For more than a century, the regulation of U.S. food and drugs has seen its share of challenges — from the filthy slaughterhouses of Upton Sinclair’s Chicago to the tainted Chinese-made blood thinner that recently killed at least 19 people. The regulatory shortcomings on display in 1937, when ethylene glycol killed 105 antibiotic consumers, were still glaring six decades later, when Vioxx users started having heart attacks.
But throughout the history of the Food and Drug Administration, and its precursor agencies, U.S. consumers could always bring the manufacturer of a faulty product to court. Now, with the FDA woefully underfunded in its key role of assuring the safety and effectiveness of foods and drugs, and with political ideologues in the agency pushing industry prerogatives, the White House and the courts may be on the verge of stripping Americans of the right to sue. This would take away the last option for those seeking protection from –or recourse for — faulty products.
Last month, in a 8-1 decision, the Supreme Court ruled that most people using medical devices do not have the right to sue manufacturers. In October, the court is expected to take up a more far-reaching case, Levine V. Wyeth, that could stop most lawsuits involving drugs. The court will examine the legality of a lawsuit preemption quietly written into an innocuous FDA labeling law in 2006. The author was Daniel E. Troy, then the FDA counsel, now an industry lobbyist. With major cuts in food and drug safety inspections, the take-home message, increasingly, is caveat emptor. Watch out for yourself, because the government won’t.
“Consumers are getting the worst of both worlds,” says David C. Vladeck, a Georgetown Law School professor. “They don’t get the protection the FDA promises because the agency is incapable these days of truly providing a safeguard for the drugs we get. And at the same time, the FDA is claiming that if we’re injured by a product falling through this quite penetrable safety net, all our rights to compensation are cut off by virtue of the FDA’s regulations—inadequate though they may be.”
Few of those who care about the FDA question that it is in deep trouble. A 180-member umbrella committee that includes academics, former government officials, business and consumer groups is pushing for more funding. At a Jan. 29 hearing of a House energy and commerce subcommittee, an expert panel reported that the FDA “cannot fulfill its mission” because of weaknesses in its staff, organization and information technology. “Science at the Food and Drug Administration today is in a precarious position,” said Peter Barton Hutt, a former FDA counsel who has chronicled the history of the agency. Hutt recommended a 50 percent increase in the FDA’s $2-billion budget over the next two years.
“In terms of both personnel and the money to support them, the agency is barely hanging on by its fingertips,” he said. “FDA has become the paradigmatic example of the hollow government syndrome; an agency with expanded responsibilities, stagnant resources and the consequent inability to implement or enforce its statutory mandates.” At the same hearing, FDA Commissioner Andrew C. von Eschenbach acknowledged, in general terms, that the agency was having problems meeting its responsibilities.
An FDA spokeswoman, asked to comment on this story, did not respond.
The FDA oversees about $1 trillion in products—25 cents on every dollar we spend. Yet despite an ever expanding mission, its budget has shrunk in real terms over the past three decades. The agency’s staff has fallen by 1,300 employees, to about 7,800, since 1994. Its competence, unsurprisngly, is also shrinking. “I’ve had telephone calls with FDA commissioners over the years in which they said, ‘Oh, we’re going to be leaner and meaner, we’ll do more with less,” said House Energy and Commerce chairman Rep. John D. Dingell (D-Mich.) “On the basis of my experience, they’re capable only of doing much less with the much less which they’ve been given.”
The Senate passed a budget resolution last week to give the FDA an additional $375 million—a 20 percent increase compared to the 3 percent proposed by the Bush administration.
When Sinclair wrote his novel “The Jungle,” about Chicago meatpacking plants, it provoked a wave of national disgust that helped lead to the creation of the first food regulatory agency in 1906. Sinclair was looking for bigger changes, though — he once said that he “aimed at the public’s heart and by accident hit its stomach.” The same is true today.
It’s often stomach-churning problems, like the slaughter of sick cows, which led to the recall of 143 million pounds of tainted beef from a California stockyard last month, that get public attention. And well they should. Since 2003, the FDA’s Center for Food Safety and Applied Nutrition, which oversees food and cosmetic inspections and the skimpy regulation of the ballooning, $20 billion dietary supplements industry, has seen a decline it its workforce from 950 to 771 full-time employees, according to Catherine E. Woteki, director of scientific affairs for Mars Inc., maker of candy and other foods. The center “no longer has the ability to generate the science needed to fulfill its human nutrition regulatory responsibilities,” she said.
But these may not even be the riskiest problems with a weakened FDA, especially now that manufacturers are getting new liability protection from the courts. “The food safety issue never really goes away, its roots are so deep,” says Donald Kennedy, the former FDA commissioner and editor of the journal “Science.” Perhaps more serious is the FDA’s inability to monitor the safety and efficacy of drugs it has approved, he said.
In 1992, under fire for failing to quickly license new drugs, the FDA instituted a user fee system, whereby drug manufacturers pay for the inspection of their products. By 2007, user fees made up about a fifth of the FDA’s budget. Yet the fees have only one purpose — to facilitate the licensing of new drugs. The safety profile of even the best-tested drug can’t be known until the drug has been on the market and is being used by millions, rather than the hundreds or a few thousand upon whom it was tested.
Yet the FDA relies mostly on passive reporting systems for drug adverse events, and it lacks the power to recall a drug unless it can show eminent peril.
“In retrospect, the user fees system was a bad step,” says Kennedy. “It didn’t do anything except make other people pay, and the funds FDA gets through user fees can’t be used for safety and efficacy monitoring or food safety or any of the other responsibilities that FDA has. We think Congress has to own up to its own responsibilities and not depend on user fees.”
Because it’s doubtful FDA could bolster its staff enough to take on this mission, some have proposed setting up a network of academic testing centers to handle the job—something similar to the way that NASA and the Pentagon use the Jet Propulsion Laboratory in California to test new industry technologies. Others, like Sen. Richard J. Durbin (D-Ill), have proposed breaking off the FDA and USDA food safety divisions and consolidating them in a single, food safety agency.
Meanwhile, in the real world, the drug industry continues to try to chip away at the authority of the FDA. In a move reported last month here, the FDA proposed allowing drug representatives to drop off copies of reprints from any peer-reviewed journals regarding off-label uses of drugs. Under current policy, the FDA has to approve such research before the drug reps distribute it. The obvious conflict is that “peer-review” is a poorly defined term, and small journals have an incentive to publish iffy research when they know that Merck, Wyeth and Co. are going to buy up hundreds of thousands of copies of the journal to pass out to doctors. It’s not a move that inspires confidence.