K
Kickin' Ass and Takin' Names
Guest
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 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.
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 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.
