The FDA is seeking new authority to hold companies accountable for misleading direct-to-consumer (DTC) advertising (PDF), adding legal weight to its opposition to deceptive drug advertising.
Last year, President Donald Trump ordered the FDA to require companies to provide balanced information about the benefits and risks of drugs in DTC advertising. Days later, the agency released a letter alleging violations of federal drug marketing regulations by companies including Bristol-Myers Squibb, Eli Lilly and Novartis. The FDA continues to send untitled letters to companies accused of violating regulations.
The FDA is currently using its fiscal year 2027 budget proposal to request new authority to regulate DTC advertising. “Additional powers are needed to more effectively address direct-to-consumer advertising, which often lacks fair balance and is misleading and confusing to consumers and patients,” the agency said.
The agency is asking lawmakers to change the law to allow drugs to be considered misbranded if DTC advertising lacks a “fair balance.” The proposed legislation would also affect advertisements that give a “misleading impression” about the approved indication for use or efficacy of a drug, such as by making or suggesting “unsupported exaggerations.”
The FDA has grilled companies in recent months for various alleged violations, reprimanding Novo Nordisk for having one actor wear a bright orange shirt and the other a dull gray shirt in an ad for Ozempic DTC, and tasking other drug companies with what they refer to as an “exploratory analysis.”
Other parts of the FDA’s proposal target compounded drugs. If passed, the requirement would require companies selling combination drugs to “clearly and conspicuously” disclose that the FDA has not approved or evaluated the safety, effectiveness, or quality of the products before they are marketed.
Failure to disclose information is one of several ways a company can have its products deemed misbranded by the FDA. Companies can also get into trouble for suggesting that a compounded drug is safe and effective without any evidence, making misleading comparisons to specific FDA-approved drugs or classes of drugs, or misrepresenting data based on clinical trials of approved drugs.
The call for lawmakers to clarify the rules for advertising compounded drugs comes at a time when the industry is filling a gap caused by a shortage of GLP-1 drugs. That period is now nearly over, with Hims & Hers’ recent decision to stop promoting its complex GLP-1 drug, leading to the recalcitrant telemedicine provider partnering with Novo Nordisk.
