Congress Moves Closer to Drug-Safety Bill

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

THURSDAY, July 12, 2007 (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.

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."

The bill, passed Wednesday in the House with a 403-16 vote, gives the FDA authority to require post-marketing safety studies, and it requires drug companies to provide timetables for completing these studies. The agency also reserves the right to mandate label changes to a drug or restrict its use or distribution, should problems arise.

But Wolfe noted that a record number of drugs have been approved by the FDA since PDUFA took effect, suggesting the agency has lost power to industry. "There have also been a record number of drugs taken off the market -- many of which should have never been approved in the first place," he said. "At the same time, there has been less congressional oversight," Wolfe added.

In addition, the bill reauthorizes a medical device industry user-fee program. That is expected to add extra cash to FDA coffers.

Another critic said both the House and the Senate bills are inadequate.

"I signed a letter recommending a repeal of PDUFA," said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic and a key player in the Vioxx withdrawal debacle. "PDUFA is part of the problem, not necessarily the solution," he said.

"When you fund a regulatory agency with funds from the industry it's designed to regulate, it creates a dependency that may not be in the best interests of public health," Nissen said.

Still, the new bill is somewhat of an improvement on the status quo, he said.

"I do think this bill is a compromise -- it doesn't have all of the provisions that I would have liked to have seen," Nissen said. "Is it better than nothing? Absolutely. Is it good legislation? I think it is. It offers better protection for drug safety."

He noted that the House bill does boost the fines companies would have to pay if they violated any of the bill's provisions. In addition, the legislation gives the FDA more authority to make drug labeling changes, he said.

"A huge difference is the issue of biogenerics, and whether they can be made available," Nissen said. Biogenerics -- generic forms of pricey biotech drugs -- are currently not covered by FDA regulations. "That is in the Senate bill but not in the House bill. It remains to be seen what happens in the conference committee," he said.

Nissen noted that whatever bill comes out of Congress has to be signed by President George Bush. He believes that the president will probably sign the bill, since the pharmaceutical industry is supporting it.

One item noticeably absent from the House bill: any provision that would allow U.S. consumers to buy cheaper drugs from abroad. The White House has said in the past that it would veto any bill containing such a clause.

More information

Learn more about the Prescription Drug User Fee Act at the U.S. Food and Drug Administration.

SOURCES: Steven E. Nissen, M.D., chairman, department of cardiovascular medicine, Cleveland Clinic, Ohio; Sidney M. Wolfe, M.D., director, Health Research Group, Public Citizen, Washington, D.C.; news release, July 11, 2007, Pharmaceutical Research and Manufacturers of America; Associated Press
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