FDA Chief Counsel Daniel Troy Resigns
FDA chief counsel Daniel Troy resigned on Tuesday, the Newark Star-Ledger reports (Silverman, Newark Star-Ledger, 11/17).
During his tenure, Troy worked in support of Bush administration efforts to block liability lawsuits against medical device manufacturers and drug makers. Troy argued in legal briefs that only FDA has the authority to determine when and how pharmaceutical companies should issue product warnings and that state court decisions could undermine the agency's authority over product labels. FDA claimed in briefs that suits against FDA-approved products would "sabotage the agency's authority"; critics called the agency's position a "back-door approach to tort reform."
Rep. Maurice Hinchey (D-N.Y.), a member of the House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies, in July said that Troy had violated an FDA tradition to avoid intervention in lawsuits against pharmaceutical companies unless asked by the courts. Hinchey also said that the briefs pose a conflict of interest because Troy represented Pfizer in his previous position as a partner in the law firm of Wiley, Rein & Fielding (California Healthline, 8/12).
FDA acting Commissioner Lester Crawford wrote in an internal e-mail that he was announcing the resignation with "mixed emotions" but added that he supported Troy's work on product liability (Newark Star-Ledger, 11/17). Crawford has called Troy a "dedicated and talented public servant who has provided excellent legal advice to FDA."
According to the Associated Press, Troy said of his resignation, "More than three years passed. And we won the election. And that's about the amount of time that I intended to serve."
Hinchey said in a statement, "Daniel Troy's resignation is a rare bright spot in what has been a dark period for the FDA." He added, "The agency is facing serious challenges, from the Vioxx recall to the flu vaccine shortage, that require strong FDA actions. Yet Mr. Troy has worked tirelessly to weaken the FDA's ability to face these challenges and protect the public health" (CongressDaily, 11/17).