FDA Wants to Increase Fees from Big Pharma

Aiming for an “impressive expansion and modernization” of its drug safety system, the U.S. Food and Drug Administration (FDA) announced a proposal to dramatically increase “user fees” collected from the pharmaceutical industry. The proposal calls for an $87.4 million increase in generated fees, bringing the total to $392.8 million.

“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 HHS Secretary Michael Leavitt. “I commend FDA for the important progress they have made and look forward to working with Congress to ensure action on these proposals.”

The new proposal centers on the Prescription Drug Use Fee Act (PDUFA), which was first approved in November of 1992. Under PDUFA, funds from the pharmaceutical industry are added to the FDA’s appropriations in order to bolster the FDA’s drug-review program. PDUFA must be reauthorized by Congress every five years, and the FDA hopes that Congress will approve their demands for increased user fees when they vote to reauthorize the program for the fourth time.

According to the agency, the increased fees “would significantly broaden and upgrade the agency’s drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public.”

However, critics charge that the increase in industry user fees will only make the FDA more indebted (and perhaps, sympathetic) to Big Pharma than it already is. “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 of the watchdog group Public Citizen.

“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.”

Wolfe notes that the nearly $400 million in annual industry money being sought by the FDA is equivalent to two days’ worth of expenditures on the Iraq war.

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