FDA Chief Counsel-designate Daniel Troy is one of the attorneys who successfully challenged the agency's approach to off-label promotion in the WLF suit.

Troy is a partner at Wiley, Rein & Fielding, the law firm that represented the Washington Legal Foundation in litigation challenging FDA's regulations governing off-label information included in journal articles and textbooks. The case was technically decided in FDA's favor on appeal, but only after the agency changed its policies to move toward the WLF position (¹ Also see "WLF Appeals Court Decision Leaves Free Speech Question Open" - Pink Sheet, 14 February, 2000.).

One of the strong supporters of the WLF case within the pharmaceutical industry was Bristol-Myers Squibb.

Troy will report to another ex-Wiley, Rein & Fielding partner, Alex Azar, who was confirmed as HHS General Counsel Aug. 3.

Troy has been with Wiley since 1990, and has also served as associate scholar of legal studies at the American Enterprise Institute since 1996. His last day at Wiley was Aug. 10.

Troy previously worked in the Office of Legal Counsel at the Department of Justice from 1987 to 1989, had a stint as special assistant to the 1989 New York City mayoral campaign of Rudy Giuliani, and clerked for Robert Bork at the D.C. Circuit Court of Appeals from 1983 to 1984. He was Bork's clerk at the time of his failed nomination to serve on the Supreme Court.

Troy is a graduate of Columbia University School of Law and has a B.S. from Cornell University's School of Industrial Relations.

Troy's criticism of FDA's First Amendment record extends beyond the WLF off-label claims. In an April 2000 speech, he argued that the agency's efforts to regulate tobacco advertising suggest that FDA continues to believe "it is immune from First Amendment scrutiny."

The new general counsel is also wary of aggressive regulatory enforcement without prior notice, and grounds his belief in limitations on government in religious principles. Troy testified at a House hearing on the Regulatory Fair Warning Act of 1998, arguing that "unfortunately, we moderns have moved away from [the] traditional, religious understanding of man" as "moral actors...possessing free will."

Following the 2000 Presidential election, Troy was a frequent commentator on political talk shows about the legal wranglings surrounding the disputed outcome.

Troy succeeds Margaret Jane Porter, who was reassigned to the Senior Executive Service Federal Executive Institute in Charlottesville, Va., in February. Michael Landa served as Acting Chief Counsel in Porter's absence.

Porter had an extraordinarily long tenure at FDA, having been named to her career SES position in October 1989, during the first Bush Administration. She served with three commissioners, Frank Young, David Kessler and Jane Henney, as well as during the interim periods between their appointments.

The transition in the FDA general counsel slot appears to be a return to the practice of earlier Republican administrations of making appointments relatively deep into agencies like FDA, below the commissioner level.

It may also signal a return to a more prominent role for the general counsel in setting a policy agenda for FDA. Many prior holders of the position emerged from FDA as prominent figures in the Washington, D.C., food and drug law arena.

One previous general counsel, Covington & Burling partner Peter Barton Hutt, is among the names that have been suggested to the Bush Administration as a potential nominee for the FDA commissioner slot. The Administration is expected to renew its effort to finalize a list of candidates after disclosing its position on stem cell research.

The changeover at the FDA general counsel level may also make it easier for the Bush Administration to compromise on the commissioner nomination.

Before the selection of Troy, the speculation within Washington was that one of the Administration's favorites for the commissioner slot, TKT General Counsel Michael Astrue, might instead be offered the FDA general counsel position after opposition was voiced to appointing him as commissioner.

House Energy & Commerce/Oversight Subcommittee staffer Alan Slobodin was also said to be under consideration for the FDA counsel slot. Slobodin was formerly president of WLF.

FDA Chief Counsel Is Attorney From WLF Case; Porter Leaves After 11 Years

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