In initial statements concerning the enforcement priorities of FDA, Commissioner Hamburg noted that enforcement letters would no longer be required to be reviewed by the Office of Chief Counsel (OCC), and that additional letters would be issued by FDA when corrections in response to warning letters were deemed sufficient by the agency. The bureaucratic response to these initiatives seems to be DDMAC's increasing reliance on untitled letters (notice of violation or "NOV" letters). Those letters generally do not require OCC review, or the need to notify sponsors when corrective actions are deemed sufficient. In the past months, DDMAC issued considerably more NOVs than warning letters. NOVs are generally used when the perceived violations are relatively minor and do not warrant use of a warning letter. DDMAC NOVs are also now being posted publicly on the FDA Web site alongside warning letters.

Details of Recent Letters

Recently posted letters related to advertising and promotion have criticized the following uses of risk information:  

  • Font size of risk information was smaller than for efficacy information.  
  • The statement "see full Prescribing Information" was insufficient.  
  • Including the "Brief Summary" on an advertisement's second page was insufficient to provide appropriate qualification for claims made on the first page.  
  • Risk information was insufficient if it was located lower on the first page than claims, or if it was backed by colors, not bolded or included topical headlines similar to claims.  
  • Internet advertisements must contain risk information upfront in the copy, and cannot rely on icons on the bottom of each screen or page linked to the package insert.