Cong Hinchey Rebukes Daniel Troy, Chief Counsel FDA, for financial conflict of interest

Cong Hinchey Rebukes Daniel Troy, Chief Counsel FDA, for financial conflict of interest

Tue, 13 Jul 2004

Daniel Troy, the FDA’s chief counsel, is under fire for his financial conflicts of interest and for perverting FDA’s mission “to ensure that the public is protected from unsafe food, drugs and other medical products.” Cong Maurice Hinchey called Daniel Troy’s interventions in at least 4 civil cases against drug manufacturers brought by aggrieved citizens, “a wholly unprecedented direction.”

“Daniel Troy is instead making it the agency’s mission to protect the drug companies from being held accountable when their products do serious harm. This is not merely a question of financial compensation for the victims and their families. Civil action is a vital tool in gaining information about medical products and protecting future users of those products. Mr. Troy is trying to take that tool away from the public his agency is supposed to protect.”

In what must surely be an embarrassing symbolic chastisement to the agency, the Congressman “plans to offer an amendment to the Agriculture Appropriations bill today, removing $500,000 from the FDA Commissioner’s budget, which funds the Chief Counsel’s office and adding those funds to the budget of the Center for Drug Evaluation Research, with the intention that it be used to ensure the accuracy of drug advertisements.”

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Maurice Hinchey NEWS
22nd C O N G R E S S I O N A L D I S T R I C T , N E W Y O R K

FOR IMMEDIATE RELEASE
Contact: Kevin O’Connell
July 13, 2004
202-225-6335

HINCHEY: FDA’S CHIEF COUNSEL SERVES INDUSTRY, NOT PUBLIC

WASHINGTON – U.S. Representative Maurice Hinchey (NY-22) today held a press conference to reveal information he has uncovered about actions taken by Daniel Troy, Chief Counsel of the Food and Drug Administration. Taking the counsel’s office in a wholly unprecedented direction, Troy has repeatedly interceded in civil suits on behalf of drug and medical device manufacturers that were accused of harming patients who had used their products. Hinchey provided evidence that Troy worked in cooperation with the manufacturers in taking these actions, that he ignored serious conflicts of interests, and that the FDA sought to mislead Hinchey in his efforts to investigate the matter.

“The mission of the Food and Drug Administration is to ensure that the public is protected from unsafe food, drugs and other medical products,” said Hinchey. “Daniel Troy is instead making it the agency’s mission to protect the drug companies from being held accountable when their products do serious harm. This is not merely a question of financial compensation for the victims and their families. Civil action is a vital tool in gaining information about medical products and protecting future users of those products. Mr. Troy is trying to take that tool away from the public his agency is supposed to protect.”

Hinchey has learned that in at least four separate cases, Troy’s Chief Counsel office has submitted briefs arguing the side of the defendant corporation against the families of people who died after using that corporation’s product. In three of those cases, Hinchey found evidence of inappropriate collusion or conflict of interest between Troy and the companies the counsel’s office stood up for.

In one case (Motus v. Pfizer), Troy was advocating on behalf of Pfizer, which had paid $360,000 for Troy’s legal services the year he accepted the FDA post. In another (Murphree v. Pacesetter), evidence shows that the defendant’s lawyer was directing the FDA on how best to intervene. In the third (Dowhal v. SmithKline Beecham Consumer Healthcare), Troy met personally with the defendant’s lawyer before filing the brief. In none of the four cases did the court request an opinion from the FDA. This unsolicited insinuation into state civil suits represents a radical departure from the FDA’s established practices, a fact Troy and the FDA have tried to obscure.

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In March, at an Agriculture Appropriations Subcommittee hearing, Hinchey questioned Acting FDA Commissioner Lester Crawford about the Chief Counsel’s actions. The FDA’s response was intentionally misleading, leading the Appropriations Committee to adopt legislative language written by Hinchey expressing concern about the agency’s credibility.

Hinchey plans to offer an amendment to the Agriculture Appropriations bill today, removing $500,000 from the FDA Commissioner’s budget, which funds the Chief Counsel’s office and adding those funds to the budget of the Center for Drug Evaluation Research, with the intention that it be used to ensure the accuracy of drug advertisements.

Hinchey was joined at the press conference by Tom Woodward and his daughter Caroline of Pennsylvania, and Kim Witczak of Minnesota. Mr. Woodward’s oldest daughter, Julie, committed suicide after using an antidepressant for a week. Ms. Witczak’s husband, Woody, committed suicide after being on an antidepressant for two weeks.

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Congressman Maurice D. Hinchey
Contact: Kevin O’Connell
U.S. House of Representatives
Phone: 202-225-6335
2431 Rayburn House Office Building
Mobile: 202-225-0817
Washington, D.C. 20515