The FDA has rebuked Viatris for a direct-to-consumer (DTC) video that allegedly misled viewers about a cystic fibrosis inhaler.
FDA officials sent (PDF) Viatris an untitled letter after watching a video about Tobi Podhaler, an inhaler that delivers an antibiotic to treat cystic fibrosis patients whose lungs contain Pseudomonas aeruginosa. In the video, a patient says they love that they can use the device in the car on the way to school. The child’s parent adds that they can use the device “anywhere,” including “while running out of the door.”
The FDA accused Viatris of creating the misleading impression that patients can administer the therapy anywhere “without concern.” Citing the product’s instructions for use, the FDA said properly preparing and administering the drug requires adequate lighting and stable conditions.
Officials highlighted parts of the instructions for use that tell users to “set the mouthpiece aside on a clean, dry surface” and “hold the used capsule up to the light and look through it.” The FDA contrasted those instructions with the claims that patients can use the inhaler “in the car” or “while running out of the door on the way to school.”
The untitled letter also addressed storage and handling of the product. Again citing the instructions for use, the FDA noted the need to only peel back the foil from one capsule at a time. Patients should only remove the capsule just before use because the blister packaging protects it from moisture. Another part of the instructions stresses the need to keep the capsules and inhaler in a dry place.
FDA officials said the misleading impression about using the inhaler is concerning because actions that result in incomplete emptying of the capsule, or storage and handling conditions that expose the inhaler or capsules to moisture, may reduce the amount of drug and result in the delivery of a suboptimal dose.
The FDA acknowledged the video contained some information on using Tobi Podhaler. However, in the agency’s view, the information failed to mitigate the misleading impression, leading the regulator to ask Viatris to immediately address the violations. The request extends the surge in untitled letters over DTC communications that began in September.
Mylan, which merged with Pfizer’s Upjohn to create Viatris, acquired Tobi Podhaler from Novartis for $463 million in 2018.