Food, Drug & Cosmetic Law Section

9:00 a.m.-9:50 a.m.

FDA Commissioner Califf’s First Year – Initial Focus Areas and What to Expect in 2023

Chief of Staff of the FDA will provide a keynote address discussing the highlights and challenges of the Commissioner’s first several months in office.

Speaker

Julia Tierney, J.D. | Chief of Staff of the FDA

Moderator

Larissa C. Bergin, Esq. | Partner at Jones Day; Washington, D.C.

9:50 a.m.-10:00 a.m.

Break

10:00 a.m.-10:50 a.m.

Orphan Drug Challenges: Life Beyond Catalyst without an Anticipated “Legislative Fix”

This panel will discuss the Catalyst case and how this disrupted how FDA’s Office of Orphan Products Development (OOPD) looks at orphan drug condition or disease labeling and the potential impact on the orphan drug community and treatment populations. Speakers from FDA’s OOPD and the main US association focusing on orphan drug diseases and patients (NORD) will reflect on the importance for Congress to pass the “legislative fix” that had been agreed to and inserted into the latest round of Prescription Drug User Fee Amendments (PDUFA), only to be stripped away in the last minute.

Speaker

Aaron Friedman | Senior Regulatory Counsel. FDA Office of Orphan Products Development (OOPD)

Karin Hoelzer | Policy and Regulatory Affairs Director, National Organization for Rare Disorders (NORD)

Moderator

Brian Malkin | Partner, McDermott, Will & Emery LLP (former who spent time in the FDA’s Office of the Commissioner and the Center for Drug Evaluation (CDER) )

10:50 a.m.-11:00 a.m.

Break

11:00 a.m. – 12:40 p.m.

Legal Attacks on Patent Thickets and Patent Settlements– Recent Efforts to Broaden a Drug Company's Potential Antitrust Liability

The panel will explore recent efforts to broaden the application of antitrust law to patents and patent litigation. Not surprisingly, the focus of these efforts has been pharmaceutical patents.

The panelists will discuss the 7th Circuit Court of Appeals decision rejecting the accumulation of pharmaceutical and biologic patents (“patent thickets”) as an antitrust violation. Mayor of Baltimore et al. v. AbbVie, Inc., 42 F.4th 709 (7th Cir. 2022). The panel will also review “pay for delay” case law and state legislation to expand the reach of FTC v. Actavis, 570 U.S. 136 (2013) and apply multimillion dollar civil penalties to settlements of pharmaceutical patent litigation. See, Ass’n for Accessible Meds. v. Bonta, 562 F.Supp.3d 973 (E.D. Cal. 2021), mod’d 2022 WL 463313 (E.D. Cal. Feb. 15, 2022).

Our panelists are experts in pharmaceutical patent and antitrust law.

Speaker

Michael Carrier | Distinguished Professor of Law, Rutgers Law School; Camden, NJ

Hans Sauer | Deputy General Counsel and Vice President for Intellectual Property, Biotechnology Innovation Organization, Adjunct Professor of Law at Georgetown Law School

Jordan Paradise | Georgia Reithal Professor of Law and Co-Director of the Beezley Institute for Health Law and Policy, Loyola University School of Law; Chiago, Illinios

Moderator

Janet B. Linn | Tarter Krinsky & Drogin, LLP; New York, NY

12:40 p.m.-12:50 p.m.

Break

12:50 p.m.-1:40 p.m.

The Changing Legal Environment Around Software as a Medical Device

More and more consumers are using technology for their health and wellness. As a result consumer groups and health advocates have raised concerns around the use and commercialization of patient data. These concerns are largely connected to the boom in software as a medical device market. This panel will dive deeper into the legal and policy concerns below:

What is a software as a medical device- FDA vs. CMS

Discussion of privacy concerns regarding individual patient data: Who owns the data, who's responsible for keeping the data safe and how do we responsibly use the data?

Discussion of health equity concerns such as racial inequity in clinical trial data, increasing technology access to underserved communities and building trust with these aforementioned communities.

Speaker

Victor Morrison | Business Development Executive, Tuzag Inc.

Donney John | Executive Director, NOVA Scripts Central

Kirk Nahra, Esq. | Partner, Wilmer Hale

Jonathan Ogurchak | STACK CEO

Moderator

Ron Lanton III, Esq. | Lanton Law

1:40 p.m.- 2:00 p.m.

Q&A