The FDA's Division of Drug Marketing, Advertising and
Communications issued 21 warning and untitled letters in 2008 – scarcely more
than the 20 letters the unit sent out in 2007.
As in 2007, 10 were “warning letters,” the remainder being of
the somewhat less serious “untitled” variety.
In 2006, DDMAC issued 22 letters reprimanding drug
manufacturers for promotional materials deemed violative of the Food, Drug and
Cosmetics Act, typically for overstating efficacy and/or underplaying risks, but
14 of those were warning letters.