The FDA is seeking (PDF) new powers to hold companies accountable for misleading direct-to-consumer (DTC) ads, adding legislative weight to its pushback against deceptive drug advertising.
Last year, President Donald Trump ordered the FDA to ensure companies provide balanced information on the benefits and risks of drugs in DTC ads. Days later, the agency published letters alleging violations of federal pharma marketing rules by companies including Bristol Myers Squibb, Eli Lilly and Novartis. The FDA has continued to send untitled letters to companies accused of breaking the rules.
Now, the FDA has included its 2027 budget proposal to request new powers to regulate DTC ads. The agency said it “needs additional authorities to more effectively address DTC advertising that lacks fair balance and is frequently misleading and confusing to consumers and patients.”
The agency wants lawmakers to update legislation so that it can deem drugs misbranded when a DTC ad lacks “fair balance.” The planned law would also affect ads that create “a misleading impression” about the approved indications for use or the drug’s efficacy, including by making or suggesting “overstated representations that are not supported.”
The FDA has dinged companies for a wide range of alleged violations in recent months, chiding Novo Nordisk for dressing one actor in a bright orange shirt and another in dull gray in an Ozempic DTC ad and taking other drugmakers to task for referencing “exploratory analyses.”
Other parts of the FDA’s proposal target compounded drugs. If the request is enacted, companies that market compounded drugs will need to “clearly and prominently” disclose that the FDA hasn’t approved or evaluated the products for safety, effectiveness or quality prior to marketing.
Failing to make the disclosure is one of several ways that companies could cause the FDA to deem their products misbranded. Companies could also get into trouble for suggesting compounded drugs are safe and effective without any evidence, making misleading comparisons to a particular FDA-approved drug or class of drugs and misrepresenting data based on clinical trials of authorized medicines.
The call for lawmakers to clarify the rules on advertising compounded drugs follows a period in which the sector filled gaps created by the shortage of GLP-1 medicines. That period is now largely over, with Hims & Hers’ recent decision to stop promoting compounded GLP-1 drugs bringing a holdout telehealth provider into partnership with Novo Nordisk.
