The FDA's ad-screening division has been issuing warning letters at a feverish pace, one side effect of more enforcement-minded leadership at the agency. But FDA officials say they're so poorly staffed, they can't keep up with the thousands upon thousands of promotional materials drugmakers produce each year.
"We do review the ads and can take action when we think there are misrepresentations or inadequate presentation of risks, but the volume makes it very, very difficult," FDA Commissioner Margaret Hamburg has said (as quoted by Reuters). "The fact is: we don't review them, sign off, and then they go up." Indeed, DDMAC official Thomas Abrams says he has 57 staffers to review some 75,000 promos. Obviously, they can't get to them all, so they have to prioritize.
As Reuters points out, it's not just short staffing that's the problem. FDA reviewers look at TV and Internet ads on paper, in storyboard form; they don't have the technology to accept digital submissions.
And the FDA is behind the times online in another way--establishing guidelines for drug companies' digital promotions. It has gathered input from industry and other experts, but hasn't yet issued any rules. Abrams tells the news service that they're coming later this year.
- check out the Reuters story