Just 10 days after issuing its space-limited guidance that included a significant discussion of Google search ads, the Office of Prescription Drug Promotion (OPDP) issued a new letter to Gilead for a a paid search ad.
Here's the violative ad as posted by the FDA:
The infractions don't differ substantially from those cited in the landmark 2009 set of 14 letters for inappropriate paid search campaigns that in many ways began the current emphasis on the unique characteristics of space-limited contexts.
In those 2009 letters, multiple products were cited for three infractions:
1. Failure to use the required established name
2. Omission of risk information
3. Inadequate communication of indication
In addition, one product was cited for overstatement of efficacy.
The new letter includes again the omission of risk information and failure to use the required established name; however, this time the FDA cited a lack of adequate directions for use and a failure to submit under form 2253.
The failure to submit under 2253 is well understood.
The lack of adequate directions for use points to the inclusion of the word "prevention." Viread is currently approved for the treatment but not the prevention of hepatitis B.
As I mentioned previously, I'm working on a new article for the September issue of Regulatory Focus that will revisit Google paid search and pull together everything we have learned from the 2009 enforcement action, subsequent statements from the FDA, and the new draft guidance. This enforcement action definitely adds another piece to that puzzle.