(x-posted from Spark Blog)
The FDA has released a warning letter to AMAG Pharmaceuticals for failing to include appropriate risk information and accurate product claims on webpages for its GastroMARK® and Feraheme® products. Although each page includes a link to the full package inserts, this does not adequately fulfill fair balance requirements. Drug companies can avoid this in the future by ensuring that all risk information is presented alongside product claims, and by submitting all promotional material to DDMAC before publication.
Download the Perspective (pdf)