Showing no signs of slowing down, Food and Drug Administration’s (FDA’s) Division of Drug Marketing, Advertising and Communications (DDMAC) issued two more enforcement letters to pharmaceutical companies for unlawful promotion. The Untitled Letter challenged a convention panel as misleading, because it broadened the approved drug product’s indication and made unsubstantiated superiority claims. The Warning Letter cited another company’s product-specific web pages for omitting risk information, not including important indication information, and promoting unapproved uses. The company also failed to submit the websites to DDMAC on Form 2253, as required by law. In the Warning Letter, DDMAC specifically cited public health concerns raised by broadening the product’s indication or claiming safety when not demonstrated by substantial evidence or substantial clinical experience.
Click the link below to read the full alert.