THURSDAY, Jan. 11, 2007 (HealthDay News) -- The U.S. Food and Drug Administration asked Thursday for a substantial increase in annual fees paid by the pharmaceutical industry, money the agency uses to help test new drugs prior to their approval.
If the request is authorized by Congress, the yearly fees would rise $87 million, nearly 29 percent, to $393 million.
"This will allow FDA to significantly broaden and upgrade drug-safety programs, provide timely and rigorous review of television drug advertisements submitted to us for comment, and bring new medications to the American public in a careful, efficient manner," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said at a Thursday teleconference.
The user fee program was first authorized by Congress in 1992 as part of the Prescription Drug User Fee Act (PDUFA) and has to be reauthorized by Congress every five years. According to the FDA, the addition of the drug industry money has allowed the agency to speed the review process for new medicines and increase the oversight of post-marketing safety of approved drugs.
But critics found fault with the FDA's proposal to expand the pool of drug-industry fees.
"I'm not entirely pleased with the whole PDUFA approach, as it really causes the FDA to be strongly beholden to the pharmaceutical industry for financial support, which creates a relationship which doesn't necessarily result in optimal vigilance around drug safety," said Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic. "By increasing user fees, this makes the FDA even more dependent on PDUFA."
"I do think some of the proposals in this are reasonable, such as greater vigilance around direct-to-consumer advertising. But the question is, do we believe this is the right way to fund an agency that has such an important public health and public safety role to play?" Nissen said. "It is actually increasing the dependence of the agency on industry-generated user fees. I personally would prefer to see this agency funded through appropriate congressional appropriations."
Others expressed similar concerns.
Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a prepared statement: "The FDA's crucial drug-regulatory functions are too important to be tainted and compromised by direct funding from the very companies whose drugs the agency reviews for safety. All the better ideas that have been discussed for improving FDA functions of reviewing new drugs, post-market safety studies and advertising should be included in the agency's upcoming budget proposal to the congressional appropriations committees. The agency should request these additional funds through the same process that funded the agency from 1906 through 1992 -- that is, the money should come from the federal Treasury, not the pharmaceutical industry."
Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports, said: "At a time when countless drugs have safety problems, it isn't enough to just rely on money paid by the pharmaceutical industry to fund needed drug safety reforms. To address the wholly inadequate drug safety system, consumers need a commitment from the Administration to completely fund drug safety, and new laws that will ensure we don't have any more Vioxx-type disasters."
The FDA has been the target of criticism in several years, with two episodes in particular raising questions about the agency's ability to safeguard the American public.
One was the September 2004 withdrawal from the market of the arthritis drug Vioxx after studies found the painkiller increased the risk of potentially fatal heart attacks or strokes. The FDA was also criticized for being slow to acknowledge studies linking the use of some antidepressants called SSRIs with an increased risk of suicidal thoughts or actions among children and teens.
On Thursday, Galson defended the basic structure of the agency's operations and the user-fee system. "We've always said we're agnostic about where our resources come from," he said. "We want to do our job and want to get resources from whatever sources are available. We feel very strongly that the program benefits from the strength of getting resources of several different sources."
The extra money requested by the agency would be used for a number of "enhancements," including:
- $29.3 million for safety surveillance of medications already approved by the FDA.
- $4.6 million for 20 employees to help expand the FDA's implementation of guidance for agency reviewers and the development of guidelines for industry on clinical trial designs and other topics.
- $4 million to improve information technology for human drug review by moving the agency and industry toward an all-electronic environment.
The FDA is also seeking to create a new and separate user-free program to collect fees from drug companies that want FDA advisory reviews of direct-to-consumer television advertisements. The agency said the fees would total $6.2 million in the first year, supporting 27 additional staff members.
More information
Learn more about the proposal at the FDA.
