialization Credits Required||10||10|
|Program Course Requirements||1) Law and Regulation of Drugs, Devices, and Biologics; 2) Either Food and Drug Law or Food Law||1) Law and Regulation of Drugs, Devices, and Biologics; 2) Either Food and Drug Law or Food Law|
|GPA Requirement||Minimum B- (2.67/4.00) in specialization courses||Minimum B- (2.67/4.00) in specialization courses|
To learn more, please contact:
Phone: (202) 662-6664
Email Address: Sarah Roache
J.D. Seminar (cross-listed) | 2-3 credit hours
This course examines a variety of legal and policy issues associated with the intellectual property protection available to biotechnological innovations, with an emphasis on patents.
Specific issues that will be examined within this framework include legal utility; conception and reduction-to-practice of biological molecules; anticipation and obviousness of nucleic acids; written description and enablement requirements for biological processes and molecules; experimental use; export and import issues; infringement; and potentially developments outside the US.
Course readings rely primarily on cases, statutes, and regulations. A biotechnology background is not necessary.
Prerequisite: Patent Law or patent law experience.
Note: J.D. students must register for the three-credit section of the course if they wish to write a paper fulfilling the J.D. Upperclass Legal Writing Requirement. A take home exam is required for the two-credit section.
J.D. Practicum | 4 credit hours
In fieldwork practicum courses, students participate in weekly seminars and conduct related fieldwork at outside organizations. This fieldwork practicum course will focus on federal regulation of tobacco and personal-care products by the Food and Drug Administration (FDA) under the Food, Drug, and Cosmetic Act and how public interest groups advocate greater protections for consumers. Students will participate in a two-hour/week seminar and carry out either 10 or 15 hours/week of fieldwork as interns with one of two national consumer and environmental health organizations: the Campaign for Tobacco-Free Kids or the Environmental Working Group. (Two pass/fail credits will be awarded for 10 hours/week of fieldwork, and three pass/fail credits will be awarded for 15 hours/week of fieldwork.)
SEMINAR: In the two-credit, graded, seminar portion of the practicum, students will utilize legislative and administrative materials as well as case law to become familiar with the processes by which the federal government regulates tobacco and personal-care products, and to critique both the statutory framework and FDA’s performance in protecting consumers. The 2009 Tobacco Act created a new regulatory regime very different from the FDA’s existing authority to regulate other products within its jurisdiction. Examination of the agency’s initial steps to carry out this responsibility provides a chance for students to understand how a federal agency responds to a legislative mandate requiring innovative action to address a major public health problem. On the other hand, FDA has minimal authority to regulate personal-care products, raising real concerns for consumer protection. The course will also touch on related topics such as the role of the Federal Trade Commission in the regulation of trade practices, the Freedom of Information Act, the legislative process and the interaction of federal and state regulation.
FIELDWORK: In the two- or three-credit, mandatory pass-fail, fieldwork portion of the practicum, students will work as interns with the Campaign for Tobacco-Free Kids or the Environmental Working Group on projects aimed at strengthening the legislative or administrative processes, or on matters in litigation, under the supervision of attorneys connected with these organizations. (Students who have completed this course will have priority consideration if they opt to apply for the year-long Toni Stabile Graduate Fellowship at the Environmental Working Group after graduation.)
Prerequisite: J.D. students must complete the required first-year program prior to enrolling in this course (part-time and interdivisional transfer students may enroll prior to completing Criminal Justice, Property, or their first-year elective).
Recommended: Administrative Law; Food and Drug Law-related courses.
Mutually Excluded Courses: Students may not concurrently enroll in an externship or a clinic or another practicum course.
Note: LL.M. students must seek professor permission to apply.
Evening students who work during the day are encouraged to reach out to the professors to determine whether this practicum course would be compatible with their schedules.
This is either a four or a five credit course, depending on the number of fieldwork hours/week. Two credits will be awarded for the two-hour weekly seminar and either two credits (for 10 hours/week) or three credits (for 15 hours/week) for the fieldwork. The fieldwork will be conducted over a minimum of 11 weeks, to be arranged with the faculty members. Students will have the ability to choose the credit option that best fits their schedules. However, the fieldwork must be completed during normal business hours. All students will initially be registered for a total of four credits, which is the two-credit seminar plus the two-credit fieldwork section. Once the preregistration results are released, contact the Office of the Registrar to confirm the number of credits you wish to receive for the fieldwork and she will inform the Office of the Registrar of any changes that need to be made. If you enroll after the preregistration period and wish to enroll for additional fieldwork credits, contact Bernice Ines at firstname.lastname@example.org. All requests for additional fieldwork credits beyond the two credits that are automatically assigned must be received by 5:00 p.m. on January 20, 2017.
The two-credit seminar portion of this practicum will be graded. The two or three credits of fieldwork are mandatory pass/fail. Students will be allowed to take another course pass/fail in the same semester as the fieldwork.
Note: The course will typically meet on Wednesday afternoons, but will have one additional class meeting on Saturday, January 21, 2017, from 9:00 a.m. to 1:00 p.m., in an effort to frontload some of the course material before students begin their fieldwork. On two Wednesdays later in the semester, the class will not meet, to account for the one Saturday session.
Students who enroll in this course will be automatically enrolled in both the seminar and fieldwork components and may not take either component separately. After Add/Drop, a student who wishes to withdraw from a practicum course must obtain permission from the faculty member and the Assistant Dean for Experiential Education. The Assistant Dean will grant such withdrawal requests only when remaining enrolled in the practicum would cause significant hardship for the student. A student who is granted permission to withdraw will be withdrawn from both the seminar and fieldwork components.
Default attendance rule for all practicum courses (unless the professor indicates otherwise): Regular and punctual attendance is required at all practicum seminars and fieldwork placements. Students in project-based practicum courses are similarly required to devote the requisite number of hours to their project. If a student must miss seminar, fieldwork, or project work, he or she must speak to the professor as soon as possible to discuss the absence. Unless the professor indicates otherwise, a student with more than one unexcused absence from the practicum seminar (out of 13 total seminar sessions), or one week of unexcused absences from the fieldwork or project work (out of a total of 11 weeks of fieldwork or project work), may receive a lower grade or, at the professor’s discretion, may be withdrawn from the practicum course.
J.D. Seminar (cross-listed) | 3 credit hours
This seminar introduces students to the laws and regulations that govern our food. The seminar will primarily cover law at the federal level, including but not limited to such topics as the legal definition of food, rules on food labeling, standards for food safety, and regulation of genetically modified organisms. Beyond the law itself, we will consider the scientific, economic, and ethical principles implicated by legal decisions concerning food.
Prerequisite: Administrative Law or the first-year course, Government Processes, or the first-year electives, The Regulatory and Administrative State, Congress and the Administrative State, Legislation and Regulation, or The Regulatory State.
Note: FIRST CLASS ATTENDANCE IS MANDATORY. All enrolled and waitlisted students must be in attendance at the start of the first class session in order to be eligible for a seat in the class.
LL.M Course (cross-listed) | 3 credit hours
Beyond health insurance and the delivery of health care, goods and services related to individual and public health are highly regulated in the United States, and often serve as a basis for international regulations. These goods and services are a large and growing part of the U.S. and world economy, with some estimates being that more than one-quarter of U.S. food and medical products are regulated by the FDA alone. This regulation is carried out directly by a variety of State and Federal agencies (such as the FDA, the CDC, and the NIH) as well as indirectly through the purchasing power of federally financed programs, such as Medicare.
This course will include an introduction to the basic legal and regulatory frameworks within public health and an overview of the Constitutional limits and policy choices that have led to current law. The course will then move to a review of several major fields of regulation. From a high-level, this includes the regulation of health professionals, health systems, and medical or food products impacting human health. The course will then conclude with an examination of several contemporary problems, such as the safe and effective use of human drug products, infectious-disease prevention and control, ethical research practices, and rationing and allocation of limited resources.
The primary objective of the course is to teach students about the regulation of public health at the intersection of state and federal levels, recognizing that such regulatory frameworks often become the template for international policies. Students will be called on to learn the basics of two fundamental statutes—the Public Health Service Act (PHSA) and the Food, Drug and Cosmetic Act (FDCA). Students will also be called upon to follow examples of administrative change under these statutes, each year analyzing a new set of proposed regulations and sub-regulatory guidance documents. By the end of the course, students will be able to describe the major means by which goods and services used in both personal and public health are controlled, as well as areas in which future changes are likely.
Currently, there is no text or case book on this subject. The primary readings will be assigned by the professor.
Note: This is a required course for the U.S. Health Law Certificate.
LL.M Seminar (cross-listed) | 2 credit hours
This course will cover the interface between the intellectual property rights, international trade and public health, focusing in particular on the WTO TRIPS Agreement and subsequent agreements. It will provide an introduction to the law and economics relating to this subject, and cover the provisions of the TRIPS Agreement relevant to public health, including disputes settled in the WTO, such as the India mailbox and the Canada regulatory exception cases. It will examine the background, content and implications of the Doha Declaration on the TRIPS Agreement and Public Health and of the subsequent decisions at the WTO implementing compulsory licenses for exports. It will also discuss the relevance of bilateral or regional free trade area agreements to the subject.
The course would study relevant national/regional implementing legislation, for example on compulsory licenses, and discuss use of the WTO export compulsory license provisions, namely the Rwanda-Canada case. Students will be asked to participate in class presentations and/or group exercises on the topics covered, for example on a hypothetical case study of exports, taking up the role of advisors based in either the importing country or the exporting country.
Finally, the course will also cover recent work on trade, intellectual property and public health in other intergovernmental organizations, in particular in the World Health Organization.
Recommended: Coursework in International Trade, Intellectual Property Rights, or Public Health.
Note: ATTENDANCE IS MANDATORY AT ALL CLASS SESSIONS. All enrolled and waitlisted students must be in attendance at the start of the first class session in order to be eligible for a seat in the class and must attend each class session in its entirety.A student will be permitted to drop a course that meets for the first time after the add/drop period, without a transcript notation, if a student submits a written request to the Office of the Registrar prior to the start of the second class meeting. Students may not withdraw from this class after the start of the second class session without the permission of the professor.
LL.M Seminar (cross-listed) | 2 credit hours
Technological advances in diagnostics and therapeutics have the potential to revolutionize health care and improve the lives of millions of people. However, many of these technologies remain out of reach to those who need them, particularly the poor in low- and middle-income countries.
With increased investment and global attention over the last decade, there has been tremendous progress in building a pipeline of candidate medical technologies to meet the health needs of the world’s poorest people. This course will explore the legal, regulatory and policy issues that are shaping the research, development, and delivery of those drugs, vaccines, and diagnostics. Part I of the course will provide an overview of the burden of neglected diseases in low- and middle-income countries and the new institutions and initiatives that have arisen to address that burden. Part II will examine the incentives for global health innovation, including intellectual property management, regulatory and tax incentives, and prizes and advance market commitments. Part III will consider the role of national and international regulation, international clinical trials and the globalization of research, and World Health Organization’s policy processes for ensuring drug and vaccine safety and recommending their use. Part IV of the course will explore the legal, regulatory and policy issues that arise in the delivery and use of global health technologies, particularly supply chain contracting, drug resistance, and post-market surveillance in low- and middle-income countries.
LL.M Course (cross-listed) | 2 credit hours
Proper nutrition is one of the many contributor’s to overall health and could be one of the most cost-effective approaches to address many of societal, environmental and economic challenges facing the world today. Increasingly, law and policy has been recognized as a high-impact and robust approach for accelerating progress toward reducing and managing nutrition-related chronic diseases such as obesity, cardiovascular disease, type 2 diabetes mellitus and certain types of cancer. In various jurisdictions, policymakers enact courses of action, regulatory measures, laws and policies, and set funding priorities designed to address food insecurity, hunger, obesity prevention, chronic diseases, among other health and well-being concerns. This course focuses on policies, programs and practices across the globe—at the national, tribal, state and local levels—that improve or hinder healthy eating. Students will examine the evidence informing these courses of action, along with the historical and contemporary legislative, regulatory and judicial aspects. Topics and themes include dietary guidance, food and nutrition assistance programs, food and nutrition labeling, and other environmental and policy strategies to improve access to healthier foods and beverages.
Student Learning Goals:
- Identify key law and policy approaches used across the globe that have been used or have the potential to improve or hinder healthy eating;
- Discuss and debate the historical and contemporary legislative, regulatory and judicial aspects of the key nutrition law and policy approaches during collaborative in-class exercises; and
- Execute analytical and strategic planning during in-class exercises and the final project for developing, implementing, evaluating, and sustaining a nutrition law and policy approach
Recommended: Constitutional Law, Property, Contracts, Torts, as well as Food and Drug Law, Introduction to Health Law, and Land Use and Planning.