[Congressional Record (Bound Edition), Volume 150 (2004), Part 13]
[Senate]
[Page 17045]
[From the U.S. 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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