From Our 2007 Archives

FDA Report Says Nation's Health at Risk

By Steven Reinberg
HealthDay Reporter

FRIDAY, Nov. 30 (HealthDay News) -- A new report by a U.S. Food and Drug Administration subcommittee says the agency can no longer adequately protect the nation's food and drug supply.

The Subcommittee on Science and Technology lays the blame squarely on inadequate funding, which it says has not kept pace with increasing demands on the agency.

"This imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public," the report states.

And things could get worse, the report stresses: "...the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities."

William Hubbard, a former FDA associate commissioner and an advisor to the Coalition for a Stronger FDA, a group that lobbies on behalf of the agency, called the report "one of the most remarkable reports I've ever seen. They are basically saying the FDA can't protect the public, and they are saying that our future competitiveness in new technology, emerging science and pharmaceuticals and devices is seriously threatened."

Hubbard also thinks that more money is needed for the FDA to do its job. "The number doesn't matter -- it just needs to be a lot," he said. "You would need a steady increase over five years to fix the FDA."

The report started as a review of the science at the FDA, Hubbard said, and mushroomed into something more.

"The committee was horrified that the science wasn't there, then they were horrified that the capabilities weren't there -- and the only way to fix that is funding," he said.

The FDA budget request for 2008 is $1.74 billion, plus another $444 million in user fees. These fees are paid by drug makers and medical device makers to underwrite the approval process of their products.

Another expert thinks that the FDA needs more money, but to really protect the public the agency's culture also needs changing.

"You need not only an overhaul of resources but an overhaul of philosophy on what safety and efficacy really means," said Dr. A. Mark Fendrick, a professor of internal medicine and professor of health management and policy at the University of Michigan.

"While a substantial increase in resources will enhance the scientific capabilities and capacity of the FDA, funding alone will not address the inherent tension between America's insatiable demand for immediate access for innovative products and an unwillingness to tolerate products that are anything but perfectly safe," Fendrick explained.

Another FDA supporter also thinks that improving the FDA starts with money.

"There are a lot of problems in the FDA that can't be solved without more resources," said Steven Grossman, a spokesman for the FDA Alliance, which lobbies on behalf of the agency. "All the problems don't go away if you have more money, but there are a whole lot of problems you can't confront without money."

Grossman thinks there is need for another $450 million in unrestricted spending to start bringing the agency up to snuff. That request is currently winding its way through Congress. "We hope to get at least a third of that," he said. It's going to take several years of increased funding to get the FDA to where it should be, he added.

According to the report, the FDA's "inability to keep up with scientific advances means that American lives are at risk." The committee noted that while science had undergone radical changes, the agency' evaluation methods haven't hanged in more than 50 years.

In addition, the food supply is at risk, the report said: "Crisis management in [the] FDA's two food safety centers, [the] Center for Food Safety and Applied Nutrition (CFSAN) and [the] Center for Veterinary Medicine (CVM), has drawn attention and resources away from FDA's ability to develop the science base and infrastructure needed to efficiently support innovation in the food industry, provide effective routine surveillance, and conduct emergency outbreak investigation activities to protect the food supply."

The report also calls for better-trained FDA scientists and improvements in the agency's computer technology. The full report will be presented at a meeting of the FDA's Science Board on Monday.

In recent years, numerous food recalls and the withdrawal from the market of popular medications -- the removal of the painkiller Vioxx in 2004 was one of the most high-profile examples -- have eroded public confidence in the FDA. A recent survey found that 47 percent of Americans rated its performance as fair or poor.

And a study published in September found the number of serious adverse drug events more than doubled between 1998 and 2005 in the United States, as did the number of related deaths. From 1998 to 2005, the number of reported serious adverse drug events increased from 34,966 to 89,842. The number of fatal adverse drug events almost tripled during the same time period, from 5,519 in 1998 to 15,107 in 2005.

The number of adverse events increased four times faster than the total number of outpatient prescriptions, which rose from 2.7 billion to 3.8 billion during that time frame, according to the study, which was published in the Archives of Internal Medicine.

Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, called the new FDA report a "partial and simplistic view of what is wrong with the FDA."

"There seems to be more importance placed on satisfying industry [at the FDA]. It's not an atmosphere where people are free to express their differing opinions," he said.

Wolfe thinks the agency needs to be changed substantially, including new legislation that would strengthen its ability to regulate food additives, drugs and dietary supplements. He also thinks user fees should be abolished, because the fees make the relationship between the agency and drug companies too close.

SOURCES: Steven Grossman, spokesman, FDA Alliance; William Hubbard, former associate commissioner, U.S. Food and Drug Administration, and advisor, Coalition for a Stronger FDA; A. Mark Fendrick, M.D., professor, internal medicine, University of Michigan School of Medicine, and professor, health management and policy, University of Michigan School of Public Health, Ann Arbor; Sidney M. Wolfe, M.D., director, Health Research Group, Public Citizen, Washington, D.C.; November 2007, FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology

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