Mr. Outside moves inside
Daniel Troy fought the FDA for years; now he's helping to run it
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.