FDA Policy/General

FDA Cites Sanofi Over Misleading Beyfortus Promotional Emails

FDA has issued an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respiratory syncytial virus (RSV) prevention product Beyfortus (nirsevimab-alip) were false or misleading because they overstated the drug's approved indication. In the letter, CDER’s Office of Prescription Drug Promotion (OPDP) said two professional emails submitted by Sanofi under Form FDA 2253 created the misleading impression that Beyfortus is indicated for the general prevention of RSV disease in infants, rather than its approved use for preventing RSV lower respiratory tract disease (RSV-LRTD).

According to the agency, the emails included statements such as "Help prevent RSV disease in infants with Beyfortus," "Beyfortus is a monoclonal antibody that helps prevent RSV disease starting from Day 1 after injection," and that immunizing infants with the product could reduce the community burden of RSV disease.

FDA said those claims omitted an important limitation of the product's approved indication. Beyfortus is approved to prevent RSV lower respiratory tract disease in certain infants and young children, not RSV disease generally, which could include upper respiratory tract infections. Although the promotional materials later referred to protection against "RSV-LRTI," the agency said that disclosure was insufficient to correct the overall misleading impression created by the broader claims. As a result, FDA concluded that the promotional communications misbranded Beyfortus under the Federal Food, Drug, and Cosmetic Act.

The agency requested that Sanofi immediately cease dissemination of the misleading promotional materials and submit a written response within 15 working days. FDA also asked the company to identify any other Beyfortus promotional communications containing similar claims and describe its plans to discontinue or revise those materials.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome