FDA warns Amgen over misleading Vectibix cancer drug promotional video

The FDA issued a warning letter to Amgen on April 25, 2017, regarding a promotional video for Vectibix, a colorectal cancer drug, that the agency deemed misleading for emphasizing benefits while inadequately disclosing serious safety risks and patient limitations. This action was part of a broader FDA enforcement effort that saw warning letters sent to 14 companies for marketing over 65 fraudulent cancer products. Companies receiving warning letters have 15 business days to respond with compliance plans or face potential product recalls, criminal prosecution, substantial fines, or federal prison time. The FDA has issued more than 90 such warning letters over the past decade targeting fraudulent cancer treatments marketed through sophisticated techniques.

FDA warning letters to companies

• ▪The FDA issued warning letters to 14 companies on April 25, 2017 for peddling a total of over 65 products falsely claiming to cure or treat cancer.
• ▪The products subject to FDA warning letters were marketed to treat or cure cancer despite not having been approved as safe and effective by the FDA.
• ▪Douglas W. Stearn is the director of the Office of Enforcement and Import Operations in the FDA's Office of Regulatory Affairs.
• ▪The FDA has issued more than 90 warning letters over the past decade regarding fraudulent cancer treatments.
• ▪The products subject to FDA warning letters came in forms including pills, creams, drops, and syrups.
• ▪Nicole Kornspan is a consumer safety officer at the FDA.

Fraudulent cancer product marketing tactics

• ▪Vendors of fraudulent cancer products would boldly advertise miraculous results but include a barely noticeable disclaimer in an attempt to evade the law.
• ▪Companies selling fraudulent cancer products used slick ads, videos, and other sophisticated marketing techniques to promote the products.
• ▪New fraudulent cancer product companies tend to spring up as soon as one company is shut down, partially due to the ease of creating new websites.

Consumer safety risks from products

• ▪The ingredients in fraudulent cancer products may be a direct risk to health and could interact in a dangerous way with professionally-prescribed treatments.
• ▪The FDA urged patients to avoid fraudulent cancer products and consult a healthcare professional before taking any sort of treatment for their cancer.
• ▪Fraudulent cancer products could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment.

FDA enforcement penalties for violations

• ▪Companies that fail to respond to FDA warning letters could face a forced product recall or criminal prosecution that may result in substantial fines or time in federal prison.
• ▪Companies that received FDA warning letters have 15 business days to respond with a plan to become compliant with the Federal Food, Drug and Cosmetic Act.

Fraudulent pet cancer treatments

• ▪People who cannot afford to spend large sums at the animal hospital to treat cancer in their pets are searching for less expensive remedies.
• ▪Bogus remedies claiming to cure cancer in cats and dogs are increasingly showing up online.

Perspective of U.S. Food and Drug Administration

• ▪The Amgen promotional video for Vectibix highlighted benefits while failing to adequately disclose serious safety risks and patient limitations.
• ▪The FDA issued a warning letter to Amgen on Tuesday regarding the misleading Vectibix promotional video.