• FDA Will Step Up Inspection of Drug Ads
  • April 17, 2008
  • Law Firm: Manatt, Phelps & Phillips, LLP - Los Angeles Office
  • The Food and Drug Administration has received $6.1 million for the current fiscal year to review direct-to-consumer drug ads.

    The amount is more than in the previous five years combined. In 2007, the agency had $2.2 million to scrutinize drug ads and in 2006, just $1 million.

    For years, the FDA has been so flooded with drug ads that it is able to review only a “small portion,” according to a 2006 report by the Government Accountability Office. Last year, there were 12,616 drug ads for the FDA to review. Even when the agency did find ads false or misleading, it was not until well after the ad campaigns were completed, the GAO said. The FDA says it intends to use the extra money to increase hires to review ads. Currently, there are 13 FDA employees examining DTC drugs ads.

    The White House hopes to convince Congress to authorize industry user fees for drug ad reviews. The program did not pass this year because of funding concerns and resistance from some members of Congress. In its proposed 2009 budget sent to Congress last month, the White House is trying again, requesting $14 million in fees to pay for 27 employees dedicated to DTC ad reviews. The FDA would be required to examine TV drug ads within 45 days of receiving them from pharmaceutical companies and before the ads are aired.

    Opponents of user fees argue that Congress should give the FDA a direct appropriation to minimize industry influence in the agency.

    Pharmaceutical Research and Manufacturers of America, the biggest industry trade association, backs user fees. The FDA currently gets user fees to examine new human and animal drugs and medical devices. In Bush’s proposed budget, 25% of the FDA’s budget would come from fees paid by industries that the FDA regulates.