FDA reprimands Gilead for paid-search link
- Gilead received a letter from FDA on June 27 regarding what the agency considered a misleading paid-search link advertising use of Viread for treatment of hepatitis B.
- FDA notes that the content of the link was inconsistent with product labeling for Viread.
- The overall regulatory framework for pharma’s use of social media is still developing.
The link that lead to the letter from the FDA Office of Prescription Drug Promotion read “Hepatitis B Prevention.” FDA suggested that this link implies that Viread is both safe and effective for preventing hepatitis B, which is not reflected in the content of Viread’s Product Information. Another problem cited by FDA is the lack of communication about the risks associated with Viread and the related side effects.
The letter comes in the wake of draft guidance on social media and Internet communications about medical products issued by the FDA in mid-June.