ERASING THE RULES, PART II

WASHINGTON -- Two years ago, California walnut growers conceived the perfect promotion: put labels on packages saying walnut consumption reduces the risk of heart disease.

There was one problem.

The 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."

Even 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."

The eased 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 public health.

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.

Letters 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 product-liability cases.

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 says.

"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 constant."

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 claim."

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 being ignored."

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 affairs.

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 Foundation.

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 products.

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 approved.

The policy, Troy wrote in 1999, reflects "an overzealous FDA."

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.

In 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 show.

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 Troy.

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.

"We asked them to put it off. They've done what we asked," said Tom Donegan, general counsel of the Cosmetic, Toiletry and Fragrance Association.

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 said.

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 common.

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 in 2006.

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 fat.

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 is acceptable.

Thirty-two university-based scientists told the FDA its label "would be confusing and misleading."

Troy, 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."

Yet 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 days.

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 met.

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 risks.

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 year.

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."

Troy's 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 makers.

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 effects.

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 scientific judgment."

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.

That theory 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 authority.

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 regulatory activism."

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."

The 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 Zoloft.

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 Pfizer.

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 Zoloft.

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 arguing pre-emption.

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.

Two months later the judge reversed herself. "The court," she wrote, "finds FDA's evidence persuasive."

TOMORROW: The effort to rewrite pollution rules