HarvardX course on drug regulation

Howie and Harlan are joined by Aaron Kesselheim, a physician, attorney, and public health expert, to discuss the shifting legal landscape for healthcare regulation and his experiences serving on an FDA advisory committee. Harlan reports on the growing evidence of widespread health impacts from microplastics; Howie provides an update on the bird flu outbreak.

Links:

Microplastics

"Landmark study links microplastics to serious health problems"

"Microplastics: Are we facing a new health crisis—and what can be done about it?"

"Microplastics are inside us all. What does that mean for our health?"

"Microplastics are everywhere—we need to understand how they affect human health"

"How do plastics, including microplastics and plastic-associated chemicals, affect human health?"

"The potential of micro- and nanoplastics to exacerbate the health impacts and global burden of non-communicable diseases"

Aaron Kesselheim

PORTAL: Program on Regulations, Therapeutics, and Law

"The End of Chevron Deference: What Does It Mean, and What Comes Next?"

"Biden Administration Proposes Covering Obesity Drugs In Medicare And Medicaid"

"Biden-Harris Administration Announces Medicare Advantage and Medicare Part D Prescription Drug Proposals that Aim to Improve Care and Access for Enrollees"

"3 Experts Have Resigned From An FDA Committee Over Alzheimer's Drug Approval"

X: Aaron Kesselheim's resignation letter

Congressional testimony of Aaron Kesselheim: "The Inflation Reduction Act of 2022: Reducing Excessive Spending and Supporting Patient Access to Brand-Name Drugs while Promoting Meaningful Innovation"

Congressional testimony of Aaron Kesselheim: "How the US Government Supports Meaningful Drug and Device Innovation: Funding Development of Transformative Therapies and Avoiding Excessive Prices for new Products with Limited Benefits"

Aaron Kesselheim: "US public investment in development of mRNA covid-19 vaccines: retrospective cohort study"

Harvard Online: Prescription Drug Regulation, Cost, and Access: Current Controversies in Context

New York Times Weddings/Celebrations: Jennifer Cohn, Aaron Kesselheim

Bird flu

CDC: USDA Reported H5N1 Bird Flu Detections in US Backyard and Commercial Poultry

CDC: H5 Bird Flu: Current Situation

"Bird Flu, Explained"

"California suspends distribution of Raw Farm raw milk products after bird flu detection"

"Canadian probe into teen's critical H5N1 infection finds no clear source"

USDA Economic Research Service: Farm Labor

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