Caronia panel: Off-label enforcement paradigm is shifting

01/29/2013

During a Drug Information Association Webinar held last week to discuss the implications of the U.S. Court of Appeals for the Second Circuit decision in U.S. v. Caronia, a panel of industry experts, moderated by Coalition for Healthcare Communication Executive Director John Kamp, concurred that many questions remain about how the decision will change FDA marketing regulations and related U.S. Department of Justice actions under the False Claims Act. Kamp reminded DIA attendees that even though the ground is shifting, industry should not “read this decision as stripping the FDA of its authority to regulate off-label promotion. FDA’s authority to regulate ‘false and misleading’ promotion is intact and the agency fully intends to use it.” Read more.

View Full Article in:

http://www.cohealthcom.org/2013/01/28/caronia-decision-may-force-fda-doj-to-alte...

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Senior Director, Biostatistics
Edwards Lifesciences
Irvine, CA
Diagnostic Technician
Roche
Marlborough, MA
Test Technician
Roche
Marlborough, MA
Associate - Food and Drug
Keller and Heckman LLP
Washington, DC
Senior Paralegal - Research & Development, and Medical
Boehringer Ingelheim
Ridgefield, CT