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In the wake of President Donald Trump’s recent executive action directing the Department of Health and Human Services and the Food and Drug Administration to “rein in misleading” direct-to-consumer pharma ads on TV and social media, the FDA issued 100 untitled letters to drugmakers regarding their DTC marketing efforts.

MM+M has obtained a copy of one sent to AstraZeneca regarding its recently launched campaign supporting the at-home version of its nasal flu vaccine, FluMist. The letter, addressed to Yeasin Chowdhury, Astra Zeneca’s director of promotional regulatory affairs, is posted on the FDA website. 

In a letter dated September 9 and signed by Center for Biologics Evaluation and Research Director Vinay Prasad MD, MPH, the FDA informed AstraZeneca that it determined its minute-long TV ad promoting FluMist is “false or misleading.”

The drugmaker received a untitled letter primarily due to the portrayal of two minors in the commercial advising an adult and another minor on how to obtain and use the medication, which the FDA argued could be considered misleading about who can access and administer the vaccine.

“Specifically, the presentation misleadingly suggests that a minor may order FLUMIST online and use it,” the letter states. “The statement in small text in another scene of the video that reads, ‘A caregiver should administer FLUMIST to individuals 2 through 17 years of age,’ is not sufficient to mitigate the misleading impression created by these representations.”

The minute-long ad promoted a version of FluMist available for patients between the ages of 18 and 49 to self-administer and for caregivers of minors between the ages of two and 17.

The FDA approved the at-home version of FluMist in September 2024. The British pharma giant launched the campaign last month, ahead of the start of the respiratory illness season.

Of note, Edelman supported FluMist’s launch event and media outreach.

The untitled letter is an example of a larger shift toward stricter FDA enforcement of DTC pharma ads and a more aggressive look at the stylistic choices brands take with their marketing efforts.

In the near term, Hale Advisors CEO Zoe Dunn advised AstraZeneca to change the music and pacing of the spot as well as edit or re-shoot the ad to remove the content flagged in the letter by the FDA.

In its communication to AstraZeneca, the FDA stated the drugmaker needs to provide a written response within 15 working days addressing the concerns highlighted by the agency. 

From a governance perspective, Dunn said the letter emphasized how certain elements of the ad distracted from the clear communication of risks and benefits — which is now a top regulatory concern for the Trump administration.

If there’s a long-term adjustment that can be made, she said, it’s to engage with MLR review teams earlier in the process to ensure the spots don’t run afoul of these regulatory landmines.

“I do think it’s important for companies to ensure that they have reviewers who are looking at the materials all the way through and helping with those creative decisions,” Dunn said. “Perhaps that would have kept [AstraZeneca] out of hot water.”

Since its release last week, the memorandum has rippled across the healthcare communications community, including point of care. 

“We share the industry’s concern and are watching this very carefully,” said David Paragamian, CEO of Health Monitor Network. “That said, while POC is part of the health communications ecosystem, we’re a bit different from DTC. POC information is delivered in a doctor’s office, often by the HCP themself. That context is a lot different from someone watching TV at home.”

Meanwhile, Cassandra Sinclair, president of VCCP Health US, said tighter rules will force pharma to think even more about authenticity and create hyper-personalized content that speaks to the whole person. 

“HCPs are overwhelmed, so pharma needs to be a true partner in supporting them and their patients, offering clear, reliable information and tools,” she said. “This will mean moving beyond broad ads to deeper digital engagement, personalized education and real support that respects patients’ needs and builds lasting trust. It’s a big shift, but also a real chance for pharma to lead with care, not just commercial messages.”

For Jay Carter, EVP of business development at CG Life, his advice to clients echoes what many others across the industry have been preaching since Wednesday: “stay the course.”

He underscored the need for drugmakers to ensure compliance with their ads while not making drastic changes in response to recent regulatory pressures. 

Carter, a board member on the Coalition for Healthcare Communications, stressed that pharma brands and their agency partners should await future opportunities to challenge these clampdowns in court, if needed.

While some medical marketers may chafe at the increased spotlight the industry is under, Carter noted that the mission to improve patient outcomes is not in conflict with the desire by regulators to have informative, accurate advertising.

After all, working within the restrictions established and enforced by the FDA, Carter argued, is what differentiates medical marketing from other forms of advertising.

“I want us to play by the rules, but I don’t want to take [DTC advertising] away because some people have broken rules,” he said. “I want to chastise and re-engage offenders so they don’t offend again.”

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