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Article Published: Wednesday, July
14, 2004

Congressman: FDA lying about lawyer

Agency's
lead attorney accused of helping drug firms battle consumers

By Anne C.
Mulkern
Denver Post Staff Writer

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.

Advertisement

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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