Last week, on the same day the Trump administration laid out its plan to rein in direct-to-consumer drug advertising, the FDA sent out its first untitled letter in months, this one taking issue with a commercial for AstraZeneca’s self-administered FluMist influenza vaccine.
The Sept. 9 letter came from the FDA’s Center for Biologics Evaluation and Research (CBER), marking CBER’s first such missive since 2018. Most marketing scoldings are sent from the Center for Drug Evaluation and Research’s (CDER’s) Office of Prescription Drug Promotion, which has issued three untitled letters so far this year, though, as of Tuesday morning, none since April.
The latest letter homed in on a 60-second TV ad in which people in a variety of settings—at a soccer game, a salon, their workplaces and so on—explain the concept of self-administering a flu vaccine to their confused friends, colleagues and passersby. The ad specifically highlights AstraZeneca’s newly launched FluMist Home service, which delivers the nasal spray directly to patients’ homes.
According to the letter’s author, CBER director Vinay Prasad, M.D., the ad is “false or misleading” and therefore “misbrands” FluMist.
Prasad took issue with several aspects of the commercial. For one, he singled out a scene in which a trio of young people discuss FluMist over milkshakes at a diner, which he suggested may contradict the vaccine’s labeling, requiring caregivers to administer the nasal spray to those between the ages of 2 and 17.
Though there are no indicators of the actors’ ages in the commercial, Prasad claimed that they “appear to be 17 years of age or younger.” He added, “The overall impression is that these teenagers are able to purchase FLUMIST online and use it themselves in the absence of a caregiver.”
Another scene in the ad shows two children discussing FluMist, with one explaining, “My mom does it,” while text on the screen notes the restrictions on minors’ self-administration. Prasad said that information is “not sufficient to mitigate the misleading impression created by” the earlier scene.
Elsewhere, he also argued that the ad does not adequately balance the amount of information offered about both risks and benefits of FluMist
“Specifically, the fast pacing of the risk concepts and the presentation of compelling and attention-grabbing visuals during the presentation of risk information, all of which are unrelated to the risk message, in addition to frequent scene changes, compete for the viewers’ attention and make it difficult for the viewer to adequately process and comprehend the risk information,” he wrote.
Though 20 seconds of the ad are dedicated to its major statement, with a voiceover and corresponding text on screen—often referred to as “supers”—listing the most important risks and contraindications, as required by current FDA rules, Prasad said the major statement is “not presented in a clear, conspicuous, and neutral manner.”
“The loud background music and visual distractions, including numerous scene changes, quick camera movements, and close-ups, interfere with the viewer’s ability to read the SUPERs while processing the audio information disclosing the risks associated with use of FLUMIST,” he wrote, also taking issue with the “relatively small” size of the supers. “The overall effect undermines the communication of the risk information and the consequences that may result from the use of FLUMIST.”
The FDA has given AstraZeneca 15 working days to respond to the letter, describing either its plan for addressing the alleged violations or its reasoning for why the ad is not in violation of agency rules.
AstraZeneca declined a request for comment from Fierce Pharma Marketing.
The letter was sent the same day that President Donald Trump issued a memorandum directing the FDA to crack down on DTC pharma advertising. The FDA simultaneously put out its own announcement pledging to do just that, saying that it was in the process of sending out thousands of letters warning drugmakers to “remove misleading ads,” plus about 100 more cease-and-desist missives “to companies with deceptive ads.”
In a subsequent editorial, FDA Commissioner Marty Makary, M.D., explained that the agency is planning to increase enforcement of existing rules, while also closing the so-called adequate provision “loophole” introduced in 1997. The rule reduced the requirements around how much information about drug risks and side effects had to be included in a broadcast ad, setting up a TV drug ad boom throughout the ensuing decades.
Though Makary wrote that the agency isn’t attempting to outright ban drug ads, many industry watchers have noted that ending the adequate provision rule could ultimately end up blocking most TV drug ads due to the difficulties of fitting all contraindications, warnings and precautions into a typical 60-second-or-less commercial.
Makary himself acknowledged as much in a recent interview with CNBC, saying, “We are beginning [to take] action to close that loophole, which will require more disclosures and longer ads that may make the ads no longer feasible.”