FDA Approps Amendment Targets Chief Counsel Troy; Pfizer Ties Challenged
This article was originally published in The Tan Sheet
Executive Summary
The House FDA appropriations bill cuts $500,000 from the budget of the chief counsel's office in response to actions taken by Chief Counsel Daniel Troy
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The House FDA appropriations bill cuts $500,000 from the budget of the chief counsel's office in response to actions taken by Chief Counsel Daniel Troy. The amendment, introduced by Rep. Maurice Hinchey (D-N.Y.) and accepted without opposition, moves $500,000 of FDA's appropriations from the Office of the Commissioner to the Center for Drug Evaluation & Research, where it is intended to be used for the Division of Drug Marketing, Advertising & Communications. Hinchey introduced his amendment on the floor with a speech sharply criticizing the actions of FDA Chief Counsel Daniel Troy. The New York Democrat accused Troy of taking "the agency in a radical new direction, and in doing so has wasted taxpayer money on pursuits that are undermining FDA's basic mission." Troy is "actively soliciting private industrial company lawyers to bring him cases in which FDA can intervene in support of drug and medical device manufacturers" when they are being sued by individuals harmed by their products, Hinchey said. These actions undermine FDA's mission by "shutting down avenues used to expose fraud in the drug industry," Hinchey stated. The cases in which FDA intervened are private civil suits filed in state courts, and the judge did not solicit FDA's opinion, Hinchey said. He claimed the agency has devoted 622 hours to working on the cases. Hinchey highlighted three cases on the House floor: one against Pfizer in California (Motus v. Pfizer), one against device manufacturer Pacesetter in Tennessee (Murphree v. Pacesetter), and one against GlaxoSmithKline in California (Dowhal v. SmithKline Beecham Consumer Care). The California Supreme court ruled in favor of GSK, finding that federal law preempted plaintiffs' attempts to have Prop 65 warnings required for nicotine replacement therapy products (1 (Also see "California Supreme Court Rules In Favor Of Glaxo, FDA On Prop 65 Warnings" - Pink Sheet, 19 Apr, 2004.), p. 3). The suit against Pfizer charges the firm with negligence under state law because there is no warning in the Zoloft label that use of the antidepressant could induce suicide. At a July 13 press conference, Hinchey emphasized the Troy-Pfizer connection by having relatives of people who had committed suicide after taking Zoloft speak out against FDA for trying to influence the case. Troy said FDA intervened in the cases because he wants to ensure the agency retains control over decisions regarding the approval and regulation of drugs and devices. Hinchey also suggested a financial conflict of interest. He noted that one of Troy's clients during his tenure with the Washington, D.C.-based law firm Wiley, Rein & Fielding was Pfizer, "which paid that firm $415,000 for services provided directly by Mr. Troy." At the press conference, Hinchey claimed Pfizer paid $360,000 for Troy's legal services in 2001, the year he took the chief counsel position at the agency. A Pfizer attorney contacted Troy less than a year after he had left private practice to join FDA, he noted. Hinchey questioned FDA Acting Commissioner Lester Crawford, PhD, about Troy's conflict of interest at the House Appropriations Committee's March 11 hearing for the funding bill. Crawford's answer failed to mention Pfizer's payments to Wiley, Rein & Fielding for services "provided directly by" Troy, Hinchey said. The committee expressed concern with Crawford's "misleading" answer in its appropriations bill 2 report when it approved the legislation June 23. "The question was posed due to concerns about a conflict of interest. The committee is concerned about whether the response was fully forthcoming and whether it may have had the effect of misleading the committee," the report states. "The committee intends to look into this matter further and expects FDA to cooperate fully in this effort," the report concludes. Crawford issued a statement July 13 saying that Troy "fully complied with the ethical requirement to recuse himself from any matter involving a past client for a year after beginning work in the public sector." "FDA has accurately reported the scope and nature of Dan's private sector work. Any allegation that he has not conducted himself in compliance with applicable legal and ethical rules is simply false." |