The Food and Drug Administration recently issued a Warning Letter to a pharmaceutical company based on a consumer-directed patient testimonial DVD, which was also included on the company’s webpage. While the Warning Letter is publicly available, we will not identify here the company or prescription drug product. FDA contended that the promotional DVD, which included basketball legend, Earvin “Magic” Johnson, misbranded the product by minimizing the drug’s serious risks, overstating its efficacy, and including unsubstantiated claims. The product labeling included with the DVD was also outdated. It is noteworthy that FDA previously sent the company an untitled letter for a print ad and poster for the same drug. FDA required the company to issue corrective information.
Click the link below to read the full alert.