Harvard to Offer Free Online Course on Pharma Controversies
Beginning 26 March, three professors at Harvard Medical School will begin offering a new free online course on controversial topics related to FDA, prescription drug prices, off-label marketing and other programs like the priority review voucher and Orphan Drug Act.The course will also cover topics such as the safety evaluation of prescription drugs using real world data, topics stirring debate over the scope of FDA regulation, such as with dietary supplements, special classes of prescription drugs and “right to try” laws.
Aaron Kesselheim, director of the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women's Hospital at Harvard University and an instructor for the online course, told Focus: “I think the audience is really anyone interested in drug policy issues ranging from FDA approval to drug pricing to post-approval safety surveillance.”
He said students, policymakers and health practitioners “should all be up to speed on these things (we offer CME) – as our recent JAMA publication showed, many physicians are unclear on things as fundamental as the basis for drug approval.”
Jonathan Darrow and Ameet Sarpatwari, both instructors of medicine at PORTAL, will also be instructors for the course. According to the syllabus, the course will be set up with six modules:
Module 1: Overview and history of the FDA
Module 2: Drug development and approval
Module 3: Drug pricing in the United States
Module 4: Marketing strategies
Module 5: Post-approval evaluation
Module 6: Emerging medical technologies
The FDA and Prescription Drugs: Current Controversies in Context