[Congressional Record Volume 142, Number 97 (Thursday, June 27, 1996)]
[Extensions of Remarks]
[Pages E1190-E1191]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                           FDA APPROPRIATIONS

                                 ______
                                 

                            HON. JOE BARTON

                                of texas

                    in the house of representatives

                        Thursday, June 27, 1996

  Mr. BARTON of Texas. Mr. Speaker, I again note that the 
Appropriations Committee is recommending increased funding for the Food 
and Drug Administration. As chairman of the Oversight and 
Investigations Subcommittee of the Committee on Commerce, I commend the 
Committee on Appropriations for its strong support of the Food and Drug 
Administration, which plays an important role in protecting public 
health. In addition, I commend my colleagues on the Committee on 
Appropriations for their oversight activities regarding the Food and 
Drug Administration.
  The Subcommittee on Oversight and Investigations has worked 
diligently in this Congress to identify shortcomings in FDA's 
performance of its important duties and work with the agency to correct 
those shortcomings. No problem in agency performance is as vexing as 
the systematic failure of FDA to meet its statutory duties to timely 
review various applications and petitions about food, drugs, and 
medical devices. Indeed, not only does the agency fail to meet its 
statutory duty for timely reviews, the agency refuses to acknowledge 
it. In testimony before the Committee on Appropriations, as well as the 
Committee on Commerce, Commissioner Kessler has boasted of meeting the 
goals of the Prescription Drug User Fee Act, alluding to objectives he 
identified and included in letters sent to Congress that were then made 
part of the legislative history of the Prescription Drug User Fee Act. 
However, Commissioner Kessler's testimony has consistently ignored the 
plain language of the Federal Food, Drug, and Cosmetic Act specifying 
review periods. Given Commissioner Kessler's legal training, one would 
expect that his testimony might be more mindful of the plain language 
of FDA's authorizing statute.
  Timely review of applications and petitions is a matter of very real 
consequence. Witnesses who have come before the Oversight and 
Investigations Subcommittee have repeatedly told heart-wrenching 
stories of their inability to obtain in the United States safe and 
effective treatments that are available elsewhere. These patients, 
often fighting life-

[[Page E1191]]

threatening diseases, are the very personal side of the grim statistics 
regarding the adverse effect on public health caused by excessive delay 
in approval of safe and effective drugs and medical devices. There are 
also economic consequences. Hearing records explain clearly that as 
approval of medical devices is excessively delayed in the United 
States, the developers of those devices, principally U.S. firms, are 
forced by economic realities to begin manufacture of those devices 
overseas where more timely approvals have been obtained. It is dark 
humor that a joke told at an international medical device conference 
observed that if a medical device is approved in the United States, it 
must be obsolete. These delays not only deny American patients the most 
safe and effective therapies, but also result in the loss of U.S. jobs.
  Regrettably, these are not small shortcomings. I urge my colleagues 
to review a table that lists the statutory deadline for review of 
certain applications and petitions, as well as the average time that 
FDA takes to conduct these reviews, according to the latest published 
FDA reports.
  I trust my colleagues will share my concerns that agency performance 
is woefully off the mark. The Committee on Appropriations is to be 
commended for directing FDA to meet its statutory duties for timely 
review. I ask unanimous consent that this statement be printed 
following my remarks.

       Food Additive Petitions.--Within 180 days (6 months) after 
     filing of a petition, FDA is required to publish a regulation 
     authorizing the use of the food additive or deny the 
     petition. 21 U.S.C. Sec. 348(c). Current ``average time to 
     approval''--48 months. ``Agriculture, Rural Development, Food 
     and Drug Administration, and Related Appropriations for 
     1996,'' Hearings Before the Subcommittee on Agriculture, 
     Rural Development, Food and Drug Administration, and Related 
     Agencies of the Committee on Appropriations, House of 
     Representative, Part 6, 104th Cong., 1st Sess., p. 664 (Mar. 
     28, 1995) (hereafter ``FY 96 House Agriculture Appropriations 
     Hearings'').
       Health and Nutrient Content Claim Petitions.--Within 190 
     days (6.25 months) after filing of a petition, FDA is 
     required to propose regulations authorizing the use of the 
     health or nutrient content claim or deny the petition. 21 
     U.S.C. Sec. 343(r)(4). Current average review time from 
     filing to issuance of a proposed rule--10 months. 62 Fed. 
     Reg. 296 (Jan. 4, 1996); 60 Fed. Reg. 37,507 (July 20, 1995).
       Nutrient Content Claim Synonym Petition.--Within 90 days (3 
     months) after submission of a petition, FDA is required to 
     approve the use of the synonym for nutrient content claims or 
     deny the petition. 21 U.S.C. Sec. 343(r)(4). Current average 
     review time from submission to approval--19.5 months.\1\ FDA 
     Docket No. 94P-0216 (Letter from F. Edward Scarborough, 
     Ph.D., Director, Office of Food Labeling to Douglas C. 
     Marshall, Darigold, Inc. (Oct. 30, 1995)).
---------------------------------------------------------------------------
     \1\ To date, FDA has received only one synonym petition.
---------------------------------------------------------------------------
       New Human Drug Applications (NDAs).--Within 180 days (6 
     months) after filing of an application, FDA is required to 
     approve the human drug or give the application notice of an 
     opportunity for a hearing before FDA on the question of 
     whether the application is approvable. 21 U.S.C. 
     Sec. 355(c)(1). Current average time for ``first action''--
     twelve months. Statement by David A. Kessler, M.D., 
     Commissioner of Food and Drugs, Department of Health and 
     Human Resources Before the Subcommittee on Health and 
     Environment, Committee on Commerce, U.S. House of 
     Representatives, p. 4 (May 1, 1996) (hereafter, ``Health and 
     Environment Subcommittee Hearing'').
       Abbreviated New Drug Applications (ANDAs).--Within 180 days 
     (6 months) after initial receipt of an application, FDA is 
     required to approve the drug or give the applicant notice of 
     an opportunity for a hearing before FDA on the question of 
     whether the applicant is approvable. 21 U.S.C. 
     Sec. 355(j)(4)(A). Current average review time from receipt 
     to approval--34.2 months. Department of Health and Human 
     Services Fiscal Year 1997 Justification of Estimates for 
     Appropriations Committees for the Food and Drug 
     Administration,'' p. 65 (hereafter ``FY 97 FDA Justification 
     of Estimates for Appropriations Committees'').
       Medical Device Premarket Approval Applications (PMAs).--
     Within 180 days (6 months) after receipt of an application, 
     FDA is required to approve the medical device or deny the 
     application. 21 U.S.C. Sec. 360e(d)(1)(A). ``Current average 
     review time''--20 months. Health and Environment Subcommittee 
     Hearing, pp. 9-10.
       New Animal Drug Applications (NADAs).--Within 180 days (6 
     months) after filing of an application, FDA is required to 
     approve the animal drug or give the applicant notice of an 
     opportunity for a hearing before FDA on the question of 
     whether the application is approvable. 21 U.S.C. 
     Sec. 360b(c)(1). Current average review time from receipt to 
     approval--39 months. FY 97 FDA Justification of Estimates for 
     Appropriations Committees, p. 83.
       Abbreviated New Animal Drug Applications (ANADAs).--Within 
     180 days (6 months) after initial receipt of an application, 
     FDA is required to approve the generic animal drug or give 
     the applicant notice of an opportunity for a hearing before 
     FDA on the question of whether the application is approvable. 
     21 U.S.C. Sec. 360b(c)(2)(C). Current average review time 
     from receipt to approval--31 months. FY 97 FDA Justification 
     of Estimates for Appropriations Committees, p. 84.

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