RAPS New York-New Jersey 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  • Draft Guidance: Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers
  • Draft Guidance: Drug and Device Manufacturer Communications With Payors, Formulary Committees and Similar Entities—Questions and Answers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.




  • At a Glance
  • Agenda
  • Speakers
  • Registration Info
  • Cancellation

At a Glance

Date:

Tuesday, 9 May 2017 (5:00–8:00 pm EDT) 

Location:

Loeb and Loeb LLP
345 Park Avenue
21st Floor
New York, NY 10154

Directions are available online.

RAC Credits:

Two RAC certification credits upon completion of the program. 

Registration Fees:

Prior to 2 May 2017
RAPS Members: $25
List: $40

On or after 2 May 2017 
RAPS Members: $35
List: $50

Agenda

Tuesday, 9 May 2017 (5:00–8:00 pm EDT) 

5:00–5:30 pm         Registration Check-In
5:30–6:00 pm         Dinner and Networking
6:00–8:00 pm         Speaker Presentation and Interactive Question and Answer Session

Speakers

Scott Liebman, Esq., co-chair, Life Sciences, Loeb and Loeb LLP
Jenny Stohlmann, RAC, regulatory specialist, Loeb and Loeb LLP

Registration Info

Prior to 2 May 2017
RAPS Members: $25
List: $40

On or after 2 May 2017
RAPS Members: $35
List: $50

>> Registration Online

>> Registration Form (PDF) – for registration by mail or fax.

Other Information

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.

Program Contact

Local Contact: Linda Bowen, RAC, FRAPS, chair, RAPS New York/New Jersey Chapter 

RAPS Contact: Wesley Carr, senior program manager, chapter and volunteer relations

Cancellation

Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.