CDER Enforcement Expands Beyond Manufacturing: Attorneys
A new analysis by Hogan Lovells finds CDER enforcement activities are “substantially larger, broader in scope, and more centralized than they were two years ago. Moreover, the composition of enforcement activity has shifted in ways that should prompt pharmaceutical manufacturers to reassess their compliance risks.”
Examining CDER Office of Compliance’s annual reports between 2023 to 2025, Hogan Lovells attorneys Melissa Mendoza and Ted Lis found Warning Letters increasing nearly 85% as the agency targeted oversight of drug compounding, telehealth companies, online pharmacies and pharmaceutical advertising.
CDER said it issued 314 Warning Letters in 2025, a significant increase driven largely by violations involving unapproved or misbranded drugs and manufacturing quality failures (FDA Webview 4/24). More than 180 letters cited illegal or misleading drug marketing, while over 120 targeted manufacturing facilities for deviations from current good manufacturing practices.
Compounding enforcement showed particularly sharp growth, the Hogan Lovells analysis found. CDER issued 72 compounding-related warning letters in 2025, compared with 11 in fiscal 2023. Of the 2025 letters, 58 involved false or misleading advertising rather than manufacturing quality deficiencies.
The analysis also identified FDA's crackdown on GLP-1 products as an example of its broader enforcement strategy, encompassing misleading advertising, imported active pharmaceutical ingredients, counterfeit products and drug supply chain violations.
Online enforcement also expanded. In 2025, CDER issued 37 warning letters to online pharmacy operators, 58 to telehealth companies, 18 concerning unapproved botulinum toxin products marketed online and 15 involving illegal online sales of controlled substances.
Manufacturing compliance remained a major priority, with more than 120 current good manufacturing practice-related warning letters issued during 2025. However, the proportion of warning letters involving adulterated drugs declined from 45% in fiscal 2023 to 32% in calendar 2025.
Additionally, the analysis highlighted FDA's increasing reliance on remote oversight. In 2025, 15 CGMP-related warning letters followed records requests under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. Alternative oversight tools were used in connection with 55 of 76 companies added to CGMP-related import alerts.
CDER also increased its ClinicalTrials.gov enforcement activity, issuing 42 preliminary notices of noncompliance and two formal notices in 2025, compared with 32 preliminary notices in fiscal 2023.
Meanwhile, FDA's 2024 reorganization centralized the classification of voluntary action indicated inspections within CDER's Office of Compliance, which already handled official action indicated classifications. “The practical effect of this change should be greater speed and uniformity in reviewing Form FDA 483 responses and classifying inspections,” the analysis noted.
The attorneys said the trends demonstrate that FDA enforcement risks now extend well beyond manufacturing quality to include promotional claims, online distribution, clinical trial reporting and supply chain oversight.