Congress Moves Closer to Drug-Safety Bill

House plan earmarks $400 million in FDA fees to track medicines already on market

By Steven Reinberg
HealthDay Reporter

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THURSDAY, July 12 (HealthDay News) -- Following recent drug-safety scandals, including the 2004 Vioxx withdrawal, the U.S. House of Representatives has voted in favor of giving health officials more resources to do their job.

The Prescription Drug User Fee Act (PDUFA) gives the U.S. Food and Drug Administration an additional $400 million in fees collected from the drug industry. The money is earmarked for drug safety oversight over the next five years, including increased "postmarketing" surveillance of drugs already on the market.

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The Senate has already passed a similar bill. Both bills mandate the continuance, through 2012, of a program whereby drug companies pay fees to the FDA to offset agency expenditures on the review of new medicines. House and Senate committees must now work on a compromise bill acceptable to both bodies.

"It's become increasingly clear FDA needs two of more things: It needs more resources and more authority, particularly in the area of postmarketing surveillance," Rep. Henry Waxman, D-Calif., told the Associated Press.

But the fee-for-service tie between FDA and the drug industry has its critics.

"Neither of the bills are acceptable," said Dr. Sidney M. Wolfe, director of the Health Research Group at Public Citizen, a consumer advocacy organization based in Washington, D.C.

"We have advocated for a long time repealing PDUFA. The damage that's been done by having direct industry funding of the FDA is unacceptable," Wolfe said. "When people in the FDA start describing the industry as their client -- because the majority of salaries in drug review are being paid by the industry -- there is obviously something wrong with it," he said.

But a drug industry representative defended the current system and applauded the new bills.

"Since its original enactment in 1992, PDUFA has been a resounding success for the FDA, pharmaceutical companies, taxpayers and, most importantly, patients," Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) said in a statement released Wednesday. "The resources and additional staffing made possible by the fees charged by the FDA have enabled the agency to review new medicines more efficiently, while maintaining its stringent safety and efficacy standard."

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