Summary
FDA's Office of Prescription Drug Promotion issued a warning letter to Amgen Inc. on August 12, 2026, finding that a promotional video for Vectibix (panitumumab) misbrands the drug under 21 U.S.C. 352(a) and (n) and 21 CFR 202.1(e)(3)(ii) and (iii). The video omitted all risk information, including a boxed warning for dermatologic toxicity and serious risks such as infusion reactions and pulmonary fibrosis, and failed to disclose the drug's limitations of use. Amgen has 15 working days to respond, identify other similarly deficient promotional materials, and submit a corrective communication plan.
What this may mean
Amgen faces potential seizure and injunction if it does not cease the identified promotional communications and provide corrective communications to the same audience that received the video. The warning letter requires a corrective communication plan that covers the omitted risk and indication information. Pharmaceutical manufacturers promoting oncology products are on notice that omission of boxed-warning risk information and limitations of use in any promotional format violates the FD&C Act.
Informational only. Not legal, medical, financial, or other professional advice. Always consult a qualified professional familiar with your specific facts before relying on any item.
Related items
- FDA Warning Letters · November 5, 2026RonanRx, Inc. dba RonanRxScore 60
- FDA Warning Letters · October 27, 2026Calibrate IV HydrationScore 50
- FDA Warning Letters · November 3, 2026Guangdong Bangze Medicine Co., Ltd.Score 46
- FDA Warning Letters · October 20, 2026Signature Formulations LLCScore 46
- FDA Warning Letters · October 20, 2026Rohto Pharmaceutical Co., Ltd.Score 43
- FDA Warning Letters · November 5, 2026Conroe Welding Supply, Inc.Score 40