Flood of warning letters follows DTC ad clampdown
FDA Commissioner Dr Marty Makary, announcing the action on pharma ads on social media.
The FDA has lost no time following through on its pledge to tighten up direct-to-consumer (DTC) advertising of medicines, sending dozens of letters to drugmakers reprimanding them for not meeting standards.
One letter – taking AstraZeneca to task for a DTC ad for its FluMist flu vaccine – was shared shortly after the regulator's announcement last week. Now, dozens of untitled letters and potentially more serious warning letters have been sent out by the agency.
Drugmakers including Eli Lilly, CSL Behring, and Novo Nordisk, are among the list of companies with warning letters from the FDA's Center for Drug Evaluation and Research (CDER) in the latest drop, although, the bulk of them have been sent to online pharmacies and compounding pharmacies, many of them promoting GLP-1 agonist-based drugs for weight loss.
Lilly has been sent three warning letters about its GLP-1 therapy Zepbound/Mounjaro (tirzepatide), two for DTC online videos posted on local news websites and a third for material aired during an Oprah Winfrey special on GLP-1 drugs last year.
Novo Nordisk's letter refers to the same Oprah Winfrey show and its GLP-1 weight-loss drug Wegovy (semaglutide), while CSL Behring has been given a warning for a broadcast ad concerning its immune globulin product Hizentra, which the FDA said overstated its efficacy and minimised safety information.
Among the compounders getting a warning letter is Hims & Hers, which FDA Commissioner Marty Makary singled out in a recent editorial for advertising the benefits of GLP-1 drugs "without any mention of side effects or disclaimers."
Meanwhile, the long list of untitled letters – an initial communication from the FDA that identifies violations that don't meet the threshold for a full-blown warning – features multiple entries for AbbVie, AZ, Boehringer Ingelheim, Bristol Myers Squibb, Lilly, Novartis, Phathom Pharma, Supernus Pharma, Takeda, Teva, and UCB.
The letters are all dated 9th September – the day the new policy was announced – and are signed by CDER Director George Tidmarsh.
When the new policy was announced by the Department of Health and Human Services (HHS), which oversees the FDA, it was made clear that a key part of the reform is to close a loophole in the law – introduced in 1997 – that allowed companies to "merely footnote" safety and other information like contraindications via links to webpages and toll-free phone numbers.
Makary has said that, as a result, many drug ads are misleading, distort the doctor-patient relationship, and help drive demand for medicines "regardless of clinical appropriateness."
