Correcting The Record Regarding Unfounded Attacks On Fda General Counsel
Mr. Speaker, on Tuesday, July 13, 2004, on the floor of this House, Representative Hinchey of New York made several statements about Daniel E. Troy, Chief Counsel of the FDA. Allegations were leveled against Mr. Troy that he took…
Mr. Speaker, on Tuesday, July 13, 2004, on the floor of this House, Representative Hinchey of New York made several statements about Daniel E. Troy, Chief Counsel of the FDA.
Allegations were leveled against Mr. Troy that he took unprecedented action regarding the FDA's involvement in the submission of briefs in product liability cases. His actions were neither unprecedented nor unusual. In a letter dated July 15, 2004, to Chairman Bonilla, five former FDA chief counsels--two of them Democrats--state, Mr. Troy's actions in this regard are neither ``radical'' nor ``even novel.''
The FDA must have the ability to carry out the responsibilities Congress has given the Agency. His interest in those cases is to vindicate FDA's authority over medical product risk communication and to safeguard the agency's primary jurisdiction. As Chief Counsel for the FDA, Mr. Troy appears to have acted completely within the scope of his duties and obligations. In order to address the allegation that Mr. Troy acted inappropriately, I would like to submit a copy of that letter for the Record.
July 15, 2004.
Re Hinchey amendment to cut $500,000 from the appropriations
for the FDA Office of Chief Counsel.
Hon. Henry Bonilla,
Chairman, Subcommittee on Agriculture, Rural Development,
Food and Drug Administration and Related Agencies
Appropriations Committee, House of Representatives,
Washington, DC.
Dear Mr. Chairman: 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-TI5599 (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. 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 than 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).