FDA1 — Health Hippo

fda1

FILE s830.
enr –S.830–S.830

An Act 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.

This Act may be cited as the ‘Food and Drug Administration Modernization Act of 1997’

TITLE I–IMPROVING
REGULATION OF DRUGS

SUBTITLE A–FEES RELATING TO DRUGS

SEC. 101. Findings

SEC. 102. Definitions

SEC. 103. Authority to assess and use drug
fees

SEC. 104. Annual reports

SEC. 105. Savings

SEC. 106. Effective date

SEC. 107. Termination of effectiveness

SUBTITLE B–OTHER IMPROVEMENTS

SEC. 111. Pediatric studies of drugs

SEC. 112. Expediting study and approval of
fast track drugs

SEC. 113. Information program on clinical
trials for serious or life-threatening diseases

SEC. 114. Health care economic information

SEC. 115. Clinical investigations

SEC. 116. Manufacturing changes for drugs

SEC. 117. Streamlining clinical research on
drugs

SEC. 118. Data requirements for drugs and
biologics

SEC. 119. Content and review of applications

SEC. 120. Scientific advisory panels

SEC. 121. Positron emission tomography

SEC. 122. Requirements for
radiopharmaceuticals

SEC. 123. Modernization of regulation

SEC. 124. Pilot and small scale manufacture

SEC. 125. Insulin and antibiotics

SEC. 126. Elimination of certain labeling
requirements

SEC. 127. Application of Federal law to
practice of pharmacy compounding

SEC. 128. Reauthorization of clinical
pharmacology program

SEC. 129. Regulations for sunscreen products

SEC. 130. Reports of postmarketing approval
studies

SEC. 131. Notification of discontinuance of
a life saving product

SUBTITLE A–FEES RELATING TO DRUGS

SEC. 101. 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 subtitle will
be dedicated toward expediting the drug development process and the
review of human drug applications as set forth in the goals
identified, for purposes of part 2 of subchapter C of chapter VII of
the Federal Food, Drug, and Cosmetic Act, in the letters 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 in the Congressional Record.

SEC. 102. 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 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 for further
manufacturing use only, and does not include a drug 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) by amending the first sentence of paragraph (5) to read as
follows:

‘(5) The term ‘prescription drug establishment’ means a foreign or
domestic place of business which is at one general physical location
consisting of one or more buildings all of which are within five
miles of each other and at which one or more prescription drug
products are manufactured in final dosage form.’;

(5) in paragraph (7)(A)– (A) by striking ’employees under
contract’ and all that follows through ‘Administration,’ the second
time it occurs 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,’;

(6) 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’; and (B) in subparagraph (B)– (i)
by striking ‘section 254(d)’ and inserting ‘section 254(c)’; (ii) by
striking ‘1992’ and inserting ‘1997’; and (iii) by striking ‘102d
Congress, 2d Session’ and inserting ‘105th Congress, 1st Session’;
and

(7) 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) one 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. 103. 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 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 shall not be subject to a fee under
subparagraph (A), unless the human drug application includes an
indication for other than a rare disease or condition. A supplement
proposing to include a new indication for a rare disease or condition
in a human drug application shall not be subject to a fee under
subparagraph (A), if the drug has been designated pursuant to section
526 as a drug for a rare disease or condition with regard to the
indication proposed in such supplement.

‘(F) EXCEPTION FOR SUPPLEMENTS FOR PEDIATRIC INDICATIONS- A
supplement to a human drug application proposing to include a new
indication for use in pediatric populations shall not be assessed a
fee under subparagraph (A).

‘(G) REFUND OF FEE IF APPLICATION WITHDRAWN- If an application or
supplement is withdrawn after the application or supplement was
filed, the Secretary may 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 refund a fee or a portion of the fee under this
subparagraph. A determination by the Secretary concerning a refund
under this paragraph shall not be reviewable.’;

(3) by striking paragraph (2) and inserting the following:

‘(2) PRESCRIPTION DRUG ESTABLISHMENT FEE- ‘(A) IN GENERAL- Except
as provided in subparagraph (B), each person that– ‘(i) is named as
the applicant in a human drug application; and ‘(ii) after September
1, 1992, had pending before the Secretary a human drug application or
supplement, shall be assessed an annual fee established in subsection
(b) for each prescription drug establishment listed in its approved
human drug application as an establishment that manufactures the
prescription drug product named in the application. The annual
establishment fee shall be assessed in each fiscal year in which the
prescription drug product named in the application is assessed a fee
under paragraph (3) unless the prescription drug establishment listed
in the application does not engage in the manufacture of the
prescription drug product during the fiscal year. The establishment
fee shall be payable on or before January 31 of each year. Each such
establishment shall be assessed only one fee per establishment,
notwithstanding the number of prescription drug products manufactured
at the establishment. In the event an establishment is listed in a
human drug application by more than one applicant, the establishment
fee for the fiscal year shall be divided equally and assessed among
the applicants whose prescription drug products are manufactured by
the establishment during the fiscal year and assessed product fees
under paragraph (3).

‘(B) EXCEPTION- If, during the fiscal year, an applicant initiates
or causes to be initiated the manufacture of a prescription drug
product at an establishment listed in its human drug application–
‘(i) that did not manufacture the product in the previous fiscal
year; and ‘(ii) for which the full establishment fee has been
assessed in the fiscal year at a time before manufacture of the
prescription drug product was begun; the applicant will not be
assessed a share of the establishment fee for the fiscal year in
which the manufacture of the product began.’; 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 is submitted 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), under an abbreviated
application filed under section 507 (as in effect on the day before
the date of enactment of the Food and Drug Administration
Modernization Act of 1997), 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.’

(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) TOTAL 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.’

(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 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 one or more fees assessed under subsection (a) where the
Secretary finds that–‘;

(3) in subparagraph (C) (as so redesignated in paragraph (1)), by
striking ‘, or’ and inserting a comma;

(4) in subparagraph (D) (as so redesignated in paragraph (1)), by
striking the period and inserting ‘, or’;

(5) by inserting after subparagraph (D) (as so redesignated in
paragraph (1)) the following: ‘(E) the applicant involved 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.’;

(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 are 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 under
this section that 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 this section
pursuant to appropriation Acts for a subsequent fiscal year.’

(g) REQUIREMENT FOR WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, AND
REFUNDS- 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 WAIVERS AND REFUNDS- Any requests for waivers
or refunds for fees assessed under section 736 of the Federal Food,
Drug, and Cosmetic Act (42 U.S.C. 379h) 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. Any requests for waivers or refunds pertaining
to a fee for a human drug application or supplement accepted for
filing prior to October 1, 1997 or to a product or establishment fee
required by such Act for a fiscal year prior to fiscal year 1998,
shall be evaluated according to the terms of the Prescription Drug
User Fee Act of 1992 (as in effect on September 30, 1997) and part 2
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (as in effect on September 30, 1997).

The term ‘person’ in such Acts shall continue to include an
affiliate thereof.

SEC. 104. ANNUAL REPORTS

(a) PERFORMANCE 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 letters described in section
101(4) during such fiscal year and the future plans of the Food and
Drug Administration for meeting the goals.

(b) FISCAL 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. 105. SAVINGS

Notwithstanding section 105 of the Prescription Drug User Fee Act
of 1992, the Secretary shall retain the authority to assess and
collect any fee required by part 2 of subchapter C of chapter VII of
the Federal Food, Drug, and Cosmetic Act for a human drug application
or supplement accepted for filing prior to October 1, 1997, and to
assess and collect any product or establishment fee required by such
Act for a fiscal year prior to fiscal year 1998.

SEC. 106. EFFECTIVE DATE

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

SEC. 107. TERMINATION OF EFFECTIVENESS

The amendments made by sections 102 and 103 cease to be effective
October 1, 2002, and section 104 ceases to be effective 120 days
after such date.

SUBTITLE B–OTHER IMPROVEMENTS

SEC. 111. PEDIATRIC STUDIES OF DRUGS

Chapter V (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 new drug in the
pediatric population may produce health benefits in that population,
the Secretary makes a written request for pediatric studies (which
shall 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 accepted in
accordance with subsection (d)(3)–

‘(1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of
section 505, and in subsection (j)(4)(D)(ii) of such section, is
deemed to 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 such
section to four years, to forty-eight months, and to seven and
one-half years are deemed to be four and one-half years, fifty-four
months, and eight years, respectively; or

‘(ii) the period referred to in clauses (iii) and (iv) of
subsection (c)(3)(D) of such section, and in clauses (iii) and (iv)
of subsection (j)(4)(D) of such section, is deemed to be three years
and six months rather than three years; and

‘(B) if the drug is designated under section 526 for a rare
disease or condition, the period referred to in section 527(a) is
deemed to be seven years and six months rather than seven years; and

‘(2)(A) if the drug is the subject of– ‘(i) a listed patent for
which a certification has been submitted under subsection
(b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 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 subsections
(b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505, 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 subsection (b)(2)(A)(iv) or
(j)(2)(A)(vii)(IV) of section 505, 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 the Food and Drug Administration
Modernization Act of 1997, the Secretary, after consultation with
experts in pediatric research 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 to the holder of an approved
application under section 505(b)(1) for pediatric studies (which
shall include a timeframe for completing such studies) concerning a
drug identified in the list described in subsection (b), the holder
agrees to the request, the studies are completed within any such
timeframe, and the reports thereof are submitted in accordance with
subsection (d)(2) or accepted in accordance with subsection (d)(3)–

‘(B) if the drug is designated under section 526 for a rare
disease or condition, the period referred to in section 527(a) is
deemed to be seven years and six months rather than seven years; and

‘(2)(A) if the drug is the subject of– ‘(i) a listed patent for
which a certification has been submitted under subsection
(b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 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 subsection
(b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505, 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

‘(d) CONDUCT OF PEDIATRIC STUDIES-

‘(1) AGREEMENT FOR STUDIES- The Secretary may, pursuant to a
written request from the Secretary under subsection (a) or (c), 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 new 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. Such agreement shall be in writing and shall include a
timeframe for such studies

‘(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, have been conducted in accordance
with commonly accepted scientific principles and protocols, and have
been reported in accordance with the requirements of the Secretary
for filing

‘(e) DELAY OF EFFECTIVE DATE FOR CERTAIN APPLICATION- If the
Secretary determines that the acceptance or approval of an
application under section 505(b)(2) or 505(j) for a new 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 the applicable period under
clauses (ii) through (iv) of section 505(c)(3)(D) or clauses (ii)
through (iv) of section 505(j)(4)(D), 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) until the determination under subsection
(d) is made, but any such delay shall not exceed 90 days. In the
event that requirements of this section are satisfied, the applicable
six-month period under 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 subsection (b)(2) or (j) of section 505 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 one 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) LIMITATIONS- A drug to which the six-month period under
subsection (a) or (b) has already been applied–

‘(1) may receive an additional six-month period under subsection
(c)(1)(A)(ii) for a supplemental application if all other
requirements under this section are satisfied, except that such a
drug may not receive any additional such period under subsection
(c)(2); and

‘(2) may not receive any additional such period under subsection
(c)(1)(B)

‘(i) RELATIONSHIP TO REGULATIONS- Notwithstanding any other
provision of law, if any pediatric study is required pursuant to
regulations promulgated by the Secretary and such study meets the
completeness, timeliness, and other requirements of this section,
such study shall be deemed to satisfy the requirement for market
exclusivity pursuant to this section

‘(j) SUNSET- A drug may not receive any six-month period under
subsection (a) or (c) unless the application for the drug under
section 505(b)(1) is submitted on or before January 1, 2002. After
January 1, 2002, a drug shall receive a six-month period under
subsection (c) if–

‘(1) the drug was in commercial distribution as of the date of
enactment of the Food and Drug Administration Modernization Act of
1997;

‘(2) the drug was included by the Secretary on the list under
subsection (b) as of January 1, 2002;

‘(3) the Secretary determines that there is a continuing need for
information relating to the use of the drug in the pediatric
population and that the drug may provide health benefits in that
population; and

‘(4) all requirements of this section are met

‘(k) REPORT- The Secretary shall conduct a study and report to
Congress not later than January 1, 2001, based on the experience
under the program established under this section. 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 on taxpayers and
consumers, including the impact of the lack of lower cost generic
drugs on patients, including on lower income patients; and

‘(4) any suggestions for modification that the Secretary
determines to be appropriate.’

SEC. 112. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS

(a) IN GENERAL- Chapter V (21 U.S.C. 351 et seq.), as amended by
section 125, is amended by inserting before section 508 the
following:

‘SEC. 506. FAST TRACK PRODUCTS

‘(a) DESIGNATION OF DRUG AS A FAST TRACK PRODUCT-

‘(1) IN GENERAL- The Secretary shall, at the request of the
sponsor of a new drug, facilitate the development and expedite the
review of such drug if it is intended for the treatment of a serious
or life-threatening condition and it demonstrates the potential to
address unmet medical needs for such a condition. (In this section,
such a drug is referred to as a ‘fast track product’.)

‘(2) REQUEST FOR DESIGNATION- The sponsor of a new drug may
request the Secretary to designate the drug as a fast track product.
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)(3) of the Public
Health Service Act.

‘(3) DESIGNATION- Within 60 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 product and shall take such actions as are appropriate to
expedite the development and review of the application for approval
of such product.

‘(b) APPROVAL OF APPLICATION FOR A FAST TRACK PRODUCT-

‘(1) IN GENERAL- The Secretary may approve an application for
approval of a fast track product under section 505(c) or section 351
of the Public Health Service Act upon a determination that the
product has an effect on a clinical endpoint or on a surrogate
endpoint that is reasonably likely to predict clinical benefit.

‘(2) LIMITATION- Approval of a fast track product 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 effect on the clinical endpoint;
and ‘(B) that the sponsor submit copies of all promotional materials
related to the fast track product during the preapproval review
period and, following approval and for such period thereafter as the
Secretary determines to be appropriate, at least 30 days prior to
dissemination of the materials.

‘(3) EXPEDITED WITHDRAWAL OF APPROVAL- The Secretary may withdraw
approval of a fast track product using expedited procedures (as
prescribed by the Secretary in regulations which shall include 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 product
fails to verify clinical benefit of the product; ‘(C) other evidence
demonstrates that the fast track product is not safe or effective
under the conditions of use; or ‘(D) the sponsor disseminates false
or misleading promotional materials with respect to the product.

‘(c) REVIEW OF INCOMPLETE APPLICATIONS FOR APPROVAL OF A FAST
TRACK PRODUCT-

‘(1) IN GENERAL- If the Secretary determines, after preliminary
evaluation of clinical data submitted by the sponsor, that a fast
track product may be effective, the Secretary shall evaluate for
filing, and may commence review of portions of, an application for
the approval of the product before the sponsor submits a complete
application. The Secretary shall commence such review only if the
applicant– ‘(A) provides a schedule for submission of information
necessary to make the application complete; and ‘(B) pays 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 disseminate to physicians, patient organizations,
pharmaceutical and biotechnology companies, and other appropriate
persons a description of the provisions of this section applicable to
fast track products; and

‘(2) establish a 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 products (as defined in section 506(a)(1) of the
Federal Food, Drug, and Cosmetic Act) that describes the policies and
procedures that pertain to section 506 of such Act.

(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)(A)
The Secretary, acting through the Director of NIH, shall establish,
maintain, and operate a data bank of information on clinical trials
for drugs for serious or life-threatening diseases and conditions (in
this subsection referred to as the ‘data bank’). The activities of
the data bank shall be integrated and coordinated with related
activities of other agencies of the Department of Health and Human
Services, and to the extent practicable, coordinated with other data
banks containing similar information.

‘(B) The Secretary shall establish the data bank 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.

‘(2) In carrying out paragraph (1), the Secretary shall collect,
catalog, store, and disseminate the information described in such
paragraph. 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
section 505(i) of the Federal Food, Drug, and Cosmetic Act, which
provides a description of the purpose of each experimental drug,
either with the consent of the protocol sponsor, or when a trial to
test effectiveness begins. Information provided shall consist of
eligibility criteria for participation in the clinical trials, 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
shall be forwarded to the data bank by the sponsor of the trial not
later than 21 days after the approval of the protocol.

‘(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 Secretary under section 561(c) of the Federal
Food, Drug, and Cosmetic Act; or ‘(ii) as a Group C cancer drug (as
defined by the National Cancer Institute).

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 provided a detailed certification to
the Secretary that disclosure of such information would substantially
interfere with the timely enrollment of subjects in the
investigation, unless the Secretary, after the receipt of the
certification, provides the sponsor with a detailed written
determination that such disclosure would not substantially interfere
with such enrollment.

‘(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
Act shall not be used 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 data bank
under section 402(j) of the Public Health Service Act.

(2) REPORT- Not later than two 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– (A) of the public health need, if any, for
inclusion of device investigations within the scope of the data bank
under section 402(j) of the Public Health Service Act; (B) on 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; and (C) on such other issues
relating to such section 402(j) as the Secretary determines to be
appropriate.

SEC. 114. HEALTH CARE ECONOMIC INFORMATION

(a) IN GENERAL- Section 502(a) (21 U.S.C. 352(a)) is amended by
adding at the end the following: ‘Health care economic information
provided to a formulary committee, or other similar entity, in the
course of the committee or the entity carrying out its
responsibilities for the selection of drugs for managed care or other
similar organizations, shall not be considered to be false or
misleading under this paragraph if the health care economic
information directly relates to an indication approved under section
505 or under section 351(a) of the Public Health Service Act for such
drug and is based on competent and reliable scientific evidence. The
requirements set forth in section 505(a) or in section 351(a) of the
Public Health Service Act shall not apply to health care economic
information provided to such a committee or entity in accordance with
this paragraph. Information that is relevant to the substantiation of
the health care economic information presented pursuant to this
paragraph shall be made available to the Secretary upon request. In
this paragraph, the term ‘health care economic information’ means any
analysis that identifies, measures, or compares the economic
consequences, including the costs of the represented health outcomes,
of the use of a drug to the use of another drug, to another health
care intervention, or to no intervention.’

(b) STUDY AND REPORT- The Comptroller General of the United States
shall conduct a study of the implementation of the provisions added
by the amendment made by subsection (a). Not later than 4 years and 6
months after the date of enactment of this Act, the Comptroller
General of the United States shall prepare and submit to Congress a
report containing the findings of the study.

SEC. 115. CLINICAL INVESTIGATIONS

(a) CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL
INVESTIGATIONS FOR APPROVAL- Section 505(d) (21 U.S.C. 355(d)) is
amended by adding at the end the following: ‘If the Secretary
determines, based on relevant science, that data from one adequate
and well-controlled clinical investigation and confirmatory evidence
(obtained prior to or after such investigation) are sufficient to
establish effectiveness, the Secretary may consider such data and
evidence to constitute substantial evidence for purposes of the
preceding sentence.’

(b) WOMEN AND MINORITIES- Section 505(b)(1) (21 U.S.C. 355(b)(1))
is amended by adding at the end the following: ‘The Secretary shall,
in consultation with the Director of the National Institutes of
Health and with representatives of the drug manufacturing industry,
review and develop guidance, as appropriate, on the inclusion of
women and minorities in clinical trials required by clause (A).’

SEC. 116. MANUFACTURING CHANGES FOR DRUGS

(a) IN GENERAL- Chapter V, as amended by section 112, is amended
by inserting after section 506 the following section:

‘SEC. 506A. MANUFACTURING CHANGES

‘(a) IN GENERAL- With respect to a drug for which there is in
effect an approved application under section 505 or 512 or a license
under section 351 of the Public Health Service Act, a change from the
manufacturing process approved pursuant to such application or
license may be made, and the drug as made with the change may be
distributed, if–

‘(1) the holder of the approved application or license (referred
to in this section as a ‘holder’) has validated the effects of the
change in accordance with subsection (b); and

‘(2)(A) in the case of a major manufacturing change, the holder
has complied with the requirements of subsection (c); or

‘(B) in the case of a change that is not a major manufacturing
change, the holder complies with the applicable requirements of
subsection (d).

‘(b) VALIDATION OF EFFECTS OF CHANGES- For purposes of subsection
(a)(1), a drug made with a manufacturing change (whether a major
manufacturing change or otherwise) may be distributed only if, before
distribution of the drug as so made, the holder involved validates
the effects 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.

‘(c) MAJOR MANUFACTURING CHANGES-

‘(1) REQUIREMENT OF SUPPLEMENTAL APPLICATION- For purposes of
subsection (a)(2)(A), a drug made with a major manufacturing change
may be distributed only if, before the distribution of the drug as so
made, the holder involved submits to the Secretary a supplemental
application for such change and the Secretary approves the
application. The application shall contain such information as the
Secretary determines to be appropriate, and shall include the
information developed under subsection (b) by the holder in
validating the effects of the change.

‘(2) CHANGES QUALIFYING AS MAJOR CHANGES- For purposes of
subsection (a)(2)(A), a major manufacturing change is a manufacturing
change that is determined by the Secretary to have substantial
potential to adversely affect the identity, strength, quality,
purity, or potency of the drug as they may relate to the safety or
effectiveness of a drug. Such a change includes a change that– ‘(A)
is made in the qualitative or quantitative formulation of the drug
involved or in the specifications in the approved application or
license referred to in subsection (a) for the drug (unless exempted
by the Secretary by regulation or guidance from the requirements of
this subsection); ‘(B) is determined by the Secretary by regulation
or guidance to require completion of an appropriate clinical study
demonstrating equivalence of the drug to the drug as manufactured
without the change; or ‘(C) is another type of change determined by
the Secretary by regulation or guidance to have a substantial
potential to adversely affect the safety or effectiveness of the
drug.

‘(d) OTHER MANUFACTURING CHANGES-

‘(1) IN GENERAL- For purposes of subsection (a)(2)(B), the
Secretary may regulate drugs made with manufacturing changes that are
not major manufacturing changes as follows: ‘(A) The Secretary may in
accordance with paragraph (2) authorize holders to distribute such
drugs without submitting a supplemental application for such changes.

‘(B) The Secretary may in accordance with paragraph (3) require
that, prior to the distribution of such drugs, holders submit to the
Secretary supplemental applications for such changes.

‘(C) The Secretary may establish categories of such changes and
designate categories to which subparagraph (A) applies and categories
to which subparagraph (B) applies.

‘(2) CHANGES NOT REQUIRING SUPPLEMENTAL APPLICATION- ‘(A)
SUBMISSION OF REPORT- A holder making a manufacturing change to which
paragraph (1)(A) applies shall submit to the Secretary a report on
the change, which shall contain such information as the Secretary
determines to be appropriate, and which shall include the information
developed under subsection (b) by the holder in validating the
effects of the change. The report shall be submitted by such date as
the Secretary may specify.

‘(B) AUTHORITY REGARDING ANNUAL REPORTS- In the case of a holder
that during a single year makes more than one manufacturing change to
which paragraph (1)(A) applies, the Secretary may in carrying out
subparagraph (A) authorize the holder to comply with such
subparagraph by submitting a single report for the year that provides
the information required in such subparagraph for all the changes
made by the holder during the year.

‘(3) CHANGES REQUIRING SUPPLEMENTAL APPLICATION- ‘(A) SUBMISSION
OF SUPPLEMENTAL APPLICATION- The supplemental application required
under paragraph (1)(B) for a manufacturing change shall contain such
information as the Secretary determines to be appropriate, which
shall include the information developed under subsection (b) by the
holder in validating the effects of the change.

‘(B) AUTHORITY FOR DISTRIBUTION- In the case of a manufacturing
change to which paragraph (1)(B) applies: ‘(i) The holder involved
may commence distribution of the drug involved 30 days after the
Secretary receives the supplemental application under such paragraph,
unless the Secretary notifies the holder within such 30-day period
that prior approval of the application is required before
distribution may be commenced.

‘(ii) The Secretary may designate a category of such changes for
the purpose of providing that, in the case of a change that is in
such category, the holder involved may commence distribution of the
drug involved upon the receipt by the Secretary of a supplemental
application for the change.

‘(iii) If the Secretary disapproves the supplemental application,
the Secretary may order the manufacturer to cease the distribution of
the drugs that have been made with the manufacturing change.’

(b) TRANSITION RULE- The amendment made by subsection (a) takes
effect upon the effective date of regulations promulgated by the
Secretary of Health and Human Services to implement such amendment,
or upon the expiration of the 24-month period beginning on the date
of the enactment of this Act, whichever occurs first.

SEC. 117. STREAMLINING CLINICAL RESEARCH ON DRUGS

Section 505(i) (21 U.S.C. 355(i)) is amended–

(1) by redesignating paragraphs (1) through (3) as subparagraphs
(A) through (C), respectively;

(2) by inserting ‘(1)’ after ‘(i)’;

(3) by striking the last two sentences; and

(4) by inserting after paragraph (1) (as designated by paragraph
(2) of this section) the following new paragraphs: ‘(2) Subject to
paragraph (3), a clinical investigation of a new drug may begin 30
days after the Secretary has received from the manufacturer or
sponsor of the investigation a submission containing such information
about the drug and the clinical investigation, including–

‘(A) information on design of the investigation and adequate
reports of basic information, certified by the applicant to be
accurate reports, necessary to assess the safety of the drug for use
in clinical investigation; and

‘(B) adequate information on the chemistry and manufacturing of
the drug, controls available for the drug, and primary data
tabulations from animal or human studies.

‘(3)(A) At any time, the Secretary may prohibit the sponsor of an
investigation from conducting the investigation (referred to in this
paragraph as a ‘clinical hold’) if the Secretary makes a
determination described in subparagraph (B). The Secretary shall
specify the basis for the clinical hold, including the specific
information available to the Secretary which served as the basis for
such clinical hold, and confirm such determination in writing.

‘(B) For purposes of subparagraph (A), a determination described
in this subparagraph with respect to a clinical hold is that–

‘(i) the drug involved represents an unreasonable risk to the
safety of the persons who are the subjects of the clinical
investigation, taking into account the qualifications of the clinical
investigators, information about the drug, the design of the clinical
investigation, the condition for which the drug is to be
investigated, and the health status of the subjects involved; or

‘(ii) the clinical hold should be issued for such other reasons as
the Secretary may by regulation establish (including reasons
established by regulation before the date of the enactment of the
Food and Drug Administration Modernization Act of 1997).

‘(C) Any written request to the Secretary from the sponsor of an
investigation that a clinical hold be removed shall receive a
decision, in writing and specifying the reasons therefor, within 30
days after receipt of such request. Any such request shall include
sufficient information to support the removal of such clinical hold.

‘(4) Regulations under paragraph (1) shall provide that such
exemption shall be conditioned upon the manufacturer, or the sponsor
of the investigation, requiring that experts using such drugs for
investigational purposes certify to such manufacturer or sponsor that
they will inform any human beings to whom such drugs, or any controls
used in connection therewith, are being administered, or their
representatives, that such drugs are being used for investigational
purposes and will obtain the consent of such human beings or their
representatives, except where it is not feasible or it is contrary to
the best interests of such human beings. Nothing in this subsection
shall be construed to require any clinical investigator to submit
directly to the Secretary reports on the investigational use of
drugs.’

SEC. 118. DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS

Within 12 months after the date of enactment of this Act, the
Secretary of 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(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 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. 119. CONTENT AND REVIEW OF APPLICATIONS

(a) SECTION 505(b)- Section 505(b) (21 U.S.C. 355(b)) is amended
by adding at the end the following: ‘(4)(A) The Secretary shall issue
guidance for the individuals who review applications submitted under
paragraph (1) or under section 351 of the Public Health Service Act,
which shall relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and knowledge of
regulatory and scientific standards, and which shall apply equally to
all individuals who review such applications.

‘(B) The Secretary shall meet with a sponsor of an investigation
or an applicant for approval for a drug under this subsection or
section 351 of the Public Health Service Act if the sponsor or
applicant makes a reasonable written request for a meeting for the
purpose of reaching agreement on the design and size of clinical
trials intended to form the primary basis of an effectiveness claim.
The sponsor or applicant shall provide information necessary for
discussion and agreement on the design and size of the clinical
trials. Minutes of any such meeting shall be prepared by the
Secretary and made available to the sponsor or applicant upon
request.

‘(C) Any agreement regarding the parameters of the design and size
of clinical trials of a new drug under this paragraph that is reached
between the Secretary and a sponsor or applicant shall be reduced to
writing and made part of the administrative record by the Secretary.
Such agreement shall not be changed after the testing begins,
except–

‘(i) with the written agreement of the sponsor or applicant; or

‘(ii) pursuant to a decision, made in accordance with subparagraph
(D) by the director of the reviewing division, that a substantial
scientific issue essential to determining the safety or effectiveness
of the drug has been identified after the testing has begun.

‘(D) A decision under subparagraph (C)(ii) by the director shall
be in writing and the Secretary shall provide to the sponsor or
applicant an opportunity for a meeting at which the director and the
sponsor or applicant will be present and at which the director will
document the scientific issue involved.

‘(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by, the
field or compliance division personnel unless such field or
compliance division personnel demonstrate to the reviewing division
why such decision should be modified.

‘(F) No action by the reviewing division may be delayed because of
the unavailability of information from or action by field personnel
unless the reviewing division determines that a delay is necessary to
assure the marketing of a safe and effective drug.

‘(G) For purposes of this paragraph, the reviewing division is the
division responsible for the review of an application for approval of
a drug under this subsection or section 351 of the Public Health
Service Act (including all scientific and medical matters, chemistry,
manufacturing, and controls).’

(b) SECTION 505(j)-

(1) AMENDMENT- Section 505(j) (21 U.S.C 355(j)) is amended– (A)
by redesignating paragraphs (3) through (8) as paragraphs (4) through
(9), respectively; and (B) by adding after paragraph (2) the
following: ‘(3)(A) The Secretary shall issue guidance for the
individuals who review applications submitted under paragraph (1),
which shall relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and knowledge of
regulatory and scientific standards, and which shall apply equally to
all individuals who review such applications.

‘(B) The Secretary shall meet with a sponsor of an investigation
or an applicant for approval for a drug under this subsection if the
sponsor or applicant makes a reasonable written request for a meeting
for the purpose of reaching agreement on the design and size of
bioavailability and bioequivalence studies needed for approval of
such application. The sponsor or applicant shall provide information
necessary for discussion and agreement on the design and size of such
studies. Minutes of any such meeting shall be prepared by the
Secretary and made available to the sponsor or applicant.

‘(C) Any agreement regarding the parameters of design and size of
bioavailability and bioequivalence studies of a drug under this
paragraph that is reached between the Secretary and a sponsor or
applicant shall be reduced to writing and made part of the
administrative record by the Secretary. Such agreement shall not be
changed after the testing begins, except–

‘(i) with the written agreement of the sponsor or applicant; or

‘(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by, the
field or compliance office personnel unless such field or compliance
office personnel demonstrate to the reviewing division why such
decision should be modified..

‘(G) For purposes of this paragraph, the reviewing division is the
division responsible for the review of an application for approval of
a drug under this subsection (including scientific matters,
chemistry, manufacturing, and controls).’

(2) CONFORMING AMENDMENTS- Section 505(j) (21 U.S.C. 355(j)), as
amended by paragraph (1), is further amended– (A) in paragraph
(2)(A)(i), by striking ‘(6)’ and inserting ‘(7)’; (B) in paragraph
(4) (as redesignated in paragraph (1)), by striking ‘(4)’ and
inserting ‘(5)’; (C) in paragraph (4)(I) (as redesignated in
paragraph (1)), by striking ‘(5)’ and inserting ‘(6)’; and (D) in
paragraph (7)(C) (as redesignated in paragraph (1)), by striking
‘(5)’ each place it occurs and inserting ‘(6)’.

SEC. 120. SCIENTIFIC ADVISORY PANELS

Section 505 (21 U.S.C. 355) is amended by adding at the end the
following: ‘(n)(1) For the purpose of providing expert scientific
advice and recommendations to the Secretary regarding a clinical
investigation of a drug or the approval for marketing of a drug under
section 505 or section 351 of the Public Health Service Act, the
Secretary shall establish panels of experts or use panels of experts
established before the date of enactment of the Food and Drug
Administration Modernization Act of 1997, or both.

‘(2) The Secretary may delegate the appointment and oversight
authority granted under section 904 to a director of a center or
successor entity within the Food and Drug Administration.

‘(3) The Secretary shall make appointments to each panel
established under paragraph (1) so that each panel shall consist of–

‘(A) members who are qualified by training and experience to
evaluate the safety and effectiveness of the drugs to be referred to
the panel and who, to the extent feasible, possess skill and
experience in the development, manufacture, or utilization of such
drugs;

‘(B) members with diverse expertise in such fields as clinical and
administrative medicine, pharmacy, pharmacology, pharmacoeconomics,
biological and physical sciences, and other related professions;

‘(C) a representative of consumer interests, and a representative
of interests of the drug manufacturing industry not directly affected
by the matter to be brought before the panel; and

‘(D) two or more members who are specialists or have other
expertise in the particular disease or condition for which the drug
under review is proposed to be indicated.

Scientific, trade, and consumer organizations shall be afforded an
opportunity to nominate individuals for appointment to the panels.

No individual who is in the regular full-time employ of the United
States and engaged in the administration of this Act may be a voting
member of any panel. The Secretary shall designate one of the members
of each panel to serve as chairman thereof.

‘(4) Each member of a panel shall publicly disclose all conflicts
of interest that member may have with the work to be undertaken by
the panel. No member of a panel may vote on any matter where the
member or the immediate family of such member could gain financially
from the advice given to the Secretary. The Secretary may grant a
waiver of any conflict of interest requirement upon public disclosure
of such conflict of interest if such waiver is necessary to afford
the panel essential expertise, except that the Secretary may not
grant a waiver for a member of a panel when the member’s own
scientific work is involved.

‘(5) The Secretary shall, as appropriate, provide education and
training to each new panel member before such member participates in
a panel’s activities, including education regarding requirements
under this Act and related regulations of the Secretary, and the
administrative processes and procedures related to panel meetings.

‘(6) Panel members (other than officers or employees of the United
States), while attending meetings or conferences of a panel or
otherwise engaged in its business, shall be entitled to receive
compensation for each day so engaged, including traveltime, at rates
to be fixed by the Secretary, but not to exceed the daily equivalent
of the rate in effect for positions classified above grade GS-15 of
the General Schedule. While serving away from their homes or regular
places of business, panel members may be allowed travel expenses
(including per diem in lieu of subsistence) as authorized by section
5703 of title 5, United States Code, for persons in the Government
service employed intermittently.

‘(7) The Secretary shall ensure that scientific advisory panels
meet regularly and at appropriate intervals so that any matter to be
reviewed by such a panel can be presented to the panel not more than
60 days after the matter is ready for such review. Meetings of the
panel may be held using electronic communication to convene the
meetings.

‘(8) Within 90 days after a scientific advisory panel makes
recommendations on any matter under its review, the Food and Drug
Administration official responsible for the matter shall review the
conclusions and recommendations of the panel, and notify the affected
persons of the final decision on the matter, or of the reasons that
no such decision has been reached. Each such final decision shall be
documented including the rationale for the decision.’

SEC. 121. POSITRON EMISSION TOMOGRAPHY

(a) REGULATION OF COMPOUNDED POSITRON EMISSION TOMOGRAPHY DRUGS-
Section 201 (21 U.S.C. 321) is amended by adding at the end the
following: ‘(ii) The term ‘compounded positron emission tomography
drug’–

‘(1) means a drug that– ‘(A) exhibits spontaneous disintegration
of unstable nuclei by the emission of positrons and is used for the
purpose of providing dual photon positron emission tomographic
diagnostic images; and ‘(B) has been compounded by or on the order of
a practitioner who is licensed by a State to compound or order
compounding for a drug described in subparagraph (A), and is
compounded in accordance with that State’s law, for a patient or for
research, teaching, or quality control; and

‘(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 such a drug.’

(b) ADULTERATION-

(1) IN GENERAL- Section 501(a) (21 U.S.C. 351(a)) 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, that it purports or is
represented to possess; or (3)’

(2) SUNSET- Section 501(a)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not apply 4 years after
the date of enactment of this Act or 2 years after the date on which
the Secretary of Health and Human Services establishes the
requirements described in subsection (c)(1)(B), whichever is later.

(c) REQUIREMENTS FOR REVIEW OF APPROVAL PROCEDURES AND CURRENT
GOOD MANUFACTURING PRACTICES FOR POSITRON EMISSION TOMOGRAPHY-

(1) PROCEDURES AND REQUIREMENTS- (A) IN GENERAL- In order to take
account of the special characteristics of positron emission
tomography drugs and the special techniques and processes required to
produce these drugs, not later than 2 years after the date of
enactment of this Act, the Secretary of Health and Human Services
shall establish– (i) appropriate procedures for the approval of
positron emission tomography drugs pursuant to section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and (ii)
appropriate current good manufacturing practice requirements for such
drugs.

(B) CONSIDERATIONS AND CONSULTATION- In establishing the
procedures and requirements required by subparagraph (A), the
Secretary of Health and Human Services shall take due account of any
relevant differences between not-for-profit institutions that
compound the drugs for their patients and commercial manufacturers of
the drugs. Prior to establishing the procedures and requirements, the
Secretary of Health and Human Services shall consult with patient
advocacy groups, professional associations, manufacturers, and
physicians and scientists licensed to make or use positron emission
tomography drugs.

(2) SUBMISSION OF NEW DRUG APPLICATIONS AND ABBREVIATED NEW DRUG
APPLICATIONS- (A) IN GENERAL- Except as provided in subparagraph (B),
the Secretary of Health and Human Services shall not require the
submission of new drug applications or abbreviated new drug
applications under subsection (b) or (j) of section 505 (21 U.S.C.
355), for compounded positron emission tomography drugs that are not
adulterated drugs described in section 501(a)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) (as amended by
subsection (b)), for a period of 4 years after the date of enactment
of this Act, or for 2 years after the date on which the Secretary
establishes procedures and requirements under paragraph (1),
whichever is longer.

(B) EXCEPTION- Nothing in this Act shall prohibit the voluntary
submission of such applications or the review of such applications by
the Secretary of Health and Human Services. Nothing in this Act shall
constitute an exemption for a positron emission tomography drug from
the requirements of regulations issued under section 505(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)).

(d) REVOCATION OF CERTAIN INCONSISTENT DOCUMENTS- Within 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
terminating the application of the following notices and rule:

(1) A notice entitled ‘Regulation of Positron Emission Tomography
Radiopharmaceutical Drug Products; Guidance; Public Workshop’,
published in the Federal Register on February 27, 1995, 60 Fed. Reg.
10594

(2) A notice entitled ‘Draft Guideline on the Manufacture of
Positron Emission Tomography Radiopharmaceutical Drug Products;
Availability’, published in the Federal Register on February 27,
1995, 60 Fed. Reg. 10593.

(3) A final rule entitled ‘Current Good Manufacturing Practice for
Finished Pharmaceuticals; Positron Emission Tomography’, published in
the Federal Register on April 22, 1997, 62 Fed. Reg. 19493 (codified
at part 211 of title 21, Code of Federal Regulations).

(e) DEFINITION- As used in this section, the term ‘compounded
positron emission tomography drug’ has the meaning given the term in
section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321).

SEC. 122. 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. 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 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, 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, one or more disease
states.

(b) DEFINITION- In this section, the term ‘radiopharma-ceutical’
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. 123. MODERNIZATION OF REGULATION

(a) LICENSES-

(1) IN GENERAL- Section 351(a) of the Public Health Service Act
(42 U.S.C. 262(a)) is amended to read as follows: ‘(a)(1) 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–

‘(i) 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; and

‘(ii) 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).

‘(3) 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, or 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 new drug applications under
section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(b)(1)).

(g) APPLICATION OF FEDERAL FOOD, DRUG, AND COSMETIC ACT- Section
351 of the Public Health Service Act (42 U.S.C. 262), as amended by
subsection (d), is further amended by adding at the end the
following: ‘(j) The Federal Food, Drug, and Cosmetic Act applies to a
biological product subject to regulation under this section, except
that a product for which a license has been approved under subsection
(a) shall not be required to have an approved application under
section 505 of such Act.’

(h) EXAMINATIONS AND PROCEDURES- Paragraph (3) of section 353(d)
of the Public Health Service Act (42 U.S.C. 263a(d)) is amended to
read as follows:

‘(3) EXAMINATIONS AND PROCEDURES- The examinations and procedures
identified in paragraph (2) are laboratory examinations and
procedures that have been approved by the Food and Drug
Administration for home use or that, as determined by the Secretary,
are simple laboratory examinations and procedures that have an
insignificant risk of an erroneous result, including those that–
‘(A) employ methodologies that are so simple and accurate as to
render the likelihood of erroneous results by the user negligible, or
‘(B) the Secretary has determined pose no unreasonable risk of harm
to the patient if performed incorrectly.’

SEC. 124. PILOT AND SMALL SCALE MANUFACTURE

(a) HUMAN DRUGS- Section 505(c) (21 U.S.C. 355(c)) is amended by
adding at the end the following: ‘(4) A drug manufactured in a pilot
or other small facility may be used to demonstrate the safety and
effectiveness of the drug and to obtain approval for the drug prior
to manufacture of the drug in a larger facility, unless the Secretary
makes a determination that a full scale production facility is
necessary to ensure the safety or effectiveness of the drug.’

(b) ANIMAL DRUGS- Section 512(c) (21 U.S.C. 360b(c)) is amended by
adding at the end the following: ‘(4) A drug manufactured in a pilot
or other small facility may be used to demonstrate the safety and
effectiveness of the drug and to obtain approval for the drug prior
to manufacture of the drug in a larger facility, unless the Secretary
makes a determination that a full scale production facility is
necessary to ensure the safety or effectiveness of the drug.’

SEC. 125. INSULIN AND ANTIBIOTICS

(a) CERTIFICATION OF DRUGS CONTAINING INSULIN-

(1) AMENDMENT- Section 506 (21 U.S.C. 356), as in effect before
the date of the enactment of this Act, is repealed.

(2) Conforming amendments- (A) Section 301(j) (21 U.S.C. 331(j))
is amended by striking ‘506, 507,’.

(B) Subsection (k) of section 502 (21 U.S.C. 352) is repealed.

(C) Sections 301(i)(1), 510(j)(1)(A), and 510(j)(1)(D) (21 U.S.C.
331(i)(1), 360(j)(1)(A), 360(j)(1)(D)) are each amended by striking
‘, 506, 507,’.

(D) Section 801(d)(1) (21 U.S.C. 381(d)(1)) is amended by
inserting after ‘503(b)’ the following: ‘or composed wholly or partly
of insulin’.

(E) Section 8126(h)(2) of title 38, United States Code, is amended
by inserting ‘or’ at the end of subparagraph (B), by striking ‘; or’
at the end of subparagraph (C) and inserting a period, and by
striking subparagraph (D).

(b) CERTIFICATION OF ANTIBIOTICS-

(1) AMENDMENT- Section 507 (21 U.S.C. 357) is repealed.

(2) Conforming amendments- (A) Section 201(aa) (21 U.S.C. 321(aa))
is amended by striking out ‘or 507’, section 201(dd) (21 U.S.C.
321(dd)) is amended by striking ‘507,’, and section 201(ff)(3)(A) (21
U.S.C. 321(ff)(3)(A)) is amended by striking ‘, certified as an
antibiotic under section 507,’.

(B) Section 301(e) (21 U.S.C. 331(e)) is amended by striking
‘507(d) or (g),’.

(D) Section 502 (21 U.S.C. 352) is amended by striking subsection
(l).

(E) Section 520(l) (21 U.S.C. 360j(l)) is amended by striking
paragraph (4) and by striking ‘or Antibiotic Drugs’ in the subsection
heading.

(F) Section 525(a) (21 U.S.C. 360aa(a)) is amended by inserting
‘or’ at the end of paragraph (1), by striking paragraph (2), and by
redesignating paragraph (3) as paragraph (2).

(G) Section 525(a) (21 U.S.C. 360aa(a)) is amended by striking ‘,
certification of such drug for such disease or condition under
section 507,’.

(H) Section 526(a)(1) (21 U.S.C. 360bb) is amended by striking
‘the submission of an application for certification of the drug under
section 507,’, by inserting ‘or’ at the end of subparagraph (A), by
striking subparagraph (B), and by redesignating subparagraph (C) as
subparagraph (B).

(I) Section 526(b) (21 U.S.C. 360bb(b)) is amended– (i) in
paragraph (1), by striking ‘, a certificate was issued for the drug
under section 507,’; and (ii) in paragraph (2) by striking ‘, a
certificate has not been issued for the drug under section 507,’ and
by striking ‘, approval of an application for certification under
section 507,’.

(J) Section 527(a) (21 U.S.C. 360cc(a)) is amended by inserting
‘or’ at the end of paragraph (1), by striking paragraph (2), by
redesignating paragraph (3) as paragraph (2), and by striking ‘,
issue another certification under section 507,’.

(K) Section 527(b) (21 U.S.C. 360cc(b)) is amended by striking ‘,
if a certification is issued under section 507 for such a drug,’, ‘,
of the issuance of the certification under section 507,’, ‘, issue
another certification under section 507,’, ‘, of such
certification,’, ‘, of the certification,’, and ‘, issuance of other
certifications,’.

(L) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by striking
‘, section 507 (d) or (g),’.

(M) Section 735(1) (21 U.S.C. 379g(1)(C)) is amended by inserting
‘or’ at the end of subparagraph (B), by striking subparagraph (C),
and by redesignating subparagraph (D) as subparagraph (C).

(N) Subparagraphs (A)(ii) and (B) of sections 5(b)(1) of the
Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A), 360ee(b)(1)(B)) are each
amended by striking ‘or 507’.

(O) Section 45C(b)(2)(A)(ii)(II) of the Internal Revenue Code of
1986 is amended by striking ‘or 507’.

(P) Section 156(f)(4)(B) of title 35, United States Code, is
amended by striking ‘507,’ each place it occurs.

(c) EXPORTATION- Section 802 (21 U.S.C. 382) is amended by adding
at the end the following: ‘(i) Insulin and antibiotic drugs may be
exported without regard to the requirements in this section if the
insulin and antibiotic drugs meet the requirements of section
801(e)(1).’

(d) TRANSITION-

(1) IN GENERAL- An application that was approved by the Secretary
of Health and Human Services before the date of the enactment of this
Act for the marketing of an antibiotic drug under section 507 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357), as in effect on
the day before the date of the enactment of this Act, shall, on and
after such date of enactment, be considered to be an application that
was submitted and filed under section 505(b) of such Act (21 U.S.C.
355(b)) and approved for safety and effectiveness under section
505(c) of such Act (21 U.S.C. 355(c)), except that if such
application for marketing was in the form of an abbreviated
application, the application shall be considered to have been filed
and approved under section 505(j) of such Act (21 U.S.C 355(j)).

(2) EXCEPTION- The following subsections of section 505 (21 U.S.C.
355) shall not apply to any application for marketing in which the
drug that is the subject of the application contains an antibiotic
drug and the antibiotic drug was the subject of any application for
marketing received by the Secretary of Health and Human Services
under section 507 of such Act (21 U.S.C. 357) before the date of the
enactment of this Act: (A)(i) Subsections (c)(2), (d)(6), (e)(4),
(j)(2)(A)(vii), (j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D);
and (ii) The third and fourth sentences of subsection (b)(1)
(regarding the filing and publication of patent information); and (B)
Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) if the
investigations relied upon by the applicant for approval of the
application were not conducted by or for the applicant and for which
the applicant has not obtained a right of reference or use from the
person by or for whom the investigations were conducted.

(3) PUBLICATION- For purposes of this section, the Secretary is
authorized to make available to the public the established name of
each antibiotic drug that was the subject of any application for
marketing received by the Secretary for Health and Human Services
under section 507 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 357) before the date of enactment of this Act.

(e) DEFINITION- Section 201 (21 U.S.C. 321), as amended by section
121(a)(1), is further amended by adding at the end the following:
‘(jj) The term ‘antibiotic drug’ means any drug (except drugs for use
in animals other than humans) composed wholly or partly of any kind
of penicillin, streptomycin, chlortetracycline, chloramphenicol,
bacitracin, or any other drug intended for human use containing any
quantity of any chemical substance which is produced by a
micro-organism and which has the capacity to inhibit or destroy
micro-organisms in dilute solution (including a chemically
synthesized equivalent of any such substance) or any derivative
thereof.’

SEC. 126. 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.

(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.

(a) AMENDMENT- Chapter V is amended by inserting after section 503
(21 U.S.C. 353) the following:

‘SEC. 503A. PHARMACY COMPOUNDING

‘(a) IN GENERAL- Sections 501(a)(2)(B), 502(f)(1), and 505 shall
not apply to a drug product if the drug product is compounded for an
identified individual patient based on the unsolicited receipt of a
valid prescription order or a notation, approved by the prescribing
practitioner, on the prescription order that a compounded product is
necessary for the identified patient, if the drug product meets the
requirements of this section, and if the compounding–

‘(1) is by– ‘(A) a licensed pharmacist in a State licensed
pharmacy or a Federal facility, or ‘(B) a licensed physician, on the
prescription order for such individual patient made by a licensed
physician or other licensed practitioner authorized by State law to
prescribe drugs; or

‘(2)(A) is by a licensed pharmacist or licensed physician in
limited quantities before the receipt of a valid prescription order
for such individual patient; and

‘(B) is based on a history of the licensed pharmacist or licensed
physician receiving valid prescription orders for the compounding of
the drug product, which orders have been generated solely within an
established relationship between– ‘(i) the licensed pharmacist or
licensed physician; and ‘(ii)(I) such individual patient for whom the
prescription order will be provided; or ‘(II) the physician or other
licensed practitioner who will write such prescription order.

‘(b) COMPOUNDED DRUG-

‘(1) LICENSED PHARMACIST AND LICENSED PHYSICIAN- A drug product
may be compounded under subsection (a) if the licensed pharmacist or
licensed physician– ‘(A) compounds the drug product using bulk drug
substances, as defined in regulations of the Secretary published at
section 207.3(a)(4) of title 21 of the Code of Federal Regulations–
‘(i) that– ‘(I) comply with the standards of an applicable United
States Pharmacopoeia or National Formulary monograph, if a monograph
exists, and the United States Pharmacopoeia chapter on pharmacy
compounding; ‘(II) if such a monograph does not exist, are drug
substances that are components of drugs approved by the Secretary; or
‘(III) if such a monograph does not exist and the drug substance is
not a component of a drug approved by the Secretary, that appear on a
list developed by the Secretary through regulations issued by the
Secretary under subsection (d); ‘(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; ‘(B) compounds the drug product using
ingredients (other than bulk drug substances) that comply with the
standards of an applicable United States Pharmacopoeia or National
Formulary monograph, if a monograph exists, and the United States
Pharmacopoeia chapter on pharmacy compounding; ‘(C) 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; and
‘(D) does not compound regularly or in inordinate amounts (as defined
by the Secretary) any drug products that are essentially copies of a
commercially available drug product.

‘(2) DEFINITION- For purposes of paragraph (1)(D), the term
‘essentially a copy of a commercially available drug product’ does
not include a drug product in which there is a change, made for an
identified individual patient, which produces for that patient a
significant difference, as determined by the prescribing
practitioner, between the compounded drug and the comparable
commercially available drug product.

‘(3) DRUG PRODUCT- A drug product may be compounded under
subsection (a) only if– ‘(A) such drug product is not a drug product
identified by the Secretary by regulation as a drug product that
presents demonstrable difficulties for compounding that reasonably
demonstrate an adverse effect on the safety or effectiveness of that
drug product; and ‘(B) such drug product is compounded in a State–
‘(i) that has entered into a memorandum of understanding with the
Secretary which addresses the distribution of inordinate amounts of
compounded drug products interstate and provides for appropriate
investigation by a State agency of complaints relating to compounded
drug products distributed outside such State; or ‘(ii) that has not
entered into the memorandum of understanding described in clause (i)
and the licensed pharmacist, licensed pharmacy, or licensed physician
distributes (or causes to be distributed) compounded drug products
out of the State in which they are compounded in quantities that do
not exceed 5 percent of the total prescription orders dispensed or
distributed by such pharmacy or physician.

The Secretary shall, in consultation with the National Association
of Boards of Pharmacy, develop a standard memorandum of understanding
for use by the States in complying with subparagraph (B)(i).

‘(c) ADVERTISING AND PROMOTION- A drug may be compounded under
subsection (a) only if the pharmacy, licensed pharmacist, or licensed
physician does not advertise or promote the compounding of any
particular drug, class of drug, or type of drug. The pharmacy,
licensed pharmacist, or licensed physician may advertise and promote
the compounding service provided by the licensed pharmacist or
licensed physician.

‘(d) REGULATIONS-

‘(1) IN GENERAL- The Secretary shall issue regulations to
implement this section. Before issuing regulations to implement
subsections (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A), the Secretary
shall convene and consult an advisory committee on compounding unless
the Secretary determines that the issuance of such regulations before
consultation is necessary to protect the public health. The advisory
committee shall include representatives from the National Association
of Boards of Pharmacy, the United States Pharmacopoeia, pharmacy,
physician, and consumer organizations, and other experts selected by
the Secretary.

‘(2) LIMITING COMPOUNDING- The Secretary, in consultation with the
United States Pharmacopoeia Convention, Incorporated, shall
promulgate regulations identifying drug substances that may be used
in compounding under subsection (b)(1)(A)(i)(III) for which a
monograph does not exist or which are not components of drug products
approved by the Secretary. The Secretary shall include in the
regulation the criteria for such substances, which shall include
historical use, reports in peer reviewed medical literature, or other
criteria the Secretary may identify.

‘(e) APPLICATION- This section shall not apply to–

‘(1) compounded positron emission tomography drugs as defined in
section 201(ii); or

‘(2) radiopharmaceuticals.

‘(f) DEFINITION- As used in this section, the term ‘compounding’
does not include mixing, reconstituting, or other such acts that are
performed in accordance with directions contained in approved
labeling provided by the product’s manufacturer and other
manufacturer directions consistent with that labeling.’

(b) EFFECTIVE DATE- Section 503A of the Federal Food, Drug, and
Cosmetic Act, added by subsection (a), shall take effect upon the
expiration of the 1-year period beginning on the date of the
enactment of this Act.

SEC. 128. REAUTHORIZATION OF CLINICAL PHARMACOLOGY PROGRAM

Section 2 of Public Law 102-222 (105 Stat. 1677) is amended–

(1) in subsection (a), by striking ‘a grant’ and all that follows
through ‘Such grant’ and inserting the following: ‘grants for a pilot
program for the training of individuals in clinical pharmacology at
appropriate medical schools. Such grants’; and

(2) in subsection (b), by striking ‘to carry out this section’ and
inserting ‘, and for fiscal years 1998 through 2002 $3,000,000 for
each fiscal year, to carry out this section’.

SEC. 129. REGULATIONS FOR SUNSCREEN PRODUCTS

Not later than 18 months after the date of enactment of this Act,
the Secretary of Health and Human Services shall issue regulations
for over-the-counter sunscreen products for the prevention or
treatment of sunburn.

SEC. 130. REPORTS OF POSTMARKETING APPROVAL STUDIES

(a) IN GENERAL- Chapter V, as amended by section 116, is further
amended by inserting after section 506A the following:

‘SEC. 506B. REPORTS OF POSTMARKETING STUDIES

‘(a) SUBMISSION-

‘(1) IN GENERAL- A sponsor of a drug that has entered into an
agreement with the Secretary to conduct a postmarketing study of a
drug shall submit to the Secretary, within 1 year after the approval
of such drug and annually thereafter until the study is completed or
terminated, a report of the progress of the study or the reasons for
the failure of the sponsor to conduct the study. The report shall be
submitted in such form as is prescribed by the Secretary in
regulations issued by the Secretary

‘(2) AGREEMENTS PRIOR TO EFFECTIVE DATE- Any agreement entered
into between the Secretary and a sponsor of a drug, prior to the date
of enactment of the Food and Drug Administration Modernization Act of
1997, to conduct a postmarketing study of a drug shall be subject to
the requirements of paragraph (1). An initial report for such an
agreement shall be submitted within 6 months after the date of the
issuance of the regulations under paragraph (1).

‘(b) CONSIDERATION OF INFORMATION AS PUBLIC INFORMATION- Any
information pertaining to a report described in subsection (a) shall
be considered to be public information to the extent that the
information is necessary–

‘(1) to identify the sponsor; and

‘(2) to establish the status of a study described in subsection
(a) and the reasons, if any, for any failure to carry out the study.

‘(c) STATUS OF STUDIES AND REPORTS- The Secretary shall annually
develop and publish in the Federal Register a report that provides
information on the status of the postmarketing studies–

‘(1) that sponsors have entered into agreements to conduct; and

‘(2) for which reports have been submitted under subsection
(a)(1).’

(b) REPORT TO CONGRESSIONAL COMMITTEES- Not later than October 1,
2001, the Secretary 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 containing–

(1) a summary of the reports submitted under section 506B of the
Federal Food, Drug, and Cosmetic Act;

(2) an evaluation of– (A) the performance of the sponsors
referred to in such section in fulfilling the agreements with respect
to the conduct of postmarketing studies described in such section of
such Act; and (B) the timeliness of the Secretary’s review of the
postmarketing studies; and

(3) any legislative recommendations respecting the postmarketing
studies.

(a) IN GENERAL- Chapter V, as amended by section 130, is further
amended by inserting after section 506B the following:

‘SEC. 506C. DISCONTINUANCE OF A LIFE SAVING PRODUCT

‘(a) IN GENERAL- A manufacturer that is the sole manufacturer of a
drug–

‘(1) that is– ‘(A) life-supporting; ‘(B) life-sustaining; or ‘(C)
intended for use in the prevention of a debilitating disease or
condition;

‘(2) for which an application has been approved under section
505(b) or 505(j); and

‘(3) that is not a product that was originally derived from human
tissue and was replaced by a recombinant product, shall notify the
Secretary of a discontinuance of the manufacture of the drug at least
6 months prior to the date of the discontinuance.

‘(b) REDUCTION IN NOTIFICATION PERIOD- The notification period
required under subsection (a) for a manufacturer may be reduced if
the manufacturer certifies to the Secretary that good cause exists
for the reduction, such as a situation in which–

‘(1) a public health problem may result from continuation of the
manufacturing for the 6-month period;

‘(2) a biomaterials shortage prevents the continuation of the
manufacturing for the 6-month period;

‘(3) a liability problem may exist for the manufacturer if the
manufacturing is continued for the 6-month period;

‘(4) continuation of the manufacturing for the 6-month period may
cause substantial economic hardship for the manufacturer;

‘(5) the manufacturer has filed for bankruptcy under chapter 7 or
11 of title 11, United States Code; or

‘(6) the manufacturer can continue the distribution of the drug
involved for 6 months.

‘(c) DISTRIBUTION- To the maximum extent practicable, the
Secretary shall distribute information on the discontinuation of the
drugs described in subsection (a) to appropriate physician and
patient organizations.’