http://www.usatoday.com/news/health/2007-06-11-fda-drugmakers_N.htm?csp=34FDA called 'cozy' with drugmakers
By Rita Rubin, USA TODAY
While revising their drug-review policy last year, Food and Drug Administration officials met 112 times with industry representatives but only five times with consumer and patient groups, according to data out Monday from the House Appropriations Committee.The FDA provided the data in response to questions submitted in March by Rep. Maurice Hinchey, D-N.Y.
The meetings occurred between October 2005 and December 2006 and focused on the Prescription Drug User Fee Act, under which manufacturers help pay for the review of their new drugs.
The House Energy and Commerce Subcommittee on Health today is to discuss reauthorization of the measure; the House Appropriations Subcommittee on Agriculture, of which Hinchey is a member, is to debate the FDA's 2008 budget.
"The FDA has essentially become the government affairs office of the pharmaceutical industry," Hinchey said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate." Hinchey is the author, and Bart Stupak, D-Mich., the chief co-sponsor of an FDA reform bill that would prohibit the agency from collecting fees from the companies it regulates. Instead, the money would be deposited into the general fund of the U.S. Treasury.
According to the Appropriations Committee, two officials of the Biotechnology Industry Organization and two officials of the Pharmaceutical Research and Manufacturers Association attended at least half of the 112 meetings.
In a statement, the FDA's Susan Cruzan said the agency faced a number of technical problems to be resolved before submitting the proposal. The FDA had "extensive discussions" with the industry about financing, marketing and infrastructure. She added that the agency also met with consumer groups and that each meeting followed the law's requirements.