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,''
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.
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
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.