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Cong. Hinchey calls for ouster of FDA Counsel
Sen. Bingaman & Reed tell FDA: disclose all trial info

Thu, 15 Jul 2004

Wish I'd said that: "Having Daniel Troy as chief legal counsel of the FDA, is like placing John Gotti in charge of the Justice Department." (Tom Woodward, whose 17 year old daughter committed suicide soon after taking Zoloft said that. Daniel Troy intervened in court decisions defending Pfizer's concealment of Zoloft-related adverse effects, including evidence of increased suicide).

Congress is demanding that the FDA focus its energies on protecting the rights and health of the public--not the wealth and stealth of drug companies.

At a news conference on Tuesday, Congressman Maurice Hinchey said that Troy's intervention on behalf of Pfizer and other drug / device manufacturers broke the law: "by not adhering to the responsibilities of his office to protect the public interest. He should be removed from office. He doesn't belong there."

Hinchey challenged FDA Acting Commissioner, Lester Crawford, for failing to disclose the fact that Pfizer paid Troy's firm $358,000 for Troy's services on the company's behalf in 2001 just prior to being hired by the FDA.

Congressman Hinchey noted that the FDA spent 622 hours working on court briefs Troy improperly filed on behalf of drug manufacturers. Following the press conference, the House passed Hinchey's bill shifting $500,000 from the FDA counsel's office to the office of drug safety.

AHRP has obtained a copy of a letter to Crawford from Senators Jeff Bingaman and Jack Reed reminding him that: "drug companies are required to report to FDA data regarding adverse events, whether those products are in clinical trials or already approved for sale. The FDA has also been given additional funding in recent years by the Congress, as the FDA has noted, to "protect human subjects and the integrity of research data in clinical trials."

The Senators cite an article in the May 1, 2004, edition of the Journal of the American Academy of Child and Adolescent Psychiatry, by Drs. Julie Magno Zito, Albert T. Derivan, and Laurence L. Greenhill, noting that federal regulations require: "Assuring subjects that research finding from all studies, whether proprietary or in the public domain, will be made available is a clear application of the justice principle."

The letter further notes that the Food and Drug Administration Modernization Act (FDAMA, P .L. 105-115) "encourages that all such clinical studies, whether publicly or privately funded, be listed on a publicly accessible database maintained by the National Library of Medicine (NLM)." Since manufacturers have failed to abide by the requirement--as confirmed by the FDA's own analysis-- the letter asks the FDA to respond to the following:

* What actions does FDA plan to take to ensure that drug trial sponsors respond to the current federal clinical trial reporting provisions under FDAMA?

* What is the status of the public database of adverse events FDA is considering?

* What will be done to ensure maximum public accessibility to this adverse event information and as well as compliance by manufacturers?

* Is FDA willing to pursue making clinical trials registration a condition of approval of a protocol, or consider making institutional review board approval contingent upon registration, as the AMA has recommended? Would FDA's ability to hold up clinical studies pending the sponsor's commitment to list the trial require any change in law to provide specific authority for the agency to do this?

* How does your agency respond to the recommendations set forth by Drs. Zito, Derivan and Greenhill and is there anything FDA is planning to do to address these concerns."

Contact: Vera Hassner Sharav
Tel: 212-595-8974

http://www.denverpost.com/Stories/0,1413,36%257E11676%257E2270484,00.html?search=filter#
Denver Post
July 14, 2004
Congressman: FDA lying about lawyer
Agency's lead attorney accused of helping drug firms battle consumers

By Anne C. Mulkern

Washington - The U.S. Food and Drug Administration lied and obfuscated when asked to explain why its lead attorney is helping drug companies fight consumer lawsuits, a congressman said Tuesday. Rep. Maurice Hinchey, D-N.Y., had demanded answers from FDA Commissioner Lester M. Crawford in March after learning that FDA lead counsel Daniel E. Troy has filed court briefs in three lawsuits.

Troy in those cases argued that the suits against drug companies or medical-device makers were invalid.

"I think he's broken the law by not adhering to the responsibilities of his office to protect the public interest," Hinchey said at a news conference. "He should be removed from office. He doesn't belong there."

The Denver Post in May reported that Troy, at a conference of drug company attorneys in New York last December, said he was willing to assist them with cases and invited them to call his office for help.

Troy previously worked as a private attorney and represented drug-manufacturer Pfizer Inc. He went to the FDA in August 2001.

Troy, The Post reported, is one of more than 100 former industry advocates appointed by President Bush to jobs where they now regulate their former industries.

Because so many people from industry have been hired as regulators, Hinchey said Tuesday, "some of those agencies have been corrupted."

Crawford issued a statement in response saying that Troy "is a dedicated and talented public servant who has provided excellent legal advice to FDA."

The statement said Troy "fully complied" with a government requirement to remove himself from involvement in matters involving a past client for the first year in government work.

"FDA has accurately reported the scope and nature of Dan's private-sector work," Crawford said.

"Any allegation that he has not conducted himself in compliance with applicable legal and ethical rules is simply false," he said.

The FDA would not answer any specific questions about Hinchey's accusations.

Hinchey said he has since learned of a fourth court brief and released a letter from the law firm defending a device- maker in that case.

Addressed to Troy's office, the letter gives the best timing for the FDA to submit a court motion. Hinchey said he is also disturbed to learn that Troy is soliciting new cases.

Hinchey said the FDA spent 622 hours working on the briefs Troy filed.

So Hinchey on Tuesday also introduced an amendment to a funding bill that would take $500,000 from Troy's office - the amount of taxpayer money Hinchey says Troy wasted.

The money would go to enforcement of misleading advertising, Hinchey said.

The amendment passed on the House floor. The funding bill will have to be merged with a Senate bill.

Hinchey said he learned that Pfizer paid Troy's old law firm $358,000 in 2001 for services performed by Troy.

Troy left the firm in August 2001 to go to the FDA.

The FDA, in response to questions asked of Crawford at a House committee hearing, had told Hinchey that Troy worked about 80 hours a year for Pfizer. The FDA omitted mention of the $358,000, which Hinchey called an attempt to minimize Troy's efforts for Pfizer.

The agency also said it had intervened in court cases, Hinchey said, but failed to mention that in all cases prior to Troy, it had done so only when asked to by a court.

Separately, the FDA listed four cases filed under Troy's tenure "in which FDA has been subpoenaed to produce a witness or documents."

That is false, Hinchey said, because Troy intervened without the court asking.

Hinchey also said Troy may have violated ethics laws by not getting a waiver allowing him to deal with issues affecting Pfizer and other companies.

Two of the cases in which Troy intervened involve antidepressants.

At Hinchey's news conference, three families that had lost people to suicide while on the drug Zoloft spoke out against Troy.

"Troy has turned the agency on its head and now uses it as a vehicle to protect his former clients' financial and business interests," said Tom Woodward of Pennsylvania.

Woodward's daughter, Julie, 17, killed herself a week after starting Zoloft. He has not sued.

"Having Daniel Troy as chief legal counsel of the FDA," he said, "is like placing John Gotti in charge of the Justice Department."

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