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."