WASHINGTON -- Two years ago, California walnut growers
conceived the perfect promotion: put labels on packages saying
walnut consumption reduces the risk of heart disease.
was one problem.
Food and Drug Administration demanded substantial evidence to allow
such claims, and it found that studies the growers touted were "of
poor to moderate quality" or "not directly relevant."
three outside experts the FDA hired said a link between walnuts and
heart disease was "uncertain."
But then the agency relaxed
its standards. And on March 9, it reached an unprecedented decision:
Labels could claim that walnuts "may" reduce heart-disease risk
while noting that research was "not conclusive."
standards were long sought by the food industry, which found key
allies in the Bush administration FDA. Top appointees who once
advocated for FDA-regulated industries have heeded industry lobbying
in ways that medical groups and consumer advocates say jeopardize
After food-industry groups complained, a top
appointee killed a measure to discourage consuming a
cholesterol-raising fat. Plans to eliminate misleading sunscreen
labels have been tabled following cosmetics-industry complaints. A
post-Sept. 11 plan to help contain food contamination is nearly a
year late as food-processing groups have objected.
directing drug companies to stop false or misleading ads are reduced
and delayed under new policy that some critics say increases the
public's exposure to misinformation.
In a dramatic legal
novelty, the FDA has intervened for manufacturers in lawsuits,
urging courts to dismiss damages claims against them. FDA briefs
have helped the world's two largest drug companies win
The FDA says courts are not equipped
to judge a product's safety. On regulation, officials say their
position reflects court rulings that warn about restricting
commercial speech. Allowing inconclusive health claims on food
labels such as walnuts gives consumers more information, the agency
"Naturally, our approach to enforcement may evolve as
we adapt to new FDA legal authorities or evolving science and
technology," the FDA said in a recent statement. "But the goal of
judicious enforcement of the law, to fulfill our mission of
promoting and protecting the public health, remains
The walnut industry is already profiting from the
new labels that will start next year. Walnut processing giant
Diamond of California says publicity about them has helped lift
sales 30 percent over last year.
But the American Medical
Association said consumers may be duped. The walnut claims "have a
reasonable chance of being erroneous," it said. "An educated
consumer will not know whether to believe or not to believe the
Rep. Henry Waxman (D-Calif.) wrote the 1991 law
requiring "substantial scientific evidence" for health claims.
"Congress didn't want food manufacturers to make claims without
substantiation," he said. "The clear language of the statute is just
The influence behind many FDA decisions is
chief counsel Daniel Troy, who was a sharp critic of the agency
before President George W. Bush put him in charge of its legal
A Queens-born Columbia Law School standout, Troy,
44, came to the FDA primed for activism: Clerk for conservative icon
Robert Bork; partner at blue-chip Wiley, Rein & Fielding;
scholar at the pro-business American Enterprise Institute; litigant
for the anti-regulatory Washington Legal
Representing a tobacco company against the FDA in
the late 1990s, Troy helped win a landmark Supreme Court ruling
blocking the agency's attempt to regulate tobacco
Litigating for the legal foundation, which
drug-company foundations help fund, Troy challenged the FDA's
restrictions on promoting drugs for uses the FDA has not
The policy, Troy wrote in 1999, reflects "an
Appointed in August, 2001, Troy had vast
authority. With no FDA commissioner until November 2002, Troy
reigned for more than a year as top administrator in an agency that
regulates 22 percent of the U.S. economy.
"He sent a signal
to companies that if you want to deal with the FDA on a number of
issues, he's the man to see," said a senior FDA official.
three years, Troy has held 129 meetings with lobbyists and others
with issues before the FDA.
Mark McClellan, commissioner from
October, 2002, to March, 2004, held 30 such meetings, FDA records
From 1998 to 2001, Troy's predecessor, Margaret Porter,
held one meeting.
"She did not directly interact with
industry," said Jane Henney, FDA commissioner in 1999 and 2000. "She
felt those interactions were done by the staff, and should make
their case to them."
But the Bush administration made the
chief counsel a political appointee for the first time since the
1980s, easing out civil-servant Porter and empowering
At the end of a meeting with cosmetics-industry
officials two months into his job, Troy decided to delay
indefinitely sunscreen regulations the industry opposed.
asked them to put it off. They've done what we asked," said Tom
Donegan, general counsel of the Cosmetic, Toiletry and Fragrance
Donegan's group opposed a proposed ban on
sun-protection factors higher than 30, which the FDA found provided
"extremely small" amounts of extra protection. Donegan told Troy the
ban raised free-speech issues.
"He's very receptive," Donegan
The regulations, developed after 21 years of study and
debate, also would have banned from sunscreen labels starting in
2003 terms such as "sunblock" and "waterproof," which it determined
were "misleading" and "unsupported." Their use remains
Food-industry officials got Troy's help after a
National Academy of Sciences study requested by the FDA recommended
"trans fat consumption be as low as possible" because it raised
cholesterol. The FDA wanted that statement on food labels starting
Industry officials who met Troy said the label may
violate the First Amendment and could lead consumers and food
processors to substitute similarly harmful saturated fat for trans
The proposed statement was dropped for more study. FDA
will require labels to list only the number of grams of trans fat
with no explanation of health dangers or of how much fat consumption
Thirty-two university-based scientists told
the FDA its label "would be confusing and misleading."
who declined to be interviewed, has said he's acted to avoid losing
lawsuits, particularly over commercial speech. Courts in the last
five years have found some FDA advertising and labeling restrictions
excessive and told the agency to find less onerous ways to prevent
companies from misleading the public.
In late 2001, FDA's
overseers in the Health and Human Services Department ordered Troy
to begin reviewing FDA letters that tell drug companies to correct
false or misleading ads. Officials said they wanted to make sure the
letters could withstand a court challenge.
But Thomas Abrams,
FDA's director of advertising enforcement, said: "We have not taken
a letter to court. All have resulted in compliance."
compliance now takes longer.
The Government Accountability
Office, Congress' investigative arm, found that FDA letters about
misleading TV, radio and magazine ads in 2002 were seriously delayed
by the new review -- an average of 52 days.
When FDA analysts
saw a Prevacid TV ad that misled viewers because its vague
description of heartburn symptoms may have made the drug appeal to
anyone with pain, the review by Troy's office took 78
Noting that one-third of TV drug ads run for less than
two months, the GAO said legal reviews "have taken so long that
misleading advertisements may have completed their broadcast life
cycle before FDA issued the letters."
"There are clear health
dangers that ensue from false and misleading advertising," said Sid
Wolfe, health research director at Public Citizen, a consumer
advocate. "People are are getting injured or killed as a result of
prescriptions that would not have been written" without the impetus
of an ad.
After the GAO report, Troy's office vowed to review
letters in 15 days. The FDA won't say if the goal is being
The FDA acknowledges that improper drug promotion can
"increase the risk that the drug may be improperly used" but says
the requirement for a doctor's prescription reduces
Consumer advocates also fear the FDA is less willing
to challenge problem ads. In 2002, when Troy's oversight began, the
number of letters plummeted to 27 from 68 in 2001. Ten letters have
been sent in 2004.
FDA reviews about 37,000 ads a
Troy says the reduced quantity reflects higher
standards for letters written by FDA staffers. "To the extent there
is a chilling effect, if people are reluctant to send letters to us
thinking it can't pass legal muster, that's a good thing," he said
in 2002. "When people know there will be another pair of eyes
looking at it, I think people are more careful."
boldest move has been helping drug companies defeat lawsuits -- a
move observers call tort reform but which Troy says is an effort to
prevent courts from usurping FDA authority.
In four separate
briefs since 2002, the government has asked judges to dismiss
potentially costly claims against drug and device
Unlike FDA briefs in previous administrations, filed
at a court's request to establish the agency's position, these came
when company lawyers sought help.
The recent filings have in
effect sought to block liability claims against FDA-approved
prescription and nonprescription drugs, medical devices and drug
ads, which plaintiffs claim fail to warn about side
The argument: A company that follows FDA guidelines
is following the law. When the FDA finds a product is safe or an ad
accurate "it is inappropriate for a jury to second-guess FDA's
Agency approvals "deserve substantial
deference from courts," Troy wrote last year. If courts decide
what's safe or legal, FDA national standards could be ruined by 50
different state requirements.
The pre-Bush FDA said approval
doesn't preclude liability -- the two "operate independently, each
providing a significant, yet distinct, layer of consumer
protection," as former FDA counsel Porter wrote.
said liability punished manufacturers who concealed from FDA
information about harmful side effects or continued marketing
campaigns after problems were discovered.
The Bush FDA
acknowledged in a brief that its "position represents a change for
the United States." It says it's trying to protect its
But Arthur Levine, an FDA deputy counsel from 1978
to 1991 who now represents companies before the agency, said Troy's
legal filings "set a tone and put the FDA in a place in terms of
The FDA's legal activity comes amid a
"political environment" that is challenging the influence of juries
over commerce, Levine said. "We're in an era of tort reform. Some
people believe in tort reform, including the president."
FDA briefs have helped companies win, particularly suits alleging
harm from antidepressants whose labels failed to warn about alleged
side effects such as increased suicide risk.
Pfizer Inc. won
two such cases this year in Texas. Judges agreed with Troy that
Pfizer couldn't be liable for not warning about suicide risk if it
used the FDA-approved warning label for antidepressant
Troy represented Pfizer for at least three years
before joining the FDA -- mainly in communications and insurance
law, he's said. His fees from the company were $415,000, including
$359,000 in 2001.
Two weeks after his year-long restriction
on action involving former clients ended, Troy intervened for
Company attorney Malcolm Wheeler said he never knew
Troy until calling him in July 2002, to discuss a lawsuit filed by a
widow whose husband killed himself six days after starting
When Troy signed on, Pfizer shifted its legal
strategy to mirror the FDA's argument that the agency's approval of
an ad pre-empts legal claims. The company had previously defended
Zoloft cases by probing a defendant's history and arguing he was
suicidal before taking the drug.
The advantage of the new
strategy is that favorable rulings establish case law that Pfizer --
or any drug company -- can cite in future lawsuits. Proving that a
suicide victim was depressed before taking antidepressants helps
only that case.
Wheeler, who began defending Pfizer in 1997
or 1998, said he hadn't previously thought of seeking FDA's help or
The FDA stepped in two other cases
around the same time it helped Pfizer.
A brief supporting
GlaxoSmithKline Consumer Healthcare helped sway a California state
judge to bar the state from putting stricter warning labels on
nicotine patches than FDA approved.
The company also
benefited when the FDA entered a class-action suit that sought to
stop ads for the antidepressant Paxil that plaintiffs said failed to
mention addictive side effects.
Four days after a federal
judge had ordered the ads stopped, the FDA intervened.
months later the judge reversed herself. "The court," she wrote,
"finds FDA's evidence persuasive."TOMORROW: The effort
to rewrite pollution rules