F.D.A. on the Brink?
A report says the Food and Drug Administration, which regulates $1 trillion worth of food and drugs, is dangerously underfunded and near collapse.
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You know something is seriously amiss when industry scientists, consumer groups, and a bipartisan phalanx of senior government officials past and present call for infusions of cash to bolster a federal watchdog agency.
That's the situation at the Food and Drug Administration as one report after another—issued by groups ranging from the National Academy of Sciences to the Government Accountability Office—describes an agency that was once the envy of the world but is now in danger of melting down.Businesses that create and sell F.D.A.-overseen products, from peanut oil to neuropharmaceuticals, are well aware that the F.D.A. is understaffed, underfunded, and generally overwhelmed.
The public is catching on too, after recent scandals and missteps: the Vioxx recall, for one, and the clumsy handling of last year's E. coli outbreak from bagged spinach. Last year, only 36 percent of Americans said they had confidence in the F.D.A., down from 80 percent in the 1970s, according to a Harris interactive poll.
The latest report was presented last week by a subcommittee of the F.D.A. Science Board—an advisory panel of scientists and industry experts—and was ordered by F.D.A. commissioner Andrew von Eschenbach. "F.D.A. Science and Mission at Risk" compiles information gathered during a yearlong investigation overseen by a panel of top scientists, pharma executives and researchers, and senior U.S. officials from such agencies as the National Institutes of Health.
The chief culprit, says this study and others, is a lack of funding for an agency that oversees 80 percent of what 300 million Americans eat and drink, as well as 100 percent of drugs, vaccines, and medical devices for people, pets, and livestock.
These products account for 25 cents of every dollar spent by Americans, $1 trillion total, yet the F.D.A.'s budget in real terms has declined by $300 million since 1988.
This year, the budget is $1.6 billion—$5.50 a year per American. That is less than the cost of a movie or a couple of bags of spinach at Safeway.
In short, the demands placed on the agency far exceed its ability to meet them, a shortfall that places "American lives at risk," the subcommittee concludes.
"This report is like a warning that says a bridge is about to collapse; the question is, will people listen to it?" says Nancy Myers, a former senior strategic adviser to the F.D.A. commissioner. She's also on the board of the F.D.A. Alliance, a group that includes six ex-commissioners and 121 patient-advocacy groups, nonprofits, companies, and trade associations.
The alliance has pointed out that the F.D.A.'s budget is about the same as what is spent on public schools in Montgomery County, Maryland, where the agency is based. The F.D.A.'s budget is the equivalent of three days of U.S. expenditures on the Iraq war.
Compare this with the nearly $100 billion spent on public and private research and development in medicine, just one of the F.D.A.'s purviews. Private R&D spending has nearly tripled in 20 years, while the agency's annual allotment has remained flat.
"We found that F.D.A.'s resource shortfalls have resulted in a plethora of inadequacies that threaten our society," the report concludes, "including, but not limited to, inadequate inspections of manufacturers, a dearth of scientists who understand emerging new technologies, inability to speed the development of new therapies, an import system that is badly broken, a food supply that grows riskier each year, and an information infrastructure that was identified as a source of risk in every center and program reviewed by the subcommittee."
These products account for 25 cents of every dollar spent by Americans, $1 trillion total, yet the F.D.A.'s budget in real terms has declined by $300 million since 1988.
This year, the budget is $1.6 billion—$5.50 a year per American. That is less than the cost of a movie or a couple of bags of spinach at Safeway.
In short, the demands placed on the agency far exceed its ability to meet them, a shortfall that places "American lives at risk," the subcommittee concludes.
"This report is like a warning that says a bridge is about to collapse; the question is, will people listen to it?" says Nancy Myers, a former senior strategic adviser to the F.D.A. commissioner. She's also on the board of the F.D.A. Alliance, a group that includes six ex-commissioners and 121 patient-advocacy groups, nonprofits, companies, and trade associations.
The alliance has pointed out that the F.D.A.'s budget is about the same as what is spent on public schools in Montgomery County, Maryland, where the agency is based. The F.D.A.'s budget is the equivalent of three days of U.S. expenditures on the Iraq war.
Compare this with the nearly $100 billion spent on public and private research and development in medicine, just one of the F.D.A.'s purviews. Private R&D spending has nearly tripled in 20 years, while the agency's annual allotment has remained flat.
"We found that F.D.A.'s resource shortfalls have resulted in a plethora of inadequacies that threaten our society," the report concludes, "including, but not limited to, inadequate inspections of manufacturers, a dearth of scientists who understand emerging new technologies, inability to speed the development of new therapies, an import system that is badly broken, a food supply that grows riskier each year, and an information infrastructure that was identified as a source of risk in every center and program reviewed by the subcommittee."
A prominent biotech executive says the report is "spot-on" but declines to say so on the record because his company has drug approvals pending at the F.D.A. "I hope it gives a proper sense of urgency," he adds. "Things at F.D.A. have deteriorated badly even in last 12 months."
A few details that caught my eye:
"The public is understandably confused by the growing disconnect between the promises of cutting-edge science and the reality of clinical benefit," the report says.
An illustration of this is a steep decline in F.D.A. approval of new drugs in recent years. There are several reasons for this, but a lack of funds and inadequate oversight of some products and companies—which has led to errors and, as a result, a bunker mentality among some officials who are afraid of making additional mistakes—contribute to the problem.
The report calls for a 50 percent increase in personnel and a doubling of the F.D.A.'s budget over the next two years, and adequate increases thereafter.
So far, committees in Congress have proposed increases of 8 to 12 percent for 2008, but even these modest boosts may encounter trouble from the Bush administration, which has been unwilling to raise funding for regulatory agencies or for similar initiatives.
For my part, I'd pay an extra buck or two a year to make sure my spinach isn't tainted and that the pharmaceuticals used by me or my family are safe and effective. How about you?
A few details that caught my eye:
- Email systems are so unstable that they sometimes break down, "most recently during an E. coli food contamination investigation," according to the study.
- In recent years, food inspections have dropped 78 percent at a time of rapid expansion in the food industry and as food imports have increased exponentially.
- User fees charged to drug companies have helped with funding for premarket reviews and approvals for drugs but are not enough to counter systemic deficiencies.
- The turnover rate of key scientific personnel is twice that of other agencies, as the F.D.A. fails to keep up with the latest developments in science and technology.
"The public is understandably confused by the growing disconnect between the promises of cutting-edge science and the reality of clinical benefit," the report says.
An illustration of this is a steep decline in F.D.A. approval of new drugs in recent years. There are several reasons for this, but a lack of funds and inadequate oversight of some products and companies—which has led to errors and, as a result, a bunker mentality among some officials who are afraid of making additional mistakes—contribute to the problem.
The report calls for a 50 percent increase in personnel and a doubling of the F.D.A.'s budget over the next two years, and adequate increases thereafter.
So far, committees in Congress have proposed increases of 8 to 12 percent for 2008, but even these modest boosts may encounter trouble from the Bush administration, which has been unwilling to raise funding for regulatory agencies or for similar initiatives.
For my part, I'd pay an extra buck or two a year to make sure my spinach isn't tainted and that the pharmaceuticals used by me or my family are safe and effective. How about you?




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