Meet your instructors

Douglas Arner

Janos Barberis

Huy Nguyen Trieu

Ross Buckley
About this course
Prescription drugs are among the most common health care interventions and have turned some once-fatal diseases into manageable conditions — but they have also been a growing source of controversy. Patients in the US struggle with increasing costs and express concerns about why many conditions, such as Alzheimer’s disease, remain without adequate therapeutic options.
At the center of these debates lies the US Food and Drug Administration (FDA), a federal agency responsible for monitoring the prescription drug marketplace and enforcing basic rules and laws that affect how prescription drugs are discovered, developed, and sold.
This course investigates the major issues affecting the regulatory approval and evidence-based use of prescription drugs. You will learn the rules and regulations governing the pricing, marketing, and safety monitoring of approved prescription drugs and the importance of the FDA in regulating key aspects of the pharmaceutical market.
Continuing Medical Education (CME)
Medical professionals who enroll in the verified track and successfully complete Module 2: Drug Development and Approval can earn AMA PRA Category 1 Credit™ (2 credits).
What you’ll learn
- Key controversies over how prescription drugs are developed and marketed, and why those controversies exist
- The FDA — its history, public health role, and rules affecting prescription drugs in the US
- The process of discovering, testing, and approving innovative drugs, including various perspectives on the criteria used for drug approval
- The cost of prescription drugs, including the factors affecting a drug’s market exclusivity period and the availability and use of affordable generic drugs
- Safety evaluation of prescription drugs using “real world” data
- Current topics stirring debate over the scope of FDA regulation, such as dietary supplements, special classes of prescription drugs, and “right to try” laws that allow patients to obtain drugs prior to FDA approval
- Prescription drug marketing rules and the effect of drug promotion on the behavior of physicians and patients
Prerequisites
None
Frequently asked questions
How is the honor code upheld?
HarvardX requires individuals who enroll in its courses on edX to abide by the terms of the edX honor code. HarvardX will take appropriate corrective action in response to violations of the edX honor code, which may include dismissal from the HarvardX course; revocation of any certificates received for the HarvardX course; or other remedies as circumstances warrant. No refunds will be issued in the case of corrective action for such violations. Enrollees who are taking HarvardX courses as part of another program will also be governed by the academic policies of those programs.
How does my participation contribute to research?
By registering as an online learner in our open online courses, you are also participating in research intended to enhance HarvardX’s instructional offerings as well as the quality of learning and related sciences worldwide. In the interest of research, you may be exposed to some variations in the course materials. HarvardX does not use learner data for any purpose beyond the University’s stated missions of education and research. For purposes of research, we may share information we collect from online learning activities, including Personally Identifiable Information, with researchers beyond Harvard. However, your Personally Identifiable Information will only be shared as permitted by applicable law, will be limited to what is necessary to perform the research, and will be subject to an agreement to protect the data. We may also share with the public or third parties aggregated information that does not personally identify you. Similarly, any research findings will be reported at the aggregate level and will not expose your personal identity.
Please read the edX Privacy Policy for more information regarding the processing, transmission, and use of data collected through the edX platform.
How are non-discrimination and anti-harassment supported?
Harvard University and HarvardX are committed to maintaining a safe and healthy educational and work environment in which no member of the community is excluded from participation in, denied the benefits of, or subjected to discrimination or harassment in our program. All members of the HarvardX community are expected to abide by Harvard policies on nondiscrimination, including sexual harassment, and the edX Terms of Service. If you have any questions or concerns, please contact harvardx@harvard.edu and/or report your experience through the edX contact form.
Meet your instructors

Aaron Kesselheim

Ameet Sarpatwari

Jonathan Darrow

Jerry Avorn
About this course
Bioethics provides an overview of the legal, medical, and ethical questions around reproduction and human genetics and how to apply legal reasoning to these questions.
This law course includes interviews with individuals who have used surrogacy and sperm donation, with medical professionals who are experts in current reproductive technologies like In Vitro Fertilization and Preimplantation Genetic Diagnosis, and bioethicists and journalists who study the ownership and use of genetic information within human tissue. Additional Harvard colleagues will also share with you their thoughts on topics such as disability law as it relates to reproductive technology.
While the law and ethics surrounding these technologies are a central component to this course, we also show you examples of the deeply personal and human side of these issues. Throughout the course, and with the help of law students, we will discuss leading legal cases in this field, which will illuminate the types of questions the law has struggled with – stretching and evolving over time. From the famous Baby M surrogacy case, to cases on the paternity of sperm donors, to a case related to the ownership of human tissue turned into a commercial product, and others. We will show you the ethical, legal, and rhetorical underpinnings, which have served as the basis for various court decisions over the past 20 or 30 years. We will also explore potential future technologies and their implications for society: genetic enhancements to increase our intelligence, let us live a hundred years longer, or make us immune to diseases – and the possibility of creating animal-human hybrids, for example a mouse with a humanized brain.
The content within this course is intended to be instructive, and show how legal reasoning has been applied, or could be applied, to questions related to parenthood, reproduction, and other issues surrounding human genetic material. The material organized within this course should be considered an authoritative overview, but is not intended to serve as medical or legal advice.
What you’ll learn
- How the reproductive technology industry works, and issues raised related to buying and selling human reproductive materials
- The law and ethics of surrogacy
- Civil lawsuits when things go wrong with reproductive technology: wrongful birth and wrongful life lawsuits
- The law and ethics of sperm donation and the legal status of sperm donors
- thical and legal issues raised by human enhancement
- The law and ethics of mixing human and animal genetic material
- The ownership of human tissue and its underlying genetic information
HarvardX Honor Code
HarvardX requires individuals who enroll in its courses on edX to abide by the terms of the edX honor code. HarvardX will take appropriate corrective action in response to violations of the edX honor code, which may include dismissal from the HarvardX course; revocation of any certificates received for the HarvardX course; or other remedies as circumstances warrant. No refunds will be issued in the case of corrective action for such violations. Enrollees who are taking HarvardX courses as part of another program will also be governed by the academic policies of those programs.
HarvardX Nondiscrimination/Anti-Harassment Statement
Harvard University and HarvardX are committed to maintaining a safe and healthy educational and work environment in which no member of the community is excluded from participation in, denied the benefits of, or subjected to discrimination or harassment in our program. All members of the HarvardX community are expected to abide by Harvard policies on nondiscrimination, including sexual harassment, and the edX Terms of Service. If you have any questions or concerns, please contact harvardx@harvard.edu and/or report your experience through the edX contact form.
HarvardX Research Statement
HarvardX pursues the science of learning. By registering as an online learner in an HX course, you will also participate in research about learning. Read our research statement to learn more.
Meet your instructors

I. Glenn Cohen
About this course
This course is part of the Healthcare Administration MicroMasters program which consists of 7 courses and a capstone exam. After completing the program, you can also apply to Doane University to complete your MBA online for approximately $10,500 (learn more about the program here).
To be an effective agent of change, a healthcare administrator must have a foundational understanding of healthcare advocacy, law, and regulatory issues, as well as compliance. This course will focus on a wide range of important issues in health law, health policy and the factors at play when developing a strategic advocacy platform such as bioethics and informed consent. At the conclusion of this course, learners will be able to identify health policies that promote quality, advocacy and system change within a healthcare organization.
What you’ll learn
- Discuss health law
- Explain physician-patient relations within a legal context
- Interpret laws that shape access to health care
- Explore informed consent for medical treatment
- Evaluate medical malpractice suits within healthcare systems
- Inspect the utilization of bioethics in healthcare
- Describe methods for advocating in healthcare systems.
- Identify culturally competent advocacy strategies
- Assess a health policy change that promotes quality, advocacy and system change.

MicroMasters® in Healthcare Administration
Who can take this course?
Unfortunately, learners from one or more of the following countries or regions will not be able to register for this course: Iran, Cuba and the Crimea region of Ukraine. While edX has sought licenses from the U.S. Office of Foreign Assets Control (OFAC) to offer our courses to learners in these countries and regions, the licenses we have received are not broad enough to allow us to offer this course in all locations. EdX truly regrets that U.S. sanctions prevent us from offering all of our courses to everyone, no matter where they live.
Meet Your Instructors

Alice Kindschuh
