Viewers of the Super Bowl may have seen an ad from one of the largest compounders in the United States, Hims & Hers, promoting its GLP-1 medications. PhRMA has raised concerns that the million-dollar ad misrepresents the GLP-1 medications promoted and compounded by Hims & Hers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) which requires that prescription drug advertising – including advertising for compounded drugs – not be false or misleading.
One example of misrepresentation is that the ad doesn’t include information about the risks and side effects associated with the compounded GLP-1 drugs that are displayed in the commercial and marketed by Hims & Hers. The ads shows vials and pills, apparently the compounded GLP-1 products, and includes benefit claims (i.e., describing the products as “life changing weight-loss medications” and “doctor trusted”) but fails to include any safety or risk information to balance the benefit claims. The inclusion of potential benefits and exclusion of potential risks presents a misleading impression that the unapproved compounded GLP-1 drugs are safe and effective.
The ad also claims that the GLP-1 drugs compounded by Hims & Hers are safe and effective, without evidence of such. Compounded products don’t undergo the same extensive Food and Drug Administration (FDA) review for safety and effectiveness, and Hims & Hers compounded GLP-1s haven’t undergone any major clinical studies to substantiate the claims of safety and effectiveness. Therefore, absent proof and data, the claims of safety and effectiveness are unsubstantiated, misleading, and deceptive.
Along those lines, PhRMA points that the ad does not “clearly and prominently disclose” that the FDA has not approved or evaluated the compounds. While the ad does include a brief disclosure that compounded drugs are not evaluated by the FDA (and therefore, not FDA-approved), the text is small and may be missed by viewers. This may mislead patients to believe that the products are FDA-approved – or at the very least, reviewed by the FDA for safety, effectiveness, and quality. Under FDA requirements, text and disclosures in pharmaceutical ads must be easy to read. Similar requirements do not apply to compounded drugs.
PhRMA also pointed that the Alliance for Pharmacy Compounding recently released “Best Practices for Marketing Compounded Medications,” which state that unless drugs are FDA-approved for a specific use, they should not be promoted as being “safe and effective for treating that condition.” The best practices document also goes so far as to say, “complying with all state and federal laws governing marketing and advertising of pharmaceutical products, including compounded medications, is an essential way you protect the credibility not only of your pharmacy but the entire compounding profession.”
The best practices also calls for compounders to not engage in false or misleading claims, saying “unless a drug is approved by the FDA to treat a specific condition, it cannot be promoted as safe and effective for treating that condition.” It also states that compounders that advertise may want to consider a statement such as, “Compounded medications are prepared at the direction of your healthcare provider and are not approved by the FDA.”
PhRMA is using the advertisement as a call to action for federal and state regulators to engage in oversight over compounders, including implementing requirements for advertising to not mislead patients.