Joanne Hawana | Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C

Joanne counsels’ global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized, including with respect to advertising and promotion. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, biologics, regenerative medicine products, foods, cosmetics, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications.

Jane Haviland | Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C

Jane’s practice focuses primarily on health care enforcement defense. Jane defends laboratories, physicians, and other clients facing government investigations and qui tam litigation arising from alleged violations of the federal False Claims Act (FCA), the Stark Law, and alleged criminal and civil violations of the anti-kickback statute. Jane assists clients with negotiation and structuring of global settlements with the US Department of Justice and its US Attorneys’ Offices and state Attorneys’ General Offices as well as corporate integrity agreements with the Department of Health and Human Services Office of Inspector General. Jane also defends clients in consumer protection and unfair or deceptive trade practices investigations initiated by the Federal Trade Commission or state Attorneys’ General Offices. Jane also advises clients regarding cannabis licensing, compliance, and regulatory matters.

I. An understanding of cannabinoids | 12:00pm – 12:20pm

II. The federal regulatory framework, including the Controlled Substances Act, Farm Bill, and the role of the Drug Enforcement Agency and Food and Drug Administration | 12:20pm – 12:40pm

III. The state regulatory framework, including states where medical and recreational cannabis programs exist and states where regulators have begun to address intoxicating hemp | 12:40pm – 1:00pm

Break | 1:00pm – 1:10pm

IV. Federal and state enforcement | 1:10pm – 1:25pm

V. Federal preemption issues | 1:25pm – 1:40pm