Joco Today

U.S. Senators Roger Marshall and Dick Durbin have raised concerns about a pharmaceutical advertisement set to air during the Super Bowl, which they claim misleads viewers by omitting crucial safety and side effect information. The bipartisan letter addressed to the Food and Drug Administration (FDA) highlights the advertisement's promotion of GLP-1 weight loss medications without disclosing potential risks.

The FDA oversees direct-to-consumer pharmaceutical advertisements to ensure accuracy and balance, requiring disclosure of side effects, contraindications, and effectiveness. Failure to comply can result in enforcement actions, including fines.

The Senators stated, "An upcoming Super Bowl advertisement... appears to showcase a company’s ability to prescribe and dispense GLP-1 medications... However, nowhere in this promotion is there any side effect disclosure." They noted that FDA-approved labels for such medications include significant risk disclosures.

The ad reportedly exploits a loophole concerning compounded drugs promoted by telehealth companies. The Senators argue it falls under FDA jurisdiction and suggest forthcoming legislation to address gaps in prescription drug advertising regulations.

"We recognize the important roles that pharmaceutical compounding and telehealth play... However, we believe there should be no disparity in pharmaceutical advertising requirements," they wrote. They plan to introduce legislation if necessary but believe the FDA may already have authority for enforcement against misleading marketing practices.

A recent STAT News article mentioned Hims & Hers as the company behind the Super Bowl ad promoting GLP-1 weight loss medications.