Biologics

CBER Says AstraZeneca FluMist Ad Misled Viewers

A CBER untitled letter to AstraZeneca cites the firm for running a misleading television direct-to-consumer advertisement for its nasal spray flu vaccine FluMist, warning the company that the commercial misbrands the product and violates federal law. In the 9/9 letter from CBER director Vinay Prasad, the agency says the 60-second spot, titled “FluMist DTC Home Done Different,” gave the false impression that minors could purchase and self-administer the vaccine.

The ad depicts teenagers in a diner discussing ordering FluMist online, with one girl telling another, “FluMist is a vaccine you give yourself.” FDA noted that FluMist is approved only for people ages two through 49, and specifically states that individuals under 18 should not self-administer it. The agency said a small-text disclaimer in the commercial, noting that caregivers must administer the vaccine to children, was “not sufficient to mitigate the misleading impression.”

The letter comes on the same day FDA ordered pharmaceutical companies to remove any “noncompliant ads” and bring all promotional communications into compliance with the Federal Food, Drug, and Cosmetic Act (see earlier story). Thousands of letters sent to companies under the initiative warned that the agency is moving to “take aggressive action” against violative ads, citing longstanding concerns that promotional materials distort patients’ understanding of drug benefits and risks.

“DTC advertising can distort the patient-clinician relationship and create increased demand for medications regardless of clinical appropriateness,” FDA commissioner Marty Makary wrote in the letter. He added that when risks are not clearly presented (fair balance) — or when disclosures are difficult for seniors to read or hear — patients may be misled about a drug’s safety profile. “Going forward, the agency will aggressively deploy its available enforcement tools,” an agency notice said. “The FDA is already implementing AI and other tech-enabled tools to proactively surveil and review drug ads.”

In the AstraZenenca letter, the agency also criticized the ad’s presentation of safety information, saying the risks were rushed, overshadowed by upbeat visuals, loud background music, and frequent scene changes that distracted viewers. The agency concluded that the ad failed to provide risk information in a clear, balanced, and neutral manner compared to the benefits highlighted.

FluMist carries important warnings, including the risk of wheezing in children under 24 months, exacerbation of asthma, and Guillain-Barré Syndrome, the letter noted. Common side effects include runny nose, congestion, fever in young children, and sore throat in adults.

FDA ordered AstraZeneca to cease distribution of the ad and respond within 15 working days with a plan to discontinue similar violative promotions.

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