FDA Seeking MORE Money From Drug Industry
September 21, 2006
The FDA is negotiating with the drug industry over a possible user fee increase which, if it goes through, would give the industry even more in setting the goals and priorities of its supposed regulator.
Industry user fees were first introduced in the early 1990s in an effort to help speed up the FDA's approval process; prior to that, the FDA had been funded entirely by Congress.
But steadily rising payments have led to drug makers funding more than half of the FDA's drug review process, giving them immense clout in determining how the agency is run.
Drug makes renegotiate the fees with the FDA every five years, meaning they can have a great deal of input regarding which programs will receive funding. Regulatory agencies do not normally need to negotiate their budget with the industries they oversee.
In 1993, $8.9 million of user-fee money accounted for 7 percent of the FDA's drug review budget. By 2004, the amount had risen to $232 million and 53 percent of the drug review budget.