|
Washington, D.C. - Deeply concerned about the Food and Drug Administration's (FDA) inappropriate, cozy relationship with the pharmaceutical industry, Congressman Maurice Hinchey (D-NY) today formally called for a complete overhaul of the Prescription Drug User Fee Act (PDUFA). With the FDA holding a public hearing today on the reauthorization of PDUFA, Hinchey submitted a statement for the record in which he criticized the measure's current form because it causes the FDA to be financially dependent on the drug industry, thus prohibiting the agency from fairly examining prospective drugs. Hinchey offered an alternative proposal that would free the FDA of its financial link to drug companies.
"As a result of PDUFA, the FDA now depends on fees directly from the drug industry for its financial survival and, as a result, has become far less accountable to the needs and concerns of the American people and more and more beholden to the drug industry," Hinchey said. "When you look at PDUFA, the inadequacies of the measure jump right out at you. It's unacceptable that the drug companies directly pay the FDA to review their products and that the agency also has to negotiate with those companies over how it will go about the review process. The conflict of interest here is glaring. We need to completely revamp the way the FDA does business because right now the agency treats drug companies like clients rather than regulated entities. The FDA's only 'client' should be the American people."
PDUFA is set to expire in September 2007, which is why the FDA is beginning the process of examining ways to renew it. In 2001, fees paid by drug companies funded 32 percent of the FDA's budget for drugs. Today, that figure is nearly 50 percent and it is expected to grow higher. Making matters worse, the FDA must negotiate with the drug industry over how those user fees are allocated. This financial dependency, along with the FDA's constant negotiations with drug companies over how to spend their fees, is the foundation of the cozy relationship that exists today between FDA and the pharmaceutical industry.
To restructure PDUFA and create independence at the FDA, Hinchey said Congress should adopt his FDA Improvement Act (FDAIA), which he introduced in the House in May. Among many other things, Hinchey's bill would prohibit the FDA from collecting fees paid by companies it regulates. Instead, those funds would be deposited into the general fund of the Treasury. The FDA would then receive its funding from the Treasury rather than the drug companies. In an effort to ensure there is no reduction in FDA services as a result of the loss of those fees, Hinchey's measure provides mandatory funding levels. By doing so, the FDA would be fully funded by and accountable to the U.S. taxpayers, instead of drug manufacturers.
"By separating drug company user fees from the FDA and putting an end to negotiations between the agency and drug companies over how those fees can be used, we would create a firewall that would provide the FDA with the independence it needs to effectively do its job," Hinchey said. "The health and safety of the American people must be our primary focus with the reauthorization of PDUFA. Right now, the American people are not well served because the FDA is too dependent on drug companies for its own survival. That must change."
Hinchey's FDAIA is a sweeping reform bill that would end the financial link and inappropriately close relationship between the drug industry and the FDA, eliminate conflicts-of-interest on FDA advisory committees, and vastly improve the agency's post-market drug safety operations.
###
The full text of Hinchey's public comments on the reauthorization of PDUFA follows:
November 14, 2005
To Whom it May Concern:
As the Food and Drug Administration (FDA) takes its first steps toward a 2007 reauthorization of the Prescription Drug User Fee Act (PDUFA IV), I respectfully submit the following comments regarding the future of this law.
I am alarmed by the cozy relationship that exists between the drug industry and the Food and Drug Administration; a relationship whose existence can be directly attributed to the existence of the Prescription Drug User Fee Act. Consequently, I do not believe that there should be a PDUFA IV. Instead, Congress must enact comprehensive reform to the way in which we fund the FDA's budget for drugs.
In May, I introduced the Food and Drug Administration Improvement Act of 2005 (FDAIA, or H.R. 2090). This legislation proposes to prohibit the FDA from collecting fees paid by the industries it regulates, and would instead direct those monies to the U.S. Treasury General Fund. The measure would then establish a mandatory funding stream to support those FDA activities currently covered by legislation like PDUFA, ensuring that the agency's work would continue uninterrupted despite the
funding change.
I believe that the FDAIA is necessary because of the following serious problems that exist within PDUFA's structure:
· The Food and Drug Administration depends upon drug companies for PDUFA fees, making the agency beholden to one of the industries it exists to regulate. As a result, the FDA treats pharmaceutical developers as "clients," when it should only have one true "client" - the American people.
· During each reauthorization of PDUFA, the Food and Drug Administration is required to negotiate with drug companies on how these fees will be spent. Not only does this process further strengthen the inappropriate relationship between agency and industry, but it also enables the drug companies to push for rapid turnaround of new drugs at a pace that simply is not manageable.
· In fact, its negotiation of schedules for drug review is forcing the FDA to pile excessive work on its investigators, who in turn become overburdened and overworked. As result, more and more of this crucial work is back-loaded on post-market drug studies.
PDUFA is simply not in the best interests of American consumers, the federal government, or the drug industry. Congress must act to reverse the inappropriate relationships that exist between the FDA and its regulated companies today. That is why I will oppose PDUFA IV, and fight for the FDA Improvement Act, during this round of negotiations.
Thank you for your attention to my comments. If you are in need of additional information, your staff may be in touch with Moira Campion of my office at (202) 225-6335.
Sincerely,
Maurice D. Hinchey
|
