Prescription Drug Regulation
Explore FDA regulations, drug development, pricing, and marketing in the US pharmaceutical industry.
Explore FDA regulations, drug development, pricing, and marketing in the US pharmaceutical industry.
This course delves into the complex world of prescription drug regulation, cost, and access in the United States. It examines the role of the Food and Drug Administration (FDA) in overseeing the pharmaceutical market and enforcing laws that impact drug discovery, development, and sales. Students will investigate major issues affecting regulatory approval and evidence-based use of prescription drugs. The curriculum covers key controversies in drug development and marketing, the drug approval process, factors influencing drug pricing and market exclusivity, safety evaluation using real-world data, and current debates over FDA regulation scope. Participants will gain insights into the challenges of balancing innovation, safety, and accessibility in the pharmaceutical industry. The course also explores topics such as dietary supplements, special drug classes, and "right to try" laws, providing a comprehensive understanding of the current landscape of prescription drug regulation and its impact on healthcare.
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What you'll learn
Understand the FDA's history, role, and impact on prescription drugs in the US
Explore the process of drug discovery, testing, and approval, including debates on approval criteria
Analyze factors affecting prescription drug costs and market exclusivity
Examine post-approval safety evaluation methods using real-world data
Investigate prescription drug marketing rules and their effects on physician and patient behavior
Explore current controversies in FDA regulation, including dietary supplements and "right to try" laws
Skills you'll gain
This course includes:
PreRecorded video
Graded assignments, exams
Access on Mobile, Tablet, Desktop
Limited Access access
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There are 6 modules in this course
This course provides a comprehensive overview of prescription drug regulation, cost, and access in the United States. It explores the role of the FDA in regulating the pharmaceutical market and the key issues affecting drug approval and use. The curriculum covers the history and public health role of the FDA, the process of drug discovery, testing, and approval, and the controversies surrounding these processes. Students will learn about factors influencing drug pricing, including market exclusivity and generic drug availability. The course also examines post-approval safety evaluation, marketing regulations, and their impact on physician and patient behavior. Current debates in FDA regulation, such as dietary supplements and "right to try" laws, are also discussed. Through this course, participants will gain a thorough understanding of the complex landscape of prescription drug regulation and its implications for healthcare and public health.
Overview and history of the FDA
Module 1
Drug development and approval
Module 2
Drug pricing in the United States
Module 3
Marketing strategies
Module 4
Post-approval evaluation
Module 5
Emerging medical technologies
Module 6
Fee Structure
Instructors
1 Course
Leading Expert in Pharmaceutical Policy and Health Law
Dr. Aaron S. Kesselheim serves as Professor of Medicine at Harvard Medical School and Director of the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women's Hospital, where he has revolutionized research on pharmaceutical policy and regulation. With an exceptional academic background including degrees from Harvard College, University of Pennsylvania (MD, JD), and Harvard School of Public Health (MPH), he combines expertise in medicine, law, and public health. As founder of PORTAL, he has built one of the country's largest independent research centers focusing on drug policy and regulation. His prolific scholarship includes over 600 peer-reviewed publications, making him one of the most cited health law scholars in the US. Elected to the National Academy of Medicine in 2020, he serves as editor-in-chief of the Journal of Law, Medicine, and Ethics and holds visiting professorships at Yale Law School. His influence extends beyond academia through Congressional testimonies on pharmaceutical policy and his popular HarvardX course on drug regulation reaching over 100,000 participants worldwide. As a board-certified internist at the Phyllis Jen Center for Primary Care, he maintains active clinical practice while shaping national policy on drug development, pricing, and regulation.
1 Course
Pharmaceutical Law and Policy Expert
Dr. Jonathan J. Darrow serves as Assistant Professor of Medicine at Harvard Medical School and faculty member in the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women's Hospital. His unique expertise spans law, medicine, and business, with degrees from Cornell (biological sciences/genetics), Duke (law), Boston College (business), and Harvard (research doctorate in pharmaceutical policy and LL.M.). Since joining Harvard in 2016, following his role as Senior Law Clerk at the U.S. Court of Appeals for the Federal Circuit, he has established himself as a leading authority on pharmaceutical regulation and policy. His influential research, published in prestigious journals including JAMA, the New England Journal of Medicine, and the British Medical Journal, has shaped understanding of FDA drug approval processes and pharmaceutical policy. A qualified patent attorney since 2002, his experience includes work at major law firms, international organizations (WHO, WTO, WIPO), and academic institutions. His contributions to pharmaceutical policy and regulation extend beyond academia through his widely-accessed HarvardX course on prescription drug regulation and his testimony before legislative committees on emerging healthcare technology issues.
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4.8 course rating
51 ratings
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