Food, Drug & Cosmetic Law Section

8:05 a.m. – 8:55 a.m.
Exploring U.S. Drug Pricing Policies for 2025-2026

With the new Administration we have seen issues like 232 Investigations, pharmaceutical tariff threats, the proposal of a national voucher program, debate around utilizing most favored nation and other complex policies that have caused several ripple effects throughout the healthcare marketplace. This discussion will explore these topics in depth and provide the audience with clarity on the potential after effects.

9:00 a.m. – 9:50 a.m.

A recent letter from the Secretary of Commerce to Harvard as well as his statements on the subject indicate that the Government is planning to claim ownership of patent rights on inventions resulting from government funded research in universities. The mechanism for doing so, asserting “March-in-Rights” under the Bayh Dole Act, has never been used since the legislation was passed in 1980, and requires strict conditions before the Government can claim such rights. We will discuss what March-in-Rights are, how March-in-Rights are supposed to work under Bayh Dole, and how the threatened Government ownership could affect commercialization of pharmaceutical and other patented inventions in the future.

Will Restrictions lead to off-label use?

11:00 a.m. – 11:50 a.m.

This segment will discuss pharmacy compounding practices that are currently in the cross-hairs for GLP-1 and other high demand but pricy products.  What does it mean to be have a drug shortage? When do compounders have to stop selling product?  This issue and others will be discussed in the wake of recent lawsuits.

12:00 p.m. – 12:50 p.m.

RFK Jr.’s First Year: What has he accomplished and where will this lead?