Amgen, Incorporated – FDA Warning Letter, Aug 3, 2026

On August 12, 2026, the FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to Amgen Inc. regarding a promotional video for Vectibix (panitumumab), a drug indicated for specific types of metastatic colorectal cancer. Following a regulatory review, the FDA determined that the promotional material was false or misleading, resulting in the misbranding of the product under the Federal Food, Drug, and Cosmetic Act.

The main violations include the total omission of risk information and material facts. While the video highlighted benefits—such as short infusion times and the lack of required premedication—it failed to communicate any safety risks. This is a significant public health concern because Vectibix carries a boxed warning for dermatologic toxicity and is associated with other serious risks, including pulmonary fibrosis and infusion reactions. Additionally, the video failed to disclose the drug’s full FDA-approved indication and its limitations of use, particularly concerning the necessity of specific genetic testing (RAS mutation status) before treatment.

The FDA has ordered Amgen to immediately cease the use of the misleading video and any other similar promotional materials. Amgen must provide a written response within 15 working days detailing its plan to discontinue these communications. Furthermore, the company is required to submit a comprehensive plan for corrective actions to provide truthful and complete information to the audiences that were exposed to the misleading video. Failure to comply may result in further legal action, including product seizure or injunctions.