Senators Marshall, Durbin Put FDA on Notice for Misleading Drug Commercial Set to Run During Super Bowl

Washington, D.C. – U.S. Senators Roger Marshall, M.D. and Dick Durbin (D-IL) sent a bipartisan letter to the Food and Drug Administration (FDA) to draw the agency’s attention to an upcoming pharmaceutical advertisement that is slated to air during the Super Bowl on Sunday to more than 120 million Americans, which misleads patients by omitting any safety or side effect information when promoting a specific type of weight loss medication.

FDA regulates direct-to-consumer (DTC) advertisements for pharmaceuticals to ensure they are not false or misleading, by disclosing side effects, contraindications, and effectiveness information to the public. Under federal law and regulations, the FDA requires that prescription drug advertisements be truthful, not misleading, and balanced—failure to do so risks FDA enforcement action, including civil monetary penalties.  

The Senators wrote, “An upcoming Super Bowl advertisement, which has been publicly posted online, appears to showcase a company’s ability to prescribe and dispense GLP-1 medications to patients, including with text and claims about weight loss drugs, and imagery of an injection pen with distinctive characteristics reflective of an existing brand-name medication. However, nowhere in this promotion is there any side effect disclosure, risk, or safety information as would be typically required in a pharmaceutical advertisement.”

“By comparison, the FDA-approved labels and advertisements for brand-name GLP-1 medications include significant risk disclosures to patients about side effects and contraindications, such as warnings about potential gallbladder, pancreas, vomiting, diarrhea, and other implications. Further, for only three seconds during the minute-long commercial does the screen flash in small, barely legible font, that these products are not FDA-approved,” the Senators continued.

The advertisement appears to be exploiting a perceived loophole in federal law regarding the promotions of compounded drugs by telehealth companies. However, the Senators’ letter argues this advertisement does fall under FDA’s jurisdiction, and previews legislation that will soon be introduced to close any gaps regarding prescription drug advertising.

The Senators continued, “We recognize the important roles that pharmaceutical compounding and telehealth play in the health care delivery system, helping to ensure access to FDA-approved products and filling a need for more customized treatments. However, we believe there should be no disparity in pharmaceutical advertising requirements between regulated entities.”

“To the extent this falls within a regulatory loophole for the FDA’s authorities, we plan to soon introduce bipartisan legislation to close this gap, so that patients are not deceived by advertisements that glaringly omit critical safety and side effect information. But, we believe FDA may already have the authority to take enforcement action against marketing that may mislead patients about this company’s products,” the Senators concluded.Recently, a STAT News article highlighted the direct-to-consumer telehealth company Hims & Hers, which will air a Super Bowl ad promoting its GLP-1 weight loss medications.