Durbin, Marshall Urge FDA To Pre-Review Certain Direct-To-Consumer Drug Advertisements Prior To Being Aired

Durbin, Marshall Urge FDA To Pre-Review Certain Direct-To-Consumer Drug Advertisements Prior To Being Aired

Senators cite the rise of deceptive commercials for weight-loss medication which omit safety & risk information

CARBONDALE - U.S. Senate Democratic Whip Dick Durbin (D-IL) and U.S. Senator Roger Marshall, M.D. (R-KS) today sent a bipartisan letter to the Food and Drug Administration (FDA) to urge the agency to use its existing authority to require that certain direct-to-consumer (DTC) drug advertisements be submitted to FDA for pre-review, prior to being aired on TV. Currently, FDA does not require review of DTC ads prior to the airing of the commercials. In 2007, Congress provided FDA with the authority to require some DTC drug ads to undergo pre-submission, at which point the agency could make changes to correct false or misleading statements. FDA has never used this authority.

Since September 2025, FDA has sent more than 100 warning letters to both pharmaceutical manufacturers and telehealth companies for alleged false and misleading advertising. These letters reflect renewed scrutiny of how companies depict clinical efficacy and safety in their claims. From high cost GLP-1 medications to compounded drugs, Americans have increasingly been exposed to DTC advertisements, with more than $6 billion in annual spending from Big Pharma and telehealth companies.

The Senators wrote, "The airwaves are flooded with misleading pharmaceutical promotions. For some firms, airing a deceptive advertisement achieves its commercial aim of reaching customers, and any subsequent FDA enforcement (typically resulting in the cessation of such false or misleading advertising) may be considered an acceptable cost of doing business. The unsubstantiated claim or dangerous omission nevertheless shapes patient behavior and expectations."

The Senators continued, "FDA can enhance its regulatory oversight and more effectively restrict false and misleading pharmaceutical advertisements by being proactive and sending a message to bad actors. Specifically, we write to urge the agency to use its existing authority under 21 U.S.C. 353c to require certain advertisements to undergo pre-submission to FDA before dissemination. Under the law, FDA has the tools to seek changes on the front end, before patients are inundated with harmful content, to ensure information on side effects, contraindication, and effectiveness is appropriately conveyed. The use of this authority would be particularly critical for a class of high-risk products and those with the greatest population health impact."

Durbin and Marshall previously introduced the Protecting Patients from Deceptive Drug Ads Act, bipartisan legislation that would protect public health and close regulatory loopholes by having FDA address false and misleading prescription drug promotions by social media influencers and telehealth companies. Last year, Durbin and Marshall sent a bipartisan letter to FDA to draw the agency's attention to an a pharmaceutical advertisement that aired during the Super Bowl to more than 120 million Americans, which misled patients by omitting any safety or side effect information when promoting a specific type of weight loss medication.

The Senators concluded, "While almost every other country on earth prohibits DTC drug advertisements, American patients are bombarded with Super Bowl commercials and incessant social media advertisements about specific medications. In many instances, the advertised product is not even approved by FDA, or omits basic safety and side effect information, creating risk for patients. While the agency has yet to exercise its authority under 21 U.S.C. 353c, the current landscape and sheer volume of deceptive advertisements necessitate consideration of this gatekeeping tool."

Full text of the letter is available here and below:

March 31, 2026

Dear Commissioner Makary:

Thank you for your recent efforts to enhance the Food and Drug Administration's (FDA) enforcement activities against direct-to-consumer (DTC) pharmaceutical advertisements that fail to comply with statutory requirements to be truthful, not misleading, and balanced. Over the past six months, the FDA has issued hundreds of warning letters to manufacturers and telehealth platforms for false or misleading promotions in television commercials and social media. As authors of the Protecting Patients from Deceptive Drug Ads Act (S. 652), we applaud this renewed attention to protect public health.

However, as you have noted, the airwaves are flooded with misleading pharmaceutical promotions. For some firms, airing a deceptive advertisement achieves its commercial aim of reaching customers, and any subsequent FDA enforcement (typically resulting in the cessation of such false or misleading advertising) may be considered an acceptable cost of doing business. The unsubstantiated claim or dangerous omission nevertheless shapes patient behavior and expectations.

FDA can enhance its regulatory oversight and more effectively restrict false and misleading pharmaceutical advertisements by being proactive and sending a message to bad actors. Specifically, we write to urge the agency to use its existing authority under 21 U.S.C. 353c to require certain advertisements to undergo pre-submission to FDA before dissemination. Under the law, FDA has the tools to seek changes on the front end, before patients are inundated with harmful content, to ensure information on side effects, contraindication, and effectiveness is appropriately conveyed. The use of this authority would be particularly critical for a class of high-risk products and those with the greatest population health impact.

While almost every other country on earth prohibits DTC drug advertisements, American patients are bombarded with Super Bowl commercials and incessant social media advertisements about specific medications. In many instances, the advertised product is not even approved by FDA, or omits basic safety and side effect information, creating risk for patients. While the agency has yet to exercise its authority under 21 U.S.C. 353c, the current landscape and sheer volume of deceptive advertisements necessitate consideration of this gatekeeping tool.

Thank you for your attention to this matter, we look forward to working together.

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