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 [A#01260070002]).

Troy will report to another ex-Wiley partner, Alex Azar, who was confirmed as HHS general counsel on 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.

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 Rudolph Giuliani, and clerked for Robert Bork at the Washington, D.C. Circuit Court of Appeals from 1983 to 1984. He was a Court of Appeals clerk at the time of Bork's failed nomination to serve on the U.S. 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 succeeds Margaret Jane Porter, who in February was reassigned to the Senior Executive Service Federal Executive Institute in Charlottesville, Virginia. Michael Landa has been serving 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. She served under three commissioners, Frank Young, MD, David Kessler, MD/JD, and Jane Henney, MD, and 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 making appointments at relatively deep levels within agencies like FDA - for example, below the commissioner level. The appointment also may allow the Bush administration to be more flexible in seeking a non-controversial FDA commissioner nominee.

Troy Tapped As Top FDA Attorney, Brings WLF Experience To Agency

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