[Congressional Record Volume 140, Number 60 (Monday, May 16, 1994)]
[Extensions of Remarks]
[Page E]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: May 16, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
                  BETTER PHARMACEUTICALS FOR CHILDREN

                                 ______


                           HON. MIKE KREIDLER

                             of washington

                  in the house of representatives

                          Monday, May 16, 1994

  Mr. KREIDLER. Mr. Speaker, pharmaceutical research and development 
has brought us thousands of life-saving medicines. Most of these drugs 
have been developed and tested in clinical trials for adults, with much 
less research on their uses and effects for children.
  One reason is that the Food and Drug Administration typically 
approves new drugs on the basis of studies conducted with adults. Drug 
manufacturers have little incentive to undertake costly additional 
research on drug and dosage effects on children, who are usually a 
small segment of the market for a new drug.
  That means fewer than a third of prescription drugs are labeled for 
pediatric use. Physicians can still prescribe them for children, but 
they have to estimate the appropriate doses. Estimates can be 
uncertain, especially because young children often metabolize drugs 
differently from adults. Some drugs can be less safe in children than 
in adults, even when appropriate doses are used, and side effects can 
sometimes be different.
  There is increasing concern among pediatricians and other health 
professionals about the lack of child-centered pharmaceutical research, 
and the need to encourage more. That's why I am introducing the Better 
Pharmaceuticals for Children Act with my colleagues Congresswoman 
Jolene Unsoeld and Congressman Roy Rowland. Similar legislation has 
been introduced in the Senate.
  This bill would establish a 6-month period of market exclusivity for 
new drugs whose manufacturers conduct pediatric studies at the request 
of the Secretary of Health and Human Services. Such studies would lead 
to appropriate labeling of drugs for treating children and take the 
guesswork out of an important part of medical practice.
  The bill does not allow a manufacturer to avoid competition simply 
because it wants to. The studies must be requested, and the protocols 
approved, by the Secretary of Health and Human Services. And the period 
of market exclusivity is limited to 6 months, regardless of how long 
pediatric studies may take.
  Mr. Speaker, the Better Pharmaceuticals for Children Act is a 
valuable step toward better medical care for all America's children. I 
urge my colleagues to support it.
  The text of the bill follows:

                               H.R. ----

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Better Pharmaceuticals for 
     Children Act''.

     SEC. 2. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

       Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 501 et seq.) is amended by inserting after section 505 
     the following new section:


              ``pediatric studies for new drug applications

       ``Sec. 505A. (a) If an application submitted under section 
     505(b)(1) is approved on or after the date of enactment of 
     this section, and such application includes reports of 
     pediatric studies described and requested in subsection (c), 
     and such studies are completed and the reports thereof 
     submitted in accordance with subsection (c)(2) or completed 
     and the reports thereof accepted in accordance with 
     subsection c)(3), the Secretary may not make the approval of 
     an application submitted under section 505(b)(2) or section 
     505(j) which refers to the drug for which the section 
     505(b)(1) approval is granted effective prior to the 
     expiration of 6 months from the earliest date on which the 
     approval of such application for the drug under section 
     505(b)(2) or section 505(j), respectively, could otherwise be 
     made effective under the applicable provisions of this 
     chapter.
       ``(b) If the Secretary makes a written request for 
     pediatric studies described in subsection (c) to the holder 
     of an approval under section 505(b)(1) for a drug, and such 
     studies are completed and the reports thereof submitted in 
     accordance with subsection (c)(2) or completed and the 
     reports thereof accepted in accordance with subsection 
     (c)(3), the Secretary may not make the approval of an 
     application submitted under section 505(b)(2) or section 
     505(j) which refers to the drug subject to the section 
     505(b)(1) approval effective prior to the expiration of 6 
     months from the earliest date on which an approval of such 
     application under section 505(b)(2) or section 505(j), 
     respectively, could otherwise be made effective under the 
     applicable provisions of this chapter. Nothing in this 
     subsection shall affect the ability of the Secretary to make 
     effective a section 505(b)(2) or section 505(j) approval for 
     a subject drug if such approval is proper under such 
     subsection and is made effective prior to the submission of 
     the reports of pediatric studies described in subsection (c).
       ``(c)(1) The Secretary may, pursuant to a written request 
     for studies after consultation with the sponsor of an 
     application or holder of an approval for a drug under section 
     505(b)(1), agree with the sponsor or holder for the conduct 
     of pediatric studies for such drug.
       ``(2) If the sponsor or holder and the Secretary agree upon 
     written protocols for such studies, the studies requirement 
     of subsection (a) or (b) is satisfied upon the completion of 
     the studies in accordance with the protocols and the 
     submission of the reports thereof to the Secretary. Within 60 
     days after the submission of the report of the studies, the 
     Secretary shall determine if such studies were or were not 
     conducted in accordance with the written protocols and 
     reported in accordance with the Secretary's requirements 
     for filing and so notify the sponsor or holder.
       ``(3) If the sponsor or holder and the Secretary have not 
     agreed in writing on the protocols for the studies, the 
     studies requirement of subsection (a) or (b) is satisfied 
     when such studies have been completed and the reports 
     accepted by the Secretary. Within 90 days after the 
     submission of the reports of the studies, the Secretary shall 
     accept or reject such reports and so notify the sponsor or 
     holder. The Secretary's only responsibility in accepting or 
     rejecting the reports shall be to determine, within 90 days, 
     that the studies fairly respond to the written request, that 
     such studies have been conducted in accordance with commonly 
     accepted scientific principles and protocols, and that such 
     studies have been reported in accordance with the Secretary's 
     requirements for filing.
       ``(4) As used in this section, `pediatric studies' or 
     `studies' means at least 1 human clinical investigation in a 
     population of adolescent age or younger. At the Secretary's 
     discretion, pharmacokinetic studies may be considered as 
     clinical investigations.
       ``(d) If the Secretary determines that an approval of an 
     application under section 505(b)(2) or section 505(j) for a 
     drug may be made effective after submission of reports of 
     pediatric studies under this section but before the Secretary 
     has determined whether the requirements of subsection (c) 
     have been satisfied, the Secretary may delay the effective 
     date of any approval under section 505(b)(2) or section 
     505(j), respectively, until the determination under 
     subsection (c) is made, but such delay shall not exceed 90 
     days. In the event that the requirements of this section are 
     satisfied, the 6-month period referred to in subsection (a) 
     or (b) shall be deemed to have begun on the date an approval 
     of an application under section 505(b)(2) or section 505(j), 
     respectively, would have been permitted absent action under 
     this subsection.
       ``(e) The Secretary shall publish notice of any 
     determination that the requirements of subsection (c)(2) or 
     (c)(3) have been met and that approvals for the drug will be 
     subject to deferred effective dates under this section.''.
  


                       SENATE COMMITTEE MEETINGS

  Title IV of Senate Resolution 4, agreed to by the Senate on February 
4, 1977, calls for establishment of a system for a computerized 
schedule of all meetings and hearings of Senate committees, 
subcommittees, joint committees, and committees of conference. This 
title requires all such committees to notify the Office of the Senate 
Daily Digest--designated by the Rules Committee--of the time, place, 
and purpose of the meetings, when scheduled, and any cancellations or 
changes in the meetings as they occur.
  As an additional procedure along with the computerization of this 
information, the Office of the Senate Daily Digest will prepare this 
information for printing in the Extensions of Remarks section of the 
Congressional Record on Monday and Wednesday of each week.
  Meetings scheduled for Tuesday, May 17, 1994, may be found in the 
Daily Digest of today's Record.

                           MEETINGS SCHEDULED

                                 MAY 18
     9:30 a.m.
       Energy and Natural Resources
         Business meeting, to consider pending calendar business.
                                                            SD-366
     10:00 a.m.
       Appropriations
       Labor, Health and Human Services, and Education 
           Subcommittee
         To resume hearings on the childhood immunization program.
                                                            SD-192
       Commerce, Science, and Transportation
         To resume hearings on S. 1822, to safeguard and protect 
           the public interest while permitting the growth and 
           development of new communications technologies, 
           focusing on Titles I-III relating to competition for 
           local telephone service and universal service.
                                                            SR-253
       Foreign Relations
         To hold hearings on the nominations of Jan Piercy, of 
           Illinois, to be United States Executive Director of the 
           International Bank for Reconstruction and Development, 
           and Sally A. Shelton, of Texas, to be an Assistant 
           Administrator of the Agency for International 
           Development.
                                                            SD-419
     2:00 p.m.
       Environment and Public Works
         To hold hearings on the U.S. Army Corps of Engineer Civil 
           Works program and its policies on recreation and 
           environmental protection.
                                                            SD-406
       Foreign Relations
         To hold hearings on the nomination of Timothy A. Chorba, 
           of the District of Columbia, to be Ambassador to the 
           Republic of Singapore.
                                                            SD-419

                                 MAY 19
     8:00 a.m.
       Labor and Human Resources
         Business meeting, to consider proposed legislation to 
           provide for health care security.
                                                            SD-430
     9:30 a.m.
       Armed Services
         Business meeting, to discuss pending military 
           nominations.
                                                            SR-222
       Governmental Affairs
         To hold hearings on regulatory review of the Paperwork 
           Reduction Act.
                                                            SD-342
     10:00 a.m.
       Agriculture, Nutrition, and Forestry
       Agricultural Production and Stabilization of Prices 
           Subcommittee
         To hold hearings on S. 2095, to reform the Federal crop 
           insurance program.
                                                            SR-332
       Appropriations
       VA, HUD, and Independent Agencies Subcommittee
         To hold hearings on proposed budget estimates for fiscal 
           year 1995 for the Department of Veteran's Affairs, and 
           the Selective Service System.
                                                            SD-106
     2:00 p.m.
       Banking, Housing, and Urban Affairs
         To hold hearings to examine risks and regulation of 
           financial derivatives.
                                                            SD-538
       Energy and Natural Resources
       Public Lands, National Parks and Forests Subcommittee
         To hold hearings on H.R. 3252, to provide for the 
           conservation, management, or study of certain rivers, 
           parks, trail and historic sites, H.R. 4034, to revise 
           the Urban Park and Recreation Recovery Act of 1978 to 
           authorize grants for the expansion of recreation 
           opportunities for at risk youth in urban areas with a 
           high prevalence of crime, S. 523, to expand the Fort 
           Necessity National Battlefield, S. 2089, to authorize 
           the establishment of the Steamtown National Historic 
           Site, and other pending bills and resolutions.
                                                            SD-366
       Labor and Human Resources
         Business meeting, to continue mark up of proposed 
           legislation to provide for health care security.
                                                            SD-430
     3:00 p.m.
       Environment and Public Works
       Superfund, Recycling, and Solid Waste Management 
           Subcommittee
         Business meeting, to discuss markup procedures for 
           proposed Superfund reauthorization legislation.
                                                            SD-628

                                 MAY 20
     8:00 a.m.
       Labor and Human Resources
         To continue mark up of proposed legislation to provide 
           for health care security.
                                                            SD-430
     9:00 a.m.
       Appropriations
       VA, HUD, and Independent Agencies Subcommittee
         To hold hearings on proposed budget estimates for fiscal 
           year 1995 for the Departments of Veteran Affairs and 
           Housing and Urban Development, and independent 
           agencies.
                                                            SD-138
     9:30 a.m.
       Governmental Affairs
       Regulation and Government Information Subcommittee
         To hold hearings to examine whether certain medical 
           device materials are a threat to public health.
                                                            SD-342

                                 MAY 24
     9:30 a.m.
       Armed Services
         Business meeting, to discuss issues relating to markup of 
           the proposed National Defense Authorization Act for 
           Fiscal Year 1995.
                                                            SR-222
       Energy and Natural Resources
         To hold hearings on the science concerning global climate 
           change.
                                                            SD-366
       Indian Affairs
         To hold hearings on S. 2075, to reauthorize and improve 
           programs of the Indian Child Protection and Family 
           Violence Prevention Act, and provisions of S. 2074, to 
           increase the special assessment for felonies and 
           improve the enforcement sentences imposing criminal 
           fines.
                                                            SR-485
     10:00 a.m.
       Appropriations
       Defense Subcommittee
         To hold hearings on proposed budget estimates for fiscal 
           year 1995 for the Department of Defense, focusing on 
           strategic programs.
                                                            SD-192
       Commerce, Science, and Transportation
         To resume hearings on S. 1822, to safeguard and protect 
           the public interest while permitting the growth and 
           development of new communications technologies, 
           focusing on local competition and universal service.
                                                            SR-253
     2:30 p.m.
       Appropriations
       Foreign Operations Subcommittee
         To hold hearings on proposed budget estimates for fiscal 
           year 1995 for foreign assistance programs, focusing on 
           export promotion.
                                                            SD-138
       Energy and Natural Resources
         To hold hearings on proposed legislation authorizing 
           funds for programs of the Energy Policy and 
           Conservation Act, and S. 2032, to revise the Energy 
           Policy and Conservation Act with respect to purchases 
           from the Strategic Petroleum Reserve by entities in the 
           insular areas of the United States.
                                                            SD-366

                                 MAY 25
     9:30 a.m.
       Governmental Affairs
       Permanent Subcommittee on Investigations
         To hold hearings on organized crime and its impact on the 
           United States.
                                                            SD-342
     10:00 a.m.
       Appropriations
       Interior Subcommittee
         To hold hearings on proposed budget estimates for fiscal 
           year 1995 for the Department of the Interior.
                                                    S-128, Capitol
     10:30 a.m.
       Commerce, Science, and Transportation
         To continue hearings on S. 1822, to safeguard and protect 
           the public interest while permitting the growth and 
           development of new communications technologies, 
           focusing on education and telecommunications 
           infrastructure.
                                                            SR-253

                                 MAY 26
     9:00 a.m.
       Armed Services
         Business meeting, to discuss procedures for markup of the 
           proposed National Defense Authorization Act for Fiscal 
           Year 1995.
                                                            SR-222
     9:30 a.m.
       Commerce, Science, and Transportation
         To hold hearings on S. 1350, to revise the Earthquake 
           Hazards Reduction Act of 1977 to provide for an 
           expanded Federal program of hazard mitigation and 
           insurance against the risk of catastrophic natural 
           disasters, such as hurricanes, earthquakes, and 
           volcanic eruptions.
                                                            SR-253
       Energy and Natural Resources
         To hold hearings to examine policy options for the 
           disposition of excess weapons plutonium.
                                                            SD-366
       Rules and Administration
         Business meeting, to mark up S. 1824, Legislative 
           Reorganization Act, H.R. 877, Smithsonian National 
           African American Museum, an original bill authorizing 
           appropriations for fiscal year 1995 for the Federal 
           Election Commission, S. Res. 196, printing resolution 
           for Aging Committee, an original resolution authorizing 
           the purchase of 1995 wall calendars, H. Con. Res. 222, 
           authorizing acceptance and placement of a bust in the 
           Capitol, and other legislative business.
                                                            SR-301
     10:00 a.m.
       Appropriations
       VA, HUD, and Independent Agencies Subcommittee
         To hold hearings on proposed budget estimates for fiscal 
           year 1995 for the National Aeronautics and Space 
           Administration.
                                                            SD-106
     2:30 p.m.
       Commerce, Science, and Transportation
         To hold hearings on S. 1989, to prohibit the transfer and 
           novation of an insurance policy without the prior 
           informed written consent of the policyholder.
                                                            SR-253

                                 JUNE 8
     9:30 a.m.
       Indian Affairs
         To hold hearings on S. 1936, to provide for the 
           integrated management of Indian resources, and S. 2067, 
           to establish an Assistant Secretary for Indian Health, 
           and to provide for the organizational independence of 
           the Indian Health Service within the Department of 
           Health and Human Services.
                                                            SR-485
     10:00 a.m.
       Appropriations
       Interior Subcommittee
         To hold hearings proposed budget estimates for fiscal 
           year 1995 for the Department of Energy.
                                                    S-128, Capitol
     2:30 p.m.
       Energy and Natural Resources
       Water and Power Subcommittee
         To hold hearings to examine water quality and quantity 
           problems and opportunities facing the lower Colorado 
           River area.
                                                            SD-366

                                 JUNE 9
     9:30 a.m.
       Energy and Natural Resources
       Water and Power Subcommittee
         To continue hearings on water quality and quantity 
           problems and opportunities facing the lower Colorado 
           River area.
                                                            SD-366

                                JUNE 15
     9:30 a.m.
       Indian Affairs
         To hold hearings on S. 2036, to specify the terms of 
           contracts entered into by the United States and Indian 
           tribal organizations under the Indian Self-
           Determination and Education Assistance Act.
                                                            SR-485

                                JUNE 16
     9:30 a.m.
       Rules and Administration
         To hold hearings on S.Res. 69, to require that an 
           evaluation of the financial impact that any Federal 
           mandates would have on State and local governments be 
           included in the committee report accompanying each bill 
           or resolution containing such mandates, S.Res. 157, to 
           require a supermajority for committee approval of bills 
           containing unfunded Federal mandates, and S.Res. 158, 
           to require a supermajority for Senate approval of bills 
           or amendments containing unfunded Federal mandates.
                                                            SR-301

                             CANCELLATIONS

                                 MAY 19
     2:30 p.m.
       Commerce, Science, and Transportation
       Surface Transportation Subcommittee
         To hold hearings on proposed legislation authorizing 
           funds for rail safety programs.
                                                            SR-253

                             POSTPONEMENTS

                                 MAY 17
     10:30 a.m.
       Judiciary
       Courts and Administrative Practice Subcommittee
         To hold hearings on S. 825, to revise title 28, United 
           States Code, to permit a foreign state to be subject to 
           the jurisdiction of Federal or State courts in any case 
           involving an act of international terrorism.
                                                            SD-226

                                 MAY 19
     10:00 a.m.
       Appropriations
       Defense Subcommittee
         To hold hearings on proposed budget estimates for fiscal 
           year 1995 for the Department of Defense.
                                                            SD-192