Welcome to my 500th posting!
Yesterday the Government Accountability Office released a report related to a topic often discussed in this space – the lack of FDA enforcement, specifically with regard to DTC – entitled "Trends in FDA’s Oversight of Direct-to-Consumer Advertising". The serious slowdown in warning letters from DDMAC is something that has been on-going for some time. But the GAO report focuses squarely on DTC, and delivered its findings at the May 8 hearing on DTC before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations.
Essentially what was found is that while the number of advertisements increased, the number of warnings decreased. In addition, perhaps more surprising, is the length of time that the FDA took to issue a warning letter, especially after adding a legal review cycle in 2002 for all such letters being issued by the agency. According to the report, the slowdown resulted in the fact that "[b]y the time the agency issued regulatory letters, drug companies had already discontinued use of more than half of the violative advertising materials identified in each letter."
I have often wondered why, when PDUFA dollars have increased for the agency, the enforcement level has subsided.
It was a very damning report and will doubtless inform the coming reforms aimed at DTC.