RAPS NY/NJ Chapter: First Amendment Considerations for Off-Label and Healthcare Economic Information

In response to recent First Amendment jurisprudence, FDA is reviewing its policy strategies related to speech restrictions under the Food, Drug and Cosmetic Act. On a mission to balance “ongoing developments in science and technology, medicine, healthcare delivery, and constitutional law” with “public health and safety interests served by FDA’s regulatory approach,” FDA released three documents in January 2017 that provide insight to its evolving enforcement discretion regarding certain types of medical product promotional speech.

• Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products
• Draft Guidance: Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers
• Draft Guidance: Drug and Device Manufacturer Communications With Payors, Formulary Committees and Similar Entities—Questions and Answers

This presentation is intended to familiarize regulatory professionals with new draft guidances; contextualize the First Amendment debate; explore the definition of “intended use;” and provide a working understanding of FDA’s current thinking about on-label vs. off-label communications and the appropriate sharing of healthcare economic information.

This event, hosted by Lobe & Loeb LLP, is sponsored by the RAPS New York/New Jersey Chapter and is intended to facilitate networking and knowledge sharing among area regulatory personnel. A light meal will be available for all attendees. RAC holders may claim two RAC recertification credits.