A sharp rise in enforcement actions has defined fiscal year 2025 for the Center for Drug Evaluation and Research (CDER), according to remarks from Jill Furman, Director of the Office of Compliance, at the 2025 Enforcement, Litigation, and Compliance Conference in Washington, D.C. Furman reported a 50% increase in warning letters, marking one of the most significant year-over-year jumps in recent regulatory history.
The surge reflects evolving compliance risks across the pharmaceutical landscape, particularly in telehealth, compounding, manufacturing, and clinical research oversight.
Telehealth Platforms Under Heightened Scrutiny
A major driver behind the increase is a wave of warning letters to telehealth companies, which accounted for 22% of all CDER warning letters this fiscal year. These actions targeted platforms promoting compounded drug products with unsubstantiated or misleading claims—especially compounded GLP-1 agonists marketed for diabetes or weight loss.
Furman emphasized that these enforcement efforts reflect CDER’s commitment to curbing illegal or unsafe promotion practices as telehealth continues to grow.
Manufacturing, Unapproved Drugs, and Research Violations Persist
Beyond telehealth, several traditional areas of oversight contributed to the uptick in enforcement:
- 35% of warning letters cited GMP violations at drug manufacturing facilities
- 18% involved unapproved drugs or misbranding
- 5% addressed clinical research or Institutional Review Board (IRB) violations
Furman noted that CDER is taking a more coordinated enforcement approach following the transformation of the Office of Regulatory Affairs into the new Office of Inspections and Investigations (OII), improving alignment between inspection and compliance operations.
Rising Import Alerts and Recalls Highlight Ongoing Quality Concerns
FY 2025 also saw a substantial increase in supply chain oversight activities:
- 126 import alerts were issued—significantly more than the previous year
- 317 drug recall events occurred, most classified as Class II
To strengthen supply chain integrity, CDER introduced a Green List identifying foreign drug manufacturers that have not provided adequate verification of active pharmaceutical ingredient (API) quality.
Targeting High-Risk Products: Ophthalmics and Counterfeit Botox
Furman highlighted two particularly concerning product categories:
- Ophthalmic products marketed illegally and posing contamination risks
- Fraudulent or counterfeit Botox products, which triggered 18 warning letters in FY 2025
These products may contain incorrect ingredients or unknown contaminants, increasing the risk to patients seeking cosmetic or therapeutic treatments.
Clinical Research Oversight Tightens
CDER also expanded its oversight of clinical research integrity:
- 150+ marketing applications underwent clinical data assessments
- 900+ bioresearch complaints were investigated
- 21 OAIs/Form 483s were issued for violations, including failure to submit INDs
Furman reinforced that data reliability and proper IND submission remain essential expectations as the agency evaluates new therapies.
Looking Ahead: Supply Chain Accountability in 2026
As FY 2026 approaches, Furman identified supply chain accountability as a central focus area. CDER plans to intensify monitoring of API sourcing, distribution practices, and manufacturing quality, anticipating continued challenges in global pharmaceutical supply chains.
At EMMA International, we support drug manufacturers and clinical research organizations in navigating these evolving enforcement trends—from GMP compliance and inspection readiness to data integrity, supply chain oversight, and regulatory strategy. Our experts help organizations adapt proactively to shifting expectations and mitigate enforcement risk.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
Eglovitch, J. S. (2025, December 4). CDER warning letters up 50% in FY 2025. Regulatory Focus. Regulatory Affairs Professionals Society.
U.S. Food and Drug Administration. (2025). CDER Office of Compliance enforcement updates and import alert data. U.S. Department of Health and Human Services.
Food and Drug Law Institute. (2025). 2025 Enforcement, Litigation, and Compliance Conference proceedings.
