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FDA Sends Warning Letters to Novo Nordisk, Eli Lilly, and Hims Regarding Misleading Pharmaceutical Advertising
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Key Takeaways
- The FDA issued warning letters to pharmaceutical companies for misleading drug advertisements, following an executive order to enhance transparency in direct-to-consumer advertising.
- Eli Lilly and Novo Nordisk were cited for downplaying risks in media interviews, while Hims was criticized for misleading claims on its website.
FDA warns major pharmaceutical companies to improve transparency in drug advertising, addressing misleading claims and enforcing stricter regulations.
The letters were issued as part of President Trump’s order to crack down on misleading drug advertisements.
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FDA issued warning letters to multiple pharmaceutical and drug manufacturing companies, including Eli Lilly and Company, Novo Nordisk, and Hims and Hers Health last week to adhere to President Donald Trump’s order to “crack down” on misleading pharmaceutical and drug advertisements. FDA’s website displays a plethora of letters issued on September 9 to a variety of companies that produce or distribute weight-loss drugs. On the same date the letters were issued, President Trump signed an executive order focusing on disclosing direct-to-consumer prescription drug advertising, with the order calling for FDA to step-up its enforcement laws regarding misleading or false advertisements.
What did the letters include?
FDA’s letter to Eli Lilly and company, directly cited three media interviews, including its appearance on the Oprah Winfrey back in 2024. According to regulators, company representatives discussed both Zepound and Mounjro yet omitted or understated the box warnings and other additional safety and risk warnings.
In the letter to Novo Nordisk, FDA cited the same Oprah Winfrey interview, in which the agency claims Novo presented Wegovy and Ozempic’s benefits while minimizing and downplaying the risks associated with the treatment. FDA also included cited failures of submission for material review.
Reported by Reuters, a Lilly spokesperson said the FDA's letter referred to interviews conducted by independent media, over which the company had no editorial control and did not consider them advertisements.1 Meanwhile, the letter issued to Hims, included a review of the company’s website, citing false or misleading claims regarding its compounded semaglutide products, which are the active ingredients in both Ozempic and Wegovy.
FDA Commissioner Marty Makary touched on the topic last week, saying that companies need to present a balanced view of drugs and comply with advertising rules, such as including the medications entire list of side effects.1 Makary continued to say, FDA is planning to send upwards of 100 cease-and-desist notices, along with thousands of letters.
Is there an issue with direct-to-consumer advertising?
According to the new administration, pharmaceutical companies have exploited weak enforcement from FDA on false advertainment laws for the past three decades, often giving consumers misleading information through promotional content. As of today, the U.S. is just one of two countries permitting direct-to-consumer advertising and was heavily impacted back in 1997 when an FDA regulatory change altered the advertisements allowing them to become more widespread through relaxed restrictions. Within a decade of the regulatory change, pharmaceutical spending increased upwards of 800% on advertisements, and officials have accused many of creating a misleading impression.2
According to the Federal Food, Drug, and Cosmetic Act, FDA is responsible for regulating prescription drug ads, ensuring they represent a “fair balance” of risks and benefits while also not forming a “misleading impression” on consumers. The agency is currently under transition from a reactive complaint-driven oversight, to a more proactive monitorization of all pharmaceutical advertising. The impact of direct-to-consumer advertising also effects patient prescriptions. As a systematic review conducted in 2021 yielded results reflecting how direct-to-consumer advertising increases overall prescription requests, along with boosting the chances of prescription from a clinician. It also increases rates of inappropriate use, such as leading physicians prescribing medications requested by patients, despite prescribers questioning the clinical appropriateness.2
Sources
- U.S. FDA sends drug advertising warning letters to Lilly, Novo, Hims Reuters September 16, 2025https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-sends-drug-advertising-warning-letters-lilly-novo-hims-2025-09-16/
- The FDA’s Overdue Crackdown on Misleading Pharmaceutical Advertisements Jama Network September 12, 2025 https://jamanetwork.com/journals/jama/fullarticle/2839061
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