Interested in learning more about pharmaceutical policy? Curious about the role of the FDA in ensure safe and effective drugs reach the market? Wondering why drug prices are so high in the US? Readers of my prior posts may enjoy learning more about these topics!
Check out a free HarvardX online course, “The FDA and Prescription Drugs: Current Controversies in Context,” put together by Petrie-Flom Center affiliates Dr. Aaron Kesselheim, Dr. Ameet Sarpatwari, Dr. Jonathan Darrow, and many others, that is now open for enrollment. (Disclosure: I did not play any role in the development or making of the course, but I am serving as a teaching assistant/discussion moderator for the course).
Readers of Bill of Health may have seen the earlier post by Dr. Darrow. In this post, I’ll be going into more depth about the topics covered. The course is divided into six “weekly” modules that overview the major topics in pharmaceutical policy. For those of you who have not previously taken an online course through edX (e.g., HarvardX), Coursera or other platforms, these classes are free for learners and self-paced. You can do as much or as little of the course as you like. I will briefly overview the syllabus of the class so you can get a taste of what to expect.
Week 1: Overview and History of the FDA
The first week examines the history the US “patent-drug” market and the motivations behind why Congress was compelled to create the FDA and its precursor regulatory agency in 1906. You will also learn about the legal framework that governs the FDA’s regulatory powers as it tries to ensure that safe and effective drugs make it the market as well ensure speedy approval. In this week you will also be introduced contemporaneous issues such as expanded access and “right-to-try” laws. Then listen to the special guest Dr. Margaret Hamburg give her perspective as the former FDA commissioner.
Week 2: Drug Development and Approval
The second week looks at the drug development and approval process. In this week you learn about how drugs go from the discovery phase to the clinical trials essential for regulatory approval. You will learn about the criteria the FDA uses for drug approval as well as the various pathways a drug could be approved under. You will also gain insight on the principles of clinical trial design and challenges of converting clinical trial data into real-world clinical practice.
Week 3: Drug pricing
This week’s content should be required viewing for members of Congress, given the bipartisan interest in addressing high drug prices in the US. In this module you learn about the economics behind how the related negotiating powers of manufacturers and payer’s determine drug pricing. You will also learn about the generic drug industry and the effect of generic competition on drug prices.
Week 4: Prescription Drug Promotion
Confused by why drug companies advertise their drugs on TV (at least in the US and New Zealand)? In week four, direct to consumer advertising and advertising to physicians will be explored. This has been a hot legal topic recently as the tactics of Purdue Pharma in marketing its opioids to doctors have come under intense scrutiny. The course will also explore current legal controversies such as the FDA’s power to regulate off-label marketing of drugs.
Week 5: Post-Approval Monitoring and Evaluation of Prescription Drugs
While much of the FDA’s legal authority is centered around initial drug approval, the real-world safety and effectiveness of approved drugs is what matters to patients. Given the time-limited nature of clinical trials, it is only after drug approval that we learn the long-term risks of a drug. The classic example is Vioxx (rofecoxib) a selective NSAID that was found to increase the risk of heart attack and stroke. In this module, learn about the traditional post-approval monitoring as well as newer approaches that include the FDA Adverse Events Reporting System, the FDA Sentinel Initiative, and Risk Evaluation and Mitigation Strategies (REMS) program for high-risk drugs.
Week 6: Special Classes of Drugs and Diseases
In the final week of the course, you will learn about the special consideration for certain classes of drugs. These include the regulatory framework around biologic agents and biosimilars as well the limited regulations on the supplement industry. In addition, you will learn about the special rules and incentives for rare diseases, pediatric conditions, neglected tropical diseases, and cancer treatment.
How To Enroll
Does any of this sound interesting to you? It “starts” March 26, 2019 (again, this is a self-paced course) and will be open with active forums for at least the next several months. Check out the trailer and the course website to enroll in the course or find more information.
Rahul Nayak is a 2018-2019 Petrie-Flom Center Student Fellow.