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

[Guest guest]

> JustSayNo

> Tue, 13 Jul 2004 20:58:29 -0400

> [sSRI-Research] U.S. House Democrat Says

> Agency Aiding Drugmakers in Lawsuits

>

> FDA's chief counsel, Daniel Troy, 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

>

>

>

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

> Lawsuits

>

>

http://quote.bloomberg.com/apps/news?pid=nifea & & sid=aFJtb55dWf9A

>

> 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 [THAT HAVE BEEN PUBLISHED] 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

> llitvan

>

> To contact the editor responsible for this story:

> Robert Simison in Washington at

> rsimison

>

> Last Updated: July 13, 2004 14:49 EDT

>

>

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