AMGN · News · 20261030N

Regulatory Risk

AMGEN INC · 2026-10-30 · Importance 45 · Surprise 60

Amgen received a Warning Letter from the U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) concerning a promotional video for Vectibix. The FDA said the video was false or misleading because it omitted significant risk information and inaccurately represented the drug’s indication. Amgen said an incorrect file was inadvertently sent to the FDA and was never publicly disseminated; it stated that the publicly aired version included appropriate safety information.

Key facts

• Amgen received an FDA Office of Prescription Drug Promotion Warning Letter regarding a promotional video for Vectibix. source
• The FDA deemed the Vectibix promotional video “false or misleading” due to significant omissions of risk information and an inaccurate representation of the drug's indication. source
• Amgen stated that the problematic video was an incorrect file inadvertently sent to the FDA and was never publicly disseminated. source
• Amgen asserted that the publicly aired version of the Vectibix video included appropriate safety information. source