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.

Patent March-In Rights: Unlikely Threat or Political Weapon and What it Means for Life Science Research and Companies

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.

10:00 a.m. – 10:50 a.m.

Future of Vaccine Development - Will Restrictions Lead to Off-Label Use?

With the Trump Administration’s new look at vaccines, federal and state law may be in conflict leading to variations where vaccines can be administered, by whom, and in what circumstances. Several states have made policy changes—for example, allowing pharmacists to provide counseling and vaccines without a prescription. Traditionally, vaccine recommendations have been made and adopted by the Advisory Committee on Immunization Practices (ACIP), a group of experts in infectious diseases, epidemiology, and public health who provide recommendations to the Centers for Disease Control and Prevention (CDC) on the use of vaccines in the United States. But there is now conflict between ACIP, the US Food and Drug Administration (FDA), and state laws, leading some to wonder if vaccinations will be provided “offlabel”, which is common for pharmaceuticals but less known for vaccine recommendations. For example, at the ACIP’s September 2025 meeting, the Committee recommended that COVID vaccines can be administered to anyone 6 months of age or older, after consultation with a physician or another health care provider (including, in some states, a pharmacist). FDA, however, approved this year’s COVID vaccine only for people over age 65 and those considered at high risk due to certain medical conditions. Where does that leave the COVID vaccine for tens of millions of Americans, essentially all healthy individuals between 6 months and 65 years of age? Confusion over this year’s vaccine guidelines has led to some pregnant people, people under age 65, and others seeking the vaccine being told they need to see their doctor. Individuals seeking information regarding vaccine access and eligibility in their area should consult their health care provider, pharmacy, or state/local health department for more specific information. This panel will take a look at the conflict between ACIP, FDA, and state vaccine authorizations and recommendations and whether this will create an environment for offlabel use of vaccines.

Speaker

Brian Malkin Esq. | Spencer Fane LLP

Sarah Karlin-Smith | Health Care Reporter, POLITICO

Ben Wolf Esq. | Alston & Bird, LLP

1.0 MCLE Credit in Areas of Professional Practice

11:00 a.m. – 11:50 a.m.

Supply Chain and Compounding

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. – Past, Present, Future

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