Amgen Receives FDA OPDP Warning Letter Over Misleading Vectibix Promotional Video

A promotional video for Vectibix® (panitumumab) has drawn a formal warning letter from FDA's Office of Prescription Drug Promotion (OPDP), putting Amgen Inc. on notice that its marketing materials misbranded the biologic in violation of the Federal Food, Drug, and Cosmetic Act. For regulatory affairs and QA teams across the industry, the letter is a direct signal that OPDP's scrutiny of submitted promotional content remains active and consequential.

The warning letter, addressed to Chairman and CEO Robert Bradway and dated August 12, 2026, concerns a video (USA-954-81023) submitted by Amgen under Form FDA 2253. FDA determined the video was false or misleading with respect to risk presentation, triggering misbranding provisions under 21 U.S.C. 352(a), (n); 321(n); and 331(a), and implicating 21 CFR 202.1(e)(3)(ii) and (iii); (e)(5). The agency's concern centers on a misleading impression created regarding Vectibix's safety and effectiveness profile.

The stakes are not abstract. Vectibix carries a boxed warning for dermatologic toxicity and additional warnings covering infusion reactions, pulmonary fibrosis, interstitial lung disease, acute renal failure, and embryo-fetal toxicity, among others. The drug is indicated for adult patients with wild-type RAS metastatic colorectal cancer, a population for whom accurate risk communication is clinically critical. Colorectal cancer is the second leading cause of cancer deaths in the United States, and treatment decisions in this setting carry serious and potentially fatal consequences.

For promotional review committees and regulatory operations leads, the letter reinforces a compliance baseline that is easy to underestimate: Form FDA 2253 submissions do not constitute pre-clearance, and OPDP reviews submitted materials against the full approved labeling, including limitations of use and boxed warning language. A video format does not reduce the obligation to present risk information completely and without misleading omission or implication.

Teams managing promotional review SOPs should treat this letter as a calibration point, particularly for audiovisual materials where risk information can be compressed, de-emphasized, or structurally subordinated to efficacy claims in ways that written pieces make more visible during internal review.

OPDP's issuance of a warning letter, rather than an untitled letter, indicates FDA viewed the violations as significant enough to require corrective action, a threshold that carries regulatory record implications for Amgen's BLA 125147 going forward.

Source: FDA Office of Prescription Drug Promotion via FDA.gov Warning Letters database, August 12, 2026; published October 27, 2026.