[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1094 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                H. R. 1094

To amend the Federal Food, Drug, and Cosmetic Act to make improvements 
                      in the regulation of drugs.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 18, 1997

   Mr. Fox of Pennsylvania introduced the following bill; which was 
                 referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to make improvements 
                      in the regulation of drugs.

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

SECTION 1. SHORT TITLE AND REFERENCE.

    (A) Short Title.--This Act may be cited as the ``Life Extending and 
Life Saving Drug Act''.
    (b) Reference.--Whenever 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.

SEC. 2. MISSION OF THE FOOD AND DRUG ADMINISTRATION.

    Section 903 (21 U.S.C. 393) is amended by adding at the end the 
following:
    ``(d) The mission of the Food and Drug Administration (with respect 
to drugs, biological products, and devices) is to promote and protect 
the health of the American people. This mission should be achieved by--
            ``(1) facilitating the timely availability of safe and 
        effective products that benefit the American public,
            ``(2) encouraging the efficient development of new products 
        in the United States,
            ``(3) taking prompt and appropriate action where 
        postmarketing surveillance demonstrates that products present a 
        health risk to the American public,
            ``(4) ensuring that human drugs and biological products are 
        tested and manufactured consistent with the goal of 
        harmonization of international standards,
            ``(5) facilitating the flow of information to educate 
        health professionals and the American public, and
            ``(6) enforcing the applicable statutes and regulations in 
        a timely, fair, and decisive manner.

SEC. 3. LIMITING THE REQUIREMENT FOR INVESTIGATIONS USING PRODUCTS 
              MANUFACTURED AT A FULL-SCALE TESTING FACILITY; 
              GUIDELINES; HARMONIZATION.

    (a) Facilities.--Section 505 (21 U.S.C. 355) is amended--
            (1) in subsection (b)(1), by inserting after the second 
        sentence the following: ``The investigations referred to in 
        clause (A) shall be required to be performed using products 
        manufactured at a full-scale commercial facility only if the 
        Secretary finds, after providing opportunity for an informal 
        hearing, that investigations using products manufactured at 
        such a facility are necessary to assure the safety and efficacy 
        of the drug being investigated or, in the case of a biological 
        product subject to section 351 of the Public Health Service 
        Act, to assure that the requirements applicable under such 
        section are met.''; and
            (2) in clause (1) of subsection (d), by inserting after 
        ``to subsection (b),'' the following: ``were not performed at a 
        full-scale commercial facility as required under subsection 
        (b)(1) or''.
    (b) Guidelines.--The Secretary, acting through the Commissioner of 
Food and Drugs and after consultation with the Institute of Medicine, 
shall develop guidelines for the clinical testing required by 
subsections (b) and (i) of section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355).
    (c) Harmonization.--The Secretary shall take such action as may be 
appropriate to harmonize the requirements of the Federal Food, Drug, 
and Cosmetic Act for pre-clinical and clinical investigations with the 
requirements of similar laws in foreign countries through the 
International Conference on Harmonization.

SEC. 4. REGULATION OF BIOLOGICAL PRODUCTS.

    Section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) 
is amended by inserting ``(1)(A)'' after ``(a)'' and by striking ``any 
virus'' and all that appears thereafter and inserting in lieu thereof 
the following: ``a biological product to which this section applies 
unless--
            ``(i) such biological product has been propagated, 
        manufactured, or prepared in accordance with good manufacturing 
        practices;
            ``(ii) such biological product is the subject of an 
        approved product license or complies with a standard 
        established by the Secretary; and
            ``(iii) each package of such biological product is plainly 
        marked with the proper name of the biological product contained 
        therein, the name, address, and establishment number of the 
        manufacturer, and the date beyond which the contents cannot be 
        expected to yield their specific results.
    ``(B) The Secretary shall by regulation specify which biological 
products shall be required to have a product license or shall be 
subject to standards established under subparagraph (A)(ii), except 
that tissue, blood and blood components and derivatives (other than 
blood test kits) shall be subject to standards under paragraph (4).
    ``(2)(A) The Secretary shall establish, by regulation, requirements 
for product license applications. The Secretary shall approve a product 
license application upon a demonstration that there exists reasonable 
assurance that the biological product which is the subject of the 
application is safe and effective.
    ``(B)(i) The Secretary shall establish, by regulation, standards 
for biological products subject to such standards under paragraph 
(1)(B), except that tissue, blood, and blood components or derivatives 
(other than blood test kits) shall be subject to standards established 
under paragraph (4). Standards shall, as appropriate, reasonably assure 
the safety, purity, and potency of the biological product or class of 
biological products subject to such standard.
    ``(3)(A) A product license approved by the Secretary under 
paragraph (2)(A) and regulations established by the Secretary under 
paragraph (2)(B) may require that lots or batches of a biological 
product be released only after certification that such lots or batches 
have the characteristics of safety, purity, and potency which the 
biological product purports or is represented to possess.
    ``(B)(i) A product license shall specify whether certification 
under subparagraph (A) will be by the manufacturer of the biological 
product, by the Secretary, or by a certified individual or independent 
laboratory under section 906 of the Federal Food, Drug, and Cosmetic 
Act.
    ``(ii) Certification of lots or batches by the Secretary or 
independent laboratory shall be required only for a period of not more 
than 6 months, which period will not be extended unless the Secretary 
determines in writing that continuing such certification is required to 
assure the safety and efficacy of the biological product.''.
    ``(iii) The Secretary may at any time, upon petition by the 
manufacturer or upon the Secretary's own initiative, terminate any 
requirement for certification.
    ``(4)(A) The Secretary shall by regulation establish standards for 
tissue, blood, and blood components or blood derivatives (other than 
blood test kits). Such standards shall assure the safety and integrity 
of the tissue, blood, and blood components or derivatives (other than 
blood test kits). The Secretary shall solicit the submission of one 
or more proposed standards, applicable to tissue, blood, and blood 
components or derivatives (other than blood test kits) and approved by 
the Secretary as appropriate for purposes of this section, from 
professional and scientific organizations. The Secretary shall publish 
such standards as a notice of proposed rulemaking in accordance with 
paragraph (2)(B)(ii).
    ``(B) The Secretary shall use professional and scientific 
organizations and accrediting bodies used to assure compliance with the 
standards of such organizations to assist in the implementation of 
subparagraph (A) and to assure that tissue, blood, and blood components 
or derivatives (other than blood test kits) are processed in accordance 
with good manufacturing practices established by the Secretary under 
paragraph (6).
    ``(5) For purposes of this subsection, the term `tissue' means a 
collection of human cells which are similar or the intercellular 
substances surrounding them, or both, which--
            ``(A) are intended for administration to a human being for 
        the diagnosis, cure, mitigation, treatment, or prevention of 
        any disease or condition;
            ``(B) are procured, processed, stored, or distributed by 
        methods to prevent the transmission of infectious disease and 
        to preserve or enhance clinical usefulness;
            ``(C) may be processed to remove some of its constituents 
        but have not been modified chemically;
            ``(D) may be combined with substances such as excipients, 
        fillers, or carriers that are not devices or pharmacologically 
        active;
            ``(E) if subjected to expansion, manipulation, or other 
        processing (which may include modification of physical form or 
        structure) before being transplanted or implanted, are not 
        thereby substantially altered in their inherent structural or 
        functional characteristics; and
            ``(F) achieve their principal intended purposes through 
        structural or functional support and not systematic action;
but such term does not include vascularized human organs.''.

SEC. 5. GOOD MANUFACTURING PRACTICES.

    Section 501 (21 U.S.C. 351(a)) is amended--
            (1) by inserting ``(A)'' after ``(a)(1)'' and redesignating 
        ``(2)(A)'' as ``(B)(i)'', ``(B)'' as ``(ii)'' both times it 
        appears, ``(3)'' as ``(C)'', ``(4)'' as ``(D)'', ``(5)'' as 
        ``(E)'', ``(6)'' as ``(F)'', and ``(A)'' as ``(i)'' the second 
        time it appears; and
            (2) by inserting the following at the end of subsection 
        (a):
    ``(B) The Secretary shall by regulation establish good 
manufacturing practices applicable to drugs subject to section 505 of 
this Act and biological products (other than blood) subject to section 
351 of the Public Health Service Act as follows:
            ``(i) One set of regulations shall apply only to drugs and 
        biological products which cannot be characterized adequately by 
        physical or chemical methods.
            ``(ii) A second set of regulations shall apply only to 
        drugs and biological products which can be characterized 
        adequately by physical or chemical methods.
    ``(C) Regulations established under subparagraph (B) shall 
establish requirements for submissions to the Secretary of changes in 
manufacturing practices by the applicant or holder. Such regulations 
shall provide as follows:
            ``(i) In the case of drugs and biological products which 
        can adequately be characterized by physical or chemical 
        methods, approval of manufacturing changes shall be required 
        prior to implementation of such changes only if such 
        manufacturing changes are specified in regulations as 
        substantially affecting the safety or efficacy of such drugs 
        and biological products.
            ``(ii) In the case of drugs and biological products which 
        cannot be characterized adequately by physical or chemical 
        methods, approval of such manufacturing changes before 
        implementation shall be required--
                    ``(I) in the case of a drug or a biological product 
                which is required under section 351(a)(1)(B) of the 
                Public Health Service Act to have a product license, 
                only if such manufacturing changes are specified in 
                regulations as substantially affecting the safety and 
                efficacy of such drug or biological product; or
                    ``(II) in the case of a biological product which is 
                subject to standards as determined under section 
                351(a)(1)(B) of the Public Health Service Act, only if 
                such manufacturing changes are specified in the 
                regulations as substantially affecting the safety, 
                purity, potency (or, in the case of tissue, safety, and 
                integrity) of such biological products.
            ``(iii) Such regulations shall specify the types of 
        manufacturing changes that must be submitted in writing to the 
Secretary (but not required to be approved prior to implementation). A 
request to make such changes must be submitted by the applicant or 
holder at least 30 days prior to implementation of such changes. Such 
request shall be deemed approved on the 31st day after submission 
unless on or before such day the Secretary disapproves such request and 
notifies the applicant or holder in writing of such disapproval. Such 
notification shall include a complete statement of the reasons for 
disapproval and a statement of modifications to the request which, if 
made by the applicant or holder, will allow approval of the request.
            ``(iv) A description of manufacturing changes not covered 
        by clauses (i) or (iii) shall be submitted by the applicant or 
        holder to the Secretary on an annual basis.
    ``(D)(i) The Secretary shall, after notice and opportunity for 
public comment pursuant to section 553 of title 5, United States Code, 
establish not later than December 31, 1998, regulations to be used in 
determining whether a drug or a biological product can adequately be 
characterized by physical or chemical methods.
    ``(ii) If the applicant disagrees with a determination by the 
Secretary that the drug or biological product which is the subject of 
an application cannot be adequately characterized by physical or 
chemical methods, such applicant may contest such determination by 
requesting an informal hearing.
    ``(E) For purposes of subparagraphs (B) through (D)--
            ``(i) the term `changes in manufacturing practices' means--
                    ``(I) changes in manufacturing procedures generally 
                applicable throughout the facility, such as changes in 
                recordkeeping procedures, validation processes, methods 
                of training of personnel, and methods of qualification 
                of equipment;
                    ``(II) changes in equipment; and
                    ``(III) changes in manufacturing procedures of 
                specific applicability to a biological product;
            ``(ii) the term `holder' means a person whose drug 
        application submitted under section 505 or product license 
        application submitted under section 351 of the Public Health 
        Service Act has been approved; and
            ``(iii) the term `applicant' means a person whose 
        application described under clause (ii) has been submitted to, 
        but not approved by, the Secretary.''.

SEC. 6. NEW DRUG APPROVAL STANDARD.

    The last sentence of section 505(d) (21 U.S.C. 355(d)) is amended 
to read as follows: ``As used in this subsection and subsection (e), 
the term `substantial evidence' means evidence consisting of 
scientifically sound data, including data from one well-controlled 
clinical investigation and confirmatory evidence (obtained either 
before or after such investigation) on the basis of which experts 
qualified by scientific training and experience to evaluate the 
effectiveness of the drug involved could fairly and responsibly 
conclude, taking into account the entire knowledge base on the drug's 
effectiveness and safety, interpreted as a whole, that the drug will 
have the effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the labeling 
or proposed labeling of the drug.''.

SEC. 7. EXPEDITED REVIEW OF NEW DRUGS.

    Section 505 (21 U.S.C. 355), as amended by section 6, is amended by 
adding at the end the following:
    ``(o)(1) Any person who could submit or has submitted an 
application for a new drug pursuant to subsection (b)(1), other than an 
application described in subsection (b)(2), may submit an application 
for approval pursuant to this subsection.
    ``(2) Any person may submit to the Secretary an application 
(including a supplemental application for a new indication) for 
approval of a new drug, including approval of a switch of a new drug 
from prescription to nonprescription status, at any dose and for any 
indication based upon an evaluation by a domestic nongovernmental 
organization under clause (C) following licensing or approval of such 
new drug after the date of enactment of the Life Extending and Life 
Saving Drug Act by any of the following third party organizations:
            ``(A) The European Medicines Evaluation Agency or any 
        successor organization.
            ``(B) The United Kingdom Medicines Control Agency or any 
        successor organization.
            ``(C) Any competent governmental or nongovernmental 
        organization established to evaluate the safety and 
        effectiveness of drugs which meets any general criteria that 
        the Secretary may by regulation establish.
    ``(3) The application shall consist of the following materials:
            ``(A) The complete dossier or other submission made to a 
        third party organization described in paragraph (2) (in this 
paragraph referred to as `the third party organization'), including any 
amendments or additions.
            ``(B) All correspondence, memoranda of meetings and 
        telephone discussions, and similar documents reflecting 
        communications between the applicant and the third party 
        organization or persons working with the third party 
        organization prepared or received by the applicant relating to 
        the new drug.
            ``(C) All analyses and other documents prepared by or for 
        the third party organization relating to any aspect of the new 
        drug that the third party organization provides to the 
        applicant upon request and a letter authorizing the Secretary 
        to obtain any other such document directly from the third 
        party.
            ``(D) A summary of adverse event information obtained as 
        the result of any marketing outside the United States.
            ``(E) A copy of the labeling approved by the third party 
        organization and proposed United States labeling that is 
        consistent with the Secretary's generally applicable labeling 
        requirements.
            ``(F) An adequate summary of the documents that constitute 
        the application.
    ``(4) Within 7 days after receipt of the application, the Secretary 
shall send the summary to each member of a scientific review group 
established pursuant to section 904. Within 60 days after receipt of 
the application by the Secretary, the scientific review group shall 
meet to consider the application and to make its conclusions and 
recommendations to the Secretary.
    ``(5) Within 180 days after receipt of the submission by the 
Secretary (or if an application under subsection (b)(1) was submitted 
before the submission under this subsection, then within 180 days of 
receipt of the application under subsection (b)(1) or 90 days of the 
receipt of the submission under this subsection, whichever is later), 
the Secretary, taking into account any conclusions and recommendations 
of the scientific review group, shall either (A) approve the 
application, (B) disapprove the application if the Secretary 
demonstrates, based on the information in the submission (and, if an 
application has been filed under subsection (b)(1), on the information 
in such application) that the drug is unsafe or ineffective, and (C) if 
the application is disapproved, publish a notice of the decision in the 
Federal Register. If the Secretary does not publish a notice of 
disapproval in the Federal Register within such 180 days, the 
conclusions and recommendations of the scientific review group 
regarding the application shall be deemed to be the decision of the 
Secretary and the Secretary shall implement them immediately. If the 
Secretary does not publish a notice of disapproval in the Federal 
Register within 90 days and no scientific group has made conclusions or 
recommendations within that period regarding the application, the 
application shall be deemed to be approved and the Secretary shall 
immediately approve the application. The failure of the Secretary to 
take any such action shall constitute final agency action for purposes 
of judicial review. The Secretary may at any time take action to revoke 
the approval of an application approved pursuant to this paragraph on 
the ground specified in clause (B) using the procedures established in 
subsections (e) through (h) of this section.
    ``(6) The Secretary shall continue to pursue international 
harmonization of drug regulation among nations both through (A) 
adoption of uniform technical requirements and a registration dossier 
and (B) mutual recognition of marketing approval.''.

SEC. 8. CLINICAL RESEARCH.

    Section 505(i) (21 U.S.C. 355(i)) is amended by adding at the end 
the following: ``A clinical study of a new drug may begin after the 
Secretary has received from the sponsor a notification containing 
information about the drug and the clinical study. Such notification 
shall be required to contain only summaries of basic information, 
certified by the applicant to be accurate, needed to assess the safety 
of the clinical study and shall not be required to contain detailed 
information on chemistry, manufacturing, or controls or primary data 
tabulations or case report forms or tabulations from animal or human 
studies. At any time the director of the office within which the 
application is being reviewed may issue to the sponsor in writing a 
clinical hold prohibiting the sponsor from conducting the investigation 
and specifying the basis for the clinical hold. The director of such 
office may issue a clinical hold only upon a demonstration, based on 
specific information available to the Secretary, that the drug 
represents an unreasonable risk to the safety of the persons who are 
the subject of the clinical study, taking into account the condition 
for which the drug is to be investigated and the health status of the 
subjects involved. Any response from the sponsor to the director of 
such office requesting that the clinical hold be removed shall receive 
a decision, in writing and specifying the reasons therefor, within 15 
days or the clinical hold shall be deemed to be withdrawn. The director 
may not delegate the authority to issue a clinical hold.

SEC. 9. CONTENT AND REVIEW OF NEW DRUG APPLICATION.

    (a) Section 505(b)(1) Application.--Section 505(b) (21 U.S.C. 355) 
is amended by adding at the end the following:
    ``(4)(A) An application submitted under paragraph (1) shall include 
reports of studies on safety and effectiveness certified by the 
applicant to be accurate summaries which are supported by summary 
tables of the relevant data. Such an application shall not be required 
to include the primary data tabulations or case report forms or 
tabulations. In extraordinary circumstances, the director of the office 
of the Food and Drug Administration responsible for review of the drug 
for which the application is submitted may request, in writing and 
specifying the reasons for the request, the submission of primary data 
tabulations. The director may not delegate the authority to make such a 
request.
    ``(B) In reviewing an application submitted under paragraph (1), 
the Secretary, after obtaining agreement of the applicant, shall 
contract with outside organizations or individuals with expertise in 
relevant disciplines for the review of all or parts of such 
application.
    ``(C) The Secretary shall establish standards for the review of 
applications submitted under paragraph (1) relating to promptness, 
technical excellence, lack of bias and conflict of interest, and a 
knowledge of regulatory and scientific standards which apply equally to 
outside reviewers and to employees of the Secretary who review such 
applications. The Secretary shall conduct and maintain records of 
training programs for outside reviewers and employees of the Secretary 
who review such applications to assure their compliance with good 
review practices and good review standards and shall monitor their 
compliance with such practices and standards, the requirements of 
section 708, and the statutory time limits for action.
    ``(D) Advice provided to a sponsor or applicant at its request by a 
responsible Food and Drug Administration employee regarding appropriate 
testing of a new drug shall not be changed after such testing begins 
except with the written agreement of the sponsor or applicant or by a 
decision in writing after an informal hearing by the director of the 
office in which the drug is reviewed. The director may not delegate the 
authority to require such a change.
    ``(E) The written decisions of the center for drugs and the center 
for biologics of the Food and Drug Administration on all aspects of 
matters relating to a new drug or biologic shall be binding upon, and 
may not directly or indirectly be changed by, the field personnel or 
the offices of compliance in the centers.
    ``(F) No action by the center for drugs or the center for biologics 
on any matter relating to a new drug or biologic may at any time or 
under any circumstance be delayed because of the unavailability of 
information or action by the field personnel or because of issues 
relating to the integrity of data, except on the basis of evidence 
presented to the applicant, followed by an informal hearing, that data 
in that particular application are false.''.
    (b) Summaries.--Section 505(b)(1)(A) (21 U.S.C. 355(b)(1)(A)) is 
amended by inserting ``(including detailed summaries)`` after ``full 
reports and investigations''.

SEC. 10. REVIEW BY INDEPENDENT TESTING ORGANIZATIONS.

    (a) Privatization.--Chapter IX is amended by adding after section 
905 (21 U.S.C. 395) the following:

                 ``privatization of approval functions

    ``Sec. 906. (a) The Secretary, acting through the Commissioner of 
Food and Drugs, may establish and implement a program under which the 
Commissioner will contract, in whole or in significant part, with 
individuals and laboratories certified under subsection (b) to conduct, 
under such conditions as the Secretary may specify to assure unbiased 
scientifically valid results, the following activities and 
responsibilities of the Food and Drug Administration in connection with 
the approval of drugs and devices under sections 505 and 515 and with 
reviewing notifications required under section 510(k) and making 
written recommendations of initial classification under section 
513(f)(1) of devices:
            ``(1) Toxicology reviews to determine if applicable 
        requirements are being met.
            ``(2) Chemistry reviews to determine if applicable 
        requirements are being met.
            ``(3) Statistical analysis to determine if applicable 
        requirements are being met.
            ``(4) Preapproval manufacturing practice inspections to 
        determine if applicable requirements are being met.
            ``(5) Clinical reviews to determine if applicable 
        requirements are being met.
            ``(6) Any other function of the Food and Drug 
        Administration relating to the review and approval of drugs or 
        devices that the Secretary determines can be adequately 
        performed under contract with qualified individuals and 
        laboratories.
    ``(b) The Secretary, acting through the Commissioner of Food and 
Drugs, shall certify individuals and laboratories as qualified to carry 
out the functions described in paragraphs (1) through (6) of subsection 
(a) under a contract with the Commissioner of Food and Drugs.
    ``(c) The Secretary shall provide that drugs and devices which are 
subject to review under subsection (a) shall be approved under sections 
505 and 515 if the review determines that the drugs and devices meet 
all applicable approval requirements.
    ``(d)(1) Information otherwise protected from disclosure to the 
public under section 301(j) or 520(c) may be disclosed to--
            ``(A) contractors certified under subsection (b), and
            ``(B) employees of such contractors,
if, in the opinion of the Secretary, such disclosure is necessary for 
the satisfactory performance by the contractor of work under a contract 
under subsection (a).
    ``(2) The Secretary shall, in writing, require as a condition to 
the disclosure of information under paragraph (1) that the person 
receiving such information take such security precautions respecting 
the information as the Secretary shall by regulation prescribe. 
Disclosure by such person of such information to a person not 
authorized to receive it shall constitute a violation of section 301(j) 
and of section 1905 of title 18, United States Code.
    ``(e) The review of an application for approval of a new drug or 
device under this Act or a biological product under section 351 of the 
Public Health Service Act shall not include the review of the 
environmental impact of such drug, device, or biological product under 
the Environmental Quality Improvement Act of 1970 (42 U.S.C. 4371 et 
seq.).''.
    (b) Report.--Not later than the expiration of one year from the 
date of the enactment of this Act, the Secretary of Health and Human 
Services shall report to the Congress on--
            (1) the use the Secretary has made under section 906 of the 
        Federal Food, Drug, and Cosmetic Act of the authority to 
        contract for individuals and laboratories to perform duties of 
        the Food and Drug Administration, and
            (2) any difficulties encountered in contracting under such 
        section 906.

SEC. 11. RESEARCH ACTIVITIES.

    (a) Activities.--Chapter IX, as amended by section 10, is amended 
by adding after section 906 the following:

                         ``research activities

    ``Sec. 907. Research activities of the Food and Drug Administration 
relating to drugs, devices, and biological products, which are 
authorized under section 903(b)(2)(D) and section 352 of the Public 
Health Service Act, shall directly relate to the review and approval of 
drugs, devices, and biological products. In conducting such research 
activities, the Food and Drug Administration may collaborate with the 
National Institutes of Health, academic health centers, and other 
scientific institutions and the drug and device industry.''.
    (b) Purpose.--Section 903 (21 U.S.C. 393), as amended by section 2, 
is amended by adding at the end the following:
    ``(e) Any research conducted by or for the Food and Drug 
Administration shall be solely related directly to (1) the regulatory 
mission or (2) professional staff development related to that mission 
and shall be limited to the minimum necessary to achieve such 
purposes.''.

SEC. 12. POLICY AND PERFORMANCE REVIEW.

    Section 903 (21 U.S.C. 393), as amended by section 11(b), is 
amended by adding at the end the following:
    ``(f)(1) The Secretary shall establish, in the office of the 
Assistant Secretary for Health, a permanent commission responsible for 
broad oversight of the policy and performance of the Food and Drug 
Administration. The commission, which shall be subject to the 
provisions of subsection (c) of this section, shall review the 
performance of individuals and groups in meeting the mission of the 
Food and Drug Administration and the development of appropriate agency 
policy to implement that mission and shall include outcomes 
measurements and performance assessments in evaluating agency 
activities. Such review shall also include a comparison of the 
performance of the Food and Drug Administration with that of agencies 
performing similar functions for other countries and an evaluation of 
the effect of the Food and Drug Administration's performance on the 
competitiveness of the regulated American industries.
    ``(2)(A) The members of the commission shall include the nation's 
leading medical experts, medical society representatives, scientific 
and health policy authorities, and representatives from the trade 
associations for the regulated industries and from voluntary health 
associations.
    ``(B) Members of the commission shall serve at the discretion of 
the Secretary from year to year with no fixed term.
    ``(C) The Secretary shall pay members of the commission at an 
appropriate level commensurate with the services they provide.
    ``(3)(A) The commission shall issue a report to the Secretary and 
the Congress annually on the performance of the Food and Drug 
Administration. The Food and Drug Administration shall be given an 
opportunity to review and respond to the report before it is submitted 
to the Secretary and the Congress.
    ``(B) As part of its annual report under subparagraph (A), the 
commission shall recommend personnel and policy changes to improve the 
performance of the Food and Drug Administration in order to meet its 
mission as set forth in subsection (d).''.

SEC. 13. APPEALS.

    Section 903 (21 U.S.C. 393), as amended by section 12, is amended 
by adding the following new subsection at the end thereof:
    ``(g)(1) The Secretary shall establish within the Food and Drug 
Administration a drug and biologics policy appeals committee consisting 
of the director and deputy director of the center for drugs and the 
director and deputy director of the center for biologics. The appeals 
committee shall meet to hear and consider any dispute raised by an 
individual who wishes to contest a policy matter relating to drugs or 
biologics. The appeals committee shall meet to hear the individual 
within 15 days of receiving the request from the individual and shall 
decide the matter within 10 days after the hearing.
    ``(2) The Secretary shall establish standing panels of qualified 
experts who are not employees of the United States Government or of any 
State or local government for the purpose of hearing appeals by 
individuals who have exhausted their informal appeals within the Food 
and Drug Administration and who wish to contest the action or failure 
to act by the Food and Drug Administration in a particular matter. The 
Secretary shall establish an appeal procedure that assures immediate 
access to such a panel and prompt conclusions and recommendations by 
the panel. Following the conclusions and recommendations of the panel, 
the official of the Food and Drug Administration who reports to the 
Commissioner of Food and Drugs and is the director of the component 
responsible for regulation of the matter shall personally review the 
matter, in light of such conclusions and recommendations, and shall 
make a final decision within 15 days after receiving the conclusions 
and recommendations. Such official may not delegate the requirement to 
review and make a final decision. The decision of that official shall 
immediately be implemented. If that official fails to make a decision 
within 15 days, or if the decision is not immediately implemented, the 
conclusions and recommendations of the panel shall be deemed to be the 
decision of the Food and Drug Administration and shall be implemented 
immediately. The failure of the Secretary to take action to implement 
that decision immediately shall constitute final agency action for 
purposes of judicial review.''.

SEC. 14. EXPORT OF NEW DRUGS.

    Section 801(e) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381(e) is amended--
            (1) in paragraph (1), by inserting after ``under this Act'' 
        the following: ``or in violation of section 505 or section 351 
        of the Public Health Service Act'',
            (2) in paragraph (1), by striking the last sentence, and
            (3) by amending paragraph (2) to read as follows:
    ``(2) Paragraph (1) does not apply to the export of--
            ``(A) any device--
                    ``(i) which does not comply with an applicable 
                requirement under section 514 or 515,
                    ``(ii) which under section 520(g) is exempt from 
                either such section, or
                    ``(iii) which is a banned device under section 516, 
                or
            ``(B) any drug (including a biological product) which does 
        not comply with an applicable requirement under section 505 or 
        512 or section 351 of the Public Health Service Act,
unless the device or drug is in compliance with the requirements of 
paragraph (1). In the case of a device or drug for which an export 
notice is required under this paragraph, the Secretary may prohibit the 
export of such device or drug if the Secretary determines that the 
possibility of the reimportation of the device or drug into the United 
States presents an imminent hazard to the public health and safety of 
the United States and the only means of limiting the hazard is to 
prohibit the export of the device or drug.''.

SEC. 15. EXPORT OF CERTAIN UNAPPROVED PRODUCTS.

    Section 802 (21 U.S.C. 382) is repealed.
                                 <all>