I
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 Representa-
tives 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 amend-
ment 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 provi-
sion of the Federal Food, Drug, and Cosmetic Act.
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SEC. 2. MISSION OF THE FOOD AND DRUG ADMINISTRA-
TION.
Section 903 (21 U.S.C. 393) is amended by adding
at the end the following:
‘‘(d) The mission of the Food and Drug Administra-
tion (with respect to drugs, biological products, and de-
vices) 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 pub-
lic,
‘‘(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 edu-
cate health professionals and the American public,
and
‘‘(6) enforcing the applicable statutes and regu-
lations in a timely, fair, and decisive manner.
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SEC. 3. LIMITING THE REQUIREMENT FOR INVESTIGA-
TIONS USING PRODUCTS MANUFACTURED AT
A FULL-SCALE TESTING FACILITY; GUIDE-
LINES; 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 per-
formed 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 effi-
cacy 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 re-
quirements 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 re-
quired 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
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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 require-
ments of the Federal Food, Drug, and Cosmetic Act for
pre-clinical and clinical investigations with the require-
ments 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 propa-
gated, 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 stand-
ard established by the Secretary; and
‘‘(iii) each package of such biological product is
plainly marked with the proper name of the biologi-
cal product contained therein, the name, address,
and establishment number of the manufacturer, and
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the date beyond which the contents cannot be ex-
pected to yield their specific results.
‘‘(B) The Secretary shall by regulation specify which
biological products shall be required to have a product li-
cense 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 Sec-
retary shall approve a product license application upon a
demonstration that there exists reasonable assurance that
the biological product which is the subject of the applica-
tion is safe and effective.
‘‘(B)(i) The Secretary shall establish, by regulation,
standards for biological products subject to such stand-
ards 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 para-
graph (4). Standards shall, as appropriate, reasonably as-
sure the safety, purity, and potency of the biological prod-
uct or class of biological products subject to such stand-
ard.
‘‘(3)(A) A product license approved by the Secretary
under paragraph (2)(A) and regulations established by the
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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 characteris-
tics of safety, purity, and potency which the biological
product purports or is represented to possess.
‘‘(B)(i) A product license shall specify whether certifi-
cation under subparagraph (A) will be by the manufac-
turer of the biological product, by the Secretary, or by a
certified individual or independent laboratory under sec-
tion 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 pe-
riod 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 safe-
ty and efficacy of the biological product.’’.
‘‘(iii) The Secretary may at any time, upon petition
by the manufacturer or upon the Secretary’s own initia-
tive, 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
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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 sci-
entific organizations and accrediting bodies used to assure
compliance with the standards of such organizations to as-
sist in the implementation of subparagraph (A) and to as-
sure that tissue, blood, and blood components or deriva-
tives (other than blood test kits) are processed in accord-
ance 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 distrib-
uted by methods to prevent the transmission of in-
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fectious 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 trans-
planted 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 or-
gans.’’.
SEC. 5. GOOD MANUFACTURING PRACTICES.
Section 501 (21 U.S.C. 351(a)) is amended—
(1) by inserting ‘‘(A)’’ after ‘‘(a)(1)’’ and redes-
ignating ‘‘(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
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(2) by inserting the following at the end of sub-
section (a):
‘‘(B) The Secretary shall by regulation establish good
manufacturing practices applicable to drugs subject to sec-
tion 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 char-
acterized adequately by physical or chemical meth-
ods.
‘‘(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 fol-
lows:
‘‘(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
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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 prod-
ucts which cannot be characterized adequately by
physical or chemical methods, approval of such man-
ufacturing 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 manufac-
turing 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 sub-
stantially 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
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writing to the Secretary (but not required to be ap-
proved 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 ap-
proved on the 31st day after submission unless on
or before such day the Secretary disapproves such
request and notifies the applicant or holder in writ-
ing of such disapproval. Such notification shall in-
clude a complete statement of the reasons for dis-
approval and a statement of modifications to the re-
quest 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 an-
nual basis.
‘‘(D)(i) The Secretary shall, after notice and oppor-
tunity 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 character-
ized by physical or chemical methods.
‘‘(ii) If the applicant disagrees with a determination
by the Secretary that the drug or biological product which
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is the subject of an application cannot be adequately char-
acterized 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 prac-
tices’ means—
‘‘(I) changes in manufacturing procedures
generally applicable throughout the facility,
such as changes in recordkeeping procedures,
validation processes, methods of training of per-
sonnel, and methods of qualification of equip-
ment;
‘‘(II) changes in equipment; and
‘‘(III) changes in manufacturing proce-
dures 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 ap-
proved; and
‘‘(iii) the term ‘applicant’ means a person
whose application described under clause (ii) has
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conflict of interest, and a knowledge of regulatory and sci-
entific standards which apply equally to outside reviewers
and to employees of the Secretary who review such appli-
cations. 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 re-
view 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 di-
rector of the office in which the drug is reviewed. The di-
rector 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 Admin-
istration 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 of-
fices of compliance in the centers.