Ropes & Gray Hosts FDA Regulatory Roundtable: Off-Label Scientific Communications in Focus

Ropes & Gray hosted an FDA Regulatory Roundtable: Off-Label Scientific Communications in Focus, an in-person event in Cambridge, MA on March 4.

Greg Levine, a partner in the firm’s life sciences regulatory & compliance practice, moderated the event and was joined by panelist  Josh Oyster, partner in the life sciences regulatory & compliance practice, as well as partner Douglas Hallward-Driemeier, who leads the firm’s Appellate & Supreme Court practice.

The speakers discussed the U.S. Food and Drug Administration’s (FDA’s) January 7 publication of final guidance describing recommendations for medical product manufacturers intending to disseminate or discuss off-label scientific information contained in reprints, clinical practice guidelines, reference texts, or digital clinical practice resources.

The roundtable also covered the FDA’s January 7 release of an addendum to its 2017 First Amendment memorandum, which represents FDA’s latest defense of its legal framework governing manufacturer communications.

The speakers explored the practical considerations, constitutional implications, and enforcement risk regarding the final guidance and the addendum, as well as their perspectives on the future of FDA promotional enforcement under the new administration.