Viatris has received a formal rebuke from the US Food and Drug Administration over a direct-to-consumer video that allegedly misled viewers about the use of a cystic fibrosis inhaler.
The FDA sent Viatris an untitled letter after officials reviewed a video promoting Tobi Podhaler, an inhaler that delivers an antibiotic to treat cystic fibrosis patients whose lungs contain Pseudomonas aeruginosa.
Tobi Podhaler is used by patients, including children, to manage a serious and chronic bacterial lung infection that is a leading cause of health decline among cystic fibrosis sufferers.
In the video, a patient states they love that they can use the device in the car on the way to school, suggesting the treatment can be administered freely during everyday activities.
A parent featured in the video adds that the inhaler can be used “anywhere,” including “while running out of the door,” a claim that FDA officials say creates a dangerously misleading impression.
The FDA accused Viatris of suggesting patients can administer the therapy anywhere “without concern,” a characterisation the agency said contradicts the product’s own instructions for use.
According to the FDA, properly preparing and administering the drug requires adequate lighting and stable conditions, neither of which may be present in a moving vehicle or during a rushed morning routine.
Officials highlighted specific sections of the instructions telling users to “set the mouthpiece aside on a clean, dry surface” and “hold the used capsule up to the light” to verify it has been fully emptied.
The FDA warned that actions resulting in incomplete emptying of the capsule, or exposure to moisture during storage and handling, may reduce the amount of drug delivered and result in a suboptimal dose reaching the patient.
While the agency acknowledged the video did contain some information about how to use Tobi Podhaler, it concluded that this content was insufficient to offset the overall misleading impression created by the advertising.
The regulator asked Viatris to immediately address the violations identified in the untitled letter, consistent with its increasing scrutiny of direct-to-consumer pharmaceutical communications.
The action against Viatris forms part of a broader surge in untitled letters concerning direct-to-consumer communications that the FDA began issuing from September onwards, signalling a tougher regulatory posture on pharmaceutical advertising.
Pharmaceutical companies promoting prescription treatments face strict requirements to ensure advertising materials do not overstate benefits or downplay the conditions under which a drug must be properly used.
The case highlights growing regulatory pressure on drugmakers to ensure that patient-facing content, particularly video advertising, accurately reflects real-world requirements for safe and effective administration of their products.