Navigating the Still Murky Waters of Manufacturer Communications: Promotion, Commercial Speech, and Scientific Exchange
Off-label communications have always represented a challenging area for the regulated industry. However, recent Court decisions have come down in favor of less government restriction of commercial speech. In the wake of these cases, the FDA convened a public hearing in November 2016 and has since issued two important draft guidance documents that address some, but certainly not all, issues regarding information that companies can proactively communicate outside the information expressly contained in a product’s approved full prescribing information. During this webinar we will examine these recent developments and consider where companies might consider altering their traditional policies and where it may be prudent to continue exercising caution.
Continuing Education Credits are not available for this event.
- Off-label communications
- FDA guidance
Who should attend?
- Regulatory Affairs
- Medical Information and Affairs
- Senior Management
- Understand the evolving legal landscape relevant to prescription drug and medical device manufacturers’ external communications
- Understand the FDA’s current thinking on certain categories of manufacturer speech as elucidated in recent draft guidance documents and public statements
- Identify areas of greater flexibility regarding proactive communications to payors and the communication of information that is consistent with FDA-required labeling