FDA Issues Letter to Gilead Calling for Removal of Sponsored Links
July 8, 2014 | In mid-June, FDA released two draft guidances on how companies should deal with social media and sponsored links. Now the Agency has issued a letter to Gilead Sciences requesting that the company discontinue use of a sponsored Google link for Gilead's Viread, an FDA-approved treatment for chronic hepatitis B, because the links constitute misbranding under the Federal Food, Drug, and Cosmetic Act.
The FDA's guidance for sponsored links includes instruction that benefit information should be accurate and non-misleading, and should be accompanied by risk information. In Gilead's case, the FDA contends that the sponsored link suggests that Viread would be effective as a treatment for Hepatitis B, and that any risk information is omitted. The FDA also takes issue with the fact that the "required established name" of the drug (tenofovir disoproxil fumarate) was not used.
Gilead has until July 11 to respond to the FDA's letter, "explaining your plan for discontinuing of such materials."
The two draft guidances were posted on June 18 to to Regulations.gov, launching a 90-day comment period. As of this writing, the two guidances together had received 5 total comments.
