Drug Industry Had Large Role in User Fee Bill
FDA officials over 15 months met 112 times with pharmaceutical industry representatives and only five times with consumer and patient advocacy groups to discuss the development of a proposal for legislation to reauthorize the Prescription Drug User Fee Act, according to data released on Monday by the House Appropriations Committee, USA Today reports.
According to the committee, two officials from the Biotechnology Industry Organization and two officials from the Pharmaceutical Research and Manufacturers of America attended at least half of the 112 meetings, which occurred between October 2005 and December 2006 (Rubin, USA Today, 6/12).
Congress has begun to consider legislation to reauthorize PDUFA that in large part follows the FDA proposal and also includes a number of prescription drug safety provisions. The Senate passed a version of the bill last month, and the House Energy and Commerce Health Subcommittee has scheduled a hearing for Tuesday on a different version of the legislation (Washington Post, 6/12).
FDA provided the data on the meetings in response to questions submitted in March by Rep. Maurice Hinchey (D-N.Y.). Hinchey in a statement said, "The FDA has essentially become the government affairs office of the pharmaceutical industry." He added that the relationship between FDA and the pharmaceutical industry is "far too cozy and inappropriate."
However, Susan Cruzan, a spokesperson for FDA, said that the agency had "extensive discussions" with pharmaceutical representatives about the proposal for legislation to reauthorize PDUFA to resolve a number of technical problems and that all of the meetings complied with federal law (USA Today, 6/12).
Pharmaceutical and advertising industry lobbyists "who thwarted attempts in the Senate to rein in drug advertising" as a provision in the bill to reauthorize PDUFA "now turn their attention to the House," which plans to consider the legislation on Tuesday, the Boston Globe reports.
The Senate version of the legislation originally included a provision that would have allowed FDA to require pharmaceutical companies to wait two years before they aired advertisements for new medications, but senators later replaced the provision with a measure that would allow the agency to fine companies for false or misleading ads.
As the House begins to consider a different version of the bill, pharmaceutical and advertising industry lobbyists hope to eliminate a provision from the legislation that would allow FDA to require pharmaceutical companies to wait three years before they air advertisements for new medications (Henderson, Boston Globe, 6/12).