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been submitted to, but not approved by, the Sec-
retary.’’.
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 evi-
dence’ means evidence consisting of scientifically sound
data, including data from one well-controlled clinical inves-
tigation 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 re-
sponsibly conclude, taking into account the entire knowl-
edge base on the drug’s effectiveness and safety, inter-
preted 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 label-
ing 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 submit-
ted an application for a new drug pursuant to subsection
(b)(1), other than an application described in subsection
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(b)(2), may submit an application for approval pursuant
to this subsection.
‘‘(2) Any person may submit to the Secretary an ap-
plication (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 non-
prescription status, at any dose and for any indication
based upon an evaluation by a domestic nongovernmental
organization under clause (C) following licensing or ap-
proval 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 non-
governmental organization established to evaluate
the safety and effectiveness of drugs which meets
any general criteria that the Secretary may by regu-
lation establish.
‘‘(3) The application shall consist of the following ma-
terials:
‘‘(A) The complete dossier or other submission
made to a third party organization described in
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paragraph (2) (in this paragraph referred to as ‘the
third party organization’), including any amend-
ments or additions.
‘‘(B) All correspondence, memoranda of meet-
ings and telephone discussions, and similar docu-
ments reflecting communications between the appli-
cant 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 pre-
pared 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 gen-
erally applicable labeling requirements.
‘‘(F) An adequate summary of the documents
that constitute the application.
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‘‘(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 applica-
tion 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 ei-
ther (A) approve the application, (B) disapprove the appli-
cation if the Secretary demonstrates, based on the infor-
mation 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 recommenda-
tions of the scientific review group regarding the applica-
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tion 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 imme-
diately approve the application. The failure of the Sec-
retary 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 appli-
cation 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 inter-
national harmonization of drug regulation among nations
both through (A) adoption of uniform technical require-
ments and a registration dossier and (B) mutual recogni-
tion of marketing approval.’’.
SEC. 8. CLINICAL RESEARCH.
Section 505(i) (21 U.S.C. 355(i)) is amended by add-
ing 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 re-
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quired 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, manufactur-
ing, 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 appli-
cation is being reviewed may issue to the sponsor in writ-
ing 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 un-
reasonable risk to the safety of the persons who are the
subject of the clinical study, taking into account the condi-
tion 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.
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SEC. 9. CONTENT AND REVIEW OF NEW DRUG APPLICA-
TION.
(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 effective-
ness 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 tab-
ulations. In extraordinary circumstances, the director of
the office of the Food and Drug Administration respon-
sible for review of the drug for which the application is
submitted may request, in writing and specifying the rea-
sons for the request, the submission of primary data tab-
ulations. 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) re-
lating to promptness, technical excellence, lack of bias and
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‘‘(F) No action by the center for drugs or the center
for biologics on any matter relating to a new drug or bio-
logic may at any time or under any circumstance be de-
layed 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 de-
tailed summaries)‘‘ after ‘‘full reports and investigations’’.
SEC. 10. REVIEW BY INDEPENDENT TESTING ORGANIZA-
TIONS.
(a) PRIVATIZATION.—Chapter IX is amended by add-
ing 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 im-
plement 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 as-
sure unbiased scientifically valid results, the following ac-
tivities and responsibilities of the Food and Drug Adminis-
tration in connection with the approval of drugs and de-
vices under sections 505 and 515 and with reviewing noti-
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fications required under section 510(k) and making writ-
ten recommendations of initial classification under section
513(f)(1) of devices:
‘‘(1) Toxicology reviews to determine if applica-
ble requirements are being met.
‘‘(2) Chemistry reviews to determine if applica-
ble requirements are being met.
‘‘(3) Statistical analysis to determine if applica-
ble requirements are being met.
‘‘(4) Preapproval manufacturing practice in-
spections 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 labora-
tories as qualified to carry out the functions described in
paragraphs (1) through (6) of subsection (a) under a con-
tract with the Commissioner of Food and Drugs.
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‘‘(c) The Secretary shall provide that drugs and de-
vices which are subject to review under subsection (a) shall
be approved under sections 505 and 515 if the review de-
termines that the drugs and devices meet all applicable
approval requirements.
‘‘(d)(1) Information otherwise protected from disclo-
sure 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 nec-
essary for the satisfactory performance by the contractor
of work under a contract under subsection (a).
‘‘(2) The Secretary shall, in writing, require as a con-
dition to the disclosure of information under paragraph
(1) that the person receiving such information take such
security precautions respecting the information as the Sec-
retary 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
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not include the review of the environmental impact of such
drug, device, or biological product under the Environ-
mental 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 Sec-
retary of Health and Human Services shall report to the
Congress on—
(1) the use the Secretary has made under sec-
tion 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
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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 develop-
ment 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 commis-
sion responsible for broad oversight of the policy and per-
formance of the Food and Drug Administration. The com-
mission, which shall be subject to the provisions of sub-
section (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 as-
sessments in evaluating agency activities. Such review