After the FDA went on to state that it was taking on what it has understood to be misleading or deceptive direct-to-consumer pharmaceutical ads, the floodgates have gone on to open, and how?
In the first few days post the announcement, the agency went ahead and publicly shared only one of what it said happened to be thousands of letters informing the drugmakers of their alleged violations pertaining to federal pharma marketing rules – a sort of missive from the Center for Biologics Evaluation and Research (CBER) that took aim at a TV commercial for the self-administered FluMist vaccine from AstraZeneca.
Around midday on September 16, however, the Center for Drug Evaluation and Research (CDER) uploaded a flood of both warning letters, which were serious as well as untitled letters for public perusal.
It is well to be noted that the first batch comprises 40 untitled letters, all dated September 9, the same day the Trump administration unveiled its crackdown plans, and were inked by George Tidmarsh, M.D., Ph.D., the CDER Director.
Apparently, as FDA targets drugmakers, most of which received not one but multiple letters. At the top of the untitled heap happened to be five for AstraZeneca and another for its Alexion rare-disease-focused subsidiary, as well as three each for Boehringer Ingelheim, UCB, Phathom Pharmaceuticals, and Bristol Myers Squibb and Novartis.
Interestingly, Takeda, AbbVie, and Teva Pharmaceuticals, as well as Supernus Pharmaceuticals, each received a couple of letters, while Sanofi and Pfizer were among the ones who received one each.
It is worth noting that each of the untitled letters goes on to argue that a specific DTC ad looks to be false or misleading and hence, in a way, misbrands the drug it’s advertising. The companies are now given 15 days to formally respond to such allegations.
A scolding pertaining to one of the Kesimpta ads, from Novartis, for instance, takes issue with its attention-grabbing visuals, which may well distract from the major statement in terms of risks and side effects, along with the claim of the commercial that the multiple sclerosis med can be taken at home in just a minute a month, which, as per Tidmarsh, happens to be oversimplifying the steps that are actually involved.
On the other hand, all three of the letters to Boehringer concern a different one of the musical theater-themed Jardiance ads from the company. In each of the missives, the FDA went on to criticize the commercials for having fast-paced and compelling visuals with frequent scene changes and also background music for, in a way, stealing the attention of the viewers away from drug safety information.
It is well to be noted that the marketing-related warning letters, which were uploaded on September 9, number almost 70, although the majority target online pharmacies as well as the sellers of compounded drugs for which Marty Makary, M.D., the FDA Commissioner, pledged in a recent JAMA op-ed to extend the marketing crackdown due to their brazen advertisements of drugs having only the upsides mentioned.
Notably, eight of the warning letters that were sent to the pharma companies include three for Eli Lilly, two for Aytu BioPharma, and one each for Novo Nordisk, Alora Pharmaceuticals, and CSL Behring, the last of which did come from CBER and not the CDER, as it happens to concern Hizentra, the biologic med.
The warning letter to Novo is related to the Oprah Winfrey TV special on GLP-1 drugs, which was aired in 2024. The broadcast went on to feature a Novo executive along with a pair of doctors who were both paid consultants when it came to Big Pharma. As per the FDA, the special happened to include many representations pertaining to the benefits of Ozempic, Wegovy as well as Victoza that were made by Novo Nordisk representatives; however, it omits the significant risk information and in a way minimizes the risks of such drug products.
The three warning letters that were sent to Lilly, meanwhile, concern its own GLP-1 products, namely, Zepbound as well as Mounjaro. One happens to take aim at the same Oprah-led broadcast, which also had certain Lilly representatives. The other two are concerning the local TV news segments within Oklahoma City and Dayton, Ohio, each of which happened to be labeled as being sponsored by the company and at the same time featured a reporter interviewing the two company executives on Zepbound. Both the segments, as per the FDA, fail to actually communicate any risk information pertaining to the drug.
As for the untitled letters, the companies which were receiving the warning letters had been given 15 days to respond, with the FDA warning that the failure to address adequately any violations may well result in a legal action without any sort of further notice, which may include, without limitation, seizure and, for that matter, even injunction.
It is worth noting that the 40 newly released untitled letters go on to mark the first posted by the CDER since April 2025 and sent the annual total skyrocketing as compared to recent years. Apparently, the regulator sent out five untitled letters last year, four in 2023 and only three in 2022. The warning letters for perceived marketing violations have been fewer and farther between, with just one going out in 2023 and nothing in 2024.
Interestingly, as FDA targets drugmakers, it recently said that it was in the process of sending thousands of letters warning them to delist their misleading ads, with 100 more severe cease-and-desist notices for the ones who it deemed to be airing certain deceptive ads.
In the September 12, 2025, op-ed, Makary went on to criticize the weak enforcement of the agency, which has already seen its annual warning letters’ number dwindle in the recent decades.
He had written that the enforcement trajectory of the FDA goes on to demonstrate a regulatory collapse through the last 25 years and that they are taking action so as to correct the regulatory failure which has existed for decades.
