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.
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.