Don't be surprised if your patients are not only deluged with drug ads, but pumped full of misinformation, too. With direct-to-consumer drug advertising volume already hitting $4.2 billion per year--and growing at 20 percent per year--the FDA has too few resources to respond to ads that violate its rules, according to a new report from the Government Accountability Office. According to GAO research, between 2002 and 2005 it took FDA staffers an average of four months to get out warning letters or related correspondence to pharmacos who violated advertising rules. Legal review of the letters seems to be the bottleneck. Between 1997 and 2002, before FDA lawyers began reviewing the letters routinely, it took only two weeks to issue the warnings, and the agency was issuing twice as many warnings as it does today. Sheer man (and woman) power is also an issue. The agency must screen approximately 10,000 ads and Web sites per year, a number which has doubled in the last four months alone, but has only six staff members dedicated to the process.
Get more background on this issue:
- read the GAO's report [1]
Links:
[1] http://www.fiercebiotech.com/node/4951