After the FDA announced it was cracking down on what it has determined to be “misleading” or “deceptive” direct-to-consumer pharmaceutical ads, the floodgates have opened.
In the first few days after the announcement, the agency publicly shared only one of what it said were thousands of letters informing drugmakers of their alleged violations of federal pharma marketing rules: a missive from the Center for Biologics Evaluation and Research (CBER) taking aim at a TV commercial for AstraZeneca’s self-administered FluMist vaccine.
Around midday Tuesday, however, the Center for Drug Evaluation and Research (CDER) uploaded a flood of both untitled letters and more serious warning letters for public perusal.
The first swath comprises 40 untitled letters, all dated Sept. 9—the day the Trump administration unveiled the crackdown plans—and signed by CDER Director George Tidmarsh, M.D., Ph.D.
The letters target many of the biggest drugmakers, several of which received multiple letters. At the top of the untitled heap were five for AstraZeneca—plus another for its Alexion rare disease-focused subsidiary—and three each for Bristol Myers Squibb, Novartis, UCB, Boehringer Ingelheim and Phathom Pharmaceuticals. AbbVie, Takeda, Teva Pharmaceuticals and Supernus Pharmaceuticals each received two letters, while Sanofi and Pfizer were among those who received one apiece.
Each of the untitled letters argues that a particular DTC ad is “false or misleading” and so “misbrands” the drug it’s advertising. The companies have been given 15 days to formally respond to the allegations.
A scolding for one of Novartis’ Kesimpta ads, for example, takes issue with its “attention-grabbing visuals” that may distract from the major statement of risks and side effects, as well as with the commercial’s claim that the multiple sclerosis med can be taken “at home in one minute a month,” which Tidmarsh wrote is “oversimplifying the steps involved.”
Meanwhile, all three of Boehringer’s letters concern a different one of the company’s musical theater-themed Jardiance ads. In each missive, the FDA criticized the commercials’ “fast-paced” and “compelling” visuals, “frequent scene changes” and background music for potentially stealing viewers’ attention away from the drug safety information.
The marketing-related warning letters uploaded Tuesday number nearly 70, though the majority target online pharmacies and sellers of compounded drugs—to which FDA Commissioner Marty Makary, M.D., pledged in a recent JAMA op-ed to extend the marketing crackdown for their “brazen” advertisements of drugs “with only upsides mentioned.”
Eight of the warning letters did go to pharmas, including three for Eli Lilly, two for Aytu BioPharma and one each for Novo Nordisk, Alora Pharmaceuticals and CSL Behring, the last of which came from CBER rather than CDER, since it concerns the biologic med Hizentra.
Novo’s warning letter concerns the Oprah Winfrey-hosted TV special on GLP-1 drugs that aired last year. The broadcast featured a Novo executive as well as a pair of doctors who had both been paid consultants for the Big Pharma. According to the FDA, “the special includes numerous representations about the benefits of Wegovy, Ozempic, and Victoza made by representatives of Novo Nordisk, but omits important risk information and otherwise minimizes the risks of these drug products.”
Lilly’s three warning letters, meanwhile, concern its own GLP-1 products, Zepbound and Mounjaro. One takes aim at the same Oprah-led broadcast, which also included Lilly representatives. The other two concern local TV news segments in Oklahoma City and Dayton, Ohio, each of which were labeled as being sponsored by the company and featured a reporter interviewing two company execs about Zepbound. Both segments, per the FDA, “[fail] to communicate any risk information” about the drug.
As with the untitled letters, the companies receiving warning letters were given 15 days to respond, with the FDA warning that “failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.”
The 40 newly released untitled letters mark the first posted by CDER since April and send the annual total skyrocketing compared to recent years; the regulator sent out five untitled letters in 2024, four in 2023 and just three in 2022. Warning letters for perceived marketing violations have been even fewer and farther between, with only one going out in 2023 and zero last year.
Last week, the FDA said it was in the process of sending out thousands of letters warning drugmakers to remove their “misleading ads” as well as 100 more severe cease-and-desist notices for those it deemed to be airing “deceptive ads.”
In Friday’s op-ed, Makary criticized the agency’s “weak enforcement” that saw its annual number of warning letters dwindle in recent decades.
“The FDA’s enforcement trajectory demonstrates a regulatory collapse over the past 25 years,” he wrote, adding, “We are taking action to correct decades of regulatory failure.”