[DOCID: f:publ115.105]
[[Page 2295]]
FOOD AND DRUG ADMINISTRATION MODERIZATION ACT OF 1997
[[Page 111 STAT. 2296]]
Public Law 105-115
105th Congress
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. <<NOTE: Nov. 21,
1997 - [S. 830]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Food and Drug
Administration Modernization Act of 1997.>>
SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.
<<NOTE: 21 USC 301 note.>> (a) Short Title.--This Act may be cited
as the ``Food and Drug Administration Modernization Act of 1997''.
(b) References.--Except as otherwise specified, whenever in this Act
an amendment or repeal is expressed in terms of an amendment to or a
repeal of a section or other provision, the reference shall be
considered to be made to that section or other provision of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(c) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; references; table of contents.
Sec. 2. Definitions.
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.
[[Page 111 STAT. 2297]]
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.
TITLE II--IMPROVING REGULATION OF DEVICES
Sec. 201. Investigational device exemptions.
Sec. 202. Special review for certain devices.
Sec. 203. Expanding humanitarian use of devices.
Sec. 204. Device standards.
Sec. 205. Scope of review; collaborative determinations of device data requirements.
Sec. 206. Premarket notification.
Sec. 207. Evaluation of automatic class III designation.
Sec. 208. Classification panels.
Sec. 209. Certainty of review timeframes; collaborative review process.
Sec. 210. Accreditation of persons for review of premarket notification reports.
Sec. 211. Device tracking.
Sec. 212. Postmarket surveillance.
Sec. 213. Reports.
Sec. 214. Practice of medicine.
Sec. 215. Noninvasive blood glucose meter.
Sec. 216. Use of data relating to premarket approval; product development protocol.
Sec. 217. Clarification of the number of required clinical investigations for approval.
TITLE III--IMPROVING REGULATION OF FOOD
Sec. 301. Flexibility for regulations regarding claims.
Sec. 302. Petitions for claims.
Sec. 303. Health claims for food products.
Sec. 304. Nutrient content claims.
Sec. 305. Referral statements.
Sec. 306. Disclosure of irradiation.
Sec. 307. Irradiation petition.
Sec. 308. Glass and ceramic ware.
Sec. 309. Food contact substances.
TITLE IV--GENERAL PROVISIONS
Sec. 401. Dissemination of information on new uses.
Sec. 402. Expanded access to investigational therapies and diagnostics.
Sec. 403. Approval of supplemental applications for approved products.
Sec. 404. Dispute resolution.
Sec. 405. Informal agency statements.
Sec. 406. Food and Drug Administration mission and annual report.
Sec. 407. Information system.
Sec. 408. Education and training.
Sec. 409. Centers for education and research on therapeutics.
Sec. 410. Mutual recognition agreements and global harmonization.
Sec. 411. Environmental impact review.
Sec. 412. National uniformity for nonprescription drugs and cosmetics.
Sec. 413. Food and Drug Administration study of mercury compounds in drugs and food.
Sec. 414. Interagency collaboration.
Sec. 415. Contracts for expert review.
Sec. 416. Product classification.
Sec. 417. Registration of foreign establishments.
Sec. 418. Clarification of seizure authority.
Sec. 419. Interstate commerce.
Sec. 420. Safety report disclaimers.
Sec. 421. Labeling and advertising regarding compliance with statutory requirements.
Sec. 422. Rule of construction.
TITLE V--EFFECTIVE DATE
Sec. 501. Effective date.
<<NOTE: 21 USC 321 note.>> SEC. 2. DEFINITIONS.
In this Act, the terms ``drug'', ``device'', ``food'', and ``dietary
supplement'' have the meaning given such terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
[[Page 111 STAT. 2298]]
TITLE I--IMPROVING REGULATION OF DRUGS
Subtitle A--Fees Relating to Drugs
<<NOTE: 21 USC 379g note.>> 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
[[Page 111 STAT. 2299]]
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)--
[[Page 111 STAT. 2300]]
(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
[[Page 111 STAT. 2301]]
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
[[Page 111 STAT. 2302]]
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.''.
(c) Increases and Adjustments.--Section 736(c) (21 U.S.C. 379h(c))
is amended--
(1) in the subsection heading, by striking ``Increases
and'';
(2) in paragraph (1)--
(A) by striking ``(1) Revenue'' and all that follows
through ``increased by the Secretary'' and inserting the
following: ``(1) Inflation adjustment.--The fees and
total fee revenues established in subsection (b) shall
be adjusted by the Secretary'';
(B) in subparagraph (A), by striking ``increase''
and inserting ``change'';
(C) in subparagraph (B), by striking ``increase''
and inserting ``change''; and
(D) by adding at the end the following flush
sentence:
``The adjustment made each fiscal year by this subsection will
be added on a compounded basis to the sum of all adjustments
made each fiscal year after fiscal year 1997 under this
subsection.'';
(3) in paragraph (2), by striking ``October 1, 1992,'' and
all that follows through ``such schedule.'' and inserting the
following: ``September 30, 1997, adjust the establishment and
product fees described in subsection (b) for the fiscal year in
which the adjustment occurs so that the revenues collected from
each of the categories of fees described in paragraphs (2) and
(3) of subsection (b) shall be set to be equal to the revenues
collected 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:
[[Page 111 STAT. 2303]]
``(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,
[[Page 111 STAT. 2304]]
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.''.
<<NOTE: 21 USC 379h note.>> (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.
<<NOTE: 21 USC 379g note.>> 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
[[Page 111 STAT. 2305]]
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.
<<NOTE: 21 USC 379g note.>> 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.
<<NOTE: 21 USC 379g note.>> SEC. 106. EFFECTIVE DATE.
The amendments made by this subtitle shall take effect October 1,
1997.
<<NOTE: 21 USC 379g note.>> 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:
<<NOTE: 21 USC 355a.>> ``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--
[[Page 111 STAT. 2306]]
``(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)--
``(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)
[[Page 111 STAT. 2307]]
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
``(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).
``(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
[[Page 111 STAT. 2308]]
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.
[[Page 111 STAT. 2309]]
``(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:
<<NOTE: 21 USC 356.>> ``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
[[Page 111 STAT. 2310]]
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.''.
<<NOTE: 21 USC 356 note.>> (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.
SEC. 113. INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERIOUS OR
LIFE-THREATENING DISEASES.
(a) In General.--Section 402 of the Public Health Service Act (42
U.S.C. 282) is amended--
(1) by redesignating subsections (j) and (k) as subsections
(k) and (l), respectively; and
[[Page 111 STAT. 2311]]
(2) by inserting after subsection (i) the following:
<<NOTE: Establishment.>> ``(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
[[Page 111 STAT. 2312]]
such disclosure would not substantially interfere with such enrollment.
<<NOTE: Appropriation authorization.>> ``(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.''.
<<NOTE: 42 USC 282 note.>> (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.''.
<<NOTE: 21 USC 352 note.>> (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.
[[Page 111 STAT. 2313]]
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:
<<NOTE: 21 USC 356a.>> ``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.
[[Page 111 STAT. 2314]]
``(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)
[[Page 111 STAT. 2315]]
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.''.
<<NOTE: 21 USC 356a note.>> (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.
[[Page 111 STAT. 2316]]
``(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.''.
<<NOTE: 21 USC 355 note.>> 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.
[[Page 111 STAT. 2317]]
``(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
[[Page 111 STAT. 2318]]
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
``(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 office personnel unless such field or compliance
office 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 (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
[[Page 111 STAT. 2319]]
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.
[[Page 111 STAT. 2320]]
``(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)''.
<<NOTE: 21 USC 351 note.>> (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.
[[Page 111 STAT. 2321]]
<<NOTE: 21 USC 355 note.>> (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)).
<<NOTE: Federal Register, publication.>> (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.
[[Page 111 STAT. 2322]]
(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).
<<NOTE: 21 USC 355 note.>> (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).
<<NOTE: 21 USC 355 note.>> 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.
[[Page 111 STAT. 2323]]
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.''.
[[Page 111 STAT. 2324]]
(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)''.
<<NOTE: 21 USC 355 note.>> (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:
[[Page 111 STAT. 2325]]
``(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),''.
(C) Section 306(d)(4)(B)(ii) (21 U.S.C.
335a(d)(4)(B)(ii)) is amended by striking ``or 507''.
(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).
[[Page 111 STAT. 2326]]
(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 <<NOTE: 26 USC 45C.>> 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).''.
<<NOTE: 21 USC 355 note.>> (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
[[Page 111 STAT. 2327]]
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.
(c) Conforming Amendments.--
(1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended--
(A) by striking subparagraph (A); and
[[Page 111 STAT. 2328]]
(B) by redesignating subparagraphs (B) and (C) as
subparagraphs (A) and (B), respectively.
(2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by
striking ``section 502(d) and''.
(3) Section 102(9)(A) of the Controlled Substances Act (21
U.S.C. 802(9)(A)) is amended--
(A) in clause (i), by striking ``(i)''; and
(B) by striking ``(ii)'' and all that follows.
SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHARMACY
COMPOUNDING.
(a) Amendment.--Chapter V is amended by inserting after section 503
(21 U.S.C. 353) the following:
<<NOTE: 21 USC 353a.>> ``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
[[Page 111 STAT. 2329]]
``(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.
[[Page 111 STAT. 2330]]
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.''.
<<NOTE: 21 USC 353a note.>> (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
[[Page 111 STAT. 2331]]
(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''.
<<NOTE: 21 USC 393 note.>> 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:
<<NOTE: 21 USC 356b.>> ``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 re