FDA Law and Policy, YALE LAW SCHOOL
Lead faculty: Aaron S. Kesselheim
Official course description: The FDA is the premier consumer protection agency in the United States, with control over the availability and public discourse about potentially life-saving therapeutics, foods, supplements, and related consumer products. Its authority has been built in response to public health crises, and is constantly under scrutiny from all sides of the political spectrum. In this course, we will review the history of the FDA, the noteworthy legislation and regulations that have shaped its oversight, Supreme Court and other cases affecting its authority, and key current controversies in FDA law. The enduring approach will be to consider how the FDA balances its vital public safety role against countervailing forces of personal autonomy and rights of consumers, patients, health care professionals, and corporations.
One semester, 2 credits; taught 2015-present (cross-registered with Yale School of Public Health)
Official course description: The FDA is the premier consumer protection agency in the United States, with control over the availability and public discourse about potentially life-saving therapeutics, foods, supplements, and related consumer products. Its authority has been built in response to public health crises, and is constantly under scrutiny from all sides of the political spectrum. In this course, we will review the history of the FDA, the noteworthy legislation and regulations that have shaped its oversight, Supreme Court and other cases affecting its authority, and key current controversies in FDA law. The enduring approach will be to consider how the FDA balances its vital public safety role against countervailing forces of personal autonomy and rights of consumers, patients, health care professionals, and corporations.
One semester, 2 credits; taught 2015-present (cross-registered with Yale School of Public Health)
FDA Law and Policy, Yale School Of Public Health
Lead faculty: Aaron S. Kesselheim
Official course description: The FDA is the premier consumer protection agency in the United States, with control over the availability and public discourse about potentially life-saving therapeutics, foods, supplements, and related consumer products. Its authority has been built in response to public health crises, and is constantly under scrutiny from all sides of the political spectrum. In this course, we will review the history of the FDA, the noteworthy legislation and regulations that have shaped its oversight, Supreme Court and other cases affecting its authority, and key current controversies in FDA law. The enduring approach will be to consider how the FDA balances its vital public safety role against countervailing forces of personal autonomy and rights of consumers, patients, health care professionals, and corporations.
One semester, 2 credits; taught 2015-present (cross-registered with Yale Law School)
Official course description: The FDA is the premier consumer protection agency in the United States, with control over the availability and public discourse about potentially life-saving therapeutics, foods, supplements, and related consumer products. Its authority has been built in response to public health crises, and is constantly under scrutiny from all sides of the political spectrum. In this course, we will review the history of the FDA, the noteworthy legislation and regulations that have shaped its oversight, Supreme Court and other cases affecting its authority, and key current controversies in FDA law. The enduring approach will be to consider how the FDA balances its vital public safety role against countervailing forces of personal autonomy and rights of consumers, patients, health care professionals, and corporations.
One semester, 2 credits; taught 2015-present (cross-registered with Yale Law School)
HEALTH LAW, POLICY, AND BIOETHICS, HARVARD MEDICAL SCHOOL, MASTER OF BIOETHICS PROGRAM
Lead faculty: Aaron S. Kesselheim and Brendan Abel
Official course description: This course is an introduction to legal topics in health policy and bioethics. It requires no experience in law, beginning with a brief primer on American law and how it works. Topics covered will include legal aspects of the doctor-patient relationship, medical malpractice, privacy issues, health care finance, end-of-life issues, organ donation, disability, mental health, public health, medical product regulation, food regulation, and intellectual property.
One semester, 4 credits; taught 2016-present
To be offered in spring 2018
Public Health Law, Harvard T.H. Chan School of Public Health
Lead faculty: Ameet Sarpatwari
The course is designed to provide students with an overview of what public health law is; why it matters to public health practitioners and providers; how the law can be used to change health outcomes; and how the law can negatively affect population health. Among the questions explored are:The course is designed to provide students with an overview of what public health law is; why it matters to public health practitioners and providers; how the law can be used to change health outcomes; and how the law can negatively affect population health.
Among the questions explored are:
1. What authority does the government have to regulate in the interest of public health?
2. How are individual rights balanced against this authority?
3. How can criminal statutes, civil litigation, and patent law be used to promote or negatively affect public health?
The course investigates these issues as they operate a range of specific contexts in public health and medical care, including the control and prevention of HIV/AIDS and other communicable diseases, influencing health behaviors that lead to obesity, rights to medical care, reproductive health, and lawsuits against tobacco and gun companies. The course touches on constitutional law, criminal law, tort law, and intellectual property law.
Half-semester, 2.5 credits, taught 2016-present
The course is designed to provide students with an overview of what public health law is; why it matters to public health practitioners and providers; how the law can be used to change health outcomes; and how the law can negatively affect population health. Among the questions explored are:The course is designed to provide students with an overview of what public health law is; why it matters to public health practitioners and providers; how the law can be used to change health outcomes; and how the law can negatively affect population health.
Among the questions explored are:
1. What authority does the government have to regulate in the interest of public health?
2. How are individual rights balanced against this authority?
3. How can criminal statutes, civil litigation, and patent law be used to promote or negatively affect public health?
The course investigates these issues as they operate a range of specific contexts in public health and medical care, including the control and prevention of HIV/AIDS and other communicable diseases, influencing health behaviors that lead to obesity, rights to medical care, reproductive health, and lawsuits against tobacco and gun companies. The course touches on constitutional law, criminal law, tort law, and intellectual property law.
Half-semester, 2.5 credits, taught 2016-present
Research Ethics, Harvard Medical School Center for Bioethics, Master of Bioethics Program
Lead faculty: Spencer P. Hey and Rebecca Li
Official course description: This 14-week Research Ethics course is designed to provide the student with a comprehensive foundation in research ethics. After taking this course, students will be prepared to manage many of the complex, real-life ethical issues that have attracted public attention in recent years, such as undue influence and coercion of research participants, concerns about privacy and confidentiality of clinical trial data, concerns about unjust research trials in low resource countries, and uncertainty about the value of genetic testing in drug development and study design.
One semester, 4 credits, taught fall 2016-present
Official course description: This 14-week Research Ethics course is designed to provide the student with a comprehensive foundation in research ethics. After taking this course, students will be prepared to manage many of the complex, real-life ethical issues that have attracted public attention in recent years, such as undue influence and coercion of research participants, concerns about privacy and confidentiality of clinical trial data, concerns about unjust research trials in low resource countries, and uncertainty about the value of genetic testing in drug development and study design.
One semester, 4 credits, taught fall 2016-present
Reasoning & Writing in Bioethics, Harvard Medical School Center for Bioethics, Master of Bioethics Program
Lead faculty: Spencer P. Hey and Martha Montello
Official course description: The course will identify forms of argument and skills for communicating those arguments with emphasis on topics in bioethics and discourse in the field of bioethics. Students will build on skills already learned during the first semester of study to advance their aptitude with shaping argument structure, content, and efficacy in their own work and in the work of others.
2 credits, taught 2017-present
Official course description: The course will identify forms of argument and skills for communicating those arguments with emphasis on topics in bioethics and discourse in the field of bioethics. Students will build on skills already learned during the first semester of study to advance their aptitude with shaping argument structure, content, and efficacy in their own work and in the work of others.
2 credits, taught 2017-present
Health policy and bioethics consortium tutorial, harvard medical school
Lead faculty: Aaron S. Kesselheim
Official course description: This course consists of monthly seminars hosted by PORTAL that feature a moderator and 2 expert discussants. Each seminar is centered around a different topical policy issue with ethical ramifications. Bioethics masters students attend the seminar and are be involved in a special student-only small group discussion with the moderator and discussants afterwards. There is pre-reading on each topic. Topics covered will vary based on current key issues and in 2016-2017 are scheduled to include: FDA regulatory science, international trade and access to medicines, precision medicine, returning results to patients, and patient safety/medical error. Students are evaluated via class participation and written work.
Year long, 2 credits; taught 2016-present
Official course description: This course consists of monthly seminars hosted by PORTAL that feature a moderator and 2 expert discussants. Each seminar is centered around a different topical policy issue with ethical ramifications. Bioethics masters students attend the seminar and are be involved in a special student-only small group discussion with the moderator and discussants afterwards. There is pre-reading on each topic. Topics covered will vary based on current key issues and in 2016-2017 are scheduled to include: FDA regulatory science, international trade and access to medicines, precision medicine, returning results to patients, and patient safety/medical error. Students are evaluated via class participation and written work.
Year long, 2 credits; taught 2016-present
DRUG LAW AND POLICY, NORTHEASTERN UNIVERSITY SCHOOL OF LAW
Lead faculty: Michael S. Sinha
Official course description: The field of Drug Law spans the discovery, manufacture, distribution, and control of agents and devices that alter the human condition. This course provides an introduction to the regulatory regime created by the Federal Food, Drug and Cosmetics Act and the Food and Drug Administration and maps out connections to additional laws and institutions. In addition to traditional content on pharmaceutical regulation, we will examine topics such as human subjects concerns in clinical trials, the opioid crisis, tobacco control, the drug policy reform movement, and debates between human rights and intellectual property proponents in medication access. The course is intended for students contemplating legal practice involving pharmaceuticals, those thinking critically about the origins and directions of domestic and international drug control, as well as those interested in the interplay of law, policy, and public health. Students will be expected to participate actively and to conduct substantial research and writing.
Fall Quarter 2019, 3 credits
Official course description: The field of Drug Law spans the discovery, manufacture, distribution, and control of agents and devices that alter the human condition. This course provides an introduction to the regulatory regime created by the Federal Food, Drug and Cosmetics Act and the Food and Drug Administration and maps out connections to additional laws and institutions. In addition to traditional content on pharmaceutical regulation, we will examine topics such as human subjects concerns in clinical trials, the opioid crisis, tobacco control, the drug policy reform movement, and debates between human rights and intellectual property proponents in medication access. The course is intended for students contemplating legal practice involving pharmaceuticals, those thinking critically about the origins and directions of domestic and international drug control, as well as those interested in the interplay of law, policy, and public health. Students will be expected to participate actively and to conduct substantial research and writing.
Fall Quarter 2019, 3 credits
