Mr. Outside moves inside
Daniel Troy fought the FDA for years; now he's helping to run it
For a decade, a Washington lawyer named Daniel Troy tried to restrict the regulatory powers of the Food and Drug Administration. He won his share of legal battles, taking the side of the tobacco and pharmaceutical industries against the federal agency. But Troy is no longer on the outside throwing stones. He's now an insider, running the FDA's legal division.
Last July, Troy stalled efforts to investigate complaints about ephedra, an herb used in a dietary supplement suspected as a factor in at least 100 deaths, including that of Baltimore Orioles pitcher Steve Bechler, who collapsed and died last month. When a top regulatory official at the FDA's Washington headquarters opposed Troy's decision, he was transferred to Texas, according to current and former agency officials. Troy played no role in the transfer, he says.
Since taking over as the FDA's chief counsel in August 2001, Troy, 43, has held dozens of private meetings with drug manufacturers and others regulated by the FDA. He kept no notes or minutes of those meetings. A U.S. News inquiry shows he has also favored less rigorous enforcement of regulations for some products and has been lenient about scrutinizing advertising claims by companies.
Troy is one of dozens of low-profile, high-impact political appointees toiling in the Bush administration. He brings to the FDA strong opinions on the limits of government authority, views honed over the years at the knee of a famous conservative jurist and at influential Washington think tanks. Troy's beliefs are not idle cocktail-party chatter. As the ephedra case demonstrates, he helps shape decisions that affect how Americans get information about the safety of everything from food supplements to the latest medications.
"Open door." The FDA's reach is vast: It regulates products that account for close to one quarter of every dollar spent by consumers in the United States. It does this in two ways. The FDA must approve, after careful scientific review, drugs and other medical products that come to market. And the agency watches to be sure that companies market their products without misleading the public. It is in this second role--enforcing the rules--that Troy holds sway. "Dan has changed the nature of the general counsel's office and converted it from a legal office to an activist policy office," says Wayne Pines, a former FDA official who is now president of regulatory services and healthcare at APCO, a Washington, D.C., communications consulting firm. He has an "open-door policy" with industry, Pines says. "He's probably been as receptive [to industry] as any general counsel has ever been within the agency."
Troy's doorway has been crowded by an industry legendary for its lobbying clout. A report from the consumer watchdog group Public Citizen shows drug companies employed 625 lobbyists in 2000--more than one for every member of Congress. Between September 2001 and November 2002, Troy operated as the de facto head of the FDA, sources in the drug industry say; it was not until November 14 that Mark McClellan, a medi-cal doctor and healthcare economist, was sworn in as FDA commissioner. During that period, documents show, Troy held at least 50 meetings with representatives from the industries FDA regulates. U.S. News sought records of those meetings with industry under the Freedom of Information Act but was informed by Troy's office that there are "no minutes, no memos, no nothing." Troy declined to say why he did not keep notes of those meetings. FDA rules do not require him to do so. However, says Pines, "On policy issues that affect the broad industry, public records should be kept."
What is known is that after some of these meetings, Troy took industry's side. On Jan. 15, 2002, Troy and others from the FDA met with representatives from the citrus juice industry to discuss new rules set to go into effect the following week. The juice makers made a last-ditch pitch to loosen one requirement, which they argued would be costly to implement. They told Troy that if the rules went into effect and forced companies to manufacture their product at a single site, there would be no orange juice concentrate left on store shelves. It had taken FDA officials nearly 3 1/2 years to write regulations designed to rid fruit juice of contaminants such as E. coli, a bacterium that has sickened thousands of people and led to a handful of deaths. Nevertheless, a week after the meeting, Troy, with the consent of the FDA's food experts, wrote the industry group that the FDA would use its "discretion" when enforcing the disputed manufacturing regulation.
In June 2002, Troy met with representatives from Fashion Wear Services, the makers of decorative contact lenses that change the appearance of the eye but do not correct vision. The company's lawyers told Troy that its lenses should be regulated as cosmetics rather than as medical devices because the company didn't claim that the lenses serve a medical purpose. A few days after the meeting, Troy told FDA employees the lenses should be treated as cosmetics, which are governed by standards that are less stringent than those established for medical devices. Medical officers at the FDA, who had not been consulted, feared the decision would endanger the public. Decorative lenses already were too easy to get; they were readily available at flea markets and on the Internet. In 2001, for example, Robyn Rouse, a 15-year-old from Cleveland, was nearly blinded in one eye by a tinted contact lens that she bought in a grocery store. Within hours of inserting the lens, she developed a serious bacterial infection, which required her to undergo a cornea transplant operation. In October, four months after Troy's initial recommendation and after further medical review, the FDA issued a public-health alert and banned imports of British-based Fashion Wear's lenses under its authority to regulate cosmetics.
What next? Some lawmakers are not satisfied. Sen. Edward Kennedy, a longtime champion of an aggressive FDA, and others fear the decision to treat the lenses as a cosmetic could set a dangerous precedent and confine the FDA to regulating any product based only on what a company claims it can be used for. These critics say the FDA has the power to look not only at what a company says about its product but also at its use by consumers to determine how it should be regulated. "Simply put," says Kennedy, "this interpretation of the statute could eviscerate FDA's regulatory authority, thwart congressional intent, and severely harm public health."
Troy's instinct to limit the FDA's regulatory authority helps explain his reluctance to let the agency go after ephedra. The FDA had been offered the chance last July, by a Justice Department lawyer, to obtain detailed consumer complaints about a top-selling product containing ephedra that is made by San Diego-based Metabolife International. These "adverse event reports"--which had been introduced in a private lawsuit--could have provided the FDA much needed data to study the supplement's safety. Indeed, the agency had labored for several years, without success, to obtain the documents from Metabolife. But presented with this chance to get them, Troy balked. Dennis Baker, then the FDA's associate commissioner for regulatory affairs, opposed Troy on ephedra, among other matters, and argued that the FDA should take Justice up on the offer. The agency eventually got some documents; under pressure from a Justice Department criminal investigation, Metabolife decided to release the reports.
In an interview, Troy would not discuss his role in the FDA's handling of the Metabolife complaints. "It's an open, active criminal investigation," he says. However, a congressional aide says, when Troy was pressed on the issue last summer, he argued that it was not appropriate for the agency to intervene in a private lawsuit.
Baker was transferred to an FDA office in Dallas--in part because he crossed Troy, according to a current FDA official and a former top agency administrator. Baker declined to be interviewed. Last summer's run-in was not the first time Baker had done battle over ephedra. He worked for the Texas Department of Health in the late 1990s, when that agency tried to restrict the use of the product. Metabolife hired powerful Texas lobbyists--both with close ties to then Gov. George W. Bush--to kill the effort. In the end, Texas ordered companies to put a warning label on ephedra products. Between 1999 and 2002, Metabolife spent $1.2 million to lobby Congress and federal agencies.
After baseball player Bechler died in February, the FDA stopped short of banning ephedra, citing a lack of evidence about its safety. Instead, it proposed that products containing ephedra carry a warning label. Separately, the agency also proposed new regulations governing the manufacture of all dietary supplements. The proposal requires cleaner facilities and precise labeling of products.
Censor. The FDA's central focus, however, remains the regulation of pharmaceuticals. During Troy's tenure, the FDA has seen a falloff in enforcement actions against drug companies for questionable advertising claims. The agency has cited far fewer companies than in past years. Its Division of Drug Marketing, Advertising, and Communications issued more than 270 enforcement letters between January 1999 and December 2001, an average of about 90 a year. But last year that number dwindled to fewer than 30. One possible reason for the drop-off: Under a new policy, Troy's office now reviews all enforcement letters. That has led some at the agency to censor themselves, officials there say. "The underlying message is to be less regulatory," says one FDA veteran. "It intimidates people to do less."
Commissioner McClellan disagrees. He says that Troy has strengthened the FDA by ensuring that its enforcement actions will stand up in court. Troy explains: "Public health could not abide FDA having a bad reputation in the courts; we need to know where the courts are." And the courts have not been with the agency, says Lester Crawford, the FDA's deputy commissioner. "We had a pattern of losses in the court, and a number of them that were particularly vexing to me had to do with the First Amendment."
Troy is a big reason the FDA is having trouble with the First Amendment. It was, after all, Troy's efforts to limit the FDA's ability to restrict tobacco advertising in the 1990s that led the Supreme Court to rule in 2001 that such advertis-ing was protected by the First Amendment.
His views were shaped early in his career. After graduating from Columbia Law School in 1983, Troy clerked for then Judge Robert Bork of the U.S. Court of Appeals, District of Columbia Circuit, who was known for his conservative legal opinions and strict interpretation of the Constitution. "Clerking for Judge Bork was a great experience," Troy says. "I learned a lot." The Senate's rejection of Bork's nomination to the Supreme Court in 1987 energized his disciples. Troy landed at the Justice Department and, in 1988, joined the Federalist Society, a group of conservative and libertarian lawyers who advocate limiting government power to enhance individual freedoms.
That credo guided Troy's early legal tangles with the FDA. He represented the Brown & Williamson Tobacco Corp. in its effort to fend off the FDA in the 1990s. He also fought the FDA in court to let drug makers promote to doctors "off label," or unapproved, uses of their drugs. In both instances, Troy argued that the FDA's approach violated the First Amendment. The Supreme Court, which took up only the tobacco case, eventually agreed.
But last year, in a twist, Troy found himself in the unusual position of defending the FDA's right to restrict advertising by pharmacies in a First Amendment case that reached the Supreme Court. This time, he lost. But in a sense, given his long history of fighting the FDA on such issues, he had won.
This story appears in the March 24, 2003 print edition of U.S. News & World Report.