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FDA wants more funds to monitor drug safety

WASHINGTON—The Food and Drug Administration recommended Thursday that Congress approve an $87.4 million increase in fees paid by drug companies so the agency can hire 82 employees to better monitor the safety of prescription medications already on the market.

The 29 percent increase would bring annual revenue from the prescription drug user-fee program to $392.8 million and could help quell criticism that the FDA is lax on drug safety issues. Agency critics said the request was a step in the right direction but that more was needed to address their concerns with FDA operations.

The FDA intends to use the additional funds to beef up its review of television drug advertisements, modernize its operations and help keep pace with an increasing drug review workload.

"The proposed recommendations would support significant improvements in FDA's ability to monitor and respond to emerging drug safety issues, as well as continuing FDA's commitment to scientific improvements and streamlining the drug approval process," said Health and Human Services Secretary Mike Leavitt.

But Sen. Charles Grassley, R-Iowa, a frequent FDA critic, was unimpressed, calling the additional funding request a "modest contribution" toward improved safety.

"I don't want to denigrate any step in that direction when a step is made with good intention, but to make sure the FDA is doing everything it should to keep American consumers safe, comprehensive reform of the agency's structure and culture is needed," Grassley said.

The funding request follows strong criticism from health experts and lawmakers that the FDA's safety reviews for previously approved drugs were inadequate and therefore endangered public health. Among the issues the critics pointed to was the FDA's failure to address safety concerns about heart complications from popular painkillers, such as Vioxx, and suicidal tendencies among young people who used prescription anti-depressants.

Critics said Thursday that the agency should be asking Congress for more taxpayer money instead of relying on drug industry money.

"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," said Bill Vaughan, a senior policy analyst for Consumers Union. "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 Prescription Drug User Fee Act of 1992 allows drug industry money to help expedite the FDA's review of proposed drugs. The law was enacted because of long delays in the agency's review process for new drugs. The program has dramatically cut those review times and has been credited with speeding new drugs to market. The user-fee program is up for its five-year congressional reauthorization this year.

"In the last 14 years, three consecutive user-fee programs have brought enormous public health gains to our, and indeed the world's, consumers, by helping FDA make increasingly complex medications available to patients faster than was ever possible before without sacrificing quality," said FDA Commissioner Andrew C. von Eschenbach.

But in September, a report by The Institute of Medicine, a federal advisory panel, found the user fees helped create a "troubling resource imbalance" at the FDA. The bulk of user-fee money funded reviews of potential new drugs, but the report indicated that the FDA had inadequate safety reviews of drugs already on drugstore shelves.

In addition, the report claimed that some FDA staff and others felt the user fees gave the impression that "powerful industry interests control or strongly influence the (FDA's) decision-making" and create "a sense of obligation" within the agency to please drug makers.

"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," said Dr. Sidney M. Wolfe, director of the Health Research Group at Public Citizen, a consumer watchdog agency.

Doug Arbesfeld, an FDA spokesman, said the drug review unit operates at the "highest global standards and maintains its integrity."

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(c) 2007, McClatchy-Tribune Information Services.

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