Pharmaceutical advertising compliance
Pharmaceutical advertising compliance in Healthcare & Life Sciences sits under active, multi-jurisdictional scrutiny, with the U.S. Food and Drug Administration's Office of Prescription Drug Promotion and the U.S. Federal Trade Commission both issuing enforcement actions and updated guidance on direct-to-consumer promotion, disease awareness claims, and social media endorsements. The European Medicines Agency has separately tightened expectations around off-label digital promotion across member states. Compliance teams are currently stress-testing promotional review workflows against FDA's 2023 social media guidance and mapping agency-specific disclosure rules before new enforcement cycles open.
Watch
- FDA OPDP draft guidance on presenting risk information in DTC broadcast ads
- FTC endorsement rule amendments affecting paid patient influencer programs
- EMA member-state divergence on off-label digital content enforcement
- Untitled letters and Warning Letters issued to pharma companies for omission of risk
- State AG actions targeting prescription drug pricing claims in consumer advertising
Recent material activity in Healthcare & Life Sciences
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FDA issues Complete Response Letter for novel GLP-1 receptor agonist oral formulation
The FDA issued a CRL for a once-daily oral GLP-1 receptor agonist citing manufacturing consistency concerns at the primary production facility. The agency requested additional CMC data and a pre-approval inspection befor…
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