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November 17, 2004

Troy Resigns from FDA

Good News: Daniel Troy is resigning from the Food and Drug Administration. The Washington Post reports:

Daniel E. Troy, the Food and Drug Administration's chief counsel, criticized by a congressman in July for intervening on the side of drugmakers in legal cases, will resign effective Nov. 24, the agency said. Troy, who was named to the post in 2001, planned to stay with the agency just a few years, acting FDA Commissioner Lester M. Crawford said in an interview after speaking at a Senate hearing on flu vaccine.

Why is this good news? Troy is in the pocket of industry. He is one of the big forces behind creating constitutional protections for drug advertising, thus placing it outside of consumer protections that currently exist (such as disclosing adverse side effects and requiring proof of effectiveness). Representative Maurice Hinchey has assembed quite a dossier on Troy:

For the first time in FDA's history the FDA's Chief Counsel is actively soliciting private industrial company lawyers to bring him cases in which the FDA can intervene in support of drug and medical device manufacturers. The cases he is seeking out are private state civil litigation cases. These are cases in which in which drug companies and medical device manufacturers are being sued by people harmed by their products. The court has not asked for FDA involvement in these cases. In other words, FDA is spending taxpayer dollars to defend drug companies who are being sued in state court. Since August 2001, the FDA has expended over 600 hours to file at least six briefs on behalf of these companies in four such cases across the country...

FDA is Placing Corporations Above Public

Daniel Troy, Chief Counsel of the Food and Drug Administration, is taking the counsel's office in a wholly unprecedented direction, repeatedly interceding in civil suits on behalf of drug and medical device manufacturers that were accused of harming patients who had used their products. In doing so, Troy has worked in cooperation with the manufacturers, ignoring serious conflicts of interests. The FDA has attempted to mislead Congressman Hinchey in his efforts to look onto this matter.

A narrative with built-in links appears below. Or you may access specific documents here.

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Amicus Brief written by Professor O'Reilly

Text of Hinchey Amendment

Text of Hinchey Floor Statement

Video of Hinchey Floor Statement

Letter from Hinchey to FDA requesting more documentation

Letter from former FDA chief counsels to Chairman Bonilla

Letter from Hinchey to Bonilla, refuting former counsels' claims

BACKGROUND

On August 20, 2001 President Bush appointed Daniel Troy to be Chief
Counsel of the Food and Drug Administration. Previously, civil servants
held this position. Troy was the first political appointee to the FDA
post.

Congressman Hinchey has been following Mr.
Troy's activities for several years now and has done extensive research
and investigative work beginning in early 2004.

The FDA is the government agency charged
with protecting the public by ensuring that foods are safe, wholesome,
sanitary and properly labeled; and by ensuring that drugs and medical
devices are safe and effective.

The FDA is failing in that mission in large
part because of a radical new direction that Daniel Troy has taken
FDA's Office of Chief Counsel, at the behest of the pharmaceutical
industry.

RADICAL DEPARTURE

For the first time in FDA's history the FDA's Chief Counsel is actively
soliciting private industrial company lawyers to bring him cases in
which the FDA can intervene in support of drug and medical device
manufacturers. The cases he is seeking out are private state
civil litigation cases. These are cases in which in which drug
companies and medical device manufacturers are being sued by
people harmed by their products. The court has not asked for FDA
involvement in these cases.

In other words, FDA is spending taxpayer dollars
to defend drug companies who are being sued in state court. Since
August 2001, the FDA has expended over 600 hours to file at least six
briefs on behalf of these companies in four such cases across the
country.

Mr. Troy is using the argument of preemption to
shut down these cases before they can even begin and has stated that
there is a well-documented precedent. Yet when Congressman Hinchey's
office contacted several former FDA officials and Justice
Department officials, not one had ever heard of such an action by the
United States before Dan Troy came to power. Moreover, Mr. Troy's
immediate predecessor stated clearly in 1997 that FDA long had a policy
against preempting courts in this way. Explaining the
reason for that policy she wrote, "Even the most thorough regulation of
a product such as a critical medical device may fail to identify
potential problems presented by the product. ... Preemption of all such
[tort liability] claims would result in the loss of a significant layer
of consumer protection."

Legal scholars agree as well. Professor James
O'Reilly from the University of Cincinnati Law School is one of the
country's preeminent legal scholars on FDA issues. He is also
acknowledged by the Supreme Court as an expert on FDA legal matters and
is a former drug industry lawyer. Professor O'Reilly has stated that he knows of no precedent for FDA's actions.

In fact, in 1996, the United States argued before
the Supreme Court that the private lawsuits Mr. Troy is seeking to kill
should be allowed and are necessary to hold companies accountable for
their actions (Medtronic v. Lohr). For Mr. Troy to now be arguing the
opposite, and to do so without any precedent, is completely outside the
bounds of normal jurisprudence.

The overwhelming response from Mr. Troy's fellow
lawyers is that what he is doing represents a radical departure from
past government efforts. Not one person Mr. Hinchey's
office spoke with could identify anything remotely similar to what
Troy is doing at FDA.

MASSIVE CONFLICTS OF INTEREST

Prior to Mr. Troy's appointment to the FDA he was a partner at Wiley,
Rein and Fielding - a large Washington, DC law firm. He was also
involved with the Washington Legal Foundation, which is a "public
interest" that supports weaker government regulations of drug companies
and medical device manufacturers.

One of Mr. Troy's clients at Wiley, Rein was
Pfizer, which in the three years prior to his appointment at FDA paid
Wiley, Rein $415,000 for "services provided directly by" Mr. Troy.

In July of 2002 Malcolm Wheeler, an attorney for
Pfizer, called Mr. Troy, then FDA's chief counsel, and requested that
FDA get involved in a private state lawsuit against Pfizer that was
ongoing in California. Mr. Troy obliged and in September, less than two
months later, FDA, through the Department of Justice, filed a court
brief in support of Pfizer.

That same July Mr. Troy also had a meeting with Michele Corash from Morrison and Foerster on "Proposition 65 issues." Morrison
and Foerster, one of the world's largest firms, is based in California.
At the time of this meeting, it was representing Glaxo Smith Kline in a
private lawsuit in California that revolved around California's
Proposition 65 or the Safe Drinking Water and Toxic Enforcement Act.
Michele Corash was the lead attorney. On September 12, less than two
months after that meeting, Mr. Troy's FDA filed a brief in support of
Ms. Corash's client - GSK.

This pattern continued in 2003. On December 12,
2003 FDA filed a Statement of Interest in the case of Murphree v.
Pacesetter in support of the medical device manufacturer Pacesetter.
The company was being sued in Tennessee state court for a faulty
pacemaker. Congressman Hinchey's office obtained a letter to FDA,
dated November 25, 2003 from the law firm of Feldman, Gale and Weber
directing FDA on how it should assist its case. The firm was
representing Pacesetter.

In re Paxil is a fourth case in which
FDA submitted an unsolicited. According to remarks by Mr. Troy, he
involved FDA because he thought a California state judge's ruling in
the case was "crazy."

What these few cases describe are massive
conflicts of interest and a pattern of collusion between a federal
agency and the industry it is supposed to regulate. If FDA did for some
reason need to get involved in these cases, it should have done so
independently of the drug companies, not in coordination with them. Mr.
Troy is supposed to be acting to protect the public's health, not his
former drug company clients. Instead, he is actively seeking
opportunities to help the drug companies.

On December 15, 2003 Mr. Troy was the featured
speaker at the 8th Annual Conference for In-House Counsel and Trial
Attorneys, entitled "Drug And Medical Device Litigation."
Conspicuously, this event was not noted on FDA's public calendar, which
listed 44 other speeches Mr. Troy has delivered. The conference program
uses his official title.

It seems unlikely that omission was accidental. According to
a signed affidavit of a conference participant Mr. Troy took credit for
FDA's involvement in private civil litigation cases and solicited cases
in which the FDA could intercede. He told the audience "we can't
afford to get involved in every case, we have to pick our shots," so
"make it sound like a Hollywood pitch."

Mr. Troy also outlined his reason for getting
involved in these cases: tort reform. He specifically stated that FDA
is "deeply immersed in tort reform issues," and that it was FDA's goal
to "control the flow of risk info regarding these [drug and medical
device] products."

MISLEADING CONGRESS

Congressman Hinchey raised this issue with acting-FDA Commissioner
Lester Crawford when he testified before the House Appropriations
Agriculture Subcommittee on March 11, 2003. He asked about Mr.
Troy's relationship with Pfizer prior to his appointment. The answer FDA provided for
the record sought to minimize that relationship. According to FDA, Mr.
Troy worked an average of less than 80 hours per year on matters
related to Pfizer. Congressman Hinchey later discovered that
Pfizer paid Mr. Troy's law firm $415,000 over three years for work
performed directly by Mr. Troy. This included over $358,000 in 2001,
the year Mr. Troy was appointed to his FDA post.

On a bipartisan basis, the House Appropriations
Committee included language written by Congressman Hinchey in the
Agriculture Appropriations report, expressing concern about the
misleading nature of FDA's answer.

Subsequently Hinchey uncovered additional
evidence that FDA provided misleading or even false answers
on the record.

In that same response, FDA asserted that Mr. Troy
"became involved in a case affecting Pfizer more than a year after
leaving private practice." According to press reports,
however, Pfizer's lawyer contacted Mr. Troy in July of 2002 about
his case, which was less than a year after Mr. Troy left his firm.

In response to another question Mr. Hinchey asked
about FDA's history of involvement in these lawsuits, FDA again
provided a misleading answer. The response sought to imply precedent
for FDA actions by citing previous cases, failing to note that these
cases were in response to court requests. None of the pre-Troy cases
cited involved the FDA actively seeking to intervene in private
lawsuits.

That same answer also failed to list two other lawsuits in which FDA filed briefs under Mr. Troy, unsolicied by the court.

And finally, in response to another question from
Rep. Marcy Kaptur, FDA provided a list of cases and stated that those
"that do not name the government (FDA, United States or HHS) are cases
in which FDA has been subpoenaed to produce a witness or documents."
This is simply false. There are at least four cases in which FDA got
involved without being subpoenaed. Mr. Troy himself has even stated
that he was "the initiator" of such cases.

These five instances of misleading or false
answers in response to questions from members of Congress are deeply
troubling and severely undermine the credibility of the FDA.

PEOPLE HARMED

Over the last few months it has been widely reported that drug
companies are providing the public and federal officials with less and
less information about possible harmful side effects of their products.
We know that these companies often do not share the results of clinical
trials that demonstrate problems with their drugs. This has spurred the
American Medical Association and the editors of several major medical
journals to call for a public registry of all clinical trials for
FDA-approved drugs.

The lawsuits that Mr. Troy is seeking to shut
down have become the last line of defense to get that information and
hold companies accountable for misleading consumers. With
whistleblowers becoming more and more rare, most scandals involving
consumer products are uncovered through lawsuits just like these. Our
country has relied on them for decades to ensure that consumers have a
remedy and an avenue to defend their interests.

ACTION TAKEN BY HINCHEY

On July 13, 2004, Congressman Hinchey offered an amendment to the Agriculture Appropriations bill, taking $500,000 away from FDA' Chief Counsel's office. In offering the amendment,
Mr. Hinchey stated his intention that the funds be cut from FDA's
Office of General Counsel, which is housed in the Commissioner's
office, and added to FDA's Division of Drug Marketing, Advertising, and
Communication, the office responsible for monitoring drug
advertisements. The amendment was accepted without opposition.

Since then, Mr. Troy and FDA have
sought to restore the funding. Mr. Troy has visited legislators
on Capitol Hill, distributing a copy of a letter from five former FDA chief counsels.
This letter has also been submitted to the Congressional Record to
refute Congressman Hinchey's assertions. The letter contains
several false claims.

Rep. Hinchey's argument is mischaracterized in
the letter from the counsels, which reads in part, "Representative
Hinchey states that Mr. Troy 'has taken the agency in a radical new
direction' by submitting amicus curiae briefs in cases in which courts
have been asked to require labeling for pharmaceutical products that
conflicts with FDA decisions about appropriate labeling for those
products." That is not what Rep. Hinchey has argued. The "radical new
direction" refers to Mr. Troy's practice of soliciting lawyers for
drug companies and medical device companies to come to him with cases
in which to intervene; and submitting briefs in private civil cases in
which FDA has not been asked for its opinion.

The letter then cites four examples of cases to
show that in fact this type of activity on the part of the FDA predates
Mr. Troy's term in office. None of the cases, however, provide such
precedent.

Here's why:

Weinberger v. Bentex: FDA had no choice but to file
briefs since the agency was the defendant, not an intervener. Rep.
Hinchey is arguing that the FDA never before intervened without
being requested to do so.

Jones v. Rath Packing: The FDA submitted a brief to
the U.S. Supreme Court in a case involving a government agency and the
labeling of flour. Again, far different from interceding in a state
civil case between two private parties about product liability.

Bernhardt v. Pfizer: The court requested FDA's statement of interest.

Eli Lilly v. Marshall: According to the court's
decision, FDA did not submit anything in this case and the case had
nothing to do with product liability.

The former chief counsels wrote, "In none of
these cases did any court request FDA's opinion. Thus, there is ample
precedent for the actions that Mr. Troy has recently been undertaking.
His action is not radical or even novel." That assertion is inaccurate.

Congressman Hinchey has written a letter to Acting Commissioner Crawford, requesting further documentaion in this matter. He has also written to Agriculture Appropriations Subcommittee Chairman Henry Bonilla to refute the claims of the former chief counsels.

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