[Congressional Record (Bound Edition), Volume 150 (2004), Part 13]
[Extensions of Remarks]
[Pages 17402-17403]
[From the U.S. Government Publishing Office, www.gpo.gov]




   CORRECTING THE RECORD REGARDING UNFOUNDED ATTACKS ON FDA GENERAL 
                                COUNSEL

                                 ______
                                 

                            HON. JOE BARTON

                                of texas

                    in the house of representatives

                        Thursday, July 22, 2004

  Mr. BARTON of Texas. 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

[[Page 17403]]

     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).

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