[Congressional Record Volume 143, Number 120 (Thursday, September 11, 1997)]
[Senate]
[Pages S9133-S9157]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 
                                  1997

  The PRESIDING OFFICER. The clerk will report the bill.
  The legislative clerk read as follows:

       A bill (S. 830) to amend the Federal Food, Drug, and 
     Cosmetic Act and the Public Health Service Act to improve the 
     regulation of food, drugs, devices, and biological products, 
     and for other purposes, which had been reported from to the 
     Committee on Labor and Human Resources, with an amendment 
     to strike all after the enacting clause and inserting in 
     lieu thereof the following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Food and Drug Administration 
     Modernization and Accountability Act of 1997''.

     SEC. 2. TABLE OF CONTENTS.

       The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References.

                   TITLE I--IMPROVING PATIENT ACCESS

Sec. 101. Mission of the Food and Drug Administration.
Sec. 102. Expedited access to investigational therapies.
Sec. 103. Expanded humanitarian use of devices.

         TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES

Sec. 201. Interagency collaboration.
Sec. 202. Sense of the committee regarding mutual recognition 
              agreements and global harmonization efforts.
Sec. 203. Contracts for expert review.
Sec. 204. Accredited-party reviews.
Sec. 205. Device performance standards.

          TITLE III--IMPROVING COLLABORATION AND COMMUNICATION

Sec. 301. Collaborative determinations of device data requirements.
Sec. 302. Collaborative review process.

           TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES

Sec. 401. Policy statements.
Sec. 402. Product classification.
Sec. 403. Use of data relating to premarket approval.
Sec. 404. Consideration of labeling claims for product review.

[[Page S9134]]

Sec. 405. Definition of a day for purposes of product review.
Sec. 406. Certainty of review timeframes.
Sec. 407. Limitations on initial classification determinations.
Sec. 408. Clarification with respect to a general use and specific use 
              of a device.
Sec. 409. Clarification of the number of required clinical 
              investigations for approval.
Sec. 410. Prohibited acts.

                   TITLE V--IMPROVING ACCOUNTABILITY

Sec. 501. Agency plan for statutory compliance and annual report.

     TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES

Sec. 601. Minor modifications.
Sec. 602. Environmental impact review.
Sec. 603. Exemption of certain classes of devices from premarket 
              notification requirement.
Sec. 604. Evaluation of automatic class III designation.
Sec. 605. Secretary's discretion to track devices.
Sec. 606. Secretary's discretion to conduct postmarket surveillance.
Sec. 607. Reporting.
Sec. 608. Pilot and small-scale manufacture.
Sec. 609. Requirements for radiopharmaceuticals.
Sec. 610. Modernization of regulation of biological products.
Sec. 611. Approval of supplemental applications for approved products.
Sec. 612. Health care economic information.
Sec. 613. Expediting study and approval of fast track drugs.
Sec. 614. Manufacturing changes for drugs and biologics.
Sec. 615. Data requirements for drugs and biologics.
Sec. 616. Food contact substances.
Sec. 617. Health claims for food products.
Sec. 618. Pediatric studies marketing exclusivity.
Sec. 619. Positron emission tomography.

                   TITLE VII--FEES RELATING TO DRUGS

Sec. 701. Short title.
Sec. 702. Findings.
Sec. 703. Definitions.
Sec. 704. Authority to assess and use drug fees.
Sec. 705. Annual reports.
Sec. 706. Effective date.
Sec. 707. Termination of effectiveness.

                       TITLE VIII--MISCELLANEOUS

Sec. 801. Registration of foreign establishments.
Sec. 802. Elimination of certain labeling requirements.
Sec. 803. Clarification of seizure authority.
Sec. 804. Intramural research training award program.
Sec. 805. Device samples.
Sec. 806. Interstate commerce.
Sec. 807. National uniformity for nonprescription drugs and cosmetics.
Sec. 808. Information program on clinical trials for serious or life-
              threatening diseases.
Sec. 809. Application of Federal law to the practice of pharmacy 
              compounding.

     SEC. 3. REFERENCES.

       Except as otherwise expressly provided, wherever in this 
     Act an amendment or repeal is expressed in terms of an 
     amendment to, or repeal of, a section or other provision, the 
     reference shall be considered to be made to a section or 
     other provision of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321 et seq.).
                   TITLE I--IMPROVING PATIENT ACCESS

     SEC. 101. MISSION OF THE FOOD AND DRUG ADMINISTRATION.

       Section 903 (21 U.S.C. 393) is amended--
       (1) by redesignating subsections (b) and (c) as subsections 
     (c) and (d), respectively; and
       (2) by inserting after subsection (a) the following:
       ``(b) Mission.--
       ``(1) In general.--The Administration shall protect the 
     public health by ensuring that--
       ``(A) foods are safe, wholesome, sanitary, and properly 
     labeled;
       ``(B) human and veterinary drugs are safe and effective;
       ``(C) there is reasonable assurance of safety and 
     effectiveness of devices intended for human use;
       ``(D) cosmetics are safe; and
       ``(E) public health and safety are protected from 
     electronic product radiation.
       ``(2) Special rules.--The Administration shall promptly and 
     efficiently review clinical research and take appropriate 
     action on the marketing of regulated products in a manner 
     that does not unduly impede innovation or product 
     availability. The Administration shall participate with other 
     countries to reduce the burden of regulation, to harmonize 
     regulatory requirements, and to achieve appropriate 
     reciprocal arrangements with other countries.''.

     SEC. 102. EXPEDITED ACCESS TO INVESTIGATIONAL THERAPIES.

       Chapter V (21 U.S.C. 351 et seq.) is amended by adding at 
     the end the following:

          ``Subchapter D--Unapproved Therapies and Diagnostics

     ``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND 
                   DIAGNOSTICS.

       ``(a) In General.--Any person, acting through a physician 
     licensed in accordance with State law, may request from a 
     manufacturer or distributor, and any manufacturer or 
     distributor may provide to a person after compliance with the 
     provisions of this section, an investigational drug 
     (including a biological product) or investigational device 
     for the diagnosis, monitoring, or treatment of a serious 
     disease or condition, or any other disease or condition 
     designated by the Secretary as appropriate for expanded 
     access under this section if--
       ``(1) the licensed physician determines that the person has 
     no comparable or satisfactory alternative therapy available 
     to diagnose, monitor, or treat the disease or condition 
     involved;
       ``(2) the licensed physician determines that the risk to 
     the person from the investigational drug or investigational 
     device is not greater than the risk from the disease or 
     condition;
       ``(3) the Secretary determines that an exemption for the 
     investigational drug or investigational device is in effect 
     under a regulation promulgated pursuant to section 505(i) or 
     520(g) and the sponsor of the drug or device and 
     investigators comply with such regulation;
       ``(4) the Secretary determines that the manufacturer of the 
     investigational drug or investigational device is actively 
     pursuing marketing approval with due diligence;
       ``(5) the Secretary determines that expanded access to the 
     investigational drug or investigational device will not 
     interfere with adequate enrollment of patients by the 
     investigator in the ongoing clinical investigation of the 
     investigational drug or investigational device authorized 
     under section 505(i) or 520(g); and
       ``(6) the Secretary determines that there is sufficient 
     evidence of safety and effectiveness to support the expanded 
     use of the investigational drug or investigational device in 
     accordance with this section.
       ``(b) Protocols.--A manufacturer or distributor may submit 
     to the Secretary 1 or more expanded access protocols covering 
     expanded access use of a drug or device described in 
     subsection (a). The protocols shall be subject to the 
     provisions of section 505(i) or 520(g) and may include any 
     form of use of the drug or device outside a clinical 
     investigation, prior to approval of the drug or device for 
     marketing, including protocols for treatment use, emergency 
     use, or uncontrolled trials, and single patient protocols. If 
     the request for expanded access to an investigational drug or 
     investigational device is intended for a single patient only, 
     the Secretary may waive the requirements of paragraphs (3) 
     and (4) of subsection (a) and accept a submission under 
     section 505(i) or 520(g) for an exemption for the 
     investigational drug or investigational device for the single 
     patient use. In the case of an emergency that does not allow 
     sufficient time for a submission under section 505(i) or 
     520(g), the Secretary may, prior to the submission, authorize 
     the shipment of the investigational drug or investigational 
     device for a single patient use.
       ``(c) Notification of Availability.--The Secretary shall 
     inform national, State, and local medical associations and 
     societies, voluntary health associations, and other 
     appropriate persons about the availability of an 
     investigational drug or investigational device under expanded 
     access protocols submitted under this section, except that 
     this subsection shall not apply to expanded access protocols 
     for single patient use.
       ``(d) Termination.--The Secretary may at anytime terminate 
     expanded access provided under subsection (a) for an 
     investigational drug or investigational device if the 
     requirements under this section are no longer met.''.

     SEC. 103. EXPANDED HUMANITARIAN USE OF DEVICES.

       Section 520(m) (21 U.S.C. 360j(m)) is amended--
       (1) in paragraph (2), by adding at the end the following 
     flush sentences:
     ``The request shall be in the form of an application 
     submitted to the Secretary. Not later than 60 days after the 
     date of the receipt of the application, the Secretary shall 
     issue an order approving or denying the application.'';
       (2) in paragraph (4)--
       (A) in subparagraph (B), by inserting after ``(2)(A)'' the 
     following: ``, unless a physician determines that waiting for 
     such an approval from an institutional review committee will 
     cause harm or death to a patient, and makes a good faith 
     effort to obtain the approval, and does not receive a timely 
     response from an institutional review committee on the 
     request of the physician for approval to use the device for 
     such treatment or diagnosis''; and
       (B) by adding at the end the following flush sentences:
     ``In a case in which a physician described in subparagraph 
     (B) uses a device without an approval from an institutional 
     review committee, the physician shall, after the use of the 
     device, notify the chairperson of the institutional review 
     committee of such use. Such notification shall include the 
     identification of the patient involved, the date on which the 
     device was used, and the reason for the use.''; and
       (3) by striking paragraph (5) and inserting the following:
       ``(5) The Secretary may require a person granted an 
     exemption under paragraph (2) to demonstrate continued 
     compliance with the requirements of this subsection if the 
     Secretary believes such demonstration to be necessary to 
     protect the public health or if the Secretary has reason to 
     believe that the criteria for the exemption are no longer 
     met.''.
         TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES

     SEC. 201. INTERAGENCY COLLABORATION.

       Section 903(b) (21 U.S.C. 393(b)), as added by section 
     101(2), is amended by adding at the end the following:
       ``(3) Interagency collaboration.--The Secretary shall 
     implement programs and policies that will foster 
     collaboration between the Administration, the National 
     Institutes of Health, and other science-based Federal 
     agencies, to enhance the scientific and technical expertise 
     available to the Secretary in the conduct of the duties of 
     the Secretary with respect to the development, clinical 
     investigation, evaluation, and postmarket monitoring of 
     emerging medical therapies, including complementary 
     therapies, and advances in nutrition and food science.''.

[[Page S9135]]

     SEC. 202. SENSE OF THE COMMITTEE REGARDING MUTUAL RECOGNITION 
                   AGREEMENTS AND GLOBAL HARMONIZATION EFFORTS.

       It is the sense of the Committee on Labor and Human 
     Resources of the Senate that--
       (1) the Secretary of Health and Human Services should 
     support the Office of the United States Trade Representative, 
     in consultation with the Secretary of Commerce, in efforts to 
     move toward the acceptance of mutual recognition agreements 
     relating to the regulation of drugs, biological products, 
     devices, foods, food additives, and color additives, and the 
     regulation of good manufacturing practices, between the 
     European Union and the United States;
       (2) the Secretary of Health and Human Services should 
     regularly participate in meetings with representatives of 
     other foreign governments to discuss and reach agreement on 
     methods and approaches to harmonize regulatory requirements; 
     and
       (3) the Office of International Relations of the Department 
     of Health and Human Services (as established under section 
     803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     383)) should have the responsibility of ensuring that the 
     process of harmonizing international regulatory requirements 
     is continuous.

     SEC. 203. CONTRACTS FOR EXPERT REVIEW.

       Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 906. CONTRACTS FOR EXPERT REVIEW.

       ``(a) In General.--
       ``(1) Authority.--The Secretary may enter into a contract 
     with any organization or any individual (who is not an 
     employee of the Department) with expertise in a relevant 
     discipline, to review, evaluate, and make recommendations to 
     the Secretary on part or all of any application or submission 
     (including a petition, notification, and any other similar 
     form of request) made under this Act for the approval or 
     classification of an article or made under section 351(a) of 
     the Public Health Service Act (42 U.S.C. 262(a)) with respect 
     to a biological product. Any such contract shall be subject 
     to the requirements of section 708 relating to the 
     confidentiality of information.
       ``(2) Increased efficiency and expertise through 
     contracts.--The Secretary shall use the authority granted in 
     paragraph (1) whenever the Secretary determines that a 
     contract described in paragraph (1) will improve the 
     timeliness or quality of the review of an application or 
     submission described in paragraph (1). Such improvement may 
     include providing the Secretary increased scientific or 
     technical expertise that is necessary to review or evaluate 
     new therapies and technologies.
       ``(b) Review of Expert Review.--
       ``(1) In general.--Subject to paragraph (2), the official 
     of the Food and Drug Administration responsible for any 
     matter for which expert review is used pursuant to subsection 
     (a) shall review the recommendations of the organization or 
     individual who conducted the expert review and shall make a 
     final decision regarding the matter within 60 days after 
     receiving the recommendations.
       ``(2) Limitation.--A final decision under paragraph (1) 
     shall be made within the applicable prescribed time period 
     for review of the matter as set forth in this Act or in the 
     Public Health Service Act (42 U.S.C. 201 et seq.).
       ``(3) Authority of secretary.--Notwithstanding subsection 
     (a), the Secretary shall retain full authority to make 
     determinations with respect to the approval or disapproval of 
     an article under this Act, the approval or disapproval of a 
     biologics license with respect to a biological product under 
     section 351(a) of the Public Health Service Act, or the 
     classification of an article as a device under section 
     513(f)(1).''.

     SEC. 204. ACCREDITED-PARTY REVIEWS.

       Subchapter A of chapter V (21 U.S.C. 351 et seq.) is 
     amended by adding at the end the following:

     ``SEC. 523. ACCREDITED-PARTY PARTICIPATION.

       ``(a) Accreditation.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of this section, the Secretary shall accredit 
     entities or individuals who are not employees of the Federal 
     Government, to review reports made to the Secretary under 
     section 510(k) for devices and make recommendations to the 
     Secretary regarding the initial classification of such 
     devices under section 513(f)(1), except that this paragraph 
     shall not apply to reports made to the Secretary under 
     section 510(k) for devices that are--
       ``(A) life-supporting;
       ``(B) life sustaining; or
       ``(C) intended for implantation in the human body for a 
     period of over 1 year.
       ``(2) Special rule.--The Secretary shall have the 
     discretion to accredit entities or individuals who are not 
     employees of the Federal Government--
       ``(A) to review reports made to the Secretary under section 
     510(k) for devices described in subparagraphs (A) through (C) 
     of paragraph (1), and make recommendations of initial 
     classification of such devices; or
       ``(B) to review applications for premarket approval for 
     class III devices under section 515 and make recommendations 
     with respect to the approval or disapproval of such 
     applications.
       ``(b) Accreditation.--Within 180 days after the date of 
     enactment of this section, the Secretary shall adopt methods 
     of accreditation that ensure that entities or individuals who 
     conduct reviews and make recommendations under this section 
     are qualified, properly trained, knowledgeable about handling 
     confidential documents and information, and free of conflicts 
     of interest. The Secretary shall publish the methods of 
     accreditation in the Federal Register on the adoption of the 
     methods.
       ``(c) Withdrawal of Accreditation.--The Secretary may 
     suspend or withdraw the accreditation of any entity or 
     individual accredited under this section, after providing 
     notice and an opportunity for an informal hearing, if such 
     entity or individual acts in a manner that is substantially 
     not in compliance with the requirements established by the 
     Secretary under subsection (b), including the failure to 
     avoid conflicts of interest, the failure to protect 
     confidentiality of information, or the failure to competently 
     review premarket submissions for devices.
       ``(d) Selection and Compensation.--Subject to subsection 
     (a)(2), a person who intends to make a report described in 
     subsection (a), or to submit an application described in 
     subsection (a), to the Secretary shall have the option to 
     select an accredited entity or individual to review such 
     report or application. Upon the request by a person to have a 
     report or application reviewed by an accredited entity or 
     individual, the Secretary shall identify for the person no 
     less than 2 accredited entities or individuals from whom the 
     selection may be made. Compensation for an accredited entity 
     or individual shall be determined by agreement between the 
     accredited entity or individual and the person who engages 
     the services of the accredited entity or individual and shall 
     be paid by the person who engages such services.
       ``(e) Review by Secretary.--
       ``(1) In general.--The Secretary shall require an 
     accredited entity or individual, upon making a recommendation 
     under this section with respect to an initial classification 
     of a device or approval or disapproval of an application for 
     premarket approval, to notify the Secretary in writing of the 
     reasons for such recommendation.
       ``(2) Time period for review.--
       ``(A) Initial classification.--Not later than 30 days after 
     the date on which the Secretary is notified under paragraph 
     (1) by an accredited entity or individual with respect to a 
     recommendation of an initial classification of a device, the 
     Secretary shall make a determination with respect to the 
     initial classification.
       ``(B) Premarket approval.--Not later than 60 days after the 
     date on which the Secretary is notified under paragraph (1) 
     by an accredited entity or individual with respect to a 
     recommendation of an approval or disapproval of an 
     application for a device, the Secretary shall make a 
     determination with respect to the approval or disapproval.
       ``(3) Special rule.--The Secretary may change the initial 
     classification under section 513(f)(1), or the approval or 
     disapproval of the application under section 515(d), that is 
     recommended by the accredited entity or individual under this 
     section, and in such case shall notify in writing the person 
     making the report or application described in subsection (a) 
     of the detailed reasons for the change.
       ``(f) Duration.--The authority provided by this section 
     terminates--
       ``(1) 5 years after the date on which the Secretary 
     notifies Congress that at least 2 persons accredited under 
     subsection (b) are available to review devices for each of at 
     least 70 percent of the generic types of devices subject to 
     review under subsection (a); or
       ``(2) 4 years after the date on which the Secretary 
     notifies Congress that at least 35 percent of the devices 
     that are subject to review under subsection (a), and that 
     were the subject of final action by the Secretary in the 
     fiscal year preceding the date of such notification, were 
     reviewed by the Secretary under subsection (e),
     whichever occurs first.
       ``(g) Report.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of this section, the Secretary shall contract with 
     an independent research organization to prepare and submit to 
     the Secretary a written report examining the use of 
     accredited entities and individuals to conduct reviews under 
     this section. The Secretary shall submit the report to 
     Congress not later than 6 months prior to the conclusion of 
     the applicable period described in subsection (f).
       ``(2) Contents.--The report by the independent research 
     organization described in paragraph (1) shall identify the 
     benefits or detriments to public and patient health of using 
     accredited entities and individuals to conduct such reviews, 
     and shall summarize all relevant data, including data on the 
     review of accredited entities and individuals (including data 
     on the review times, recommendations, and compensation of the 
     entities and individuals), and data on the review of the 
     Secretary (including data on the review times, changes, and 
     reasons for changes of the Secretary).''.

     SEC. 205. DEVICE PERFORMANCE STANDARDS.

       (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is 
     amended by adding at the end the following:

                      ``Recognition of a Standard

       ``(c)(1)(A) In addition to establishing performance 
     standards under this section, the Secretary may, by 
     publication in the Federal Register, recognize all or part of 
     a performance standard established by a nationally or 
     internationally recognized standard development organization 
     for which a person may submit a declaration of conformity in 
     order to meet premarket submission requirements or other 
     requirements under this Act to which such standards are 
     applicable.
       ``(B) If a person elects to use a performance standard 
     recognized by the Secretary under subparagraph (A) to meet 
     the requirements described in subparagraph (A), the person 
     shall provide a declaration of conformity to the Secretary 
     that certifies that the device is in conformity with such 
     standard. A person may elect to use data, or information, 
     other than data required by a standard recognized under 
     subparagraph (A) to fulfill or satisfy any requirement under 
     this Act.
       ``(2) The Secretary may withdraw such recognition of a 
     performance standard through publication of a notice in the 
     Federal Register that the Secretary will no longer recognize 
     the

[[Page S9136]]

     standard, if the Secretary determines that the standard is no 
     longer appropriate for meeting the requirements under this 
     Act.
       ``(3)(A) Subject to subparagraph (B), the Secretary shall 
     accept a declaration of conformity that a device is in 
     conformity with a standard recognized under paragraph (1) 
     unless the Secretary finds--
       ``(i) that the data or information submitted to support 
     such declaration does not demonstrate that the device is in 
     conformity with the standard identified in the declaration of 
     conformity; or
       ``(ii) that the standard identified in the declaration of 
     conformity is not applicable to the particular device under 
     review.
       ``(B) The Secretary may request, at any time, the data or 
     information relied on by the person to make a declaration of 
     conformity with respect to a standard recognized under 
     paragraph (1).
       ``(C) A person relying on a declaration of conformity with 
     respect to a standard recognized under paragraph (1) shall 
     maintain the data and information demonstrating conformity of 
     the device to the standard for a period of 2 years after the 
     date of the classification or approval of the device by the 
     Secretary or a period equal to the expected design life of 
     the device, whichever is longer.''.
       (b) Section 301.--Section 301 (21 U.S.C. 331) is amended by 
     adding at the end the following:
       ``(x) The falsification of a declaration of conformity 
     submitted under subsection (c) of section 514 or the failure 
     or refusal to provide data or information requested by the 
     Secretary under section 514(c)(3).''.
       (c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is 
     amended--
       (1) by striking ``(e)'' and inserting ``(e)(1)''; and
       (2) by inserting at the end the following:
       ``(2) If it is, declared to be, purports to be, or is 
     represented as, a device that is in conformity with any 
     performance standard recognized under section 514(c) unless 
     such device is in all respects in conformity with such 
     standard.''.
          TITLE III--IMPROVING COLLABORATION AND COMMUNICATION

     SEC. 301. COLLABORATIVE DETERMINATIONS OF DEVICE DATA 
                   REQUIREMENTS.

       Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by 
     adding at the end the following:
       ``(C)(i)(I) The Secretary, upon the written request of any 
     person intending to submit an application under section 515, 
     shall meet with such person to determine the type of valid 
     scientific evidence (within the meaning of subparagraphs (A) 
     and (B)) that will be necessary to demonstrate the 
     effectiveness of a device for the conditions of use proposed 
     by such person, to support an approval of an application. The 
     written request shall include a detailed description of the 
     device, a detailed description of the proposed conditions of 
     use of the device, and, if available, information regarding 
     the expected performance from the device. Within 30 days 
     after such meeting, the Secretary shall specify in writing 
     the type of valid scientific evidence that will provide a 
     reasonable assurance that a device is effective under the 
     conditions of use proposed by such person.
       ``(II) Any clinical data, including 1 or more well-
     controlled investigations, specified in writing by the 
     Secretary for demonstrating a reasonable assurance of device 
     effectiveness shall be specified as a result of a 
     determination by the Secretary--
       ``(aa) that such data are necessary to establish device 
     effectiveness; and
       ``(bb) that no other less burdensome means of evaluating 
     device effectiveness is available that would have a 
     reasonable likelihood of resulting in an approval.
       ``(ii) The determination of the Secretary with respect to 
     the specification of valid scientific evidence under clause 
     (i) shall be binding upon the Secretary, unless--
       ``(I) such determination by the Secretary would be contrary 
     to the public health; or
       ``(II) based on new information (other than the information 
     reviewed by the Secretary in making such determination) 
     obtained by the Secretary prior to the approval of an 
     application for an investigational device exemption under 
     section 520(g), the Secretary finds that such determination 
     is scientifically inappropriate.''.

     SEC. 302. COLLABORATIVE REVIEW PROCESS.

       Section 515(d) (21 U.S.C. 360e(d)) is amended--
       (1) in paragraph (1)(A), by striking ``paragraph (2) of 
     this subsection'' each place it appears and inserting 
     ``paragraph (4)'';
       (2) by redesignating paragraphs (2) and (3) as paragraphs 
     (4) and (5), respectively; and
       (3) by inserting after paragraph (1) the following:
       ``(2)(A)(i) The Secretary shall, upon the written request 
     of the applicant involved, meet with the applicant not later 
     than 100 days after the receipt of an application, from the 
     applicant, that has been filed as complete under subsection 
     (c), to discuss the review status of the application.
       ``(ii) If the application does not appear in a form that 
     would require an approval under this subsection, the 
     Secretary shall in writing, and prior to the meeting, provide 
     to the applicant a description of any deficiencies in the 
     application identified by the Secretary and identify the 
     information (other than information the Secretary needs to 
     make a finding under paragraph (4)(C)) that is required to 
     bring the application into an approvable form.
       ``(iii) The Secretary and the applicant may, by mutual 
     consent, establish a different schedule for a meeting 
     required under this paragraph.
       ``(B) The Secretary shall notify the applicant immediately 
     of any deficiency identified in the application that was not 
     described as a deficiency in the written description provided 
     by the Secretary under subparagraph (A).''.
           TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES

     SEC. 401. POLICY STATEMENTS.

       Section 701(a) (21 U.S.C. 371(a)) is amended--
       (1) by striking ``(a) The'' and inserting ``(a)(1) The''; 
     and
       (2) by adding at the end the following:
       ``(2) Not later than February 27, 1999, the Secretary, 
     after evaluating the effectiveness of the Good Guidance 
     Practices document published in the Federal Register at 62 
     Fed. Reg. 8961, shall promulgate a regulation specifying the 
     policies and procedures of the Food and Drug Administration 
     for the development, issuance, and use of guidance 
     documents.''.

     SEC. 402. PRODUCT CLASSIFICATION.

       Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at 
     the end the following:

  ``Subchapter D--Classification of Products and Environmental Impact 
                                Reviews

     ``SEC. 741. CLASSIFICATION OF PRODUCTS.

       ``(a) Request.--A person who submits an application or 
     submission (including a petition, notification, and any other 
     similar form of request) under this Act, may submit a request 
     to the Secretary respecting the classification of an article 
     (including an article that is a combination product subject 
     to section 503(g)) as a drug, biological product, or device, 
     or respecting the component of the Food and Drug 
     Administration that will regulate the article. In submitting 
     the request, the person shall recommend a classification for 
     the article, or a component to regulate the article, as 
     appropriate.
       ``(b) Statement.--Not later than 60 days after the receipt 
     of the request described in subsection (a), the Secretary 
     shall determine the classification of the article or the 
     component of the Food and Drug Administration that will 
     regulate the article and shall provide to the person a 
     written statement that identifies the classification of the 
     article or the component of the Food and Drug Administration 
     that will regulate the article and the reasons for such 
     determination. The Secretary may not modify such statement 
     except with the written consent of the person or for public 
     health reasons.
       ``(c) Inaction of Secretary.--If the Secretary does not 
     provide the statement within the 60-day period described in 
     subsection (b), the recommendation made by the person under 
     subsection (a) shall be considered to be a final 
     determination by the Secretary of the classification of the 
     article or the component of the Food and Drug Administration 
     that will regulate the article and may not be modified by the 
     Secretary except with the written consent of the person or 
     for public health reasons.''.

     SEC. 403. USE OF DATA RELATING TO PREMARKET APPROVAL.

       (a) In General.--Section 520(h)(4) (21 U.S.C. 360j(h)(4)) 
     is amended to read as follows:
       ``(4)(A) Any information contained in an application for 
     premarket approval filed with the Secretary pursuant to 
     section 515(c) (including information from clinical and 
     preclinical tests or studies that demonstrate the safety and 
     effectiveness of a device, but excluding descriptions of 
     methods of manufacture and product composition) shall be 
     available, 6 years after the application has been approved by 
     the Secretary, for use by the Secretary in--
       ``(i) approving another device;
       ``(ii) determining whether a product development protocol 
     has been completed, under section 515 for another device;
       ``(iii) establishing a performance standard or special 
     control under this Act; or
       ``(iv) classifying or reclassifying another device under 
     section 513 and subsection (l)(2).
       ``(B) The publicly available detailed summaries of 
     information respecting the safety and effectiveness of 
     devices required by paragraph (1)(A) shall be available for 
     use by the Secretary as the evidentiary basis for the agency 
     action described in subparagraph (A).''.
       (b) Conforming Amendment.--Section 517(a) (21 U.S.C. 
     360g(a)) is amended--
       (1) in paragraph (8), by adding ``or'' at the end;
       (2) in paragraph (9), by striking ``, or'' and inserting a 
     comma; and
       (3) by striking paragraph (10).

     SEC. 404. CONSIDERATION OF LABELING CLAIMS FOR PRODUCT 
                   REVIEW.

       (a) Premarket Approval.--Section 515(d)(1)(A) (21 U.S.C. 
     360e(d)(1)(A)) is amended by adding at the end the following 
     flush sentences:

     ``In making the determination whether to approve or deny the 
     application, the Secretary shall rely on the conditions of 
     use included in the proposed labeling as the basis for 
     determining whether or not there is a reasonable assurance of 
     safety and effectiveness, if the proposed labeling is neither 
     false nor misleading. In determining whether or not such 
     labeling is false or misleading, the Secretary shall fairly 
     evaluate all material facts pertinent to the proposed 
     labeling.''.
       (b) Premarket Notification.--Section 513(i)(1) (21 U.S.C. 
     360c(i)(1)) is amended by adding at the end the following:
       ``(C) Whenever the Secretary requests information to 
     demonstrate that the devices with differing technological 
     characteristics are substantially equivalent, the Secretary 
     shall only request information that is necessary to make a 
     substantial equivalence determination. In making such a 
     request, the Secretary shall consider the least burdensome 
     means of demonstrating substantial equivalence and shall 
     request information accordingly.
       ``(D) The determinations of the Secretary under this 
     section and section 513(f)(1) with respect to the intended 
     use of a device shall be based on the intended use included 
     in proposed labeling of the device submitted in a report 
     under section 510(k).''.

[[Page S9137]]

     SEC. 405. DEFINITION OF A DAY FOR PURPOSES OF PRODUCT REVIEW.

       Section 201 (21 U.S.C. 321) is amended by adding at the end 
     the following:
       ``(ii) In any provision relating to a review of any 
     application or submission (including a petition, 
     notification, and any other similar form of request), made 
     under this Act with respect to an article that is a new drug, 
     device, biological product, new animal drug, an animal feed 
     bearing or containing a new animal drug, color additive, or 
     food additive, that is submitted to the Secretary to obtain 
     marketing approval, to obtain classification of a device 
     under section 513(f)(1), or to establish or clarify the 
     regulatory status of the article--
       ``(1) the term `day' means a calendar day in which the 
     Secretary has responsibility to review such an application or 
     submission; and
       ``(2) a reference to a date relating to the receipt of such 
     an application or submission by the Secretary shall be deemed 
     to be a reference to the date on which the Secretary receives 
     a complete application or submission within the meaning of 
     this Act and the regulations promulgated under this Act.''.

     SEC. 406. CERTAINTY OF REVIEW TIMEFRAMES.

       (a) Clarification on the 90-Day Timeframe for Premarket 
     Notification Reviews.--Section 510(k) (21 U.S.C. 360) is 
     amended by adding at the end the following flush sentence:

     ``The Secretary shall review the notification required by 
     this subsection and make a determination under section 
     513(f)(1) not later than 90 days after receiving the 
     notification.''.
       (b) Certainty of 180-Day Review Timeframe.--Section 515(d) 
     (21 U.S.C. 360e(d)), as amended by section 302, is amended by 
     inserting after paragraph (2) the following:
       ``(3) Except as provided in paragraph (1), the period for 
     the review of an application by the Secretary under this 
     subsection shall be not more than 180 days. Such period may 
     not be restarted or extended even if the application is 
     amended.''.

     SEC. 407. LIMITATIONS ON INITIAL CLASSIFICATION 
                   DETERMINATIONS.

       Section 510 (21 U.S.C. 360) is amended by adding at the end 
     the following:
       ``(m) The Secretary may not withhold a determination of the 
     initial classification of a device under section 513(f)(1) 
     because of a failure to comply with any provision of this Act 
     that is unrelated to a substantial equivalence decision, 
     including a failure to comply with the requirements relating 
     to good manufacturing practices under section 520(f).''.

     SEC. 408. CLARIFICATION WITH RESPECT TO A GENERAL USE AND 
                   SPECIFIC USE OF A DEVICE.

       Not later than 270 days after the date of enactment of this 
     section, the Secretary of Health and Human Services shall 
     promulgate a final regulation specifying the general 
     principles that the Secretary of Health and Human Services 
     will consider in determining when a specific intended use of 
     a device is not reasonably included within a general use of 
     such device for purposes of a determination of substantial 
     equivalence under section 513(f)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)).

     SEC. 409. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL 
                   INVESTIGATIONS FOR APPROVAL.

       (a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C. 
     360c(a)(3)(A)) is amended by striking ``clinical 
     investigations'' and inserting ``1 or more clinical 
     investigations''.
       (b) New Drugs.--Section 505(d) (21 U.S.C. 355(d)) is 
     amended by adding at the end the following: ``Substantial 
     evidence may, as appropriate, consist of data from 1 adequate 
     and well-controlled clinical investigation and confirmatory 
     evidence (obtained prior to or after such investigation), if 
     the Secretary determines, based on relevant science, that 
     such data and evidence are sufficient to establish 
     effectiveness.''.

     SEC. 410. PROHIBITED ACTS.

       Section 301(l) (21 U.S.C. 331(l)) is repealed.
                   TITLE V--IMPROVING ACCOUNTABILITY

     SEC. 501. AGENCY PLAN FOR STATUTORY COMPLIANCE AND ANNUAL 
                   REPORT.

       Section 903(b) (21 U.S.C. 393(b)), as amended by section 
     201, is further amended by adding at the end the following:
       ``(4) Agency plan for statutory compliance.--
       ``(A) In general.--Not later than 180 days after the date 
     of enactment of this paragraph, the Secretary, after 
     consultation with relevant experts, health care 
     professionals, representatives of patient and consumer 
     advocacy groups, and the regulated industry, shall develop 
     and publish in the Federal Register a plan bringing the 
     Secretary into compliance with each of the obligations of the 
     Secretary under this Act and other relevant statutes. The 
     Secretary shall biannually review the plan and shall revise 
     the plan as necessary, in consultation with such persons.
       ``(B) Objectives of agency plan.--The plan required by 
     subparagraph (A) shall establish objectives, and mechanisms 
     to be used by the Secretary, acting through the Commissioner, 
     including objectives and mechanisms that--
       ``(i) minimize deaths of, and harm to, persons who use or 
     may use an article regulated under this Act;
       ``(ii) maximize the clarity of, and the availability of 
     information about, the process for review of applications and 
     submissions (including petitions, notifications, and any 
     other similar forms of request) made under this Act, 
     including information for potential consumers and patients 
     concerning new products;
       ``(iii) implement all inspection and postmarket monitoring 
     provisions of this Act by July 1, 1999;
       ``(iv) ensure access to the scientific and technical 
     expertise necessary to ensure compliance by the Secretary 
     with the statutory obligations described in subparagraph (A);
       ``(v) establish a schedule to bring the Administration into 
     full compliance by July 1, 1999, with the time periods 
     specified in this Act for the review of all applications and 
     submissions described in clause (ii) and submitted after the 
     date of enactment of this paragraph; and
       ``(vi) reduce backlogs in the review of all applications 
     and submissions described in clause (ii) for any article with 
     the objective of eliminating all backlogs in the review of 
     the applications and submissions by January 1, 2000.
       ``(5) Annual report.--
       ``(A) Contents.--The Secretary shall prepare and publish in 
     the Federal Register and solicit public comment on an annual 
     report that--
       ``(i) provides detailed statistical information on the 
     performance of the Secretary under the plan described in 
     paragraph (4);
       ``(ii) compares such performance of the Secretary with the 
     objectives of the plan and with the statutory obligations of 
     the Secretary;
       ``(iii) analyzes any failure of the Secretary to achieve 
     any objective of the plan or to meet any statutory 
     obligation;
       ``(iv) identifies any regulatory policy that has a 
     significant impact on compliance with any objective of the 
     plan or any statutory obligation; and
       ``(v) sets forth any proposed revision to any such 
     regulatory policy, or objective of the plan that has not been 
     met.
       ``(B) Statistical information.--The statistical information 
     described in subparagraph (A)(i) shall include a full 
     statistical presentation relating to all applications and 
     submissions (including petitions, notifications, and any 
     other similar forms of request) made under this Act and 
     approved or subject to final action by the Secretary during 
     the year covered by the report. In preparing the statistical 
     presentation, the Secretary shall take into account the date 
     of--
       ``(i) the submission of any investigational application;
       ``(ii) the application of any clinical hold;
       ``(iii) the submission of any application or submission 
     (including a petition, notification, and any other similar 
     form of request) made under this Act for approval or 
     clearance;
       ``(iv) the acceptance for filing of any application or 
     submission described in clause (iii) for approval or 
     clearance;
       ``(v) the occurrence of any unapprovable action;
       ``(vi) the occurrence of any approvable action; and
       ``(vii) the approval or clearance of any application or 
     submission described in clause (iii).''.
     TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES

     SEC. 601. MINOR MODIFICATIONS.

       (a) Action on Investigational Device Exemptions.--Section 
     520(g) (21 U.S.C. 360j(g)) is amended by adding at the end 
     the following:
       ``(6)(A) The Secretary shall, not later than 120 days after 
     the date of enactment of this paragraph, by regulation modify 
     parts 812 and 813 of title 21, Code of Federal Regulations to 
     update the procedures and conditions under which a device 
     intended for human use may, upon application by the sponsor 
     of the device, be granted an exemption from the requirements 
     of this Act.
       ``(B) The regulation shall permit developmental changes in 
     a device (including manufacturing changes) in response to 
     information collected during an investigation without 
     requiring an additional approval of an application for an 
     investigational device exemption or the approval of a 
     supplement to such application, if the sponsor of the 
     investigation determines, based on credible information, 
     prior to making any such changes, that the changes--
       ``(i) do not affect the scientific soundness of an 
     investigational plan submitted under paragraph (3)(A) or the 
     rights, safety, or welfare of the human subjects involved in 
     the investigation; and
       ``(ii) do not constitute a significant change in design, or 
     a significant change in basic principles of operation, of the 
     device.''.
       (b) Action on Application.--Section 515(d)(1)(B) (21 U.S.C. 
     360e(d)(1)(B)) is amended by adding at the end the following:
       ``(iii) The Secretary shall accept and review data and any 
     other information from investigations conducted under the 
     authority of regulations required by section 520(g), to make 
     a determination of whether there is a reasonable assurance of 
     safety and effectiveness of a device subject to a pending 
     application under this section if--
       ``(I) the data or information is derived from 
     investigations of an earlier version of the device, the 
     device has been modified during or after the investigations 
     (but prior to submission of an application under subsection 
     (c)) and such a modification of the device does not 
     constitute a significant change in the design or in the basic 
     principles of operation of the device that would invalidate 
     the data or information; or
       ``(II) the data or information relates to a device approved 
     under this section, is available for use under this Act, and 
     is relevant to the design and intended use of the device for 
     which the application is pending.''.
       (c) Action on Supplements.--Section 515(d) (21 U.S.C. 
     360e(d)), as amended by section 302, is further amended by 
     adding at the end the following:
       ``(6)(A)(i) A supplemental application shall be required 
     for any change to a device subject to an approved application 
     under this subsection that affects safety or effectiveness, 
     unless such change is a modification in a manufacturing 
     procedure or method of manufacturing and the holder of the 
     approved application submits a written notice to the 
     Secretary that describes in detail the change, summarizes the 
     data or information supporting the change, and informs the 
     Secretary that the change has been made under the 
     requirements of section 520(f).

[[Page S9138]]

       ``(ii) The holder of an approved application who submits a 
     notice under clause (i) with respect to a manufacturing 
     change of a device shall not distribute the device for a 
     period of 14 days after the date on which the Secretary 
     receives the notice.
       ``(B)(i) Subject to clause (ii), in reviewing a supplement 
     to an approved application, for an incremental change to the 
     design of a device that affects safety or effectiveness, the 
     Secretary shall approve such supplement if--
       ``(I) nonclinical data demonstrate that the design 
     modification creates the intended additional capacity, 
     function, or performance of the device; and
       ``(II) clinical data from the approved application and any 
     supplement to the approved application provide a reasonable 
     assurance of safety and effectiveness for the changed device.
       ``(ii) The Secretary may require, when necessary, 
     additional clinical data to evaluate the design modification 
     to provide a reasonable assurance of safety and 
     effectiveness.''.

     SEC. 602. ENVIRONMENTAL IMPACT REVIEW.

       Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
     402, is further amended by adding at the end the following:

     ``SEC. 742. ENVIRONMENTAL IMPACT REVIEW.

       ``Notwithstanding any other provision of law, no action by 
     the Secretary pursuant to this Act shall be subject to an 
     environmental assessment, an environmental impact statement, 
     or other environmental consideration unless the Secretary 
     demonstrates, in writing--
       ``(1) that there is a reasonable probability that the 
     environmental impact of the action is sufficiently 
     substantial and within the factors that the Secretary is 
     authorized to consider under this Act; and
       ``(2) that consideration of the environmental impact will 
     directly affect the decision on the action.''.

     SEC. 603. EXEMPTION OF CERTAIN CLASSES OF DEVICES FROM 
                   PREMARKET NOTIFICATION REQUIREMENT.

       (a) Class I and Class II Devices.--Section 510(k) (21 
     U.S.C. 360(k)) is amended by striking ``intended for human 
     use'' and inserting ``intended for human use (except a device 
     that is classified into class I under section 513 or 520 
     unless the Secretary determines such device is intended for a 
     use that is of substantial importance in preventing 
     impairment of human health or such device presents a 
     potential unreasonable risk of illness or injury, or a device 
     that is classified into class II under section 513 or 520 and 
     is exempt from the requirements of this subsection under 
     subsection (l))''.
       (b) Publication of Exemption.--Section 510 (21 U.S.C. 360) 
     is amended by inserting after subsection (k) the following:
       ``(l)(1) Not later than 30 days after the date of enactment 
     of this subsection, the Secretary shall publish in the 
     Federal Register a list of each type of class II device that 
     does not require a notification under subsection (k) to 
     provide reasonable assurance of safety and effectiveness. 
     Each type of class II device identified by the Secretary not 
     to require the notification shall be exempt from the 
     requirement to provide notification under subsection (k) as 
     of the date of the publication of the list in the Federal 
     Register.
       ``(2) Beginning on the date that is 1 day after the date of 
     the publication of a list under this subsection, the 
     Secretary may exempt a class II device from the notification 
     requirement of subsection (k), upon the Secretary's own 
     initiative or a petition of an interested person, if the 
     Secretary determines that such notification is not necessary 
     to assure the safety and effectiveness of the device. The 
     Secretary shall publish in the Federal Register notice of the 
     intent of the Secretary to exempt the device, or of the 
     petition, and provide a 30-day comment period for public 
     comment. Within 120 days after the issuance of the notice in 
     the Federal Register, the Secretary shall publish an order in 
     the Federal Register that sets forth the final determination 
     of the Secretary regarding the exemption of the device that 
     was the subject of the notice.''.

     SEC. 604. EVALUATION OF AUTOMATIC CLASS III DESIGNATION.

       Section 513(f) (21 U.S.C. 360c(f)) is amended--
       (1) in paragraph (1)--
       (A) in subparagraph (B), by striking ``paragraph (2)'' and 
     inserting ``paragraph (3)''; and
       (B) in the last sentence, by striking ``paragraph (2)'' and 
     inserting ``paragraph (2) or (3)'';
       (2) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively; and
       (3) by inserting after paragraph (1) the following:
       ``(2)(A) Any person who submits a report under section 
     510(k) for a type of device that has not been previously 
     classified under this Act, and that is classified into class 
     III under paragraph (1), may request, within 30 days after 
     receiving written notice of such a classification, the 
     Secretary to classify the device into class I or II under the 
     criteria set forth in subparagraphs (A) through (C) 
     subsection (a)(1). The person may, in the request, recommend 
     to the Secretary a classification for the device. The request 
     shall describe the device and provide detailed information 
     and reasons for the recommended classification.
       ``(B)(i) Not later than 60 days after the date of the 
     submission of the request under subparagraph (A) for 
     classification of a device under the criteria set forth in 
     subparagraphs (A) through (C) of subsection (a)(1), the 
     Secretary shall by written order classify the device. Such 
     classification shall be the initial classification of the 
     device for purposes of paragraph (1) and any device 
     classified under this paragraph into class I or II shall be a 
     predicate device for determining substantial equivalence 
     under paragraph (1).
       ``(ii) A device that remains in class III under this 
     subparagraph shall be deemed to be adulterated within the 
     meaning of section 501(f)(1)(B) until approved under section 
     515 or exempted from such approval under section 520(g).
       ``(C) Within 30 days after the issuance of an order 
     classifying a device under this paragraph, the Secretary 
     shall publish a notice in the Federal Register announcing 
     such classification.''.

     SEC. 605. SECRETARY'S DISCRETION TO TRACK DEVICES.

       (a) Release of Information.--Section 519(e) (21 U.S.C. 
     360i(e)) is amended by adding at the end the following flush 
     sentence:

     ``Any patient receiving a device subject to tracking under 
     this section may refuse to release, or refuse permission to 
     release, the patient's name, address, social security number, 
     or other identifying information for the purpose of 
     tracking.''.
       (b) Publication of Certain Devices.--Not later than 180 
     days after the date of enactment of this Act, the Secretary 
     of Health and Human Services shall develop and publish in the 
     Federal Register a list that identifies each type of device 
     subject to tracking under section 519(e)(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)(1)). Each 
     device not identified by the Secretary of Health and Human 
     Services under this subsection or designated by the Secretary 
     under section 519(e)(2) shall be deemed to be exempt from the 
     mandatory tracking requirement under section 519 of such Act. 
     The Secretary of Health and Human Services shall have 
     authority to modify the list of devices exempted from the 
     mandatory tracking requirements.

     SEC. 606. SECRETARY'S DISCRETION TO CONDUCT POSTMARKET 
                   SURVEILLANCE.

       (a) In General.--Section 522 (21 U.S.C. 360l) is amended by 
     striking ``Sec. 522.'' and all that follows through ``(2) 
     Discretionary surveillance.--The'' and inserting the 
     following:
       ``Sec. 522. (a) Discretionary Surveillance.--The''.
       (b) Surveillance Approval.--Section 522(b) (21 U.S.C. 
     360l(b)) is amended to read as follows:
       ``(b) Surveillance Approval.--
       ``(1) In general.--Each manufacturer that receives notice 
     from the Secretary that the manufacturer is required to 
     conduct surveillance of a device under subsection (a) shall, 
     not later than 30 days after receiving the notice, submit for 
     the approval of the Secretary, a plan for the required 
     surveillance.
       ``(2) Determination.--Not later than 60 days after the 
     receipt of the plan, the Secretary shall determine if a 
     person proposed in the plan to conduct the surveillance has 
     sufficient qualifications and experience to conduct the 
     surveillance and if the plan will result in the collection of 
     useful data that can reveal unforeseen adverse events or 
     other information necessary to protect the public health and 
     to provide safety and effectiveness information for the 
     device.
       ``(3) Limitation on plan approval.--The Secretary may not 
     approve the plan until the plan has been reviewed by a 
     qualified scientific and technical review committee 
     established by the Secretary.''.
       (c) Duration of Surveillance.--Section 522 (21 U.S.C. 
     360l), as amended by subsection (b), is further amended by 
     adding at the end the following:
       ``(c) Duration of Surveillance.--
       ``(1) In general.--Each manufacturer required to conduct 
     surveillance of a device under subsection (a) shall be 
     required to conduct such surveillance for not longer than 24 
     months.
       ``(2) Extension of the period of surveillance.--If the 
     Secretary determines that additional surveillance is needed 
     to identify the incidence of adverse events documented during 
     the initial period of surveillance that were not foreseen at 
     the time of approval or classification of the device, the 
     Secretary may extend the period of surveillance for such time 
     as may be necessary after providing the person required to 
     conduct such surveillance an opportunity for an informal 
     hearing to determine whether or not additional surveillance 
     is appropriate and to determine the appropriate period, if 
     any, for such surveillance.''.

     SEC. 607. REPORTING.

       (a) Reports.--Section 519 (21 U.S.C. 360i) is amended--
       (1) in subsection (a)--
       (A) in the first sentence by striking ``make such reports, 
     and provide such information,'' and inserting ``and submit 
     such samples and components of devices (as required by 
     paragraph (10)),''; and
       (B) by inserting after the first sentence the following: 
     ``Every person who is a manufacturer or importer of a device 
     intended for human use shall make reports, and provide such 
     information, as the Secretary may by regulation reasonably 
     require to assure that such device is not adulterated or 
     misbranded and to assure the safety and effectiveness of such 
     device.'';
       (C) in the last sentence by striking ``sentence'' and 
     inserting ``sentences'';
       (D) in paragraph (8), by striking ``; and'' and inserting a 
     semicolon; and
       (E) by striking paragraph (9) and inserting the following:
       ``(9) shall require distributors to keep records and make 
     such records available to the Secretary upon request; and'';
       (2) by striking subsection (d); and
       (3) in subsection (f), by striking ``, importer, or 
     distributor'' each place it appears and inserting ``or 
     importer''.
       (b) Registration.--Section 510(g) (21 U.S.C. 360(g)) is 
     amended--
       (1) by redesignating paragraph (4) as paragraph (5);
       (2) by inserting after paragraph (3), the following:
       ``(4) any distributor who acts as a wholesale distributor 
     of devices, and who does not manufacture, repackage, process, 
     or relabel a device; or''; and
       (3) by adding at the end the following flush sentence:


[[Page S9139]]


     ``In this subsection, the term `wholesale distributor' means 
     any person who distributes a device from the original place 
     of manufacture to the person who makes the final delivery or 
     sale of the device to the ultimate consumer or user.''.

     SEC. 608. PILOT AND SMALL-SCALE MANUFACTURE.

       Section 505(c) (21 U.S.C. 355(c)) is amended by adding at 
     the end the following:
       ``(4) A new drug manufactured in a pilot or other small 
     facility may be used to demonstrate the safety and 
     effectiveness of the new drug and to obtain approval of the 
     new drug prior to scaling up to a larger facility, unless the 
     Secretary determines that a full scale production facility is 
     necessary to ensure the safety or effectiveness of the new 
     drug.''.

     SEC. 609. REQUIREMENTS FOR RADIOPHARMACEUTICALS.

       (a) Requirements.--
       (1) Regulations.--
       (A) Proposed regulations.--Not later than 180 days after 
     the date of enactment of this Act, the Secretary of Health 
     and Human Services, after consultation with patient advocacy 
     groups, associations, physicians licensed to use 
     radiopharmaceuticals, and the regulated industry, shall issue 
     proposed regulations governing the approval of 
     radiopharmaceuticals designed for diagnosis and monitoring of 
     diseases and conditions. The regulations shall provide that 
     the determination of the safety and effectiveness of such a 
     radiopharmaceutical under section 505 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the 
     Public Health Service Act (42 U.S.C. 262) shall include (but 
     not be limited to) consideration of the proposed use of the 
     radiopharmaceutical in the practice of medicine, the 
     pharmacological and toxicological activity of the 
     radiopharmaceutical (including any carrier or ligand 
     component of the radiopharmaceutical), and the estimated 
     absorbed radiation dose of the radiopharmaceutical.
       (B) Final regulations.--Not later than 18 months after the 
     date of enactment of this Act, the Secretary shall promulgate 
     final regulations governing the approval of the 
     radiopharmaceuticals.
       (2) Special rule.--In the case of a radiopharmaceutical 
     intended to be used for diagnostic or monitoring purposes, 
     the indications for which such radiopharmaceutical is 
     approved for marketing may, in appropriate cases, refer to 
     manifestations of disease (such as biochemical, 
     physiological, anatomic, or pathological processes) common 
     to, or present in, 1 or more disease states.
       (b) Definition.--In this section, the term 
     ``radiopharmaceutical'' means--
       (1) an article--
       (A) that is intended for use in the diagnosis or monitoring 
     of a disease or a manifestation of a disease in humans; and
       (B) that exhibits spontaneous disintegration of unstable 
     nuclei with the emission of nuclear particles or photons; or
       (2) any nonradioactive reagent kit or nuclide generator 
     that is intended to be used in the preparation of any such 
     article.

     SEC. 610. MODERNIZATION OF REGULATION OF BIOLOGICAL PRODUCTS.

       (a) Licenses.--
       (1) In general.--Section 351(a) of the Public Health 
     Service (42 U.S.C. 262(a)) is amended to read as follows:
       ``(a)(1) Except as provided in paragraph (4), no person 
     shall introduce or deliver for introduction into interstate 
     commerce any biological product unless--
       ``(A) a biologics license is in effect for the biological 
     product; and
       ``(B) each package of the biological product is plainly 
     marked with--
       ``(i) the proper name of the biological product contained 
     in the package;
       ``(ii) the name, address, and applicable license number of 
     the manufacturer of the biological product; and
       ``(iii) the expiration date of the biological product.
       ``(2)(A) The Secretary shall establish, by regulation, 
     requirements for the approval, suspension, and revocation of 
     biologics licenses.
       ``(B) The Secretary shall approve a biologics license 
     application on the basis of a demonstration that--
       ``(i) the biological product that is the subject of the 
     application is safe, pure, and potent; and
       ``(ii) the facility in which the biological product is 
     manufactured, processed, packed, or held meets standards 
     designed to assure that the biological product continues to 
     be safe, pure, and potent.
       ``(3) A biologics license application shall be approved 
     only if the applicant (or other appropriate person) consents 
     to the inspection of the facility that is the subject of the 
     application, in accordance with subsection (c).
       ``(4) The Secretary shall prescribe requirements under 
     which a biological product undergoing investigation shall be 
     exempt from the requirements of paragraph (1).''.
       (2) Elimination of existing license requirement.--Section 
     351(d) of the Public Health Service Act (42 U.S.C. 262(d)) is 
     amended--
       (A) by striking ``(d)(1)'' and all that follows through 
     ``of this section.'';
       (B) in paragraph (2)--
       (i) by striking ``(2)(A) Upon'' and inserting ``(d)(1) 
     Upon;'' and
       (ii) by redesignating subparagraph (B) as paragraph (2); 
     and
       (C) in paragraph (2) (as so redesignated by subparagraph 
     (B)(ii))--
       (i) by striking ``subparagraph (A)'' and inserting 
     ``paragraph (1)''; and
       (ii) by striking ``this subparagraph'' each place it 
     appears and inserting ``this paragraph''.
       (b) Labeling.--Section 351(b) of the Public Health Service 
     Act (42 U.S.C. 262(b)) is amended to read as follows:
       ``(b) No person shall falsely label or mark any package or 
     container of any biological product or alter any label or 
     mark on the package or container of the biological product so 
     as to falsify the label or mark.''.
       (c) Inspection.--Section 351(c) of the Public Health 
     Service Act (42 U.S.C. 262(c)) is amended by striking 
     ``virus, serum,'' and all that follows and inserting 
     ``biological product.''.
       (d) Definition; Application.--Section 351 of the Public 
     Health Service Act (42 U.S.C. 262) is amended by adding at 
     the end the following:
       ``(i) In this section, the term `biological product' means 
     a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, 
     blood component or derivative, allergenic product, analogous 
     product, or arsphenamine or derivative of arsphenamine (or 
     any other trivalent organic arsenic compound), applicable to 
     the prevention, treatment, or cure of a disease or condition 
     of human beings.''.
       (e) Conforming Amendment.--Section 503(g)(4) (21 U.S.C. 
     353(g)(4)) is amended--
       (1) in subparagraph (A)--
       (A) by striking ``section 351(a)'' and inserting ``section 
     351(i)''; and
       (B) by striking ``262(a)'' and inserting ``262(i)''; and
       (2) in subparagraph (B)(iii), by striking ``product or 
     establishment license under subsection (a) or (d)'' and 
     inserting ``biologics license application under subsection 
     (a)''.
       (f) Special Rule.--The Secretary of Health and Human 
     Services shall take measures to minimize differences in the 
     review and approval of products required to have approved 
     biologics license applications under section 351 of the 
     Public Health Service Act (42 U.S.C. 262) and products 
     required to have approved full new drug applications under 
     section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(b)(1)).

     SEC. 611. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED 
                   PRODUCTS.

       (a) Performance Standards.--Not later than 180 days after 
     the date of enactment of this section, the Secretary of 
     Health and Human Services shall publish in the Federal 
     Register performance standards for the prompt review of 
     supplemental applications submitted for approved articles 
     under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 
     et seq.).
       (b) Guidance to Industry.--Not later than 180 days after 
     the date of enactment of this section, the Secretary of 
     Health and Human Services shall issue final guidances to 
     clarify the requirements for, and facilitate the submission 
     of data to support, the approval of supplemental applications 
     for the approved articles described in subsection (a). The 
     guidances shall--
       (1) clarify circumstances in which published matter may be 
     the basis for approval of a supplemental application;
       (2) specify data requirements that will avoid duplication 
     of previously submitted data by recognizing the availability 
     of data previously submitted in support of an original 
     application; and
       (3) define supplemental applications that are eligible for 
     priority review.
       (c) Responsibilities of Centers.--The Secretary of Health 
     and Human Services shall designate an individual in each 
     center within the Food and Drug Administration (except the 
     Center for Food Safety and Applied Nutrition) to be 
     responsible for--
       (1) encouraging the prompt review of supplemental 
     applications for approved articles; and
       (2) working with sponsors to facilitate the development and 
     submission of data to support supplemental applications.
       (d) Collaboration.--The Secretary of Health and Human 
     Services shall implement programs and policies that will 
     foster collaboration between the Food and Drug 
     Administration, the National Institutes of Health, 
     professional medical and scientific societies, and other 
     persons, to identify published and unpublished studies that 
     may support a supplemental application, and to encourage 
     sponsors to make supplemental applications or conduct further 
     research in support of a supplemental application based, in 
     whole or in part, on such studies.

     SEC. 612. HEALTH CARE ECONOMIC INFORMATION.

       Section 502 (21 U.S.C. 352) is amended by adding at the end 
     the following:
       ``(u) In the case of a health care economic statement that 
     is included in labeling or advertising provided to a 
     formulary committee, managed care organization, or similar 
     entity with responsibility for drug selection decisions 
     (other than the label or approved physician package insert) 
     relating to an indication approved under section 505 or 351 
     of the Public Health Service Act (42 U.S.C. 262), if the 
     health care economic statement is not based on competent and 
     reliable scientific evidence. The only requirements 
     applicable to any such statement under this Act shall be the 
     requirements of this paragraph. In this paragraph, the term 
     `health care economic statement' means any statement that 
     identifies, measures, or compares the costs (direct, 
     indirect, and intangible) and health care consequences of a 
     drug to another drug, to another health care intervention for 
     the same indication, or to no intervention, where the primary 
     endpoint is an economic outcome.''.

     SEC. 613. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS.

       (a) In General.--Chapter V (21 U.S.C. 351 et seq.), as 
     amended by section 102, is further amended by adding at the 
     end the following:

                    ``Subchapter E--Fast Track Drugs

     ``SEC. 561. FAST TRACK DRUGS.

       ``(a) Designation of Drug as a Fast Track Drug.--
       ``(1) In general.--The Secretary shall facilitate 
     development, and expedite review and approval of new drugs 
     and biological products

[[Page S9140]]

     that are intended for the treatment of serious or life-
     threatening conditions and that demonstrate the potential to 
     address unmet medical needs for such conditions. In this Act, 
     such products shall be known as `fast track drugs'.
       ``(2) Request for designation.--The sponsor of a drug 
     (including a biological product) may request the Secretary to 
     designate the drug as a fast track drug. A request for the 
     designation may be made concurrently with, or at any time 
     after, submission of an application for the investigation of 
     the drug under section 505(i) or section 351(a)(4) of the 
     Public Health Service Act.
       ``(3) Designation.--Within 30 calendar days after the 
     receipt of a request under paragraph (2), the Secretary shall 
     determine whether the drug that is the subject of the request 
     meets the criteria described in paragraph (1). If the 
     Secretary finds that the drug meets the criteria, the 
     Secretary shall designate the drug as a fast track drug and 
     shall take such actions as are appropriate to expedite the 
     development and review of the drug.
       ``(b) Approval of Application for a Fast Track Drug.--
       ``(1) In general.--The Secretary may approve an application 
     for approval of a fast track drug under section 505(b) or 
     section 351 of the Public Health Service Act (21 U.S.C. 262) 
     upon a determination that the drug has an effect on a 
     surrogate endpoint that is reasonably likely to predict 
     clinical benefit.
       ``(2) Limitation.--Approval of a fast track drug under this 
     subsection may be subject to the requirements--
       ``(A) that the sponsor conduct appropriate post-approval 
     studies to validate the surrogate endpoint or otherwise 
     confirm the clinical benefit of the drug; and
       ``(B) that the sponsor submit copies of all promotional 
     materials related to the fast track drug during the 
     preapproval review period and following approval, at least 30 
     days prior to dissemination of the materials for such period 
     of time as the Secretary deems appropriate.
       ``(3) Expedited withdrawal of approval.--The Secretary may 
     withdraw approval of a fast track drug using expedited 
     procedures (as prescribed by the Secretary in regulations) 
     including a procedure that provides an opportunity for an 
     informal hearing, if--
       ``(A) the sponsor fails to conduct any required post-
     approval study of the fast track drug with due diligence;
       ``(B) a post-approval study of the fast track drug fails to 
     verify clinical benefit of the fast track drug;
       ``(C) other evidence demonstrates that the fast track drug 
     is not safe or effective under conditions of use of the drug; 
     or
       ``(D) the sponsor disseminates false or misleading 
     promotional materials with respect to the fast track drug.
       ``(c) Review of Incomplete Applications for Approval of a 
     Fast Track Drug.--
       ``(1) In general.--If preliminary evaluation by the 
     Secretary of clinical efficacy data for a fast track drug 
     under investigation shows evidence of effectiveness, the 
     Secretary shall evaluate for filing, and may commence review 
     of portions, of an application for the approval of the drug 
     if the applicant provides a schedule for submission of 
     information necessary to make the application complete and 
     any fee that may be required under section 736.
       ``(2) Exception.--Any time period for review of human drug 
     applications that has been agreed to by the Secretary and 
     that has been set forth in goals identified in letters of the 
     Secretary (relating to the use of fees collected under 
     section 736 to expedite the drug development process and the 
     review of human drug applications) shall not apply to an 
     application submitted under paragraph (1) until the date on 
     which the application is complete.
       ``(d) Awareness Efforts.--The Secretary shall--
       ``(1) develop and widely disseminate to physicians, patient 
     organizations, pharmaceutical and biotechnology companies, 
     and other appropriate persons a comprehensive description of 
     the provisions applicable to fast track drugs established 
     under this section; and
       ``(2) establish an ongoing program to encourage the 
     development of surrogate endpoints that are reasonably likely 
     to predict clinical benefit for serious or life-threatening 
     conditions for which there exist significant unmet medical 
     needs.''.
       (b) Guidance.--Within 1 year after the date of enactment of 
     this Act, the Secretary of Health and Human Services shall 
     issue guidance for fast track drugs that describes the 
     policies and procedures that pertain to section 561 of the 
     Federal Food, Drug, and Cosmetic Act.

     SEC. 614. MANUFACTURING CHANGES FOR DRUGS AND BIOLOGICS.

       (a) In General.--Chapter VII (21 U.S.C. 371 et seq.), as 
     amended by section 602, is further amended by adding at the 
     end the following:

                 ``Subchapter E--Manufacturing Changes

     ``SEC. 751. MANUFACTURING CHANGES.

       ``(a) In General.--A change in the manufacture of a new 
     drug, including a biological product, may be made in 
     accordance with this section.
       ``(b) Changes.--
       ``(1) Validation.--Before distributing a drug made after a 
     change in the manufacture of the drug from the manufacturing 
     process established in the approved new drug application 
     under section 505, or license application under section 351 
     of the Public Health Service Act, the applicant shall 
     validate the effect of the change on the identity, strength, 
     quality, purity, and potency of the drug as the identity, 
     strength, quality, purity, and potency may relate to the 
     safety or effectiveness of the drug.
       ``(2) Reports.--The applicant shall report the change 
     described in paragraph (1) to the Secretary and may 
     distribute a drug made after the change as follows:
       ``(A) Major manufacturing changes.
       ``(i) In general.--Major manufacturing changes, which are 
     of a type determined by the Secretary to have substantial 
     potential to adversely affect the identity, strength, 
     quality, purity, or potency of the drug as the identity, 
     strength, quality, purity, and potency may relate to the 
     safety or effectiveness of a drug, shall be submitted to the 
     Secretary in a supplemental application and drugs made after 
     such changes may not be distributed until the Secretary 
     approves the supplemental application.
       ``(ii) Definition.--In this subparagraph, the term `major 
     manufacturing changes' means--

       ``(I) changes in the qualitative or quantitative 
     formulation of a drug or the specifications in the approved 
     marketing application for the drug (unless exempted by the 
     Secretary from the requirements of this subparagraph);
       ``(II) changes that the Secretary determines by regulation 
     or issuance of guidance require completion of an appropriate 
     human study demonstrating equivalence of the drug to the drug 
     manufactured before such changes; and
       ``(III) other changes that the Secretary determines by 
     regulation or issuance of guidance have a substantial 
     potential to adversely affect the safety or effectiveness of 
     the drug.

       ``(B) Other manufacturing changes.--
       ``(i) In general.--As determined by the Secretary, 
     manufacturing changes other than major manufacturing changes 
     shall--

       ``(I) be made at any time and reported annually to the 
     Secretary, with supporting data; or
       ``(II) be reported to the Secretary in a supplemental 
     application.

       ``(ii) Distribution of the drug.--In the case of changes 
     reported in accordance with clause (i)(II)--

       ``(I) the applicant may distribute the drug 30 days after 
     the Secretary receives the supplemental application unless 
     the Secretary notifies the applicant within such 30-day 
     period that prior approval of such supplemental application 
     is required; and
       ``(II) the Secretary shall, after making the notification 
     to the applicant under subclause (I), approve or disapprove 
     each such supplemental application.

       ``(iii) Special rule.--The Secretary may determine types of 
     manufacturing changes after which distribution of a drug may 
     commence at the time of submission of such supplemental 
     application.''.
       (b) Existing Law.--The requirements of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) and the Public 
     Health Service Act (42 U.S.C. 201 et seq.) that are in effect 
     on the date of enactment of this Act with respect to 
     manufacturing changes shall remain in effect--
       (1) for a period of 24 months after the date of enactment 
     of this Act; or
       (2) until the effective date of regulations promulgated by 
     the Secretary of Health and Human Services implementing 
     section 751 of the Federal Food, Drug, and Cosmetic Act,

     whichever is sooner.

     SEC. 615. DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS.

       Within 12 months after the date of enactment of this Act, 
     the Secretary of the Health and Human Services, acting 
     through the Commissioner of Food and Drugs, shall issue 
     guidance that describes when abbreviated study reports may be 
     submitted, in lieu of full reports, with a new drug 
     application under section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355) and with a biologics license 
     application under section 351 of the Public Health Service 
     Act (42 U.S.C. 262) for certain types of studies. Such 
     guidance shall describe the kinds of studies for which 
     abbreviated reports are appropriate and the appropriate 
     abbreviated report formats.

     SEC. 616. FOOD CONTACT SUBSTANCES.

       (a) Food Contact Substances.--Section 409(a) (21 U.S.C. 
     348(a)) is amended--
       (1) in paragraph (1)--
       (A) by striking ``subsection (i)'' and inserting 
     ``subsection (j)''; and
       (B) by striking at the end ``or'';
       (2) by striking the period at the end of paragraph (2) and 
     inserting ``; or'';
       (3) by inserting after paragraph (2) the following:
       ``(3) in the case of a food additive as defined in this Act 
     that is a food contact substance, there is--
       ``(A) in effect, and such substance and the use of such 
     substance are in conformity with, a regulation issued under 
     this section prescribing the conditions under which such 
     additive may be safely used; or
       ``(B) a notification submitted under subsection (h) that is 
     effective.''; and
       (4) by striking the matter following paragraph (3) (as 
     added by paragraph (2)) and inserting the following flush 
     sentence:

     ``While such a regulation relating to a food additive, or 
     such a notification under subsection (h) relating to a food 
     additive that is a food contact substance, is in effect, and 
     has not been revoked pursuant to subsection (i), a food shall 
     not, by reason of bearing or containing such a food additive 
     in accordance with the regulation or notification, be 
     considered adulterated under section 402(a)(1).''.
       (b) Notification for Food Contact Substances.--Section 409 
     (21 U.S.C. 348), as amended by subsection (a), is further 
     amended--
       (1) by redesignating subsections (h) and (i), as 
     subsections (i) and (j), respectively;
       (2) by inserting after subsection (g) the following:

          ``Notification Relating to a Food Contact Substance

       ``(h)(1) Subject to such regulations as may be promulgated 
     under paragraph (3), a manufacturer or supplier of a food 
     contact substance may, at least 120 days prior to the 
     introduction or delivery for introduction into interstate 
     commerce of the food contact substance, notify the

[[Page S9141]]

     Secretary of the identity and intended use of the food 
     contact substance, and of the determination of the 
     manufacturer or supplier that the intended use of such food 
     contact substance is safe under the standard described in 
     subsection (c)(3)(A). The notification shall contain the 
     information that forms the basis of the determination, the 
     fee required under paragraph (5), and all information 
     required to be submitted by regulations promulgated by the 
     Secretary.
       ``(2)(A) A notification submitted under paragraph (1) shall 
     become effective 120 days after the date of receipt by the 
     Secretary and the food contact substance may be introduced or 
     delivered for introduction into interstate commerce, unless 
     the Secretary makes a determination within the 120-day period 
     that, based on the data and information before the Secretary, 
     such use of the food contact substance has not been shown to 
     be safe under the standard described in subsection (c)(3)(A), 
     and informs the manufacturer or supplier of such 
     determination.
       ``(B) A decision by the Secretary to object to a 
     notification shall constitute final agency action subject to 
     judicial review.
       ``(C) In this paragraph, the term `food contact substance' 
     means the substance that is the subject of a notification 
     submitted under paragraph (1), and does not include a similar 
     or identical substance manufactured or prepared by a person 
     other than the manufacturer identified in the notification.
       ``(3)(A) The process in this subsection shall be utilized 
     for authorizing the marketing of a food contact substance 
     except where the Secretary determines that submission and 
     review of a petition under subsection (b) is necessary to 
     provide adequate assurance of safety, or where the Secretary 
     and any manufacturer or supplier agree that such manufacturer 
     or supplier may submit a petition under subsection (b).
       ``(B) The Secretary is authorized to promulgate regulations 
     to identify the circumstances in which a petition shall be 
     filed under subsection (b), and shall consider criteria such 
     as the probable consumption of such food contact substance 
     and potential toxicity of the food contact substance in 
     determining the circumstances in which a petition shall be 
     filed under subsection (b).
       ``(4) The Secretary shall keep confidential any information 
     provided in a notification under paragraph (1) for 120 days 
     after receipt by the Secretary of the notification. After the 
     expiration of such 120 days, the information shall be 
     available to any interested party except for any matter in 
     the notification that is a trade secret or confidential 
     commercial information.
       ``(5)(A) Each person that submits a notification regarding 
     a food contact substance under this section shall be subject 
     to the payment of a reasonable fee. The fee shall be based on 
     the resources required to process the notification including 
     reasonable administrative costs for such processing.
       ``(B) The Secretary shall conduct a study of the costs of 
     administering the notification program established under this 
     section and, on the basis of the results of such study, 
     shall, within 18 months after the date of enactment of the 
     Food and Drug Administration Modernization and Accountability 
     Act of 1997, promulgate regulations establishing the fee 
     required by subparagraph (A).
       ``(C) A notification submitted without the appropriate fee 
     is not complete and shall not become effective for the 
     purposes of subsection (a)(3) until the appropriate fee is 
     paid.
       ``(D) Fees collected pursuant to this subsection--
       ``(i) shall not be deposited as an offsetting collection to 
     the appropriations for the Department of Health and Human 
     Services;
       ``(ii) shall be credited to the appropriate account of the 
     Food and Drug Administration; and
       ``(iii) shall be available in accordance with appropriation 
     Acts until expended, without fiscal year limitation.
       ``(6) In this section, the term `food contact substance' 
     means any substance intended for use as a component of 
     materials used in manufacturing, packing, packaging, 
     transporting, or holding food if such use is not intended to 
     have any technical effect in such food.'';
       (3) in subsection (i), as so redesignated by paragraph (1), 
     by adding at the end the following: ``The Secretary shall by 
     regulation prescribe the procedure by which the Secretary may 
     deem a notification under subsection (h) to no longer be 
     effective.''; and
       (4) in subsection (j), as so redesignated by paragraph (1), 
     by striking ``subsections (b) to (h)'' and inserting 
     ``subsections (b) to (i)''.
       (c) Effective Date.--Notifications under section 409(h) of 
     the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (b), may be submitted beginning 18 months after 
     the date of enactment of this Act.

     SEC. 617. HEALTH CLAIMS FOR FOOD PRODUCTS.

       Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by 
     adding at the end the following:
       ``(C) Notwithstanding the provisions of clauses (A)(i) and 
     (B), a claim of the type described in subparagraph (1)(B) 
     that is not authorized by the Secretary in a regulation 
     promulgated in accordance with clause (B) shall be authorized 
     and may be made if--
       ``(i) an authoritative scientific body of the Federal 
     Government with official responsibility for public health 
     protection or research directly relating to human nutrition 
     (such as the National Institutes of Health or the Centers for 
     Disease Control and Prevention), the National Academy of 
     Sciences, or a subdivision of the scientific body or the 
     National Academy of Sciences, has published an authoritative 
     statement, which is currently in effect, about the 
     relationship between a nutrient and a disease or health-
     related condition to which the claim refers;
       ``(ii) a person has submitted to the Secretary at least 90 
     days before the first introduction of a food into interstate 
     commerce a notice of the claim, including a concise 
     description of the basis upon which such person relied for 
     determining that the requirements of subclause (i) have been 
     satisfied;
       ``(iii) the claim and the food for which the claim is made 
     are in compliance with clause (A)(ii), and are otherwise in 
     compliance with paragraph (a) and section 201(n); and
       ``(iv) the claim is stated in a manner so that the claim is 
     an accurate representation of the authoritative statement 
     referred to in subclause (i) and so that the claim enables 
     the public to comprehend the information provided in the 
     claim and to understand the relative significance of such 
     information in the context of a total daily diet.
     For purposes of this paragraph, a statement shall be regarded 
     as an authoritative statement of such a scientific body 
     described in subclause (i) only if the statement is published 
     by the scientific body and shall not include a statement of 
     an employee of the scientific body made in the individual 
     capacity of the employee.
       ``(D) A claim meeting the requirements of clause (C) may be 
     made until--
       ``(i) such time as the Secretary issues a final regulation 
     under clause (B) prohibiting or modifying the claim, and the 
     regulation has become effective; or
       ``(ii) a district court of the United States in an 
     enforcement proceeding under chapter III has determined that 
     the requirements of clause (C) have not been met.''.

     SEC. 618. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

       Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 351 et seq.) is amended by inserting after section 505 
     the following:

     ``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

       ``(a) Market Exclusivity for New Drugs.--If, prior to 
     approval of an application that is submitted under section 
     505(b)(1) the Secretary determines that information relating 
     to the use of a drug in the pediatric population may produce 
     health benefits in that population, the Secretary makes a 
     written request for pediatric studies (which may include a 
     timeframe for completing such studies), and such studies are 
     completed within any such timeframe and the reports thereof 
     submitted in accordance with subsection (d)(2) or completed 
     within any such timeframe and the reports thereof are 
     accepted in accordance with subsection (d)(3)--
       ``(1)(A) the period during which an application may not be 
     submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) 
     of section 505 shall be five years and six months rather than 
     five years, and the references in subsections (c)(3)(D)(ii) 
     and (j)(4)(D)(ii) of section 505 to four years, to forty-
     eight months, and to seven and one-half years shall be deemed 
     to be four and one-half years, fifty-four months, and eight 
     years, respectively; or
       ``(B) the period of market exclusivity under subsections 
     (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of 
     section 505 shall be three years and six months rather than 
     three years; and
       ``(2)(A) if the drug is the subject of--
       ``(i) a listed patent for which a certification has been 
     submitted under section 505(b)(2)(A)(ii) or section 
     (j)(2)(A)(vii)(II) and for which pediatric studies were 
     submitted prior to the expiration of the patent (including 
     any patent extensions); or
       ``(ii) a listed patent for which a certification has been 
     submitted under section 505(b)(2)(A)(iii) or section 
     505(j)(2)(A)(vii)(III),

     the period during which an application may not be approved 
     under section 505(c)(3) or section 505(j)(4)(B) shall be 
     extended by a period of six months after the date the patent 
     expires (including any patent extensions); or
       ``(B) if the drug is the subject of a listed patent for   
     which   a   certification   has   been   submitted under 
     section 505(b)(2)(A)(iv) or section 505(j)(2)(A)(vii)(IV), 
     and in the patent infringement litigation resulting from the 
     certification the court determines that the patent is valid 
     and would be infringed, the period during which an 
     application may not be approved under section 505(c)(3) or 
     section 505(j)(4)(B) shall be extended by a period of six 
     months after the date the patent expires (including any 
     patent extensions).
       ``(b) Secretary To Develop List of Drugs for Which 
     Additional Pediatric Information May Be Beneficial.--Not 
     later than 180 days after the date of enactment of this 
     section, the Secretary, after consultation with experts in 
     pediatric research (such as the American Academy of 
     Pediatrics, the Pediatric Pharmacology Research Unit Network, 
     and the United States Pharmacopoeia) shall develop, 
     prioritize, and publish an initial list of approved drugs for 
     which additional pediatric information may produce health 
     benefits in the pediatric population. The Secretary shall 
     annually update the list.
       ``(c) Market Exclusivity for Already-Marketed Drugs.--If 
     the Secretary makes a written request for pediatric studies 
     (which may include a timeframe for completing such studies) 
     concerning a drug identified in the list described in 
     subsection (b) to the holder of an approved application under 
     section 505(b)(1) for the drug, the holder agrees to the 
     request, and the studies are completed within any such 
     timeframe and the reports thereof submitted in accordance 
     with subsection (d)(2) or completed within any such timeframe 
     and the reports thereof accepted in accordance with 
     subsection (d)(3)--
       ``(1)(A) the period during which an application may not be 
     submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) 
     of section 505 shall be five years and six months rather than 
     five years, and the references in subsections (c)(3)(D)(ii) 
     and (j)(4)(D)(ii) of section 505 to four years, to forty-
     eight months, and to seven and one-half years shall be deemed 
     to be four

[[Page S9142]]

     and one-half years, fifty-four months, and eight years, 
     respectively; or
       ``(B) the period of market exclusivity under subsections 
     (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of 
     section 505 shall be three years and six months rather than 
     three years; and
       ``(2)(A) if the drug is the subject of--
       ``(i) a listed patent for which a certification has been 
     submitted under section 505(b)(2)(A)(ii) or 
     (j)(2)(A)(vii)(II) and for which pediatric studies were 
     submitted prior to the expiration of the patent (including 
     any patent extensions); or
       ``(ii) a listed patent for which a certification has been 
     submitted under section 505(b)(2)(A)(iii) or section 
     505(j)(2)(A)(vii)(III),
     the period during which an application may not be approved 
     under section 505(c)(3) or section 505(j)(4)(B) shall be 
     extended by a period of six months after the date the patent 
     expires (including any patent extensions); or
       ``(B) if the drug is the subject of a listed patent for 
     which a certification has been submitted under section 
     505(b)(2)(A)(iv) or section 505(j)(2)(A)(vii)(IV), and in the 
     patent infringement litigation resulting from the 
     certification the court determines that the patent is valid 
     and would be infringed, the period during which an 
     application may not be approved under section 505(c)(3) or 
     section 505(j)(4)(B) shall be extended by a period of six 
     months after the date the patent expires (including any 
     patent extensions).
       ``(d) Conduct of Pediatric Studies.--
       ``(1) Agreement for studies.--The Secretary may, pursuant 
     to a written request for studies, after consultation with--
       ``(A) the sponsor of an application for an investigational 
     new drug under section 505(i);
       ``(B) the sponsor of an application for a drug under 
     section 505(b)(1); or
       ``(C) the holder of an approved application for a drug 
     under section 505(b)(1),
     agree with the sponsor or holder for the conduct of pediatric 
     studies for such drug.
       ``(2) Written protocols to meet the studies requirement.--
     If the sponsor or holder and the Secretary agree upon written 
     protocols for the studies, the studies requirement of 
     subsection (a) or (c) is satisfied upon the completion of the 
     studies and submission of the reports thereof in accordance 
     with the original written request and the written agreement 
     referred to in paragraph (1). Not later than 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 original written request and the written 
     agreement and reported in accordance with the requirements of 
     the Secretary for filing and so notify the sponsor or holder.
       ``(3) Other methods to meet the studies requirement.--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 (c) is satisfied when such 
     studies have been completed and the reports accepted by the 
     Secretary. Not later than 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 the 90 days, whether 
     the studies fairly respond to the written request, whether 
     such studies have been conducted in accordance with commonly 
     accepted scientific principles and protocols, and whether 
     such studies have been reported in accordance with the 
     requirements of the Secretary for filing.
       ``(e) Delay of Effective Date for Certain Applications; 
     Period of Market Exclusivity.--If the Secretary determines 
     that the acceptance or approval of an application under 
     section 505(b)(2) or 505(j) for a drug may occur after 
     submission of reports of pediatric studies under this 
     section, which were submitted prior to the expiration of the 
     patent (including any patent extension) or market exclusivity 
     protection, but before the Secretary has determined whether 
     the requirements of subsection (d) have been satisfied, the 
     Secretary shall delay the acceptance or approval under 
     section 505(b)(2) or 505(j), respectively, until the 
     determination under subsection (d) is made, but such delay 
     shall not exceed 90 days. In the event that requirements of 
     this section are satisfied, the applicable period of market 
     exclusivity referred to in subsection (a) or (c) shall be 
     deemed to have been running during the period of delay.
       ``(f) Notice of Determinations on Studies Requirement.--The 
     Secretary shall publish a notice of any determination that 
     the requirements of subsection (d) have been met and that 
     submissions and approvals under section 505(b)(2) or (j) for 
     a drug will be subject to the provisions of this section.
       ``(g) Definitions.--As used in this section, the term 
     `pediatric studies' or `studies' means at least 1 clinical 
     investigation (that, at the Secretary's discretion, may 
     include pharmacokinetic studies) in pediatric age-groups in 
     which a drug is anticipated to be used.
       ``(h) Limitation.--The holder of an approved application 
     for a new drug that has already received six months of market 
     exclusivity under subsection (a) or (c) may, if otherwise 
     eligible, obtain six months of market exclusivity under 
     subsection (c)(1)(B) for a supplemental application, except 
     that the holder is not eligible for exclusivity under 
     subsection (c)(2).
       ``(i) Sunset.--No period of market exclusivity shall be 
     granted under this section based on studies commenced after 
     January 1, 2004. The Secretary shall conduct a study and 
     report to Congress not later than January 1, 2003 based on 
     the experience under the program. The study and report shall 
     examine all relevant issues, including--
       ``(1) the effectiveness of the program in improving 
     information about important pediatric uses for approved 
     drugs;
       ``(2) the adequacy of the incentive provided under this 
     section;
       ``(3) the economic impact of the program; and
       ``(4) any suggestions for modification that the Secretary 
     deems appropriate.''.

     SEC. 619. POSITRON EMISSION TOMOGRAPHY.

       (a) Regulation of Compounded Positron Emission Tomography 
     Drugs Under the Federal Food, Drug, and Cosmetic Act.--
       (1) Definition.--Section 201 (21 U.S.C. 321), as amended by 
     section 405, is further amended by adding at the end the 
     following:
       ``(jj) The term `compounded positron emission tomography 
     drug' means a drug that--
       ``(1) exhibits spontaneous disintegration of unstable 
     nuclei, including the emission of positrons;
       ``(2) includes any nonradioactive reagent, reagent kit, 
     ingredient, nuclide generator, accelerator, target material, 
     electronic synthesizer, or other apparatus or computer 
     program to be used in the preparation of any such drug; and
       ``(3)(A) has been compounded in a State in accordance with 
     State law for a patient or for research, teaching, or quality 
     control by or on the order of a practitioner licensed by that 
     State to compound or order such a drug; or
       ``(B) has been compounded in a Federal facility in a State 
     in accordance with the law of the State in which the facility 
     is located.''.
       (b) Regulation as a Drug.--Section 501(a)(2) (21 U.S.C. 
     351(a)(2)) is amended by striking ``; or (3)'' and inserting 
     the following: ``; or (C) if it is a compounded positron 
     emission tomography drug and the methods used in, or the 
     facilities and controls used for, its compounding, 
     processing, packing, or holding do not conform to or are not 
     operated or administered in conformity with the positron 
     emission tomography compounding standards and the official 
     monographs of the United States Pharmacopoeia to assure that 
     such drug meets the requirements of this Act as to safety and 
     has the identity and strength, and meets the quality and 
     purity characteristics, which it purports or is represented 
     to possess; or (3)''.
       (c) Regulation as a New Drug.--Section 505 (21 U.S.C. 355) 
     is amended by adding at the end the following:
       ``(n) The provisions of subsections (a) and (j) shall not 
     apply to the preparation of a compounded positron emission 
     tomography drug.''.
       (d) Revocation of Certain Inconsistent Documents.--Not 
     later than 30 days after the date of enactment of this Act, 
     the Secretary of Health and Human Services shall publish in 
     the Federal Register a notice revoking--
       (1) a notice entitled ``Regulation of Positron Emission 
     Tomographic Drug Products: Guidance; Public Workshop'', 
     published in the Federal Register of February 27, 1995;
       (2) a notice entitled ``Guidance for Industry: Current Good 
     Manufacturing Practices for Positron Emission Tomographic 
     (PET) Drug Products'', published in the Federal Register of 
     April 22, 1997; and
       (3) a final rule entitled ``Current Good Manufacturing 
     Practice for Finished Pharmaceuticals; Positron Emission 
     Tomography'', published in the Federal Register of April 22, 
     1997.
                   TITLE VII--FEES RELATING TO DRUGS

     SEC. 701. SHORT TITLE.

       This title may be cited as the ``Prescription Drug User Fee 
     Reauthorization Act of 1997''.

     SEC. 702. FINDINGS.

       Congress finds that--
       (1) prompt approval of safe and effective new drugs and 
     other therapies is critical to the improvement of the public 
     health so that patients may enjoy the benefits provided by 
     these therapies to treat and prevent illness and disease;
       (2) the public health will be served by making additional 
     funds available for the purpose of augmenting the resources 
     of the Food and Drug Administration that are devoted to the 
     process for review of human drug applications;
       (3) the provisions added by the Prescription Drug User Fee 
     Act of 1992 have been successful in substantially reducing 
     review times for human drug applications and should be--
       (A) reauthorized for an additional 5 years, with certain 
     technical improvements; and
       (B) carried out by the Food and Drug Administration with 
     new commitments to implement more ambitious and comprehensive 
     improvements in regulatory processes of the Food and Drug 
     Administration; and
       (4) the fees authorized by amendments made in this title 
     will be dedicated toward expediting the drug development 
     process and the review of human drug applications as set 
     forth in the goals identified in the letters of 
     ______________, and ______________, from the Secretary of 
     Health and Human Services to the chairman of the Committee on 
     Commerce of the House of Representatives and the chairman of 
     the Committee on Labor and Human Resources of the Senate, as 
     set forth at ____ Cong. Rec. ________ (daily ed. __________, 
     1997).

     SEC. 703. DEFINITIONS.

       Section 735 (21 U.S.C. 379g) is amended--
       (1) in the second sentence of paragraph (1)--
       (A) by striking ``Service Act, and'' and inserting 
     ``Service Act,''; and
       (B) by striking ``September 1, 1992.'' and inserting the 
     following: ``September 1, 1992, does not include an 
     application for a licensure of a biological product for 
     further manufacturing use only, and does not include an 
     application or supplement submitted by a State or Federal 
     Government entity for a drug or biological product that is 
     not distributed commercially. Such term does include an 
     application for licensure, as described in subparagraph (D), 
     of a large volume biological product intended for single dose 
     injection for intravenous use or infusion.'';
       (2) in the second sentence of paragraph (3)--
       (A) by striking ``Service Act, and'' and inserting 
     ``Service Act,''; and
       (B) by striking ``September 1, 1992.'' and inserting the 
     following: ``September 1, 1992, does not include a biological 
     product that is licensed

[[Page S9143]]

     for further manufacturing use only, and does not include a 
     drug or biological product that is not distributed 
     commercially and is the subject of an application or 
     supplement submitted by a State or Federal Government entity. 
     Such term does include a large volume biological product 
     intended for single dose injection for intravenous use or 
     infusion.'';
       (3) in paragraph (4), by striking ``without'' and inserting 
     ``without substantial'';
       (4) in paragraph (7)(A)--
       (A) by striking ``employees under contract'' and all that 
     follows through ``Administration,'' and inserting 
     ``contractors of the Food and Drug Administration,''; and
       (B) by striking ``and committees,'' and inserting ``and 
     committees and to contracts with such contractors,'';
       (5) in paragraph (8)--
       (A) in subparagraph (A)--
       (i) by striking ``August of '' and inserting ``April of ''; 
     and
       (ii) by striking ``August 1992'' and inserting ``April 
     1997'';
       (B) by striking subparagraph (B) and inserting the 
     following:
       ``(B) 1 plus the total percentage increase for such fiscal 
     year since fiscal year 1997 in basic pay under the General 
     Schedule in accordance with section 5332 of title 5, United 
     States Code, as adjusted by any locality-based comparability 
     payment pursuant to section 5304 of such title for Federal 
     employees stationed in the District of Columbia.''; and
       (C) by striking the second sentence; and
       (6) by adding at the end the following:
       ``(9) The term `affiliate' means a business entity that has 
     a relationship with a second business entity if, directly or 
     indirectly--
       ``(A) 1 business entity controls, or has the power to 
     control, the other business entity; or
       ``(B) a third party controls, or has power to control both 
     of the business entities.''.

     SEC. 704. AUTHORITY TO ASSESS AND USE DRUG FEES.

       (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is 
     amended--
       (1) by striking ``Beginning in fiscal year 1993'' and 
     inserting ``Beginning in fiscal year 1998'';
       (2) in paragraph (1)--
       (A) by striking subparagraph (B) and inserting the 
     following:
       ``(B) Payment.--The fee required by subparagraph (A) shall 
     be due upon submission of the application or supplement.'';
       (B) in subparagraph (D)--
       (i) in the subparagraph heading, by striking ``not 
     accepted'' and inserting ``refused'';
       (ii) by striking ``50 percent'' and inserting ``75 
     percent'';
       (iii) by striking ``subparagraph (B)(i)'' and inserting 
     ``subparagraph (B)''; and
       (iv) by striking ``not accepted'' and inserting 
     ``refused''; and
       (C) by adding at the end the following:
       ``(E) Exception for designated orphan drug or indication.--
     A person that submits a human drug application for a 
     prescription drug product that has been designated as a drug 
     for a rare disease or condition pursuant to section 526, or a 
     supplement proposing to include a new indication for a rare 
     disease or condition pursuant to section 526, shall not be 
     assessed a fee under subparagraph (A), unless the human drug 
     application includes indications for other than rare diseases 
     or conditions.
       ``(F) Exception for applications and supplements for 
     pediatric indications.--A person that submits a human drug 
     application or supplement that includes an indication for use 
     in pediatric populations shall be assessed a fee under 
     subparagraph (A) only if--
       ``(i) the application is for initial approval for use in a 
     pediatric population; or
       ``(ii) the application or supplement is for approval for 
     use in pediatric and non-pediatric populations.
       ``(G) Refund of fee if application withdrawn.--If an 
     application or supplement is withdrawn after the application 
     or supplement is filed, the Secretary may waive and refund 
     the fee or a portion of the fee if no substantial work was 
     performed on the application or supplement after the 
     application or supplement was filed. The Secretary shall have 
     the sole discretion to waive and refund a fee or a portion of 
     the fee under this subparagraph. A determination by the 
     Secretary concerning a waiver or refund under this paragraph 
     shall not be reviewable.'';
       (3) in paragraph (2)(A), by striking ``505(j), and'' and 
     inserting the following: ``505(j) or under an abbreviated new 
     drug application pursuant to regulations in effect prior to 
     the implementation of the Drug Price Competition and Patent 
     Term Restoration Act of 1984, or a product approved under an 
     application filed under section 507 that is abbreviated, 
     and''; and
       (4) in paragraph (3)--
       (A) in subparagraph (A)--
       (i) in clause (i), by striking ``is listed'' and inserting 
     ``has been submitted for listing''; and
       (ii) by striking ``Such fee shall be payable'' and all that 
     follows through ``section 510.'' and inserting the following: 
     ``Such fee shall be payable for the fiscal year in which the 
     product is first submitted for listing under section 510, or 
     for relisting under section 510 if the product has been 
     withdrawn from listing and relisted. After such fee is paid 
     for that fiscal year, such fee shall be payable on or before 
     January 31 of each year. Such fee shall be paid only once for 
     each product for a fiscal year in which the fee is 
     payable.''; and
       (B) in subparagraph (B), by striking ``505(j).'' and 
     inserting the following: ``505(j), or under an abbreviated 
     new drug application pursuant to regulations in effect prior 
     to the implementation of the Drug Price Competition and 
     Patent Term Restoration Act of 1984, or is a product approved 
     under an application filed under section 507 that is 
     abbreviated.''.
       (b) Fee Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is 
     amended to read as follows:
       ``(b) Fee Amounts.--Except as provided in subsections (c), 
     (d), (f), and (g), the fees required under subsection (a) 
     shall be determined and assessed as follows:
       ``(1) Application and supplement fees.--
       ``(A) Full fees.--The application fee under subsection 
     (a)(1)(A)(i) shall be $250,704 in fiscal year 1998, $256,338 
     in each of fiscal years 1999 and 2000, $267,606 in fiscal 
     year 2001, and $258,451 in fiscal year 2002.
       ``(B) Other fees.--The fee under subsection (a)(1)(A)(ii) 
     shall be $125,352 in fiscal year 1998, $128,169 in each of 
     fiscal years 1999 and 2000, $133,803 in fiscal year 2001, and 
     $129,226 in fiscal year 2002.
       ``(2) Fee revenues for establishment fees.--The total fee 
     revenues to be collected in establishment fees under 
     subsection (a)(2) shall be $35,600,000 in fiscal year 1998, 
     $36,400,000 in each of fiscal years 1999 and 2000, 
     $38,000,000 in fiscal year 2001, and $36,700,000 in fiscal 
     year 2002.
       ``(3) Total fee revenues for product fees.--The total fee 
     revenues to be collected in product fees under subsection 
     (a)(3) in a fiscal year shall be equal to the total fee 
     revenues collected in establishment fees under subsection 
     (a)(2) in that fiscal year.''.
       (c) Increases and Adjustments.--Section 736(c) (21 U.S.C. 
     379h(c)) is amended--
       (1) in the subsection heading, by striking ``Increases 
     and'';
       (2) in paragraph (1)--
       (A) by striking ``(1) Revenue'' and all that follows 
     through ``increased by the Secretary'' and inserting the 
     following: ``(1) Inflation adjustment.--The fees and total 
     fee revenues established in subsection (b) shall be adjusted 
     by the Secretary'';
       (B) in subparagraph (A), by striking ``increase'' and 
     inserting ``change'';
       (C) in subparagraph (B), by striking ``increase'' and 
     inserting ``change''; and
       (D) by adding at the end the following flush sentence:

     ``The adjustment made each fiscal year by this subsection 
     will be added on a compounded basis to the sum of all 
     adjustments made each fiscal year after fiscal year 1997 
     under this subsection.'';
       (3) in paragraph (2), by striking ``October 1, 1992,'' and 
     all that follows through ``such schedule.'' and inserting the 
     following: ``September 30, 1997, adjust the establishment and 
     product fees described in subsection (b) for the fiscal year 
     in which the adjustment occurs so that the revenues collected 
     from each of the categories of fees described in paragraphs 
     (2) and (3) of subsection (b) shall be set to be equal to the 
     revenues collected during the past fiscal year from the 
     category of application and supplement fees described in 
     paragraph (1) of subsection (b).''; and
       (4) in paragraph (3), by striking ``paragraph (2)'' and 
     inserting ``this subsection''.
       (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 
     379h(d)) is amended--
       (1) by redesignating paragraphs (1), (2), (3), and (4) as 
     subparagraphs (A), (B), (C), and (D), respectively and 
     indenting appropriately;
       (2) by striking ``The Secretary shall grant a'' and all 
     that follows through ``finds that--'' and inserting the 
     following:
       ``(1) In general.--The Secretary shall grant a waiver from 
     or a reduction of 1 or more fees assessed under subsection 
     (a) where the Secretary finds that--'';
       (3) in subparagraph (C) (as so redesignated by paragraph 
     (1)), by striking ``, or'' and inserting a comma;
       (4) in subparagraph (D) (as so redesignated by paragraph 
     (1)), by striking the period and inserting ``, or'';
       (5) by inserting after subparagraph (D) (as so redesignated 
     by paragraph (1)) the following:
       ``(E) the applicant is a small business submitting its 
     first human drug application to the Secretary for review.''; 
     and
       (6) by striking ``In making the finding in paragraph (3),'' 
     and all that follows through ``standard costs.'' and 
     inserting the following:
       ``(2) Use of standard costs.--In making the finding in 
     paragraph (1)(C), the Secretary may use standard costs.
       ``(3) Rules relating to small businesses.--
       ``(A) Definition.--In paragraph (1)(E), the term `small 
     business' means an entity that has fewer than 500 employees, 
     including employees of affiliates.
       ``(B) Waiver of application fee.--The Secretary shall waive 
     under paragraph (1)(E) the application fee for the first 
     human drug application that a small business or its affiliate 
     submits to the Secretary for review. After a small business 
     or its affiliate is granted such a waiver, the small business 
     or its affiliate shall pay--
       ``(i) application fees for all subsequent human drug 
     applications submitted to the Secretary for review in the 
     same manner as an entity that does not qualify as a small 
     business; and
       ``(ii) all supplement fees for all supplements to human 
     drug applications submitted to the Secretary for review in 
     the same manner as an entity that does not qualify as a small 
     business.''.
       (e) Assessment of Fees.--Section 736(f)(1) (21 U.S.C. 
     379h(f)(1)) is amended--
       (1) by striking ``fiscal year 1993'' and inserting ``fiscal 
     year 1997''; and
       (2) by striking ``fiscal year 1992'' and inserting ``fiscal 
     year 1997 (excluding the amount of fees appropriated for such 
     fiscal year)''.
       (f) Crediting and Availability of Fees.--Section 736(g) (21 
     U.S.C. 379h(g)) is amended--
       (1) in paragraph (1), by adding at the end the following: 
     ``Such sums as may be necessary may be transferred from the 
     Food and Drug Administration salaries and expenses 
     appropriation account without fiscal year limitation to such 
     appropriation account for salaries and expenses with such 
     fiscal year limitation. The sums transferred shall be 
     available solely for the process for the review of human drug 
     applications within the meaning of section 735(6).'';

[[Page S9144]]

       (2) in paragraph (2)--
       (A) in subparagraph (A), by striking ``Acts'' and inserting 
     ``Acts, or otherwise made available for obligation,''; and
       (B) in subparagraph (B), by striking ``over such costs for 
     fiscal year 1992'' and inserting ``over such costs, excluding 
     costs paid from fees collected under this section, for fiscal 
     year 1997''; and
       (3) by striking paragraph (3) and inserting the following:
       ``(3) Authorization of appropriations.--There is authorized 
     to be appropriated for fees under this section--
       ``(A) $106,800,000 for fiscal year 1998;
       ``(B) $109,200,000 for fiscal year 1999;
       ``(C) $109,200,000 for fiscal year 2000;
       ``(D) $114,000,000 for fiscal year 2001; and
       ``(E) $110,100,000 for fiscal year 2002,

     as adjusted to reflect adjustments in the total fee revenues 
     made under this section and changes in the total amounts 
     collected by application, supplement, establishment, and 
     product fees.
       ``(4) Offset.--Any amount of fees collected for a fiscal 
     year which exceeds the amount of fees specified in 
     appropriation Acts for such fiscal year, shall be credited to 
     the appropriation account of the Food and Drug Administration 
     as provided in paragraph (1), and shall be subtracted from 
     the amount of fees that would otherwise be authorized to be 
     collected under appropriation Acts for a subsequent fiscal 
     year.''.
       (g) Requirement for Written Requests for Waivers, 
     Reductions, and Fees.--Section 736 (21 U.S.C. 379h) is 
     amended--
       (1) by redesignating subsection (i) as subsection (j); and
       (2) by inserting after subsection (h) the following:
       ``(i) Written Requests for Waivers, Reductions, and 
     Refunds.--To qualify for consideration for a waiver or 
     reduction under subsection (d), or for a refund, of any fee 
     collected in accordance with subsection (a), a person shall 
     submit to the Secretary a written request for such waiver, 
     reduction, or refund not later than 180 days after such fee 
     is due.''.
       (h) Special Rule for Waiver, Refunds, and Exceptions.--Any 
     requests for waivers, refunds, or exceptions for fees paid 
     prior to the date of enactment of this Act shall be submitted 
     in writing to the Secretary of Health and Human Services 
     within 1 year after the date of enactment of this Act.

     SEC. 705. ANNUAL REPORTS.

       (a) First Report.--Beginning with fiscal year 1998, not 
     later than 60 days after the end of each fiscal year during 
     which fees are collected under part 2 of subchapter C of 
     chapter VII of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 379g et seq.), the Secretary of Health and Human 
     Services shall prepare and submit to the Committee on 
     Commerce of the House of Representatives and the Committee on 
     Labor and Human Resources of the Senate a report concerning 
     the progress of the Food and Drug Administration in achieving 
     the goals identified in the letter described in section 
     702(4) during such fiscal year and the future plans of the 
     Food and Drug Administration for meeting the goals.
       (b) Second Report.--Beginning with fiscal year 1998, not 
     later than 120 days after the end of each fiscal year during 
     which fees are collected under the part described in 
     subsection (a), the Secretary of Health and Human Services 
     shall prepare and submit to the Committee on Commerce of the 
     House of Representatives and the Committee on Labor and Human 
     Resources of the Senate a report on the implementation of the 
     authority for such fees during such fiscal year and the use, 
     by the Food and Drug Administration, of the fees collected 
     during such fiscal year for which the report is made.

     SEC. 706. EFFECTIVE DATE.

       The amendments made by this title shall take effect October 
     1, 1997.

     SEC. 707. TERMINATION OF EFFECTIVENESS.

       The amendments made by sections 703 and 704 cease to be 
     effective October 1, 2002 and section 705 ceases to be 
     effective 120 days after such date.
                       TITLE VIII--MISCELLANEOUS

     SEC. 801. REGISTRATION OF FOREIGN ESTABLISHMENTS.

       Section 510(i) (21 U.S.C. 360(i)) is amended to read as 
     follows:
       ``(i)(1) Any establishment within any foreign country 
     engaged in the manufacture, preparation, propagation, 
     compounding, or processing of a drug or a device that is 
     imported or offered for import into the United States shall 
     register with the Secretary the name and place of business of 
     the establishment and the name of the United States agent for 
     the establishment.
       ``(2) The establishment shall also provide the information 
     required by subsection (j).
       ``(3) The Secretary is authorized to enter into cooperative 
     arrangements with foreign countries to ensure that adequate 
     and effective means are available for purposes of 
     determining, from time to time, whether drugs or devices 
     manufactured, prepared, propagated, compounded, or processed 
     by an establishment described in paragraph (1), if imported 
     or offered for import into the United States, shall be 
     refused admission on any of the grounds set forth in section 
     801(a).''.

     SEC. 802. ELIMINATION OF CERTAIN LABELING REQUIREMENTS.

       (a) Prescription Drugs.--Section 503(b)(4) (21 U.S.C. 
     353(b)(4)) is amended to read as follows:
       ``(4)(A) A drug that is subject to paragraph (1) shall be 
     deemed to be misbranded if at any time prior to dispensing 
     the label of the drug fails to bear, at a minimum, the symbol 
     `Rx only'.
       ``(B) A drug to which paragraph (1) does not apply shall be 
     deemed to be misbranded if at any time prior to dispensing 
     the label of the drug bears the symbol described in 
     subparagraph (A).''.
       (b) Misbranded Drug.--Section 502(d) (21 U.S.C. 352(d)) is 
     repealed.
       (c) Conforming Amendments.--
       (1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended--
       (A) by striking subparagraph (A); and
       (B) by redesignating subparagraphs (B) and (C) as 
     subparagraphs (A) and (B), respectively.
       (2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by 
     striking ``section 502(d) and''.
       (3) Section 102(9)(A) of the Controlled Substances Act (21 
     U.S.C. 802(9)(A)) is amended--
       (A) in clause (i), by striking ``(i)''; and
       (B) by striking ``(ii)'' and all that follows.

     SEC. 803. CLARIFICATION OF SEIZURE AUTHORITY.

       Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended--
       (1) in paragraph (1), in the fifth sentence, by striking 
     ``paragraphs (1) and (2) of section 801(e)'' and inserting 
     ``subparagraphs (A) and (B) of section 801(e)(1)''; and
       (2) by inserting after the fifth sentence the following: 
     ``Any person seeking to export an imported article pursuant 
     to any of the provisions of this subsection shall establish 
     that the article was intended for export at the time the 
     article entered commerce.''.

     SEC. 804. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.

       Chapter IX (21 U.S.C. 391 et seq.), as amended by section 
     203, is further amended by adding at the end the following:

     ``SEC. 907. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.

       ``(a) In General.--The Secretary, acting through the 
     Commissioner of Food and Drugs, may, directly or through 
     grants, contracts, or cooperative agreements, conduct and 
     support intramural research training in regulatory scientific 
     programs by predoctoral and postdoctoral scientists and 
     physicians, including the support through the use of 
     fellowships.
       ``(b) Limitation on Participation.--A recipient of a 
     fellowship under subsection (a) may not be an employee of the 
     Federal Government.
       ``(c) Special Rule.--The Secretary, acting through the 
     Commissioner of Food and Drugs, may support the provision of 
     assistance for fellowships described in subsection (a) 
     through a Cooperative Research and Development Agreement.''.

     SEC. 805. DEVICE SAMPLES.

       (a) Recall Authority.--
       (1) In general.--Section 518(e)(2) (21 U.S.C. 360h(e)(2)) 
     is amended by adding at the end the following:
       ``(C) If the Secretary issues an amended order under 
     subparagraph (A), the Secretary may require the person 
     subject to the order to submit such samples of the device and 
     of components of the device as the Secretary may reasonably 
     require. If the submission of such samples is impracticable 
     or unduly burdensome, the requirement of this subparagraph 
     may be met by the submission of complete information 
     concerning the location of 1 or more such devices readily 
     available for examination and testing.''.
       (2) Technical amendment.--Section 518(e)(2)(A) (21 U.S.C. 
     360h(e)(2)(A)) is amended by striking ``subparagraphs (B) and 
     (C)'' and inserting ``subparagraph (B)''.
       (b) Records and Reports on Devices.--Section 519(a) (21 
     U.S.C. 360i(a)) is amended by inserting after paragraph (9) 
     the following:
       ``(10) may reasonably require a manufacturer, importer, or 
     distributor to submit samples of a device and of components 
     of the device that may have caused or contributed to a death 
     or serious injury, except that if the submission of such 
     samples is impracticable or unduly burdensome, the 
     requirement of this paragraph may be met by the submission of 
     complete information concerning the location of 1 or more 
     such devices readily available for examination and 
     testing.''.

     SEC. 806. INTERSTATE COMMERCE.

       Section 709 (21 U.S.C. 379a) is amended by striking ``a 
     device'' and inserting ``a device, food, drug, or cosmetic''.

     SEC. 807. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND 
                   COSMETICS.

       Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
     614, is further amended by adding at the end the following:

``Subchapter F--National Uniformity for Nonprescription Drugs for Human 
                           Use and Cosmetics

     ``SEC. 761. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND 
                   COSMETICS.

       ``(a) In General.--Except as provided in subsection (b), 
     (c)(1), or (d), no State or political subdivision of a State 
     may establish or continue in effect any requirement--
       ``(1) that relates to the regulation of a drug intended for 
     human use that is not subject to the requirements of section 
     503(b)(1) or a cosmetic; and
       ``(2) that is different from or in addition to, or that is 
     otherwise not identical with, a requirement of this Act, the 
     Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et 
     seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 
     et seq.).
       ``(b) Exemption.--Upon application of a State, the 
     Secretary may by regulation, after notice and opportunity for 
     written and oral presentation of views, exempt from 
     subsection (a), under such condition as may be prescribed in 
     such regulation, a State requirement that--
       ``(1) protects an important public interest that would 
     otherwise be unprotected;
       ``(2) would not cause any drug or cosmetic to be in 
     violation of any applicable requirement or prohibition under 
     Federal law; and
       ``(3) would not unduly burden interstate commerce.
       ``(c) Scope.--For purposes of subsection (a), a requirement 
     that relates to the regulation of a drug or cosmetic--

[[Page S9145]]

       ``(1) shall not include any requirement that relates to the 
     practice of pharmacy or any requirement that a drug be 
     dispensed only upon the prescription of a practitioner 
     licensed by law to administer such drug; and
       ``(2) shall be deemed to include any requirement relating 
     to public information or any other form of public 
     communication relating to the safety or effectiveness of a 
     drug or cosmetic.
       ``(d) No Effect on Product Liability Law.--Nothing in this 
     section shall be construed to modify or otherwise affect any 
     action or the liability of any person under the product 
     liability law of any State.''.

     SEC. 808. INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERIOUS 
                   OR LIFE-THREATENING DISEASES.

       (a) In General.--Section 402 of the Public Health Service 
     Act (42 U.S.C. 282) is amended--
       (1) by redesignating subsections (j) and (k) as subsections 
     (k) and (l), respectively; and
       (2) by inserting after subsection (i), the following:
       ``(j)(1) The Secretary, acting through the Director of the 
     National Institutes of Health and subject to the availability 
     of appropriations, shall establish, maintain, and operate a 
     program with respect to information on research relating to 
     the treatment, detection, and prevention of serious or life-
     threatening diseases and conditions. The program shall, with 
     respect to the agencies of the Department of Health and Human 
     Services, be integrated and coordinated, and, to the extent 
     practicable, coordinated with other data banks containing 
     similar information.
       ``(2)(A) After consultation with the Commissioner of Food 
     and Drugs, the directors of the appropriate agencies of the 
     National Institutes of Health (including the National Library 
     of Medicine), and the Director of the Centers for Disease 
     Control and Prevention, the Secretary shall, in carrying out 
     paragraph (1), establish a data bank of information on 
     clinical trials for drugs, and biologicals, for serious or 
     life-threatening diseases and conditions.
       ``(B) In carrying out subparagraph (A), the Secretary shall 
     collect, catalog, store and disseminate the information 
     described in such subparagraph. The Secretary shall 
     disseminate such information through information systems, 
     which shall include toll-free telephone communications, 
     available to individuals with serious or life-threatening 
     diseases and conditions, to other members of the public, to 
     health care providers, and to researchers.
       ``(3) The Data Bank shall include the following:
       ``(A) A registry of clinical trials (whether federally or 
     privately funded) of experimental treatments for serious or 
     life-threatening diseases and conditions under regulations 
     promulgated pursuant to sections 505 and 520 of the Federal 
     Food, Drug, and Cosmetic Act that provides a description of 
     the purpose of each experimental drug or biological protocol, 
     either with the consent of the protocol sponsor, or when a 
     trial to test efficacy begins. Information provided shall 
     consist of eligibility criteria, a description of the 
     location of trial sites, and a point of contact for those 
     wanting to enroll in the trial, and shall be in a form that 
     can be readily understood by members of the public. Such 
     information must be forwarded to the Data Bank by the sponsor 
     of the trial not later than 21 days after the approval by the 
     Food and Drug Administration.
       ``(B) Information pertaining to experimental treatments for 
     serious or life-threatening diseases and conditions that may 
     be available--
       ``(i) under a treatment investigational new drug 
     application that has been submitted to the Food and Drug 
     Administration pursuant to part 312 of title 21, Code of 
     Federal Regulations; or
       ``(ii) as a Group C cancer drug.

     The Data Bank may also include information pertaining to the 
     results of clinical trials of such treatments, with the 
     consent of the sponsor, including information concerning 
     potential toxicities or adverse effects associated with the 
     use or administration of such experimental treatments.
       ``(4) The Data Bank shall not include information relating 
     to an investigation if the sponsor has certified to the 
     Secretary that disclosure of such information would 
     substantially interfere with the timely enrollment of 
     subjects in the investigation.
       ``(5) For the purpose of carrying out this subsection, 
     there are authorized to be appropriated such sums as may be 
     necessary. Fees collected under section 736 of the Federal 
     Food, Drug, and Cosmetic (21 U.S.C. 379h) shall not 
     be authorized or appropriated for use in carrying out this 
     subsection.''.
       (b) Collaboration and Report.--
       (1) In general.--The Secretary of Health and Human 
     Services, the Director of the National Institutes of Health, 
     and the Commissioner of Food and Drugs shall collaborate to 
     determine the feasibility of including device investigations 
     within the scope of the registry requirements set forth in 
     subsection (j) of section 402 of the Public Health Service 
     Act.
       (2) Report.--Not later than 2 years after the date of 
     enactment of this section, the Secretary of Health and Human 
     Services shall prepare and submit to the Committee on Labor 
     and Human Resources of the Senate and the Committee on 
     Commerce of the House of Representatives a report that shall 
     consider, among other things--
       (A) the public health need, if any, for inclusion of device 
     investigations within the scope of the registry requirements 
     set forth in subsection (j) of section 402 of the Public 
     Health Service Act; and
       (B) the adverse impact, if any, on device innovation and 
     research in the United States if information relating to such 
     device investigations is required to be publicly disclosed.

     SEC. 809. APPLICATION OF FEDERAL LAW TO THE PRACTICE OF 
                   PHARMACY COMPOUNDING.

       Section 503 (21 U.S.C. 353) is amended by adding at the end 
     the following:
       ``(h)(1) Sections 501(a)(2)(B), 502(f)(1), 502(l), 505, and 
     507 shall not apply to a drug product if--
       ``(A) the drug product is compounded for an identified 
     individual patient, based on a medical need for a compounded 
     product--
       ``(i) by a licensed pharmacist in a State licensed pharmacy 
     or a Federal facility, or a licensed physician, on the 
     prescription order of a licensed physician or other licensed 
     practitioner authorized by State law to prescribe drugs; or
       ``(ii) by a licensed pharmacist or licensed physician in 
     limited quantities, prior to the receipt of a valid 
     prescription order for the identified individual patient, and 
     is compounded based on a history of the licensed pharmacist 
     or licensed physician receiving valid prescription orders for 
     the compounding of the drug product that have been generated 
     solely within an established relationship between the 
     licensed pharmacist, or licensed physician, and--
       ``(I) the individual patient for whom the prescription 
     order will be provided; or
       ``(II) the physician or other licensed practitioner who 
     will write such prescription order; and
       ``(B) the licensed pharmacist or licensed physician--
       ``(i) compounds the drug product using bulk drug 
     substances--
       ``(I) that--

       ``(aa) comply with the standards of an applicable United 
     States Pharmacopeia monograph; or
       ``(bb) in a case in which such a monograph does not exist, 
     are drug substances that are covered by regulations issued by 
     the Secretary under paragraph (3);

       ``(II) that are manufactured by an establishment that is 
     registered under section 510 (including a foreign 
     establishment that is registered under section 510(i)); and
       ``(III) that are accompanied by valid certificates of 
     analysis for each bulk drug substance;
       ``(ii) compounds the drug product using ingredients (other 
     than bulk drug substances) that comply with the standards of 
     an applicable United States Pharmacopeia monograph and the 
     United States Pharmacopeia chapter on pharmacy compounding;
       ``(iii) only advertises or promotes the compounding service 
     provided by the licensed pharmacist or licensed physician and 
     does not advertise or promote the compounding of any 
     particular drug, class of drug, or type of drug;
       ``(iv) does not compound a drug product that appears on a 
     list published by the Secretary in the Federal Register of 
     drug products that have been withdrawn or removed from the 
     market because such drug products or components of such drug 
     products have been found to be unsafe or not effective;
       ``(v) does not compound a drug product that is identified 
     by the Secretary in regulation as presenting demonstrable 
     difficulties for compounding that reasonably demonstrate an 
     adverse effect on the safety or effectiveness of that drug 
     product; and
       ``(vi) does not distribute compounded drugs outside of the 
     State in which the drugs are compounded, unless the principal 
     State agency of jurisdiction that regulates the practice of 
     pharmacy in such State has entered into a memorandum of 
     understanding with the Secretary (based on the adequate 
     regulation of compounding performed in the State) that 
     provides for appropriate investigation by the State agency of 
     complaints relating to compounded products distributed 
     outside of the State.
       ``(2)(A) The Secretary shall, after consultation with the 
     National Association of Boards of Pharmacy, develop a 
     standard memorandum of understanding for use by States in 
     complying with paragraph (1)(B)(vi).
       ``(B) Paragraph (1)(B)(vi) shall not apply to a licensed 
     pharmacist or licensed physician, who does not distribute 
     inordinate amounts of compounded products outside of the 
     State, until--
       ``(i) the date that is 180 days after the development of 
     the standard memorandum of understanding; or
       ``(ii) the date on which the State agency enters into a 
     memorandum of understanding under paragraph (1)(B)(vi),
     whichever occurs first.
       ``(3) The Secretary, after consultation with the United 
     States Pharmacopeia Convention Incorporated, shall promulgate 
     regulations limiting compounding under paragraph 
     (1)(B)(i)(I)(bb) to drug substances that are components of 
     drug products approved by the Secretary and to other drug 
     substances as the Secretary may identify.
       ``(4) The provisions of paragraph (1) shall not apply--
       ``(A) to compounded positron emission tomography drugs as 
     defined in section 202(jj); or
       ``(B) to radiopharmaceuticals.''.

  The Senate proceeded to consider the bill.
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont.


                           Amendment No. 1130

              (Purpose: To provide a complete substitute)

  Mr. JEFFORDS. Mr. President, I send a modification of the committee 
amendment to the desk.
  The PRESIDING OFFICER. The clerk will report the amendment.
  The legislative clerk read as follows:

       The Senator from Vermont [Mr. Jeffords] proposes an 
     amendment numbered 1130.


[[Page S9146]]


  Mr. JEFFORDS. Mr. President, I ask unanimous consent that further 
reading of the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The text of the amendment is printed in today's Record under 
``Amendments Submitted.'')
  Mr. LOTT addressed the Chair.
  The PRESIDING OFFICER. The majority leader.
  Mr. LOTT. Will the Senator yield?
  Mr. JEFFORDS. I certainly yield to the majority leader.
  Mr. LOTT. Mr. President, this will be just very brief. I know you 
have your statements. Senator Kennedy has another event at 3 or 4 that 
he may attend. I have a conflict with other events, too.


                             Cloture Motion

  Mr. LOTT. Mr. President, I send a cloture motion to the desk and ask 
the clerk to report.
  The PRESIDING OFFICER. The cloture motion having been presented under 
rule XXII, the Chair directs the clerk to read the motion.
  The legislative clerk read as follows:

                             Cloture Motion

       We the undersigned Senators, in accordance with the 
     provisions of rule XXII of the Standing Rules of the Senate, 
     do hereby move to bring to a close debate on the substitute 
     amendment to Calendar No. 105, S. 830, the FDA reform bill:
         Trent Lott, James M. Jeffords, Pat Roberts, Kay Bailey 
           Hutchison, Tim Hutchinson, Conrad Burns, Chuck Hagel, 
           Jon Kyl, Rod Grams, Pete Domenici, Ted Stevens, 
           Christopher S. Bond, Strom Thurmond, Judd Gregg, Don 
           Nickles, and Paul Coverdell.

  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. JEFFORDS. Mr. President, the amendment that I sent to the desk is 
a modification of the committee amendment, and it is the amendment we 
desire to move forward on.
  The PRESIDING OFFICER. Amendment No. 1130 is a modification of the 
committee substitute, and cloture has been filed on that amendment.
  Mr. JEFFORDS. Thank you, Mr. President.
  First, filing a cloture motion sort of indicates a serious situation 
which requires its action. I am pleased to report that I am more 
optimistic now than I have been at any time that a vote will not be 
necessary to have cloture and that we are all working very long and 
hard upon resolving the remaining questions. The most difficult one 
that we were facing appears to be resolved. So it is my firm belief 
that by the time we come before this body again, other than today's 
debate, we will have an opportunity to expeditiously pass an FDA bill 
for the Food and Drug Administration to ensure that we have it passed 
in time to prevent the problems which might occur by failing to do so.
  Legislation to reform and modernize the Food and Drug Administration 
has been under consideration by Congress for over 3 years. At least six 
hearings have been held over the past 2 years in the Senate.
  Last year, our measure was reported out of committee but never 
reached the floor for full consideration. This year, we have held 
hearings and worked through months of negotiations with my colleague 
from Massachusetts and with the administration.
  S. 830 passed out of the Labor Committee on a vote of 14-4, a strong 
statement as to the bipartisan support this moderate measure enjoys. 
Last week we had a vote on the motion to proceed, and the vote was 89-5 
that we begin consideration of this measure. We are here today to do 
that. The Senate spoke loud and clear last week: ``Let's move on the 
bill. Let's consider amendments. And let us vote.'' We have now had 
over 15 hours of debate on this measure stretching back to before the 
August recess.
  Most recently, we spent a good part of Friday and Monday debating 
essentially 6 pages out of the 152-page bill. The time to move forward 
on this measure is now. I urge Senators to examine this measure, and I 
believe they will agree with me that it provides moderate, incremental 
but important improvements to the FDA while continuing the agency's 
``gold standard'' of public safety.
  I have never worked harder on a bill, and I say the same for the 
members of the committee, than we have on this one. The number of hours 
that have been spent bringing about consensus is incredible. I thank my 
ranking member and our staff for their cooperation and for placing us 
in a position where I believe we can expeditiously pass this next week 
without the necessity of having to invoke cloture.
  So at this point, Mr. President, I yield the floor.
  Mr. KENNEDY addressed the Chair.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, as I have on other occasions, I pay 
tribute to my friend and colleague from Vermont, Senator Jeffords, who 
has been shepherding this very complicated but enormously important 
health policy issue through the Senate. As he has correctly stated, 
there has been broad agreement on a number of the very important 
aspects of the bill that relate to the drug and medical device 
provisions.
  We have made considerable progress on one other aspect of the 
legislation, and that deals with an amendment which was added by the 
Senator from New Hampshire, which I will address momentarily. There are 
still some very important issues that are still being considered by 
Members. All of us are hopeful that we will have a positive outcome, 
but we are not quite there yet.
  Mr. President, just on another item, I want to identify myself with 
the excellent remarks of my friend and colleague from Iowa, Senator 
Harkin, on the vote that was taken just an hour or so ago about the 
block granting of various education programs.

  I think all of us have understood that the role of the Federal 
Government is very limited in terms of its help and assistance to local 
communities in terms of education. We have a much more profound 
responsibility in the areas of higher education. But our 
responsibilities in the elementary and secondary education respects 
that education is a local function but also an important State 
responsibility.
  That is why for every dollar that is expended, only about 6 cents of 
that dollar really comes from the Federal Government. The targeting of 
those programs has been in the areas where there has been, as he 
pointed out and others have recognized, general recognition nationwide 
of very important national objectives, and that is with the most 
disadvantaged students, primarily in the areas of basic skills--basic 
skills--math and science programs in the title I programs across this 
country, the neediest children in the most disadvantaged areas. It is a 
very important program. It has been evaluated, has had broad support. 
That is one of the very important areas.
  There have been adjustments about what programs will be in and what 
programs will be out, but you cannot get away from the fact that these 
programs that have been included are targeted and by and large go to 
local communities where there is wide discretion. If you take the Goals 
2000, 90 percent of that fund is spent at the local level. You can't 
get any more in terms of local control than what we have at the present 
time.
  You find that there is 2 percent administrative costs by the 
Department of Education in the overall programming, 6 percent at the 
State level of all of these various programs. A great percent of that 6 
percent is technical assistance, goes to local communities that are 
trying to deal perhaps with special-needs children. Maybe it is a small 
community that has two or three members of a class that have special 
needs. They do not develop a whole program, but there are other 
schools, other school districts that have similar kinds of needs.
  This technical assistance helps and assists those local communities: 
the School to Work Program has had strong bipartisan support--we still 
remember the strong Republican support to try to help young people move 
from school into the employment programs and into employment--the drug-
free schools to try to do something about the problems of drug 
addiction and violence in our various school districts.
  Now, we do not know. There is no accountability in this particular 
program. There is no requirement for reporting on how the money is 
expended. It bypassed even the States, so the States will not have an 
understanding of how these resources are going to be spent. We do not 
know which States

[[Page S9147]]

are going to be advantaged, which disadvantaged or communities 
advantaged or disadvantaged.
  So I join in expressing strong reservations. I want to say very 
clearly that if this comes back, this particular provision, we are 
going to take some time on the floor of the U.S. Senate to really make 
sure that not only every Member of this body understands it but all 
Americans understand it. If the local States want to expend additional 
resources, let them go out and tax their local communities to do so. If 
they want it, let them do it. But if we are going to commit ourselves 
to trying to raise resources to meet targeted needs for the neediest 
children in this country, we ought to be able to do it. If you are 
going to take that and block grant it and send it back to the States 
and just use the Federal tax system to raise these funds, that ought to 
be done in a different forum. We will have a longer time to debate it 
if it comes back. But we should not permit a vote in support of the 
general appropriations to go by without some comment.
  Now, Mr. President, I am pleased that we have achieved an important 
compromise on one of the most important issues in the FDA reform 
legislation, the issue of Federal preemption of State regulation of 
over-the-counter drugs and cosmetics.
  I compliment Senator Gregg, Secretary Shalala, and others involved in 
working out this responsible agreement. It will assure that States have 
the ability to step in to protect consumers from cosmetics when 
necessary while also providing companies reasonable guarantees that 
when the FDA has acted effectively to protect consumers, they will not 
be subjected to conflicting and potentially duplicative labeling 
requirements.
  Under the agreement, the Federal Government will not preempt State 
regulation of the safety of a cosmetic. This is appropriate. If a State 
feels strongly enough about a particular ingredient or a product to ban 
it or to take similar actions, it should be free to do so. States 
virtually never use this authority. But even though it is rarely used, 
it should be preserved.
  In the critical realm of packaging and labeling where States have 
been most active in ensuring consumers receive the information they 
need to protect themselves, this amendment strikes a fair balance. The 
reason preserving States' ability to act is so important is that FDA 
regulation has been weak. Under this agreement, States would continue 
to have the ability to act to protect their consumers except in those 
cases where the FDA has already taken appropriate action in a specific 
area.
  The compromise reached in section 762, which relates to the 
preemption of the State regulation for the packaging and labeling of 
cosmetics, will assure that the States retain full authority to 
regulate cosmetics in those circumstances when the FDA has not acted. 
As you know, I think it is essential for the States to be able to 
regulate the labeling and packaging of cosmetics whenever the FDA has 
not acted. This is especially important because there is so little FDA 
regulation in the area of cosmetics.
  Section 762 would preempt a State labeling and packaging requirement 
only when FDA has specifically acted on the same aspect of the labeling 
or packaging of that cosmetic. Thus, if FDA issues a regulation that 
requires cosmetic manufacturers to include a specific warning about an 
aspect of an ingredient in a cosmetic, a State cannot require a 
different warning about the same aspect of that ingredient.
  For example, if the FDA required a warning label for a particular 
product regarding its use by pregnant women, the State would be 
prohibited from requiring a different warning label for the same hazard 
and product. On the other hand, where the FDA has not taken action, the 
States would be free to fill the gap. So, if we are going to breathe 
new life into the FDA to take on more and more kinds of 
responsibilities to assure the public in terms of some of these health 
hazards, as a result of the debates we have had in the past days, they 
are free to do so.
  On the other hand, if a State wants to require a warning on a 
cosmetic and FDA has not acted, the State can require that warning. For 
example, Minnesota has required a caution statement on flammable 
products. This provision would not preempt that requirement because FDA 
has not acted.
  Similarly, if FDA requires a warning about a specific ingredient 
contained in a cosmetic, ingredient A, and a State wants to require a 
warning about another ingredient in the same cosmetic, ingredient B, 
the State would not be preempted. Likewise, if FDA requires a warning 
about a certain aspect of an ingredient for example, ingredient A 
causes cancer, a State can require a warning about a different aspect 
of the same ingredient for example, ingredient A causes birth defects. 
The bottom line is that the States are preempted only when FDA has 
acted on the same ingredient and the same health concern.
  Finally, this provision does not in any way affect the State's 
ability to regulate the safety of cosmetics. Thus, if FDA has a 
specific labeling requirement for a cosmetic ingredient about a 
particular concern, the State may take additional steps, such as a ban 
on the ingredient, to protect the public health, although the State 
cannot require additional labeling about the concern for that 
ingredient.
  This may very well be an invitation to give the FDA the authority and 
the resources to adequately regulate cosmetics, but if they do not do 
it, which is the condition today, we are not going to be interfering 
with the States. That is very, very important.
  The debate on this issue has highlighted the potential hazards that 
cosmetics pose to consumers, especially women, which are too often 
underestimated.
  A study by the respected, nonpartisan General Accounting Office 
reported that more than 125 ingredients available for use in cosmetics 
are suspected in causing cancer. Other cosmetics may cause adverse 
effects on the nervous system, including convulsions. Still other 
ingredients are suspected of causing birth defects. And a carefully 
controlled study found that 1 in 60 users suffered a cosmetic-related 
injury identified by a physician.
  The fact is, Mr. President, there are enormous numbers of new 
compounds, an enormous expansion of the use of various products, 
including toxic products, that are being utilized in cosmetics. We want 
to make sure that the States, through their own public health agencies 
or through various studies or through their research, are going to be 
able to raise health concerns necessary to protect their consumers.
  Mr. President, we have outlined at other times on the floor various 
items which raise some important concerns--alpha-hydroxy acid, feminine 
hygiene products, and talcum powder. We have heard from Dr. Wallinga, a 
physician at the Natural Resource Defense Council. He points out the 
dangers of these products citing studies in prestigious medical 
journals.
  We have in this compromise preserved the right of the States to 
protect the public.
  We have seen recently the impact of State laws on public health. In 
California, for example, action has been taken against Grecian Formula 
and toluene in nail polish.
  We also know of other States that have introduced legislation aimed 
at further regulation of cosmetics. New York, for example, is pursuing 
expiration dating of certain cosmetics. Ohio and Texas are also 
considering additional regulation of cosmetics. My own State of 
Massachusetts is pursuing a consumer right-to-know law similar to that 
in California.
  Nothing in this legislation will infringe upon these or similar 
activities by the States to protect the public.
  The agreement we have reached today is a very reasonable one. I 
commend Senator Gregg for his hard work in making it a reality. The 
fact is neither the Food and Drug Administration nor the States are 
doing enough to protect women from the dangers posed by cosmetics. This 
issue deserves to be a high priority. I intend to see that it is.
  Mr. President, regarding remaining issues in the legislation, I hope 
we can have the same hard work and accommodation in addressing these 
issues before we turn to the legislation. They deal with important 
questions about the procedures of the Food and Drug Administration in 
reviewing medical devices. We want to make sure that the medical 
devices that are going to be used on the American public are safe

[[Page S9148]]

and effective. We want to make sure that FDA reviewers look at data on 
the use of a medical device that is clearly indicated by the technical 
design of the device--whether or not it is on the label. Under the 
current language, FDA would be unable to make a complete review of the 
device. The public would be deprived of assurances they have today that 
devices are truly safe and effective. We talked about this previously 
on the floor of the U.S. Senate. We will have further opportunity to 
address this issue. It is an extremely important one.
  A second item we hope to address is ensuring that FDA can consider 
certain manufacturing practices that produce an unsafe product in 
clearing a medical device for marketing. The language requires FDA to 
allow a new device on the market even if the manufacturer is producing 
defective devices. This provision endangers the public health by 
putting unsafe products on the market. It also requires the Food and 
Drug Administration to spend its resources chasing after unsafe medical 
devices already on the market rather than simply requiring that the 
device be produced safely in the first place.
  These are important items and in my full statement, to a considerable 
degree, I expand on them.
  There are environment considerations, the effective removal of the 
environmental impact statements under NEPA. I do not remember 
considering this provision as part of our hearings on this legislation. 
I do not feel that we should start taking various agencies and 
exempting them from considering the environmental impact of their 
actions. I think this is an issue that we should address.
  My colleagues have raised other questions in terms of the ethical 
issues that surround the payment of third party reviewers. These 
individuals are going to be reviewing products that are manufactured by 
the same companies that are paying them. This raises important ethical 
issues. I will have an opportunity to debate and take action on some of 
those.
  I thank very much, Mr. President, the chairman of the committee, for 
his continued cooperation, and the other Members for their help and 
assistance. I am particularly grateful to Senator Gregg for his 
cooperation in helping us work out a satisfactory resolution of the 
amendment on cosmetics.
  Consumers have suffered painful, permanent injuries from hair 
treatment products that have caught fire. They have suffered serious 
urinary tract infections from bubble bath. They have suffered life-
threatening allergic reactions to hair dyes, and severe chemical burns 
from skin creams and sun tan lotions. The GAO concluded that 
``cosmetics are being marketed in the United States which may pose a 
serious hazard to the public.''
  And these are only the acute injuries that require immediate medical 
care. The poisons in cosmetics can also cause long-term injuries and 
illnesses that do not develop for years after exposure.
  Three specific products highlight the risks consumers face. Alpha-
hydroxy acid is one of the hottest selling cosmetic products on the 
market, with sales of roughly a billion dollars a year. It is sold to 
erase fine lines and tighten the skin. FDA has received numerous 
complaints of adverse effects from the use of these products. Alpha-
hydroxy acids have been linked to severe redness, burning, blistering, 
bleeding, rash, itching, and skin discoloration. Most troubling, there 
is concern that alpha-hydroxy may promote skin cancer by increasing 
sensitivity to sun exposure. Yet these products are in the 
marketplace--with no warning labels and no limits on the concentrations 
that may be sold. Under this bill, every State would be prohibited from 
requiring these sensible warnings.
  I ask unanimous consent that I may put a fact sheet laying the issues 
on alpha-hydroxy in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

Who Will Act to Protect the Public From Hazardous Products in Cosmetics 
                     If S. 830 Passes? No One Will!

(Statement of David Wallinga, MD, MPA, Senior Scientist, Public Health 
    Program, Natural Resources Defense Council, September 10, 1997)

       People often assume that government is there to protect 
     them. They figure that if a consumer product is sold at the 
     corner drug or department store, it must some passed some 
     sort of regulatory scrutiny. People would especially like to 
     believe that cosmetics--the products they put on their hair, 
     lips, faces and underarms each day--have been adequately 
     tested and found to be safe.
       They couldn't be more wrong. As a physician, I couldn't 
     believe it when it first learned how powerless the Food and 
     Drug Administration is to regulate cosmetics in a way that 
     ensures their safety. FDA's lack of regulatory authority is 
     based on a law from 1938--a time when scientists knew very 
     little about the potential health effects of the chemicals 
     found in cosmetics. This law only lets FDA act if a cosmetic 
     has been adulterated or misbranded. What's even more amazing 
     is that the law has absolutely no requirement that cosmetic 
     products be tested for safety.
       That means the thousands of chemicals currently found in 
     cosmetics: Do not have to be tested to see if they are 
     absorbed through the skin and in the blood; do not have to be 
     tested to see if the cause cancer; do not have to be tested 
     to see if they cause allergies or infections; do not have to 
     be tested for effects on the brain or nervous system; do not 
     have to be tested to see if they affect fertility or the 
     reproductive organs; and do not have to be tested for their 
     effects on infants and children, who can be more susceptible 
     to the toxic effects of certain chemicals.
       It is outrageous that products which people put on their 
     faces, their underarms and other parts of their body each day 
     are not even adequately tested for safety. Testing of the 
     pesticide in your dog's flea collar is more extensive than 
     that for cosmetics. This, despite the fact that cosmetics are 
     often used by pregnant women, and women of reproductive age. 
     Since many chemicals in cosmetics are fat-soluble, or are 
     organic solvents, it means they can penetrate the skin--and 
     possibly enter the fetus where they may cause reproductive 
     harm.
       It gets worse. The Senate is now proposing to strip the 
     states of much of their regulatory authority over cosmetics 
     as well. In particular, the Senate would limit the states 
     ability to provide consumers with product warnings and other 
     information, including adequate labeling. This will extend 
     FDA's ignorance about potentially-toxic cosmetic products to 
     consumers. It will also strip consumers of their only 
     conceivable protection against these products. In this 
     regulatory magic act, science will have been frozen solid. 
     FDA is already frozen into the science of the 1930s; now, we 
     are freezing out states from acting on any new scientific 
     information. This might be great news for a $20 billion 
     dollar-a-year industry, but its pretty lousy news for public 
     health.
       Each year, around 1000 new cosmetic products enter the 
     consumer market. In perfumes and fragrances alone, there are 
     at least 1500 different chemicals. How many of these are 
     safe? No one knows. But because of the FDA's impotence, it is 
     certain that the vast majority have not been broadly tested 
     for health effects, and are not well understood from a 
     scientific standpoint.
       There are some cosmetics, however, whose safety we already 
     have good reason to question. Skin-peeling creams, for 
     example, are extremely popular. But they contain alpa-
     hydroxyacids which have been shown to greatly increase the 
     skin's susceptibility to ultraviolent light. Someone who has 
     used one of these creams recently would want to be careful 
     about sun exposure, to prevent sunburn and avoid the 
     increased risk of skin cancer. How will the consumer know to 
     use sun screen or avoid sun exposure after using these 
     creams? The short answer is, they won't.
       FDA not only lacks the authority to require safety testing, 
     it also has very weak authority to require product labels 
     that reflect health and safety concerns about cosmetics. Even 
     worse, the proposed bill would deny individual states the 
     authority to require such labels. It doesn't seem like much 
     to ask: a label that would tell people to avoid sun or use 
     sunscreen. It's not a product ban, it's not changing the 
     formulation . . . it's just an advisory label. But it will be 
     forbidden by this law. We will instead just have to hope that 
     industry voluntarily labels its products so that people use 
     them correctly.
       There's more. In medicine we know about a disease called 
     ``talcosis'' which occurs from inhaling talcum powder. 
     Mostly, that's a problem in talc workers. But what about a 
     recent study from Yale University, a study that confirmed 
     earlier research finding an association between the use of 
     talcum powder on the genital region and ovarian cancer in 
     women? Scientists have shown that talc particles can enter 
     the body and accumulate in ovarian tissue. There, they are 
     associated with a 40% increased risk of ovarian cancer. 
     Ovarian cancer is hard to diagnose, hard to treat 
     effectively, and is often fatal. It is something which is 
     much better to prevent than to try and treat once it occurs. 
     Yet if a state wanted to notify women that talcum powder 
     should not be used regularly in the genital region, that 
     would be illegal under this new law.
       These are only two examples of the many, many potential 
     hazards from the thousands of chemicals in cosmetic products. 
     There are more: hair dyes and shampoos which contain coal 
     tars which are known to cause cancer; feminine hygiene 
     products associated with infertility, ectopic pregnancy, and 
     an increased risk of pelvic inflammatory disease; lipstick 
     and hair dyes which contain lead,

[[Page S9149]]

     used by pregnant women, and particularly dangerous for 
     fetuses; and numerous products which contain immune system 
     sensitizers, such as cinnamates, which can cause severe 
     allergic reactions, skin rashes, or asthma.
       Currently, we have an empty law regulating these cosmetics, 
     a law directing the FDA into empty regulation. Until we have 
     a better system in place at the federal level, we should 
     certainly not interfere with the right of states to act on 
     these hazards, and to protect the health of their citizens, 
     independently. Our best hope as consumers, as patients, and 
     as health care professionals, is to let states fill this 
     regulatory gap.
                                                                    ____


 Fact Sheet: FDA Reform Bill and Preemption of Cosmetic Regulation by 
                               the States

       The regulation of health and safety has traditionally 
     rested in the hands of the States.
       Cosmetics pose substantial threats to the health and safety 
     of consumers.
       There is no substantial Federal regulatory presence in 
     cosmetics (see below), but proposed cosmetic preemption would 
     completely bar the States from exercising their traditional 
     regulation of cosmetic labeling, packaging and consumer 
     information and would severely limit states ability to 
     regulate these products in other ways.


                               background

       Traditionally, preemption only takes place in areas where 
     the Federal government has a strong presence, or has 
     ``occupied that field.''
       FDA currently employs less than 30 people to regulate the 
     $20 billion cosmetics industry. Only 2 employees actually 
     regulate cosmetic packaging and labeling.
       FDA has no authority to approve cosmetic products or review 
     ingredients, require companies to register, or to even report 
     cosmetic-related injuries.
       Nor can FDA require products be tested for safety or the 
     results of safety testing be made available to the FDA or the 
     public. It has no legal access to manufacturers' records. Nor 
     can it require a product recall--cosmetic recalls are 
     voluntary.
       The basic Federal law regulating cosmetics has not been 
     amended since 1938.
       A 1978 General Accounting Office (GAO) study found that 
     more than 125 cosmetic ingredients were suspected of causing 
     cancer. Twenty ingredients were believed to cause central 
     nervous system disorders, ranging from headaches and 
     drowsiness to convulsions. Twenty-five were believed to cause 
     birth defects The industry adds approximately 1,000 new 
     chemicals annually, with no requirement to show that these 
     chemicals are safe.
       The GAO concluded that ``cosmetics are being marketed in 
     the United States which may pose a serious hazard to the 
     public'' and recommended that additional Federal authorities 
     be granted to FDA to protect the public.


                      S. 830 and state preemption

       There is no public record, hearings, testimony, studies or 
     otherwise, from the 104th or 105th Congresses which 
     substantively addresses the issue of cosmetic preemption.
       The cosmetics preemption provision was not in the 
     Chairman's original mark, nor was it subject to hearings.
       States will be completely barred from regulating cosmetic 
     labeling and packaging under S. 830. States will also be 
     barred from establishing any requirements for communicating 
     the safety and effectiveness of a drug or cosmetic to the 
     public.
       States will also be barred from other forms of safety 
     regulation if the Federal government has acted in that area, 
     even if the Federal regulation is outdated, narrow, or vague.
       The industry cannot cite one example of a burdensome state 
     regulation that this law preempts.


             others opposed to s. 830 preemption provision

       The Administration position states, ``if the bill were 
     maintained in its present form, and the outstanding issues 
     were not addressed, I would be forced to recommend to the 
     President that he veto this legislation.''
       A broad coalition of state officials, women's 
     organizations, environmental advocates, and others concerned 
     about public health opposes this provision (see attached 
     letters)


                     examples of cosmetic injuries

       A six year old girl in Oakland, California had her mother 
     apply a hair product to her head, which resulted in second 
     degree burns to the child's ears and neck.
       A 59-year old California woman almost died from an allergic 
     reaction to hair dye.
       A 47-year old woman had her cornea destroyed by a mascara 
     wand.
       Still another woman's hair caught fire as the result of an 
     inflammable hair treatment gel.
       In fact, a carefully controlled three month study found 
     that one in 60 users of cosmetics experienced adverse 
     reactions.


                    dangers of widely used products

       The attached fact sheets highlight possible dangers from 
     three widely used cosmetic products: skin creams containing 
     alpha-hydroxy products--skin irritation and burns, long-term 
     risk of skin cancer associated with greater sun sensitivity; 
     feminine hygiene products--pelvic inflammatory disease, 
     ectopic pregnancy, and infertility; and talc and talcum 
     powder--ovarian cancer.


                        international standards

       The European Union requires full ingredient listing on 
     packaging, documentary proof of good manufacturing practice 
     and similar proof that extensive testing has been carried 
     out.
                                                                    ____


   Fact Sheet: Hazards of Skin Care Products Containing Alpha-Hydroxy


                     what are alpha-hydroxy acids?

       Alpha-hydroxy acids are naturally occurring acids that have 
     recently been included in skin care products. Alpha-hydroxy 
     products promise to erase wrinkles and acne, restore skin 
     elasticity and firmness, and produce younger-looking, 
     smoother skin. They are used both in skin creams intended for 
     daily use and ``skin peels'' that are sometimes described as 
     chemical face lifts.
       Products containing alpha-hydroxy acids working by 
     penetrating the upper-layer of skin, breaking apart the bonds 
     that hold the skin cells together. The skin then sloughs off 
     these cells.
       Alpha-hydroxy products include Avon Anew Face Cream, Ponds' 
     Age Defying Complex, Alpha Hydrox Face Cream, Murad, and 
     MDForte.
       Products containing alpha-hydroxy acids are among the 
     hottest-selling cosmetics, used by millions of women, with 
     sales of roughly a billion dollars a year.


 what are the concerns about cosmetics containing alpha-hydroxy acids?

       There is very little data on the effects of alpha-hydroxy 
     acids. Researcher suggests that they can cause skin 
     irritation and increased sensitivity to UV radiation, with 
     the potential for increasing risk of skin cancer. There have 
     been no long-term studies of the safety of the product.
       FDA reported that between 1989 and 1996, there were likely 
     ``many thousands'' of complaints associated with alpha-
     hydroxy acids, including ``severe redness, swelling 
     (especially in the area of the eyes), burning, blistering, 
     bleeding, rash, itching, and skin discoloration. Many of the 
     products involved are the lower concentration, mass market 
     products.'' (February 23, 1996 letter from Dr. John E. Bailey 
     (Acting Director, Office of Cosmetics and Colors, FDA) to Dr. 
     F. Alan Andersen (Scientific Coordinator and Director, 
     Cosmetic Ingredient Review). At least one major manufacturer 
     has discontinued one of its alpha-hydroxy products because of 
     the high volume of complaints.
       In fact, FDA was sufficiently concerned about alpha-hydroxy 
     acids that it designated them as their highest priority for 
     review by the National Toxicology Program--a rare occurrence 
     for a cosmetic.
       A June 1997 report sponsored by the cosmetics industry 
     found that more study is needed to determine if the use of 
     alpha-hydroxy acids to remove the epidermis causes the skin 
     to be more UV sensitive and increasingly susceptible to skin 
     cancer. In the meantime, the report noted that ``some steps 
     should be taken to minimize the potential that use a alpha-
     hydroxy acid ingredients would result in increased sun 
     sensitivity. Accordingly, the Expert Panel admonished 
     producers of leave-on cosmetics containing alpha-hydroxy acid 
     ingredients to either formulate to avoid increasing sun 
     sensitivity or to provide directions for use that include the 
     daily use of sun protection.'' (Final Report: June 6, 1997 
     Cosmetic Ingredient Review, pg. 131). The report also made 
     safety recommendations regarding maximum acceptable levels 
     for alpha-hydroxy acids in both products for daily use and 
     products used for skin peels by cosmeticians or health 
     professionals.
       There are no binding requirements assuring that 
     manufacturers abide by the safety recommendations of the 
     advisory committee with regard to tolerance levels or provide 
     any safety information on the product. Manufacturers' 
     packaging typically includes no warnings on the need to use 
     sunscreen in conjunction with use of the product, no warning 
     on the potential danger of skin cancer from use of the 
     product, no information on risks of skin damage or 
     irritation. Nor are the manufacturers required to list on the 
     package the concentration of alpha-hydroxy acids in the 
     product, or inform users if the other ingredients strengthen 
     or weaken its effectiveness.
       Under S. 830, States would be prohibited from requiring 
     warning labels or other consumer information about alpha-
     hydroxy acids.
                                                                    ____


    Fact Sheet: Adverse Health Effects of Feminine Hygiene Products

       Over one third of all women regularly use feminine hygiene 
     products--generating roughly $100 million a year in sales.
       These products have been shown to cause upper reproductive 
     tract infections, pelvic inflammatory disease, ectopic 
     pregnancies and infertility in women.\1\
       Analyses has shown that use of these products increased the 
     overall risk of pelvic inflammatory disease by 73% and the 
     risk of ectopic pregnancy by 76%.\2\
       The current literature also suggests an increased risk in 
     cervical cancer.\3\
       Researchers at University of Washington, Brigham and 
     Women's Hospital, Harvard Medical School, Mount Sinai School 
     of Medicine and Centers for Disease Control and Prevention 
     have all published data regarding the adverse effects of 
     feminine hygiene products.\4\

[[Page S9150]]

       The National Women's Health Network testified that the FDA 
     needs to do more to educate women and recommended that 
     feminine hygiene product labeling information on their severe 
     adverse effects.\5\
       Under S. 830, States would be prohibited from requiring 
     warning labels or other consumer information on feminine 
     hygiene products.


                               footnotes

     1. J Zhang, AG Thomas, and E Leybovich. ``Vaginal douching 
     and adverse health effects: a meta-analysis.'' American 
     Journal of Public Health. 1997 Jul; 87(7): 1207-1211.
     2. Ibid.
     3. Gardner JW, KL Shuman, ML Slattery, JS Sanborn, TM Abbott, 
     and JC Overall Jr. ``Is vaginal douching related to cervical 
     carcinoma?'' American Journal of Epidemiology. 1991 Feb; 
     133(4): 368-375.
     4. Baird DD, CR Weinberg, LF Voight and JR Daling. ``Vaginal 
     douching and reduced fertility'' American Journal of Public 
     Health 1996 June: 86(6):844-850. Kendrick JS, HK Atrash, LT 
     Strauss, PM Garguiullo and YW Ahn. ``Vaginal Douching and the 
     risk of ectopic pregnancy among black women.'' American 
     Journal of Obstetrics and Gynecology. 1997 May; 176(5):991-
     997. Onderdonk AB, ML Delaney, PL Hinkson and Am DuBois. 
     ``Quantitative and qualitative effects of douche preparations 
     on vaginal microflora.'' Obstetrics and Gynecology. 1992 
     Sept; 803 Pt 1):333-8.; Phillips RS, RE Tuomala, PJ Feldblum, 
     J Schachter, MJ Rosenberg, and MD Aronson, ``The effects of 
     cigarette smoking, Chlamydia trachomatis infection, and 
     vaginal douching on ectopic pregnancy.'' Obstetrics and 
     Gynecology. 1992 Jan; 79(1): 85-90, and Zhang J, p 1207-1211.
     5. Cox, Lisa. National Women's Health Network testimony 
     before FDA Nonprescription Drugs Advisory Committee hearing, 
     15 Apr 1997.
                                                                    ____


           Fact Sheet: Talc May Pose A Risk of Ovarian Cancer

       Talc, or talcum powder, is widely used in popular bath and 
     cosmetic products, and is applied directly to the body, 
     typically after bathing. Common products with talc include 
     baby powders and sanitary napkins.
       A relationship between talc exposure and ovarian cancer has 
     been investigated by a number of prominent epidemiologists 
     and physicians for years.
       A recent study by the Yale School of Public Health 
     confirmed that talc exposure may lead to an increased risk of 
     developing ovarian cancer.\1\
---------------------------------------------------------------------------
     \1\ Footnotes at end of factsheet.
---------------------------------------------------------------------------
       Dr. Harvey Risch in the Yale study, states that, ``Several 
     lines of evidence support the argument for an association 
     between talc usage and ovarian carcinoma.'' \2\
       In the United States, approximately 26,000 women develop 
     ovarian cancer annually.\3\
       Due to its chemical similarity to asbestos, talc has long 
     been suspected as a lung and ovarian carcinogen.\4\
       A technique used to extract ovarian tumor material found 
     talc particles in approximately 75% of ovarian tumors 
     examined. Subsequent evaluations have appeared to support the 
     contention of an association between talc exposure and 
     ovarian carcinoma.\5\
       The Cancer Prevention Coalition has submitted a citizen's 
     petition to FDA expressing their concern about the possible 
     health risks posed by talc and requested the agency establish 
     regulations to require carcinogen warning labels on cosmetics 
     containing talc as an ingredient.
       Under S. 830, States would be prohibited from requiring 
     warning labels or other consumer information about the 
     possible hazards of talc.


                               footnotes

     1. Chang, Stella and Risch, Harvey. ``Perineal Talc Exposure 
     and Risk of Ovarian Carcinoma,'' Cancer. Vol. 79, No. 12, 
     June 15, 1997.
     2. Ibid.
     3. Ibid.
     4. Herbst AL. ``The Epidemiology of Ovarian Carcinoma and the 
     Current Status of Tumor Markers to Detect Disease,'' American 
     Journal of Obstetrics and Gynecology. Vol. 170, 1994.
     5. Hederson, WJ, et al. ``Talc and Carcinoma of the Ovary and 
     Cervix,'' Journal of Obstetrics and Gynecology for the 
     British Commonwealth. Vol. 78, 1971.

  Mr. KENNEDY. Mr. President, a critical point is that an industry-
appointed panel itself set out safety tolerance levels for use of the 
product with regard to short-term effects and warned that the product 
should not be used without sunscreen. Yet, there is absolutely no 
binding requirement that manufacturers follow these recommendations--
and virtually none of the products carry the information or warnings 
developed by the industry's own committee that would enable consumers 
to help protect their own safety. And, in point of fact, there has been 
no truly independent evaluation of the work of the industry panel. In 
fact, the FDA is so concerned about the safety of alpha-hydroxy acid 
that it has chosen it has its top priority for review by the 
prestigious National Toxicology Program.
  A second example is feminine hygiene products, which have sales of 
$100 million a year. More than one-third of women use them--but they 
pose serious health hazards. They have been shown to cause upper 
reproductive tract infections, pelvic inflammatory disease, ectopic 
pregnancies, and infertility. They may place women at additional hazard 
for cervical cancer. Women using these products should have the right 
to warning labels informing them of these hazards. But the FDA has done 
little to protect or warn women against these dangers.
  There are a substantial number of studies on the safety of these 
products. The evidence that they are dangerous seems incontrovertible--
but this legislation would prevent States from acting to simply warn 
women of the dangers. How outrageous it is that women should face 
illness and sterility without being warned of the danger of a seemingly 
harmless and beneficial product.
  A third example is talc, or talcum powder is widely used in popular 
bath and cosmetic products. But it is chemically similar to asbestos, 
and it has long been suspected of causing cancer. A number of studies 
have suggested the possibility of a link to ovarian cancer, which 
afflicts 26,000 women annually--but there are no warning labels on 
these products. American women deserve better protection from their 
Government.
  These three issues have been carefully analyzed by Dr. David 
Wallinga, a physician and the senior scientist at the Natural Resources 
Defense Council. He points out the dangers of each of these three 
products based on studies in prestigious medical journals from 
researchers at institutions like Yale and the Mount Sinai Hospital in 
New York. I ask unanimous consent to enter his comments in the Record, 
along with the articles analyzing these issues.
  Federal oversight of this $20 billion industry today is extremely 
limited. The basic Federal law regulating cosmetics has not been 
updated since 1938. The FDA has less than 30 employees overseeing this 
huge industry--and only two employees dealing with the critical issues 
of packaging, labeling, and consumer warnings. The FDA has no authority 
to require manufacturers to register their plants and products. It 
cannot require manufacturers to file data on the ingredients in their 
products. It cannot compel manufacturers to file reports on cosmetic-
related injuries. It cannot require that products be tested for safety 
or that the results of safety testing be made available to the agency. 
It does not have the right of access to manufacturers' records. It 
cannot require recall of a product.
  In the Federal Food, Drug and Cosmetic Act there are 126 pages 
devoted to the regulation of drugs and devices; 55 pages are devoted to 
foods regulation. A full eight pages of the act is dedicated to 
definitions. But less than two pages are devoted to cosmetic 
regulation.
  In 1938, there was no requirement that industry show safety of drugs, 
medical devices, food additives, or cosmetics before they were 
marketed. Today, the public demands higher standards of protection, and 
they have been established for drugs, for medical devices, and for food 
additives--but not for cosmetics.
  The agreement we have reached today is a highly reasonable one. I 
especially commend Senator Gregg for his hard work to make it a 
reality. But the fact is that neither the FDA and the States are doing 
enough to protect women from these dangers. This is an issue that 
deserves a higher priority, and I intend to do all I can to see that it 
gets it.
  There are important remaining issues in this legislation, and I hope 
that with the same hard work and spirit of accommodation we can reach 
agreement on these issues before we return to consideration of this 
legislation on Tuesday.
  Two changes in the regulation of devices in particular put consumers 
at unacceptable and unnecessary risk. They should be removed in this 
bill before it goes forward--and the administration has made it clear 
that they put the whole bill at risk of a veto.
  A great deal of negotiation has taken place on the medical device 
provisions of this bill, and I compliment Senator Jeffords, Senator 
Coats, and my other colleagues on the committee for resolving most of 
the device provisions in a way that is consistent with protection of 
the public health. But there are at least two medical device provisions 
in the bill which still raise substantial concerns. They could be 
corrected very simply and with negligible effect to the basic purpose 
and intent of this bill. Yet these corrections have not been made and 
my colleagues deserve a clear description of the hazards they pose.
  A brief explanation of how the FDA regulates and clears medical 
devices for marketing may first be in order. Under current law, 
manufacturers of

[[Page S9151]]

new class I and class II devices can get their products onto the market 
by showing that they are substantially equivalent to devices already on 
the market. For example, the manufacturer of a new laser can get that 
laser onto the market if it can show FDA that the laser is 
substantially equivalent to a laser that is already on the market.
  Similarly, the manufacturer of a new biopsy needle can get that 
biopsy needle onto the market by showing that it is substantially 
equivalent to a biopsy needle already on the market. And the 
manufacturer of new patient examination gloves can get those gloves 
onto the market by showing that they are substantially equivalent to 
patent gloves already on the market.
  Mr. President, these manufacturers are obliged to demonstrate 
substantial equivalence to the FDA by showing that the new product has 
the same intended use as the old product and that the new product has 
the same technological characteristics as the old product. If the new 
product has different technological characteristics, these 
characteristics must not raise new types of safety and effectiveness 
questions in order for the product to still be substantially equivalent 
to the older product.
  The logic of this process for bringing medical devices onto market is 
quite simple: if a product is very much like an existing product, it 
can get to market quickly. If it raises new safety or effectiveness 
questions, those questions should be answered before the product can be 
marketed.
  This process for getting new medical devices on the market, commonly 
known as the 510(k) process, is considered by most to be the easier 
route to the market. Devices that are not substantially equivalent to a 
class I or class II device already on the market must go through a full 
premarket review. Thus, device manufacturers have an incentive to get 
new products on the market through the 510(k) process. And in fact, 
well over 90 percent of all new devices get on the market through the 
submission of a 510(k) application.
  This legislation seriously compromises the FDA's ability to protect 
the public health through its regulation of medical devices that are 
marketed through the 510(k) process. Of the dozens of provisions that 
we have negotiated and discussed which affect medical devices in this 
bill, these two still raise fundamental public health problems. 
Although few in number, these provisions raise substantial risks to the 
public health which simply cannot be ignored.
  The first problem raised by this bill relating to medical devices is 
its prohibition on the FDA from considering how a new device will be 
used if the manufacturer has not included that use in its proposed 
labeling.
  You may think that this approach makes sense--why should the Agency 
consider the use of a device if the manufacturer has not specified that 
use on the label? I'll tell you why--because that proposed label may be 
false or misleading. How would the FDA know that? Because the design of 
the new device may make it perfectly clear that the new device is 
intended for a different use.
  Let me provide my colleagues with a few examples. Let's talk about 
the biopsy needle I mentioned before, which is used on breast lesions. 
Most biopsy needles for breast lesions currently on the market take a 
tissue sample that is about the size of the tip of pencil lead. Let's 
assume the manufacturer of a new biopsy needle comes to the FDA with a 
510(k) submission. But this new biopsy needle takes a tissue sample 
that is 50 times as big--the size of a 1-inch piece of a hot dog.
  The manufacturer of this new needle has proposed labeling that says 
that the needle will be used like the old, marketed needles to biopsy 
breast lesions. But FDA knows that the chunk of tissue being biopsied 
will usually exceed the size of the lesion. This makes it clear to 
FDA--and to any impartial observer--that the new needle will in most 
cases be used to remove the lesion.
  Under these circumstances the FDA should be able to ask the 
manufacturer to provide information on this new use. Is it safe to 
remove lesions? Does it really work? The bill, however, categorically 
bars FDA from asking these essential questions. This means that the FDA 
would be unable to make a complete review of the device and the public 
would be deprived of existing assurances that devices are truly safe 
and effective.
  The proponents of this provision have argued that the FDA could 
simply say that the change in device design or technology--such as the 
change in size of the biopsy needle--renders the new product 
unequivalent to the old product. But that is not always true. The 
manufacturer could argue that there are no new questions of safety or 
effectiveness for the purpose claimed on the label. In the case of the 
biopsy needle, Mr. President, there are times where a large sample is 
needed--a sample larger than a pencil tip.
  So long as the larger needle is safe and effective for removing a 
sample, FDA would still be barred from obtaining data about the new use 
of removing lesions--and to the extent the needle is used for the new 
use, women could be put at risk for an effective or unsafe treatment of 
breast cancer.
  Another good example is surgical lasers. Lasers have been used for 
decades to remove tissue. Several years ago, a manufacturer added a 
side-firing mechanism to their laser to improve its use in prostate 
patients. While the manufacturer did not include this specific use in 
its proposed labeling, it was transparently clear that the new side-
firing design was intended solely for this purpose of treating prostate 
patients.
  As a result, FDA required the manufacturer to submit data 
demonstrating the laser's safety and effectiveness in treating prostate 
patients. This is precisely how the device review process should work. 
Manufacturers must prove their devices live up to their claims, while 
patients and doctors receive all of the information needed to make the 
best possible treatment choices.
  But under this bill, FDA would be prohibited from getting adequate 
safety data on the laser's use on prostate patients--even though that 
would be the product's primary use. This defies common sense yet this 
is the result of one troubling and indefensible provision.
  Other examples in the way that this provision could allow unsafe and 
ineffective devices abound. A stent designed to open the bile duct for 
gallstones could be modified in a way that clearly was designed to make 
it a treatment for blockages of the carotid artery.
  Without adequate testing, it could put patients at risk of stroke or 
death. But under this bill, the FDA would be prohibited from looking 
behind the label to the actual intended use of the device. A laser to 
use to excise warts could have its power raised so that it was also 
possible to use it in smoothing facial wrinkles. But without FDA's 
ability to assure adequate testing, the use of the laser for this 
purpose could lead to irreversible scarring.
  Most companies, of course, will not try to bypass the process in this 
way. But some bad actors will. And this legislation should not force 
the FDA to fight those bad actors with one hand tied behind it. This 
provision is like asking a policeman to accept a known armed robber's 
assurance that the only reason he is wearing a mask and carrying a gun 
is that he is going to a costume party.
  The second way this bill undercuts the FDA's ability to protect the 
public health and adequately regulate medical devices is the way it 
forces the FDA to clear a new device for marketing even if the Agency 
knows that the manufacturer cannot manufacture a safe device.
  Let me repeat that statement. It sounds frankly preposterous but it 
is true. One of the bill's provisions actually requires the FDA to 
allow a new device onto the market even if the manufacturer is 
producing defective devices. Surprisingly, the proponents of this 
provision freely admit that this is true.
  Under current law, let's assume that a maker of new examination 
gloves submits a 510(k) to the FDA and claims that the new gloves are 
substantially equivalent to gloves already on the market. If the FDA 
knows for a fact from its inspectors that the company uses a 
manufacturing process that often results in these gloves having holes, 
FDA would simply not clear the gloves for marketing. FDA would find

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that these gloves are not substantially equivalent to gloves on the 
market because gloves on the market don't have holes. That's common 
sense, and fortunately, that's also the law.
  In contrast, this bill would force FDA to clear the gloves for 
marketing. At this point, these defective gloves would be sold to 
hospitals, clinics, and HMO's, where they will be used routinely by 
doctors, nurses, paramedics, and other health professionals every 
single day. Every single glove would expose these professionals 
needlessly to the risk of fatal blood-borne diseases like AIDS and 
hepatitis.
  Here is the response of the provision's supporters. They argue that 
once these defective gloves are in the market and being used by health 
professionals, FDA can simply institute an enforcement action to remove 
them from the market. But when hundreds or thousands of defective 
devices have been distributed, and when dozens or hundreds of 
facilities may be using these devices, an enforcement action entails 
far more than blowing a whistle or picking up the phone to place a 
simple call.
  In reality, the FDA must coordinate with the U.S. Attorney's office, 
the U.S. Marshal's Service and persuade the court of jurisdiction to 
issue the appropriate papers. As any attorney or law enforcement 
professional can tell you that this takes precious time. And in the 
case of a defective device which is exposing people to unnecessary 
risks, time is absolutely critical. The sooner a defective glove is 
pulled from the market, the sooner the public is protected.
  But all this makes absolutely no sense when the FDA today can prevent 
this situation from ever arising. If this provision becomes law, the 
debater's point distinguishing between different forms of FDA authority 
will ultimately be paid for in the health and safety of American 
consumers placed at needless risk of death and injury. In fact, even 
the regulated industry is willing to compromise on this provision, 
because they recognize that it is so unreasonable.
  So I hope we can continue to work to compromise these important 
devices issues over the weekend. We have been successful on so many 
other issues in this bill. These should be resolvable as well.
  The last unacceptable element of this bill is an assault on basic 
environmental protections contained in the National Environmental 
Protection Act. The National Environmental Protection Act of 1969 is a 
key Federal environmental statute which regulates the Government's own 
actions through environmental impact statements. Under NEPA, Federal 
agencies must undertake a comprehensive environmental planning process 
for every major action they take. This law is a crucial statutory 
assurance that the work of the Government and the actions of regulated 
industries are consistent with the guiding principle of environmental 
protection.
  Section 602 of the bill broadly exempts the FDA's activities from 
environmental impact assessments under NEPA. In fact, the provision 
even precludes the FDA from taking environmental considerations into 
account in its work. The administration unequivocally opposes this 
provision. This week, I spoke with the Vice President, who expressed 
his serious personal concerns about this provision. In just a few 
sentences, this bill opens the door to weakening our environmental 
protections and lays a welcome mat down for future exemptions and 
future attacks on an effective and essential environmental statute.
  This is a terrible precedent, but it also directly affects the 
environment. The FDA regulates products which constitute a quarter of 
our gross domestic product. When it makes decisions on food containers, 
or manufacturing plant approvals, or handling and disposal of medical 
supplies, it can have an immense impact on the environment.
  Ironically, this antienvironmental extremism is not even demanded by 
the regulated industry, which regards the reforms of the NEPA process 
recently announced by the Clinton administration as fair and balanced.
  We all agree on the importance of FDA reform. The reauthorization of 
the Prescription Drug User Fee Program is tremendously important to 
assure that the FDA will have adequate resources to review new drugs 
and biological products quickly and effectively. This legislation 
contains many significant reforms that can streamline the regulatory 
process and codify improvements that FDA has already taken 
administratively. I compliment Senator Jeffords, the chairman of our 
committee, and many other colleagues who have worked hard on this bill 
and have been willing to work together to eliminate many other 
troublesome provisions in the bill as originally introduced. Let us now 
move to complete this work by fixing the remaining contentious issues 
included in this legislation.
  The PRESIDING OFFICER. The Senator from Vermont is recognized.
  Mr. JEFFORDS. Mr. President, this legislation is the result of a 
well-considered process to consult with all points of view and to 
benefit from the expertise needed to craft legislation on this complex 
matter. The substitute before us today stands on the shoulders of four 
hearings and a committee markup of a comprehensive Food and Drug 
Administration reform bill in the 104th Congress.
  This year we held two more hearings, taking testimony from Food and 
Drug Administration, industry experts, physicians, and consumer 
groups--and I emphasize ``and consumer groups.'' Staff held dozens of 
meetings with Food and Drug Administration, experts and patient groups, 
discussing in detail every issue of this bill. The negotiation process 
with Food and Drug Administration, and the minority started in the 
drafting phase of the bill and continued up to and right through the 
markup, and has continued right up to this moment. This has been a 
process marked by openness and consultation.
  The philosophy of this bill is to codify recent efforts of the self-
reform of the Food and Drug Administration, and a great deal of that is 
self-reform which we are codifying, and to provide the Food and Drug 
Administration with the tools to do even better in certain areas.
  We recognize that Congress cannot micromanage an agency like the Food 
and Drug Administration, nor do we want to. But we must set realistic 
performance goals to ensure the public is protected and well served and 
that the industry is fairly treated. In an era of flat or declining 
resources, we must give the Food and Drug Administration the management 
tools it needs to manage an increasing workload without the expectation 
of ever-increasing appropriations to assist them.
  The first title of S. 830 establishes in statute that the mission of 
the Food and Drug Administration is to protect the public health, 
promptly and efficiently review clinical research, and take appropriate 
action on the marketing of regulated products in a manner that does not 
unduly impede innovation or product availability.
  From the 1906 Food and Drugs Act through the 1990 Safe Medical 
Devices Act, food and drug law has emphasized the duty of the Food and 
Drug Administration is to protect the public against unsafe or 
ineffective products. This legislation, as reflected in the mission 
statement, strengthens protection of the public from unsafe or 
ineffective products and provides a better balance in the law by 
ensuring timely access to safe and effective products. It is simple: 
Safe and effective products can be made available more quickly--and 
they should be. That is what this bill does.
  The legislation reauthorizes the Prescription Drug User Fee Act of 
1992, commonly referred to as PDUFA, to allow the continued collection 
of user fees from prescription drug manufacturers for 5 additional 
years. PDUFA I represented a consensus among the Food and Drug 
Administration, the prescription drug industry, and Congress that the 
industry would pay user fees to augment the resources of the Food and 
Drug Administration devoted to the review of human drug applications. 
PDUFA I has succeeded in substantially reducing review times for human 
drug applications, bringing those drugs to the market sooner than 
before.
  At some point in the debate I would like to engage a colloquy with 
Senator Mikulski, a cosponsor of S. 830, to discuss the importance of 
the performance enhancements that PDUFA will bring to the drug review 
process. We have all

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benefited from Senator Mikulski's determination to bring the Food and 
Drug Administration into the 21st century for the benefit of her own 
constituents who work at the FDA, for the betterment of the burgeoning 
biotechnology sector in Maryland, and for the parties throughout 
America who are served by the technologies developed by those 
companies.
  Title VII of S. 830, or PDUFA II, would build on the 
original legislation by codifying new commitments from FDA to implement 
more ambitious and comprehensive improvements in the regulatory 
process. PDUFA I focused on reducing the length of time taken by FDA in 
reviewing an application. The committee commends FDA for successfully 
meeting, and at times exceeding, the performance goals established at 
PDUFA I. However, while review times for submitted applications have 
improved, the period of time taken to get the drug through the drug 
development phase has recently increased from 5 to 7 years. 
Appropriately, PDUFA II will focus on shortening overall development 
time.

  It will streamline interaction with the FDA during the highly 
regulated drug development phase and also establish new performance 
levels and procedures for FDA that are designed to reduce the time 
required to show that a drug is ready for FDA review.
  The bill provides improved access to new treatments and important 
information needed by patients. Section 102 establishes a statutory 
right for any person, acting through a physician, to request an 
investigational drug, biological product, or device for diagnosis of a 
serious disease or condition. This provision builds upon current FDA 
programs that have proved so successful for aids and cancer drugs, and 
this is an area that is critical to all of us.
  This section of the bill includes modifications urged by the FDA and 
patient groups, that codify important patient protections. These 
provide patient access under their physician's supervision, to 
unapproved therapies, under the existing emergency use, and 
investigational device and drug treatment exemption programs.
  Another important provision advocated by the patient groups as one of 
their top priorities is section 808, which establishes a registry of 
clinical trials, both publicly or privately funded, of experimental 
drugs and biological or serious life-threatening medical conditions.
  Registry information must be understandable to the general public and 
include the purpose of experimental protocol, trial eligibility 
criteria, and sites and contact points for people wishing to enroll in 
a clinical trial. It is critical that those people who are suffering 
from the diseases of this nature be able to find out how they can get 
involved and be able to take part in a program which is designed to 
bring them back to health. Patients, health care providers, 
researchers, and the public would access the registry through toll-free 
telephone communications and other informational systems. This 
provision was included in the bill as an amendment offered by Senator 
Dodd, based on legislation introduced by Senator Snowe and Senator 
Feinstein. We are all grateful for their leadership in this area. I 
should add that Senator Dodd, who is a cosponsor of S. 830, must be 
recognized for his early and unflagging support for enacting broad-
based reform this year. He has worked incredibly hard and has been one 
of the most steadfast leaders in bringing forth a bipartisan bill.
  Yet another provision designed to speed new drugs to patients who 
need them is section 613. The FDA currently has a number of mechanisms 
aimed at streamlining the development and approval process for new 
therapies for serious and life-threatening conditions. Section 613 
establishes a statutory mechanism for identifying breakthrough drugs 
early in the product development phase. It provides sponsors of such 
drugs a reasonable opportunity for early interaction with the agency to 
further help streamline the development and approval process for such 
drugs.
  This provision is intended to clarify and to coordinate some of FDA's 
mechanisms for new drugs and biological products that are intended for 
the treatment of serious and life-threatening conditions and that 
demonstrate the potential to address unmet medical needs for such 
conditions. It defines and clarifies a process pursuant to which 
sponsors of these drugs may interact with the FDA, and includes 
provisions that will ensure that these processes are well known and 
well understood.
  I want to mention other changes made in the substitute that have been 
the subject of discussion between the committee markup and floor 
consideration.
  I want to make sure that everyone has an opportunity to know what we 
will be voting on and that they will have an opportunity to review this 
and, hopefully, fully understand it. Certainly, my staff, and I am sure 
Senator Kennedy's staff is available to enlighten them if they have 
questions. I urge all members to take a look at the bill that is now 
before the Senate.
  The third-party review provision has undergone substantial revision 
since its was first debated in the 104th Congress. This provision has 
been developed under the leadership of Senator Coats, who has played an 
important role in advancing FDA modernization throughout this process. 
This year, he has played a special role in the development of S. 830 
from its inception and provided wise counsel on how to achieve the best 
possible reform at the FDA. The third-party review pilot in this bill 
moves important expansion to the current FDA third-party review program 
for medical devices.
  I should mention that two amendments to the provision on third-party 
review for medical devices offered by Senator Harkin in committee, 
which were not agreed to, did form the basis for subsequent compromise 
reflected in the substitute now before the Senate. To meet the 
Senator's concerns and the concerns of others, the bill sponsors have 
agreed to statutory language establishing the right of FDA to review 
records related to compensation arrangements, and excluding from third-
party review class III products, products that are implanted for more 
than 1 year, products that are life sustaining or life supporting, and 
products that are of substantial importance in the prevention of 
impairment to human health.
  This was an important provision which brought peace of mind to many 
and allowed us to come forward with the bill in the form we have 
now. These changes in scope and the additional safeguards to protect 
against conflict of interest broaden public confidence in this pilot 
and provide FDA with a needed tool to manage an increasing workload of 
medical device reviews.

  Two other critical provisions to improve the medical device review 
program will make the review process more efficient and collaborative 
for high-technology products--those which offer the greatest benefit 
for patients and which also experience the longest review times at FDA. 
Senator Wellstone is the sponsor of legislation to reform the medical 
device approval process that includes these two provisions and others 
in S. 830, and I applaud his leadership on these issues. Section 301 
creates the opportunity for a manufacturer to meet with FDA to 
establish the type of scientific evidence necessary to demonstrate 
effectiveness for a device. FDA had earlier concerns about binding 
determinations of device data requirements needed to show efficacy. In 
response to the FDA, the provision has been modified to ensure that the 
agency will receive sufficient information to make such a determination 
and is provided authority to modify the determination where 
appropriate.
  Manufacturers should not have to spend months wondering if their 
application is still on track in the review process. Section 302 
requires the agency to meet with manufacturers 100 days after a 
premarket approval application is submitted to discuss deficiencies and 
any additional information required for approval. This provision, too, 
was modified to address FDA's concerns that the agency only be required 
to identify deficiencies known at the time of the 100-day meetings. And 
FDA would only be required to identify information needed to correct 
those deficiencies.

  In recognition that the mandatory postmarket surveillance authority 
established in the 1990 Safe Medical Devices Act was overbroad and 
inconsistently applied, S. 830 made the current mandatory postmarketing 
surveillance discretionary and limited surveillance to a 24-month 
period, unless FDA

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showed that longer time is needed to track device after marketing.
  Concerns of the FDA and patient group are further addressed in the 
substitute by striking the portions of the provision establishing new 
duration and scope limitations on postmarket surveillance--under the 
agreement the only change to the existing surveillance authority is to 
make it discretionary, allowing FDA the flexibility to impose 
surveillance requirements as appropriate without leaving itself or 
companies in technical violation of the law.
  Another area of disagreement prior to markup was the manner in which 
S. 830 proposed to handle certain types of manufacturing changes for 
medical devices. Senate bill 830 proposed to allow these changes to 
proceed on the basis of a notification rather than a full supplemental 
application.
  The substitute modifies the provision in the manufacturing changes 
section so that FDA may in some cases still require the submission of a 
supplement for a manufacturing change, and such supplement must be 
approved prior to implementation of the change. These manufacturing 
change supplements shall be reviewed in 135 days. This compromise will 
still allow many, if not most, manufacturing changes to proceed under a 
streamlined process.
  Senator Gregg, who worked very, very hard on this bill, has been 
certainly one of those who deserves a great deal of credit for bringing 
it to the body in the form it is in, which I believe is most 
satisfactory. He is to be also commended for his proposals to 
streamline the FDA process for the consideration of health claims based 
on Federal research and his amendments to establish uniformity for 
over-the-counter [OTC] drugs and cosmetics.
  He has modified this provision to exempt California's proposition 65 
and allow States to regulate cosmetic labeling and packaging issues 
where FDA has not acted. Senate bill 830 authorizes truthful, 
nonmisleading health claims for food products that are based on 
published authoritative statements of scientific bodies of the U.S. 
Government such as the National Institutes of Health. FDA expressed 
concern regarding the length of time the agency had to assess these 
proposed claims and the mechanism by which they might prevent a 
particular claim from going forward. Agreement with FDA was reached on 
the basis that FDA is given 30 additional days to review a health claim 
under the provision, for a total of 120 days to review a health claim. 
FDA is able to prevent the claim from being used in the marketplace by 
issuing an interim final regulation. FDA may also block a claim from 
going forward, if the conditions established under the provision 
governing claims are not met. Again, I thank the Senator for his 
excellent work in crafting this provision and reaching agreement with 
the FDA.
  The committee adopted an amendment by Senator Frist which conforms 
the statute with FDA's current practice and today's science with regard 
to the quality of data required to show drug efficacy. I am especially 
grateful to Dr. Frist, a cosponsor of the S. 830, whose medical 
expertise has lent credibility to the decisions we have made in the 
complex area of medical technology regulation.
  Senator DeWine, joined by Senator Dodd, offered an important 
amendment to establish incentives for the conduct of research into 
pediatric uses for existing and new drugs.
  The bill was improved by Senator Hutchinson's amendment, to establish 
a rational framework for pharmacy compounding, which respects the State 
regulation of pharmacy while allowing an appropriate role for FDA. I 
look forward to participating in a colloquy with the Senator and the 
ranking minority member on this topic.
  The ranking minority member, Senator Kennedy, has played a vital role 
in bringing this compromise to the floor. In markup, he offered two 
important amendments adopted by the committee. One amendment, developed 
in consultation with Senator Gregg, improved a provision from last 
year's legislation governing the regulation of radiopharmaceuticals. 
The second improved the bill's provision setting forth a streamlined 
process for the review of supplemental applications for new uses of 
approved drugs.
  I commend the Senator for his hard work and willingness to compromise 
on a number of issues which threatened to hold up proceeding on the 
bill. We reached agreement on the distribution of health care economic 
information. This data is the essential information ingredient in the 
drug selection process in the growing managed care sector of the health 
insurance marketplace. We agreed to require pharmaceutical companies to 
report annually on their efforts to comply with postapproval studies. 
This is essential information needed to provide the assurance that 
these studies will in fact be completed. Again, I thank the Senator for 
his willingness to work out these and other compromises.
  Finally, I would like to comment on the involvement of patient and 
consumer groups: They testified at one of our committee hearings. Also, 
our staff met a dozen times with representatives of these groups to 
discuss their proposals, share our ideas and drafts, and debate policy 
issues. Representatives of these groups were in key meetings with 
industry, FDA, and bipartisan staff to discuss the resolution of issues 
they identified as critical--pharmacoeconomics and the requirement of 
drug companies to comply with postapproval, or phase four, study 
requirements are examples of where we relied heavily on their advice 
and were pleased to have their information.
  The bill reflects changes to address their concerns: Companies must 
report on their compliance with phase four studies; FDA is given 
express authority to inspect compensation records of third-party 
reviewers; patients will have access to a registry of clinical trials 
information; and additional safeguards were built into the provision 
allowing expanded access to products under clinical investigation. It 
is clear that these groups have played an active and important role in 
drafting this bill.
  Mr. President, I stand before the body today with a sense of relief 
because, for the first time, I feel we are really, without any further 
delays, coming toward completion. It is also still my purpose and my 
goal to ensure that all Members will still have an opportunity to 
express themselves, and that when we come back next time, I hope that 
we will have an agreement or unanimous consent that we can proceed 
without the necessity of invoking cloture, and have amendments 
established to be considered in reasonable lengths of time, so that 
this bill can move forward. Certainly, I ask those who are desiring to 
propose amendments, when we come back here next week, to get in touch 
with us today, tomorrow, and during the weekend and the first of the 
week so we can try to accommodate all Members who desire to have 
amendments that they desire to have expeditiously considered.
  I urge all of the body to recognize that this is an important piece 
of legislation. It has to be acted upon yet by the House. They are 
anxiously awaiting us to move, so hopefully the bills can be as close 
together as possible, so that we can have the bill signed into law 
expeditiously, within a month.
  With that, Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. HARKIN. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. HARKIN. Mr. President, I yield 10 minutes to the Senator from 
Minnesota.
  The PRESIDING OFFICER (Mr. Allard). The Senator from Minnesota.
  Mr. WELLSTONE. Mr. President, I come to the floor to speak about S. 
830, the FDA Modernization Reform Act of 1997.
  I guess there are a couple of things I would like to say about this 
piece of legislation.
  First of all, I would like to thank my colleagues who have worked 
very hard on this. Senator Jeffords, Senator Kennedy, Senator Coats, 
Senator Gregg, Senator Harkin, and many others as well.
  I also would like to thank Linda Degutis, who is going to be on the 
floor with me who has been a fellow with our office. These fellow 
programs are wonderful programs. I think many of us are always looking 
for additional support and expertise. She has done a marvelous job.

[[Page S9155]]

  This bill has traveled an interesting journey. It was in committee 
markup about maybe a year ago, or thereabouts. I voted against it then. 
That was a difficult vote for me because it never really came to the 
floor. But I said then that there was much in this bill that I 
approved. I wanted to see some changes. But I thought the bill went too 
far.
  It was frustrating because on the medical device part of this bill 
our office had put much work into it. We spent about a year and a half, 
and I think other Senators know what this is like--writing a lot of the 
provisions. But I thought the legislation went too far.
  There were a number of things in it that are technical sounding. I 
will not go into all of it. But it was an overreach. It went too far 
trying to privatize FDA. The one thing you don't want to do is throw 
the baby out with the bathwater. I really have to keep the consumer 
protection part. It is quite one thing to say that you want more 
predictability and more timeliness and more focus in the regulatory 
process. I am all for that. It is one thing to say that we have to get 
these products to the market in a timely fashion. I am all for that. 
But they have to be safe and effective.
  Then we came back to committee. The second time around it was close 
again because there were some provisions in the bill that I did not 
agree with. I voted for it. I have tried to work real hard with lots of 
different people here. I don't think I need to talk about myself 
because that is not important. I think this has been a pretty darned 
important collaborative effort.
  We are almost there. I thank Senator Gregg for his cooperation. I 
think the provisions dealing with cosmetics and preemption of State 
standards, which would have affected my State in a very negative way, 
was a mistake. I think that has been worked out. We still may have some 
work to do yet with NEPA in terms of how this affects environmental 
impact statements. I believe that will be worked out. There are a 
couple of other problems that I think we are working on right now.
  But, Mr. President, let me just say that it is my belief that we can 
do better--that we can provide medical products to consumers in a more 
timely manner through the provisions in this bill while retaining 
significant consumer protection. It is my belief as a Senator that this 
legislation would improve the predictability and the timeliness and the 
focus of the regulatory process for medical products.
  Mr. President, next week when we bring this bill up, I am going to 
talk about what all of this means in specifics because this has been 
about 2\1/2\ years of work for me as a Senator from Minnesota. But as 
long as we are just kind of setting the stage here, if you will, I 
think the mood here in the Senate is very positive.
  I say to Senator Jeffords again, Senator Jeffords has done a really 
fine job of bringing people together. I actually think that we brought 
together not only Democrats and Republicans but others, a lot of people 
who have been involved with this. I will give full credit to a lot of 
the consumer organizations who have not agreed with everything in the 
bill, and they have been fighting hard and they continue to fight hard. 
They certainly have let me know when they have not agreed with 
positions I have taken, but they have done it with class, and they have 
been tough. They should be tough, and they should be critical. And they 
have been.
  By the same token, I want to make it clear that I think the business 
community, the industry has been very responsible. At one point in time 
when the Congress first started talking about FDA reform, I think there 
were some--this now goes back probably 2 years or so--who really looked 
at this as an opportunity to privatize FDA, roll back the really 
important consumer protection provisions.
  I think that is over. It is over for a lot of different reasons. It 
is over because I think people now in the Congress hopefully understand 
that people in the country are not interested in not having strong 
consumer protection. They view FDA as extremely important to them and 
the regulation that FDA does as being very important to their lives and 
to their children's lives.
  I also think people have pulled back from that because the of 
industry--and I want to give a lot of credit to the industry. There are 
a lot of people in the industry--and I know more about the medical 
device industry--who have basically every step along the way made it 
clear that, no, this goes too far; we are willing to compete with the 
gold standard; we are just asking to get our products to the market in 
a more timely fashion, but we don't want to give any ground. These 
products have to be safe and effective.
  To say that there ought to be more predictability, to say that when 
you have a protocol and you have waited for a year or you have waited 
more than a year and then all of a sudden you are told the protocol is 
no good, you had a right to learn about that earlier, you would like to 
at least have conversation with the agency, is very reasonable.
  Now, we had some provisions in the bill, including when I voted for 
it in the committee, that I thought still needed to be worked on, 
changes needed to be made. Again, Senator Jeffords, Senator Kennedy, 
and a number of people worked very hard and I think we have really 
worked very diligently, and a lot of those problems I think we have 
dealt with.
  So what we have here, Mr. President, I think is an important piece of 
legislation. We will undoubtedly have that, when we bring this bill to 
the floor--I say to my colleague, Tuesday, probably, is that correct?
  Mr. JEFFORDS. That is correct.
  Mr. WELLSTONE. There will be discussion. Some of us are still working 
on improvements. But overall what this piece of legislation does, I 
will summarize--and I will talk about it in specifics later. I will 
talk about it in a fairly technical way next week. But if I had to 
summarize, I do believe now after tough negotiation, after a lot of 
people in the country being involved with this on all sides, after 
Democrats and Republicans I think pulled together on this, with Senator 
Jeffords--and I am not just saying this because he is in the Chamber--
really providing key leadership, Senator Kennedy being in there 
fighting, with Senator Coats as well, being willing to negotiate; I am 
proud of our office's roll and other people as well, what we have is a 
piece of legislation which says essentially, look, there will be more 
predictability, there will be more timeliness, more focus on FDA's 
regulatory action, we can get products to the market in a timely 
fashion, which is important to families and consumers, but we can do it 
in such a way that we do not sacrifice consumer protection.
  We are almost there, and I think this is going to be a very important 
reform bill, and I am very proud to be a part of it.
  I thank my colleague for his work.
  Mr. JEFFORDS. Mr. President, I will yield on my time. I thank the 
Senator for all the work he has put into this bill. I know he is 
probably one of the strongest consumer advocates this Senate has ever 
seen. I would like to chat with the Senator just a bit because there is 
some concern of consumer advocates in my State who say how come we are 
getting all these editorials? And I would have to say in fairness to 
this committee they are based upon information which may have been true 
a month or 2 months or 3 months ago, but we have gone out of our way to 
put on the web pages--in fact, the most recent agreement which we have 
reached on cosmetics is now, or will be this afternoon, on the web 
pages so that all they have to do is tune in and they can see the exact 
wording.
  So I urge those who are still nervous about what is in the bill to 
find out. It is available. In the modern age of being able to have 
information available, it is available instantly around the country. I 
hope that we would continue to work on the basis of what the bill is 
instead of what it used to be.
  I acknowledge the Senator's contribution to this effort entirely. The 
Senator has been instrumental in proposing innovative ideas and finding 
solutions. He has done an outstanding job in helping myself and Senator 
Kennedy bring this bill to where it is. The Senator is looked upon by 
many as a person they can trust to protect the interests of the 
consumer. So I thank the Senator for his very active participation in 
this bill.
  Mr. WELLSTONE. Mr. President, I thank my colleague, and I think he is 
right about the time lag on information that has gotten to people. We 
have

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continued to be in tough negotiations and a good number of these 
problems have been resolved. I guess my style would be to say to the 
strong consumer organizations, keep on pushing hard to the very end. I 
think this is emerging as a real solid piece of work, and I am proud to 
be a part of it.
  I thank the Senator very much for the very gracious remarks. Linda 
Degutis, again, I thank very much for her help. She has been helpful in 
this in a big way.
  I thank the Chair.
  Mr. DODD. Mr. President, I want to begin by thanking my colleagues 
for their overwhelming support last week for cloture on the motion to 
proceed with this bill. Some 89 Senators very loudly and very clearly 
told us last week that they were ready to move forward to reauthorize 
PDUFA and to begin debating the other critical reforms this bill 
contains.
  There is no Federal agency with a more direct and significant impact 
on the lives of the American people than the Food and Drug 
Administration. The foods we serve our family, the medicines we take 
when we're sick, even the drugs we give our pets, are all approved and 
monitored by the FDA.
  We must not lose the opportunity that we have before us now to enact 
legislation that ensures the FDA has the authorities it needs to bring 
safe and effective products to the American people quickly and 
efficiently.
  I would like to again thank both Senator Jeffords and Senator Kennedy 
for their perseverance on this issue. Time after time they have been 
willing to return to the bargaining table after many others would have 
just walked away. With open minds and in good faith, they've 
extensively negotiated this bill, line by line.
  We have come to a point where issues on which Members were previously 
completely polarized--third party review of medical devices, off-label 
dissemination of information, health claims for food products, the 
number of clinical trials needed for drug approval, and just today 
national uniformity of cosmetics--we've now reached agreement.
  I don't know that any of us would have thought unanimity possible on 
these provisions even 2 months ago--yet here we are with full agreement 
on all but a handful of issues.
  I know we have a better bill for all of the arduous negotiations that 
have occurred.
  Just as an example of how far we've come, let's talk about third 
party review of medical devices. The bill would expand the pilot 
program currently administered by the FDA.
  This is a program, I should note, that is supported by the FDA as a 
way to make more efficient use of its resources.
  In last years debate, which many of you will remember as being much 
more acrimonious, we were told this provision was a nonstarter, no room 
to compromise, subject closed.
  This year, I am pleased to say, a spirit of bipartisanship and 
compromise prevailed. Senator Harkin, Senator Kennedy, and Senator 
Coats worked diligently to draft language that ensures that higher risk 
devices aren't inappropriately included in this pilot program and that 
strong conflict of interest protections are in place.
  And just last night, again on an issue that appeared unresolvable--
national uniformity for cosmetics, we have reached agreement. Senator 
Gregg has offered what I think is a very reasonable compromise. In the 
area of safety requirements, States can continue to regulate where the 
FDA has not acted.
  Conflicting State requirements that could confuse consumers will be 
removed. But where the FDA has not chosen to act, where it does not 
have either the manpower or the authority to protect the public, States 
can contain to play their historic role in regulating cosmetics.
  This is the kind of effort made over and over again on this bill--
some 30 times just since markup 2 months ago we have made improvements 
to this bill. A great many of us take pride in the product that has 
been created--a bill that will speed lifesaving drugs and devices to 
patients and that clearly retains the FDA as the undisputed arbiter of 
the safety effectiveness of these products.
  Mr. President, I would like to speak for a moment about some of the 
positive reforms contained in this bill.
  At the heart of this bill is the 5-year reauthorization of PDUFA, the 
Prescription Drug User Fee Act--a piece of legislation remarkable for 
the fact that there is unanimous agreement that it really works.
  PDUFA has set up a system of user fees which drug companies pay to 
the FDA. These fees have enabled the Agency to hire more staff. As a 
result, drug approval times have been cut almost in half, getting new 
and life-saving therapies to patients more quickly.
  In addition, by improving the certainty and clarity of the product 
review process, S. 830 encourages U.S. companies to continue to develop 
and manufacture their products in the United States. The legislation 
emphasizes collaboration early on between the FDA and industry during 
the product development and product approval phases. This will prevent 
misunderstandings about Agency expectations and should result in even 
quicker development and approval times.
  In addition, S. 830 establishes or expands upon several mechanisms to 
provide patients and other consumers with greater access to information 
and to life-saving products.
  For example, S. 830 will give individuals with life-threatening 
illness greater access to information about the location of on-going 
clinical trials of drugs.
  Based on a bill originally championed by Senators Snowe and 
Feinstein. I offered an amendment in committee, which I was pleased to 
see adopted, to expand an existing aids database to include trials for 
all serious or life-threatening diseases.
  Experimental trials offer hope for patients who have not benefited 
from treatments currently on the market. Currently, patients' ability 
to access experimental treatments is dependent upon their spending 
large amounts of time and energy contacting individual drug 
manufacturers just to discover the existence of trials.
  This is not a burden that we should place on individuals already 
struggling with chronic and debilitating diseases. This database will 
provide ``one-stop-shopping'' for patients seeking information on the 
location of and eligibility criteria for studies of promising 
treatments.
  Mr. President, I am particularly pleased that this bill incorporates 
the Better Pharmaceuticals for Children Act, legislation originally 
introduced by our former colleague from Kansas, Senator Kassebaum, and 
now cosponsored by myself and Senator DeWine, along with Senators 
Kennedy, Mikulski, Hutchinson, Collins, and Cochran.
  This provision addresses the problem of the lack of information about 
how drugs work on children, a problem that just last month President 
Clinton recognized publicly as a national crisis.
  According to the American Academy of Pediatrics, only one-fifth of 
all drugs on the market have been tested for their safety and 
effectiveness in children. This legislation provides a fair and 
reasonable market incentive for drug companies to make the extra effort 
needed to test their products for use by children. It gives the 
Secretary of Health and Human Services the authority to request 
pediatric clinical trials for new drug applications and for drugs 
currently on the market. If the manufacturer successfully conducts the 
additional research, 6 extra months of market exclusivity would be 
given.
  I recognize that there are few matters still unresolved on this bill 
despite the best efforts of all involved. And those we will need to 
simply address though the traditional process of holding votes on the 
issues.
  One issue, which I plan to discuss further when we debate the bill on 
Tuesday involves section 404 of the bill, which relates to the FDA's 
review of medical devices. This provision, the so-called labeling 
claims provision clarifies current law by stating that when reviewing a 
device for approval, FDA should look at safety and efficacy issues 
raised by the use for which the product was developed and for which it 
will be marketed.
  Again, this is current law. Unfortunately, in a few instances, the 
FDA has inappropriately expanded the scope of its review by requiring 
manufacturers to submit data on potential uses of product.
  Some have raised concerns that under this provision a manufacturer

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could propose a very narrowly worded label for a device and that the 
FDA would be barred from asking for information on other obvious uses.
  This is simply not the case. The FDA retains its current authority to 
not approve a device if based on a fair evaluation of all material 
facts, the labeling is false or misleading. Clearly, if a bad actor 
device manufacturer attempted to get a misleading label past the FDA, 
the Agency would have full authority to disapprove the product.
  I was pleased to join Senator Jeffords as the first Democratic 
cosponsor of this bill. I would thank him again for the hard work and 
long hours that he and his staff, as well, as Senator kennedy, Senator 
Mikulski, Senator Wellstone, Senator Coats, Senator Gregg, and others, 
have contributed.
  I look forward to further debate on and to joining my colleague next 
week in enacting this legislation.
  Mr. JEFFORDS. Mr. President, I make a point of order that a quorum is 
not present and ask unanimous consent that it be evenly divided between 
the minority and majority.
  The PRESIDING OFFICER. Without objection, it is so ordered. The clerk 
will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. JEFFORDS. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. JEFFORDS. The minority representative and myself are sitting 
here. There is some time left. However, we also want to move the 
calendar forward as best we can. I just want to alert all Members, 
minority and majority, if we do not receive a communication from a 
Member or staff within 10 minutes, it is our intention to yield back 
the remainder of our time in order that we may move the process of the 
Senate forward. I just let everyone know that. We will be sitting here, 
awaiting the news.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. JEFFORDS. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. JEFFORDS. Mr. President, speaking on behalf of the leader, I ask 
unanimous consent that the cloture vote with respect to FDA occur at 10 
a.m. on Tuesday, September 16, the mandatory quorum call under rule 
XXII be waived, and the time between 9:30 and 10 a.m. be equally 
divided for debate, prior to the vote.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. JEFFORDS. Therefore, under rule XXII, all first-degree amendments 
must be filed at the desk by 1 p.m. on Monday, September 15. I ask 
unanimous consent that all second-degree amendments may be filed up to 
the time of the vote on Tuesday.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. JEFFORDS. Mr. President, at this time, and I have the permission 
of the minority, I will yield back the remainder of our time, both 
minority and majority time; and I so do.
  The PRESIDING OFFICER. All time is yielded back.
  Mr. JEFFORDS. Mr. President, I make a point of order a quorum is not 
present.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. INHOFE. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. INHOFE. I ask unanimous consent that I be recognized for 5 
minutes as if in morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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