[Congressional Record Volume 150, Number 103 (Thursday, July 22, 2004)]
[Senate]
[Page S8657]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
LABOR-HHS APPROPRIATIONS
Mr. GREGG. Mr. President, the Senate will soon have the opportunity
to consider the 2005 Labor-Health and Human Services Appropriations
bill recently passed the House. Included in that bill is a provision
that would divert $500,000 in funding from the Office of the General
Counsel at the Food and Drug Administration--FDA. As chairman of the
committee with oversight over the FDA, I believe that such a provision
is not only misguided, but based upon a flawed understanding of both
the Agency and the facts.
According to the sponsors of this provision, such a punitive measure
is warranted because the current Chief Counsel, Dan Troy, is taking the
Agency ``in a radical new direction'' by filing amicus curiae briefs in
product liability cases. Sponsors of this provision also claim that Mr.
Troy's involvement in one such case is suspect because it involved
Pfizer, a client of Mr. Troy's when he was with the law firm of Wiley,
Rein & Fielding. Such charges are patently without merit, and I would
like to take this opportunity to set the record straight.
First, Mr. Troy has not broken any new ground by having the FDA
interject in product liability cases on the side of a defendants
without the court requesting the Agency's position. I have here a
letter addressed to me from five former FDA chief counsels--two of
which are Democrats--affirming that Mr. Troy's actions are neither
``radical'' nor ``novel.'' I ask unanimous consent that a copy of that
letter be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
July 21, 2004.
Re Hinchey Amendment to cut $500,000 from the appropriations
for the FDA Office of Chief Counsel
Hon. Judd Gregg,
Chairman, Health, Education, Labor and Pensions Committee,
U.S. Senate, Washington, DC.
Dear Chairman Gregg: The undersigned comprise all of the
former Chief Counsel to the Food and Drug Administration (in
both Republican and Democratic Administrations), except for
one who is currently an attorney in the Office of the General
Counsel of the Department of Health and Human Services. We
are writing to recommend reconsideration of the amendment to
the FDA appropriations bill by Representative Hinchey of New
York on the floor of the House of Representatives, which
would reduce the appropriation for the FDA Office of Chief
Counsel by $500,000 and would increase the appropriation for
the Division of Drug Marketing, Advertising, and
Communications in the FDA Center for Drug Evaluation and
Research by a corresponding amount. We support additional
funds for the Division of Drug Marketing, but we believe that
the reduction of the appropriation for the Office of Chief
Counsel and Representative Hinchey's reasons for penalizing
that Office cannot be supported.
FDA's Office of Chief Counsel performs critical functions
in the administration and enforcement of the Federal Food,
Drug, and Cosmetic Act and other laws administered by FDA.
The substantial reduction in the funding of that Office,
therefore, would materially impair its ability to meet the
needs of its client, FDA. Such impairment would be contrary
to the public interest.
Representative Hinchey's reasons for penalizing the Office
of Chief Counsel and criticizing FDA Chief Counsel Daniel E.
Troy are set forth in the House Debate on the FDA
appropriations legislation as reported in 150 Cong. Rec.
H5598-H5599 (July 13, 2004). 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.
Representative Hinchey characterizes this activity as a
``pattern of collusion between the FDA and the drug
companies and medical device companies'' in a way that has
``never happened before.''
These characterizations are inaccurate.
In Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645
(1973), the Supreme Court agreed with the briefs filed by the
Department of Justice on behalf of FDA that the agency has
primary jurisdiction over new drug issues. In Jones v. Rath
Packing Co., 425 U.S. 933 (1977), the FDA took the position
in an amicus curiae brief submitted by the Department of
Justice that federal food labeling requirements preempt
inconsistent state requirements, and the Supreme Court
agreed. In subsequent private tort litigation, FDA has taken
the position, through amicus curiae briefs filed by the
Department of Justice, that FDA decisions regarding drug
product labeling and related issues preempt inconsistent
state court determinations, and the courts have agreed. E.g.,
Bernhardt v. Pfizer, Inc., 2000 U.S. Dist. Lexis 16963
(November 16, 2000); Eli Lilly & Co. v. Marshall, 850 S.W. 2d
164 (Texas 1993). All of this was to protect a uniform
national system of food and drug law. All of it occurred
before Mr. Troy assumed his current position. 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.
The amicus curiae briefs filed by the Department of Justice
at the request of Mr. Troy protect FDA's jurisdiction and the
integrity of the federal regulatory process. There is a
greater need for FDA intervention today because plaintiffs in
courts are intruding more heavily on FDA's primary
jurisdiction then ever before. In our judgment, Mr. Troy's
actions are in the best interests of the consuming public and
FDA. If every state judge and jury could fashion their own
labeling requirements for drugs and medical devices, there
would be regulatory chaos for these two industries that are
so vital to the public health, and FDA's ability to advance
the public health by allocating scarce space in product
labeling to the most important information would be seriously
eroded. By assuring FDA's primary jurisdiction over these
matters, Mr. Troy is establishing a sound policy of national
decisions that promote the public health and, thus, the
public interest.
We therefore recommend that the $500,000 cut from the
appropriations for the FDA Office of Chief Counsel be
restored.
Sincerely yours,
Peter Barton Hutt (1972-1975).
Richard A. Merrill (1975-1977).
Richard M. Cooper (1977-1979).
Nancy L. Buc (1980-1981).
Thomas Scarlett (1981-1989).
Mr. GREGG. Mr. President, second, as stated in the letter from the
five former FDA chief counsels, the FDA has been filing amicus briefs
for such purposes since long before Mr. Troy's tenure. Mr. Troy is
responsible for safeguarding the FDA's ability to carry out the
responsibilities Congress has given the Agency, and his interest in
those cases has been to preserve the FDA's authority and to safeguard
the Agency's primary jurisdiction.
Finally, if Mr. Troy's previous work for a client--in this case
Pfizer--automatically precluded him from representing a federal agency
in any matter affecting that client, such a policy would not only
discourage, but make it extremely difficult for any private sector
attorney from taking a job in government. Additionally, I know from
personal experience that Mr. Troy has the character and the integrity
to recuse himself from a matter when appropriate. On at least one
occasion in which my office was required to interact with the FDA, Mr.
Troy recused himself from involvement in the matter, citing his
interest in complying strictly with FDA rules.
Mr. Troy's actions are neither inappropriate nor unprecedented.
Rather, these are examples of Mr. Troy doing his job and enforcing the
law. I urge my colleagues to carefully consider these facts before
supporting any provision, such as this one, that would undermine the
FDA's ability to protect the public health and patient access to safe
and effective life-saving therapies.
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