The US Food and Drug Administration (FDA) has followed up on its promise to clampdown on misleading and deceptive drug advertisements in the US, with the agency publishing a large batch of warning letters sent to pharmaceutical companies.
During the announcement of its enforcement drive against unlawful direct-to-consumer (DTC) ads, the FDA said it was in the process of sending out “thousands” of letters to pharma companies and vendors in breach of legislation.
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On 16 September, the FDA published a long list of serious warning letters it has sent to companies accused either of unlawfully selling unapproved or misbranded drugs or of making false and misleading claims, part of a clampdown on drug advertisements.
Amongst those falling foul of the former classification is Hims & Hers, an online telehealth platform singled out by FDA chief Marty Makary in a viewpoint published in the peer-reviewed medical journal JAMA. Hims & Hers sells compounded semaglutide products with various claims that the FDA says are illegal.
In the latter category, several big pharma companies are implicated. Eli Lilly was sent three warning letters about its glucagon-like peptide-1 receptor agonist (GLP-1RA) tirzepatide, known under the US brand names Mounjaro and Zepbound for type 2 diabetes treatment and weight loss, respectively. Two were for online videos posted on local news websites in the US, and a third was linked to an Oprah Winfrey special programme on weight loss drugs from March 2024.
Novo Nordisk was also sent a letter that referenced the same segment produced by Oprah Winfrey’s show. The FDA said the drug advertisement video did not fairly demonstrate the safety risks of the weight-loss drug Wegovy (semaglutide).
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By GlobalDataCSL Behring, meanwhile, was taken to task for its DTC television ad that “overstates the effectiveness and minimises the information about the safety” of immunodeficiency treatment Hizentra (immune globulin subcutaneous). Aytu BioPharma and Alora Pharmaceuticals rounded off the eight warning letters sent to pharma companies.
Many companies on the warning letter list are online pharmacies and vendors selling compounded semaglutide and/or tirzepatide products. The FDA no longer allows the production of compounded GLP-1RAs, though companies are exploiting regulatory legislation that allows offering the drugs under personalised regimen plans. The hardening of the FDA’s stance on misleading advertising signals an increased enforcement effort against compounders.
Meanwhile, a swathe of untitled letters, dated 9 September, implicate AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Novartis, and Takeda, amongst others. Untitled letters are used for violations that do not meet the threshold for a proper warning.
In Boehringer’s case, the company was accosted for the “fast-paced” nature of its ads for Jardiance. This, combined with “compelling” visuals and “frequent scene changes”, could distract viewers from the safety risks of the cardiovascular medication, the FDA claims.
Makary has described the current state of direct-to-consumer pharmaceutical drug advertising as a “public health crisis” in the US.
A report by non-profit Public Citizen backs this claim, demonstrating that the manufacturers of the first 10 drugs selected for Medicare price negotiation, in aggregate, spent $10bn more on “self-enriching activities” than on research and development in 2022.
Following the news last week of the FDA enforcement drive on drug advertisements, law firm Ropes and Gray said that pharmaceutical companies “face significant uncertainty about how to respond to FDA’s new letters and directives”.
