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U.S. House Democrat Says Agency Aiding Drugmakers in Lawsuits

July 13 (Bloomberg) -- The U.S. Food and Drug Administration interceded in lawsuits on behalf of drug- and medical-device makers including Pfizer Inc. in cases alleging the companies' products harmed patients, a move Congressman Maurice Hinchey said is a ``radical new direction'' for the agency.

Hinchey, a New York Democrat on the House appropriations subcommittee that oversees the FDA, said agency General Counsel Daniel Troy has filed briefs aiding the cases of Pfizer, GlaxoSmithKline Plc and other manufacturers. The FDA said Troy acted properly and complied with legal and ethical standards.

The briefs responded to requests from the companies for support and break with the FDA's tradition of staying silent on state lawsuits against manufacturers unless asked by the courts, Hinchey said, citing unidentified legal scholars. Hinchey also said Troy's position poses a conflict of interest because he represented Pfizer among clients in his previous job as partner in a law firm.

``Mr. Troy is supposed to act in the interests of the public and the public health, not his former drug-industry clients,'' Hinchey said.

FDA Acting Commissioner Lester M. Crawford said in a statement that Troy complied with ethical requirements to recuse himself from involvement in issues connected to his previous work for a year after his appointment as general counsel.

Troy ``has provided excellent legal advice to FDA since his appointment in August 2001,'' Crawford said. Troy declined to comment individually, FDA spokeswoman Kathleen Quinn said.

Amicus Briefs

In the four cases, Troy filed amicus, also known as friend-of- the-court, briefs arguing federal law preempts state laws the plaintiffs invoked in their claims that they were harmed by drugs or devices approved by the FDA, according to a statement Hinchey issued during a press conference in the Capitol.

In one case, Motus v. Pfizer, Troy's position benefited Pfizer in a lawsuit over the company's prescription antidepressant Zoloft.

Hinchey said Troy's financial disclosure filing with the FDA indicates his former employer, the firm of Wiley, Rein and Fielding, received $360,000 for Troy's legal services the same year he left to take the FDA post. Hinchey didn't say when Troy filed the brief.

Hinchey held his news conference flanked by three relatives of individuals who committed suicide while taking Pfizer's prescription medicine Zoloft. They said the FDA's actions in intervening in the cases might discourage future patients from filing cases in state court.

``Zoloft was a deadly snake oil for our child,'' said Tom Woodward, of North Wales, Pa. He said his teenage daughter, Julie, killed herself one week after she began taking Zoloft.

``An intense spotlight needs to be focused on Daniel Troy and the pharmaceutical companies,'' Woodward said.

The FDA in March asked Pfizer and other drugmakers to remind doctors to watch for signs of suicidal behavior in patients given antidepressants. Studies haven't proven a cause-and-effect connection, and all patients with depression should be monitored for worsening symptoms or suicidal thoughts, the FDA has said.

To contact the reporter on this story:
Laura Litvan in Washington at

To contact the editor responsible for this story:
Robert Simison in Washington at
Last Updated: July 13, 2004 14:49 EDT

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