FDA Issues Untitled Letters to Sanofi and Viatris Over Misleading Drug Promotions
核心洞察
FDA's OPDP sent an untitled letter to Sanofi over promotional emails for Beyfortus that misleadingly suggested the monoclonal antibody prevents all RSV disease, rather than only lower respiratory tract disease.
Viatris received an untitled letter for a DTC TV ad for TOBI Podhaler that implied the cystic fibrosis (搜索) treatment can be administered anywhere, contradicting FDA-approved instructions requiring adequate lighting and stable conditions.
Both companies must respond within 15 working days and take immediate corrective action, including pulling the violative promotional materials.
The Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) has issued untitled letters to Sanofi and Viatris, citing false or misleading claims in promotional materials for two distinct pharmaceutical products. The enforcement actions, which target both professional email communications and direct-to-consumer (DTC) television advertising, represent the latest in an ongoing agency crackdown on drug promotion that began in September 2025.
Sanofi's Beyfortus Emails Overstate Indication
The FDA took issue with Sanofi's promotional emails for Beyfortus (nirsevimab-alip (搜索)), a long-acting monoclonal antibody injection indicated for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (搜索) (RSV) in newborns and infants. According to the agency, the emails created a misleading impression by suggesting that Beyfortus can help prevent RSV disease broadly, including both upper and lower respiratory tract disease.
"By failing to adequately communicate the indication for Beyfortus, the emails create a misleading impression about the drug's FDA-approved indication," the FDA wrote in its letter. The agency noted that the approved labeling limits the indication specifically to lower respiratory tract disease prevention, not general RSV prevention.
The notice was addressed to Jack Scannelli, rPh, senior director of regulatory ad promo at Sanofi Vaccines U.S., and signed by Samuel Skariah, PharmD, RAC, team leader in the Division of Advertising and Promotion Review at OPDP, along with L. Sheneé Toombs, PharmD, CPH, a regulatory review officer.
A Sanofi spokesperson confirmed receipt of the letter, stating: "We take this matter seriously and are reviewing the letter carefully." The spokesperson added that "Sanofi maintains strict regulatory compliance policies for its promotional communications. We are committed to ensuring that all promotional materials for Beyfortus are accurate, balanced and fully compliant with FDA regulations. We will respond to the agency within the required timeframe."
This marks the second untitled letter Sanofi has received since the FDA's enforcement push began. The first, issued in September 2025, concerned a DTC television advertisement for Tzield (teplizumab-mzwv), an intravenous injection for type 1 diabetes (搜索).
Viatris's TOBI Podhaler Ad Minimizes Administration Requirements
In a separate action, the FDA issued an untitled letter to Viatris over a DTC television advertisement for TOBI Podhaler (tobramycin inhalation powder), a prescription aminoglycoside antibiotic used to treat chronic lung infections caused by Pseudomonas aeruginosa (搜索) in adults and children aged six years and older with cystic fibrosis (搜索).
The video features a patient named Jax, who states: "The one thing I love about the Tobi Podhaler is when I am running late, I can do it on the way to school in the car." Jax's mother adds: "We have used it on vacation, in the car, and while running out of the door on the way to school."
The FDA argued that these statements create the misleading impression that patients can perform the administration process anywhere without problems. The agency emphasized that the FDA-approved Instructions for Use (IFU) include several detailed steps requiring "adequate lighting and stable conditions to properly complete the preparation and administration of the product." These steps include washing and drying hands, placing the mouthpiece on a clean, dry surface, and holding the used capsule up to light to ensure only a fine coating of powder remains inside.
Leaving these details out is "concerning," the FDA wrote, because not completely emptying the capsules or storing them properly could "reduce the amount of the drug and result in a suboptimal dose."
"FDA has determined that the video is false or misleading. Thus, the video misbrands TOBI Podhaler and makes the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act," the agency stated. The letter was addressed to Dr. Brenda Pillari, Viatris' head of regulatory affairs for North America.
Regulatory Context and Required Actions
Both companies have been instructed to submit a written response within 15 working days and to take immediate action to address the violations, including pulling the violative videos and promotional emails. The enforcement actions are part of a broader FDA initiative that has seen the agency issue several letters per month to pharmaceutical companies over a variety of promotional materials, spanning websites, social media posts, banners, and television advertisements. Most recently, the FDA sent a letter to Lundbeck over claims about its intravenous migraine drug Vyepti on its website.