[Congressional Record Volume 143, Number 120 (Thursday, September 11, 1997)]
[Senate]
[Pages S9133-S9157]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF
1997
The PRESIDING OFFICER. The clerk will report the bill.
The legislative clerk read as follows:
A bill (S. 830) 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, which had been reported from to the
Committee on Labor and Human Resources, with an amendment
to strike all after the enacting clause and inserting in
lieu thereof the following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food and Drug Administration
Modernization and Accountability Act of 1997''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References.
TITLE I--IMPROVING PATIENT ACCESS
Sec. 101. Mission of the Food and Drug Administration.
Sec. 102. Expedited access to investigational therapies.
Sec. 103. Expanded humanitarian use of devices.
TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES
Sec. 201. Interagency collaboration.
Sec. 202. Sense of the committee regarding mutual recognition
agreements and global harmonization efforts.
Sec. 203. Contracts for expert review.
Sec. 204. Accredited-party reviews.
Sec. 205. Device performance standards.
TITLE III--IMPROVING COLLABORATION AND COMMUNICATION
Sec. 301. Collaborative determinations of device data requirements.
Sec. 302. Collaborative review process.
TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES
Sec. 401. Policy statements.
Sec. 402. Product classification.
Sec. 403. Use of data relating to premarket approval.
Sec. 404. Consideration of labeling claims for product review.
[[Page S9134]]
Sec. 405. Definition of a day for purposes of product review.
Sec. 406. Certainty of review timeframes.
Sec. 407. Limitations on initial classification determinations.
Sec. 408. Clarification with respect to a general use and specific use
of a device.
Sec. 409. Clarification of the number of required clinical
investigations for approval.
Sec. 410. Prohibited acts.
TITLE V--IMPROVING ACCOUNTABILITY
Sec. 501. Agency plan for statutory compliance and annual report.
TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES
Sec. 601. Minor modifications.
Sec. 602. Environmental impact review.
Sec. 603. Exemption of certain classes of devices from premarket
notification requirement.
Sec. 604. Evaluation of automatic class III designation.
Sec. 605. Secretary's discretion to track devices.
Sec. 606. Secretary's discretion to conduct postmarket surveillance.
Sec. 607. Reporting.
Sec. 608. Pilot and small-scale manufacture.
Sec. 609. Requirements for radiopharmaceuticals.
Sec. 610. Modernization of regulation of biological products.
Sec. 611. Approval of supplemental applications for approved products.
Sec. 612. Health care economic information.
Sec. 613. Expediting study and approval of fast track drugs.
Sec. 614. Manufacturing changes for drugs and biologics.
Sec. 615. Data requirements for drugs and biologics.
Sec. 616. Food contact substances.
Sec. 617. Health claims for food products.
Sec. 618. Pediatric studies marketing exclusivity.
Sec. 619. Positron emission tomography.
TITLE VII--FEES RELATING TO DRUGS
Sec. 701. Short title.
Sec. 702. Findings.
Sec. 703. Definitions.
Sec. 704. Authority to assess and use drug fees.
Sec. 705. Annual reports.
Sec. 706. Effective date.
Sec. 707. Termination of effectiveness.
TITLE VIII--MISCELLANEOUS
Sec. 801. Registration of foreign establishments.
Sec. 802. Elimination of certain labeling requirements.
Sec. 803. Clarification of seizure authority.
Sec. 804. Intramural research training award program.
Sec. 805. Device samples.
Sec. 806. Interstate commerce.
Sec. 807. National uniformity for nonprescription drugs and cosmetics.
Sec. 808. Information program on clinical trials for serious or life-
threatening diseases.
Sec. 809. Application of Federal law to the practice of pharmacy
compounding.
SEC. 3. REFERENCES.
Except as otherwise expressly provided, wherever in this
Act an amendment or repeal is expressed in terms of an
amendment to, or repeal of, a section or other provision, the
reference shall be considered to be made to a section or
other provision of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321 et seq.).
TITLE I--IMPROVING PATIENT ACCESS
SEC. 101. MISSION OF THE FOOD AND DRUG ADMINISTRATION.
Section 903 (21 U.S.C. 393) is amended--
(1) by redesignating subsections (b) and (c) as subsections
(c) and (d), respectively; and
(2) by inserting after subsection (a) the following:
``(b) Mission.--
``(1) In general.--The Administration shall protect the
public health by ensuring that--
``(A) foods are safe, wholesome, sanitary, and properly
labeled;
``(B) human and veterinary drugs are safe and effective;
``(C) there is reasonable assurance of safety and
effectiveness of devices intended for human use;
``(D) cosmetics are safe; and
``(E) public health and safety are protected from
electronic product radiation.
``(2) Special rules.--The Administration shall promptly and
efficiently review clinical research and take appropriate
action on the marketing of regulated products in a manner
that does not unduly impede innovation or product
availability. The Administration shall participate with other
countries to reduce the burden of regulation, to harmonize
regulatory requirements, and to achieve appropriate
reciprocal arrangements with other countries.''.
SEC. 102. EXPEDITED ACCESS TO INVESTIGATIONAL THERAPIES.
Chapter V (21 U.S.C. 351 et seq.) is amended by adding at
the end the following:
``Subchapter D--Unapproved Therapies and Diagnostics
``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND
DIAGNOSTICS.
``(a) In General.--Any person, acting through a physician
licensed in accordance with State law, may request from a
manufacturer or distributor, and any manufacturer or
distributor may provide to a person after compliance with the
provisions of this section, an investigational drug
(including a biological product) or investigational device
for the diagnosis, monitoring, or treatment of a serious
disease or condition, or any other disease or condition
designated by the Secretary as appropriate for expanded
access under this section if--
``(1) the licensed physician determines that the person has
no comparable or satisfactory alternative therapy available
to diagnose, monitor, or treat the disease or condition
involved;
``(2) the licensed physician determines that the risk to
the person from the investigational drug or investigational
device is not greater than the risk from the disease or
condition;
``(3) the Secretary determines that an exemption for the
investigational drug or investigational device is in effect
under a regulation promulgated pursuant to section 505(i) or
520(g) and the sponsor of the drug or device and
investigators comply with such regulation;
``(4) the Secretary determines that the manufacturer of the
investigational drug or investigational device is actively
pursuing marketing approval with due diligence;
``(5) the Secretary determines that expanded access to the
investigational drug or investigational device will not
interfere with adequate enrollment of patients by the
investigator in the ongoing clinical investigation of the
investigational drug or investigational device authorized
under section 505(i) or 520(g); and
``(6) the Secretary determines that there is sufficient
evidence of safety and effectiveness to support the expanded
use of the investigational drug or investigational device in
accordance with this section.
``(b) Protocols.--A manufacturer or distributor may submit
to the Secretary 1 or more expanded access protocols covering
expanded access use of a drug or device described in
subsection (a). The protocols shall be subject to the
provisions of section 505(i) or 520(g) and may include any
form of use of the drug or device outside a clinical
investigation, prior to approval of the drug or device for
marketing, including protocols for treatment use, emergency
use, or uncontrolled trials, and single patient protocols. If
the request for expanded access to an investigational drug or
investigational device is intended for a single patient only,
the Secretary may waive the requirements of paragraphs (3)
and (4) of subsection (a) and accept a submission under
section 505(i) or 520(g) for an exemption for the
investigational drug or investigational device for the single
patient use. In the case of an emergency that does not allow
sufficient time for a submission under section 505(i) or
520(g), the Secretary may, prior to the submission, authorize
the shipment of the investigational drug or investigational
device for a single patient use.
``(c) Notification of Availability.--The Secretary shall
inform national, State, and local medical associations and
societies, voluntary health associations, and other
appropriate persons about the availability of an
investigational drug or investigational device under expanded
access protocols submitted under this section, except that
this subsection shall not apply to expanded access protocols
for single patient use.
``(d) Termination.--The Secretary may at anytime terminate
expanded access provided under subsection (a) for an
investigational drug or investigational device if the
requirements under this section are no longer met.''.
SEC. 103. EXPANDED HUMANITARIAN USE OF DEVICES.
Section 520(m) (21 U.S.C. 360j(m)) is amended--
(1) in paragraph (2), by adding at the end the following
flush sentences:
``The request shall be in the form of an application
submitted to the Secretary. Not later than 60 days after the
date of the receipt of the application, the Secretary shall
issue an order approving or denying the application.'';
(2) in paragraph (4)--
(A) in subparagraph (B), by inserting after ``(2)(A)'' the
following: ``, unless a physician determines that waiting for
such an approval from an institutional review committee will
cause harm or death to a patient, and makes a good faith
effort to obtain the approval, and does not receive a timely
response from an institutional review committee on the
request of the physician for approval to use the device for
such treatment or diagnosis''; and
(B) by adding at the end the following flush sentences:
``In a case in which a physician described in subparagraph
(B) uses a device without an approval from an institutional
review committee, the physician shall, after the use of the
device, notify the chairperson of the institutional review
committee of such use. Such notification shall include the
identification of the patient involved, the date on which the
device was used, and the reason for the use.''; and
(3) by striking paragraph (5) and inserting the following:
``(5) The Secretary may require a person granted an
exemption under paragraph (2) to demonstrate continued
compliance with the requirements of this subsection if the
Secretary believes such demonstration to be necessary to
protect the public health or if the Secretary has reason to
believe that the criteria for the exemption are no longer
met.''.
TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES
SEC. 201. INTERAGENCY COLLABORATION.
Section 903(b) (21 U.S.C. 393(b)), as added by section
101(2), is amended by adding at the end the following:
``(3) Interagency collaboration.--The Secretary shall
implement programs and policies that will foster
collaboration between the Administration, the National
Institutes of Health, and other science-based Federal
agencies, to enhance the scientific and technical expertise
available to the Secretary in the conduct of the duties of
the Secretary with respect to the development, clinical
investigation, evaluation, and postmarket monitoring of
emerging medical therapies, including complementary
therapies, and advances in nutrition and food science.''.
[[Page S9135]]
SEC. 202. SENSE OF THE COMMITTEE REGARDING MUTUAL RECOGNITION
AGREEMENTS AND GLOBAL HARMONIZATION EFFORTS.
It is the sense of the Committee on Labor and Human
Resources of the Senate that--
(1) the Secretary of Health and Human Services should
support the Office of the United States Trade Representative,
in consultation with the Secretary of Commerce, in efforts to
move toward the acceptance of mutual recognition agreements
relating to the regulation of drugs, biological products,
devices, foods, food additives, and color additives, and the
regulation of good manufacturing practices, between the
European Union and the United States;
(2) the Secretary of Health and Human Services should
regularly participate in meetings with representatives of
other foreign governments to discuss and reach agreement on
methods and approaches to harmonize regulatory requirements;
and
(3) the Office of International Relations of the Department
of Health and Human Services (as established under section
803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
383)) should have the responsibility of ensuring that the
process of harmonizing international regulatory requirements
is continuous.
SEC. 203. CONTRACTS FOR EXPERT REVIEW.
Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at
the end the following:
``SEC. 906. CONTRACTS FOR EXPERT REVIEW.
``(a) In General.--
``(1) Authority.--The Secretary may enter into a contract
with any organization or any individual (who is not an
employee of the Department) with expertise in a relevant
discipline, to review, evaluate, and make recommendations to
the Secretary on part or all of any application or submission
(including a petition, notification, and any other similar
form of request) made under this Act for the approval or
classification of an article or made under section 351(a) of
the Public Health Service Act (42 U.S.C. 262(a)) with respect
to a biological product. Any such contract shall be subject
to the requirements of section 708 relating to the
confidentiality of information.
``(2) Increased efficiency and expertise through
contracts.--The Secretary shall use the authority granted in
paragraph (1) whenever the Secretary determines that a
contract described in paragraph (1) will improve the
timeliness or quality of the review of an application or
submission described in paragraph (1). Such improvement may
include providing the Secretary increased scientific or
technical expertise that is necessary to review or evaluate
new therapies and technologies.
``(b) Review of Expert Review.--
``(1) In general.--Subject to paragraph (2), the official
of the Food and Drug Administration responsible for any
matter for which expert review is used pursuant to subsection
(a) shall review the recommendations of the organization or
individual who conducted the expert review and shall make a
final decision regarding the matter within 60 days after
receiving the recommendations.
``(2) Limitation.--A final decision under paragraph (1)
shall be made within the applicable prescribed time period
for review of the matter as set forth in this Act or in the
Public Health Service Act (42 U.S.C. 201 et seq.).
``(3) Authority of secretary.--Notwithstanding subsection
(a), the Secretary shall retain full authority to make
determinations with respect to the approval or disapproval of
an article under this Act, the approval or disapproval of a
biologics license with respect to a biological product under
section 351(a) of the Public Health Service Act, or the
classification of an article as a device under section
513(f)(1).''.
SEC. 204. ACCREDITED-PARTY REVIEWS.
Subchapter A of chapter V (21 U.S.C. 351 et seq.) is
amended by adding at the end the following:
``SEC. 523. ACCREDITED-PARTY PARTICIPATION.
``(a) Accreditation.--
``(1) In general.--Not later than 1 year after the date of
enactment of this section, the Secretary shall accredit
entities or individuals who are not employees of the Federal
Government, to review reports made to the Secretary under
section 510(k) for devices and make recommendations to the
Secretary regarding the initial classification of such
devices under section 513(f)(1), except that this paragraph
shall not apply to reports made to the Secretary under
section 510(k) for devices that are--
``(A) life-supporting;
``(B) life sustaining; or
``(C) intended for implantation in the human body for a
period of over 1 year.
``(2) Special rule.--The Secretary shall have the
discretion to accredit entities or individuals who are not
employees of the Federal Government--
``(A) to review reports made to the Secretary under section
510(k) for devices described in subparagraphs (A) through (C)
of paragraph (1), and make recommendations of initial
classification of such devices; or
``(B) to review applications for premarket approval for
class III devices under section 515 and make recommendations
with respect to the approval or disapproval of such
applications.
``(b) Accreditation.--Within 180 days after the date of
enactment of this section, the Secretary shall adopt methods
of accreditation that ensure that entities or individuals who
conduct reviews and make recommendations under this section
are qualified, properly trained, knowledgeable about handling
confidential documents and information, and free of conflicts
of interest. The Secretary shall publish the methods of
accreditation in the Federal Register on the adoption of the
methods.
``(c) Withdrawal of Accreditation.--The Secretary may
suspend or withdraw the accreditation of any entity or
individual accredited under this section, after providing
notice and an opportunity for an informal hearing, if such
entity or individual acts in a manner that is substantially
not in compliance with the requirements established by the
Secretary under subsection (b), including the failure to
avoid conflicts of interest, the failure to protect
confidentiality of information, or the failure to competently
review premarket submissions for devices.
``(d) Selection and Compensation.--Subject to subsection
(a)(2), a person who intends to make a report described in
subsection (a), or to submit an application described in
subsection (a), to the Secretary shall have the option to
select an accredited entity or individual to review such
report or application. Upon the request by a person to have a
report or application reviewed by an accredited entity or
individual, the Secretary shall identify for the person no
less than 2 accredited entities or individuals from whom the
selection may be made. Compensation for an accredited entity
or individual shall be determined by agreement between the
accredited entity or individual and the person who engages
the services of the accredited entity or individual and shall
be paid by the person who engages such services.
``(e) Review by Secretary.--
``(1) In general.--The Secretary shall require an
accredited entity or individual, upon making a recommendation
under this section with respect to an initial classification
of a device or approval or disapproval of an application for
premarket approval, to notify the Secretary in writing of the
reasons for such recommendation.
``(2) Time period for review.--
``(A) Initial classification.--Not later than 30 days after
the date on which the Secretary is notified under paragraph
(1) by an accredited entity or individual with respect to a
recommendation of an initial classification of a device, the
Secretary shall make a determination with respect to the
initial classification.
``(B) Premarket approval.--Not later than 60 days after the
date on which the Secretary is notified under paragraph (1)
by an accredited entity or individual with respect to a
recommendation of an approval or disapproval of an
application for a device, the Secretary shall make a
determination with respect to the approval or disapproval.
``(3) Special rule.--The Secretary may change the initial
classification under section 513(f)(1), or the approval or
disapproval of the application under section 515(d), that is
recommended by the accredited entity or individual under this
section, and in such case shall notify in writing the person
making the report or application described in subsection (a)
of the detailed reasons for the change.
``(f) Duration.--The authority provided by this section
terminates--
``(1) 5 years after the date on which the Secretary
notifies Congress that at least 2 persons accredited under
subsection (b) are available to review devices for each of at
least 70 percent of the generic types of devices subject to
review under subsection (a); or
``(2) 4 years after the date on which the Secretary
notifies Congress that at least 35 percent of the devices
that are subject to review under subsection (a), and that
were the subject of final action by the Secretary in the
fiscal year preceding the date of such notification, were
reviewed by the Secretary under subsection (e),
whichever occurs first.
``(g) Report.--
``(1) In general.--Not later than 1 year after the date of
enactment of this section, the Secretary shall contract with
an independent research organization to prepare and submit to
the Secretary a written report examining the use of
accredited entities and individuals to conduct reviews under
this section. The Secretary shall submit the report to
Congress not later than 6 months prior to the conclusion of
the applicable period described in subsection (f).
``(2) Contents.--The report by the independent research
organization described in paragraph (1) shall identify the
benefits or detriments to public and patient health of using
accredited entities and individuals to conduct such reviews,
and shall summarize all relevant data, including data on the
review of accredited entities and individuals (including data
on the review times, recommendations, and compensation of the
entities and individuals), and data on the review of the
Secretary (including data on the review times, changes, and
reasons for changes of the Secretary).''.
SEC. 205. DEVICE PERFORMANCE STANDARDS.
(a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is
amended by adding at the end the following:
``Recognition of a Standard
``(c)(1)(A) In addition to establishing performance
standards under this section, the Secretary may, by
publication in the Federal Register, recognize all or part of
a performance standard established by a nationally or
internationally recognized standard development organization
for which a person may submit a declaration of conformity in
order to meet premarket submission requirements or other
requirements under this Act to which such standards are
applicable.
``(B) If a person elects to use a performance standard
recognized by the Secretary under subparagraph (A) to meet
the requirements described in subparagraph (A), the person
shall provide a declaration of conformity to the Secretary
that certifies that the device is in conformity with such
standard. A person may elect to use data, or information,
other than data required by a standard recognized under
subparagraph (A) to fulfill or satisfy any requirement under
this Act.
``(2) The Secretary may withdraw such recognition of a
performance standard through publication of a notice in the
Federal Register that the Secretary will no longer recognize
the
[[Page S9136]]
standard, if the Secretary determines that the standard is no
longer appropriate for meeting the requirements under this
Act.
``(3)(A) Subject to subparagraph (B), the Secretary shall
accept a declaration of conformity that a device is in
conformity with a standard recognized under paragraph (1)
unless the Secretary finds--
``(i) that the data or information submitted to support
such declaration does not demonstrate that the device is in
conformity with the standard identified in the declaration of
conformity; or
``(ii) that the standard identified in the declaration of
conformity is not applicable to the particular device under
review.
``(B) The Secretary may request, at any time, the data or
information relied on by the person to make a declaration of
conformity with respect to a standard recognized under
paragraph (1).
``(C) A person relying on a declaration of conformity with
respect to a standard recognized under paragraph (1) shall
maintain the data and information demonstrating conformity of
the device to the standard for a period of 2 years after the
date of the classification or approval of the device by the
Secretary or a period equal to the expected design life of
the device, whichever is longer.''.
(b) Section 301.--Section 301 (21 U.S.C. 331) is amended by
adding at the end the following:
``(x) The falsification of a declaration of conformity
submitted under subsection (c) of section 514 or the failure
or refusal to provide data or information requested by the
Secretary under section 514(c)(3).''.
(c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is
amended--
(1) by striking ``(e)'' and inserting ``(e)(1)''; and
(2) by inserting at the end the following:
``(2) If it is, declared to be, purports to be, or is
represented as, a device that is in conformity with any
performance standard recognized under section 514(c) unless
such device is in all respects in conformity with such
standard.''.
TITLE III--IMPROVING COLLABORATION AND COMMUNICATION
SEC. 301. COLLABORATIVE DETERMINATIONS OF DEVICE DATA
REQUIREMENTS.
Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by
adding at the end the following:
``(C)(i)(I) The Secretary, upon the written request of any
person intending to submit an application under section 515,
shall meet with such person to determine the type of valid
scientific evidence (within the meaning of subparagraphs (A)
and (B)) that will be necessary to demonstrate the
effectiveness of a device for the conditions of use proposed
by such person, to support an approval of an application. The
written request shall include a detailed description of the
device, a detailed description of the proposed conditions of
use of the device, and, if available, information regarding
the expected performance from the device. Within 30 days
after such meeting, the Secretary shall specify in writing
the type of valid scientific evidence that will provide a
reasonable assurance that a device is effective under the
conditions of use proposed by such person.
``(II) Any clinical data, including 1 or more well-
controlled investigations, specified in writing by the
Secretary for demonstrating a reasonable assurance of device
effectiveness shall be specified as a result of a
determination by the Secretary--
``(aa) that such data are necessary to establish device
effectiveness; and
``(bb) that no other less burdensome means of evaluating
device effectiveness is available that would have a
reasonable likelihood of resulting in an approval.
``(ii) The determination of the Secretary with respect to
the specification of valid scientific evidence under clause
(i) shall be binding upon the Secretary, unless--
``(I) such determination by the Secretary would be contrary
to the public health; or
``(II) based on new information (other than the information
reviewed by the Secretary in making such determination)
obtained by the Secretary prior to the approval of an
application for an investigational device exemption under
section 520(g), the Secretary finds that such determination
is scientifically inappropriate.''.
SEC. 302. COLLABORATIVE REVIEW PROCESS.
Section 515(d) (21 U.S.C. 360e(d)) is amended--
(1) in paragraph (1)(A), by striking ``paragraph (2) of
this subsection'' each place it appears and inserting
``paragraph (4)'';
(2) by redesignating paragraphs (2) and (3) as paragraphs
(4) and (5), respectively; and
(3) by inserting after paragraph (1) the following:
``(2)(A)(i) The Secretary shall, upon the written request
of the applicant involved, meet with the applicant not later
than 100 days after the receipt of an application, from the
applicant, that has been filed as complete under subsection
(c), to discuss the review status of the application.
``(ii) If the application does not appear in a form that
would require an approval under this subsection, the
Secretary shall in writing, and prior to the meeting, provide
to the applicant a description of any deficiencies in the
application identified by the Secretary and identify the
information (other than information the Secretary needs to
make a finding under paragraph (4)(C)) that is required to
bring the application into an approvable form.
``(iii) The Secretary and the applicant may, by mutual
consent, establish a different schedule for a meeting
required under this paragraph.
``(B) The Secretary shall notify the applicant immediately
of any deficiency identified in the application that was not
described as a deficiency in the written description provided
by the Secretary under subparagraph (A).''.
TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES
SEC. 401. POLICY STATEMENTS.
Section 701(a) (21 U.S.C. 371(a)) is amended--
(1) by striking ``(a) The'' and inserting ``(a)(1) The'';
and
(2) by adding at the end the following:
``(2) Not later than February 27, 1999, the Secretary,
after evaluating the effectiveness of the Good Guidance
Practices document published in the Federal Register at 62
Fed. Reg. 8961, shall promulgate a regulation specifying the
policies and procedures of the Food and Drug Administration
for the development, issuance, and use of guidance
documents.''.
SEC. 402. PRODUCT CLASSIFICATION.
Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at
the end the following:
``Subchapter D--Classification of Products and Environmental Impact
Reviews
``SEC. 741. CLASSIFICATION OF PRODUCTS.
``(a) Request.--A person who submits an application or
submission (including a petition, notification, and any other
similar form of request) under this Act, may submit a request
to the Secretary respecting the classification of an article
(including an article that is a combination product subject
to section 503(g)) as a drug, biological product, or device,
or respecting the component of the Food and Drug
Administration that will regulate the article. In submitting
the request, the person shall recommend a classification for
the article, or a component to regulate the article, as
appropriate.
``(b) Statement.--Not later than 60 days after the receipt
of the request described in subsection (a), the Secretary
shall determine the classification of the article or the
component of the Food and Drug Administration that will
regulate the article and shall provide to the person a
written statement that identifies the classification of the
article or the component of the Food and Drug Administration
that will regulate the article and the reasons for such
determination. The Secretary may not modify such statement
except with the written consent of the person or for public
health reasons.
``(c) Inaction of Secretary.--If the Secretary does not
provide the statement within the 60-day period described in
subsection (b), the recommendation made by the person under
subsection (a) shall be considered to be a final
determination by the Secretary of the classification of the
article or the component of the Food and Drug Administration
that will regulate the article and may not be modified by the
Secretary except with the written consent of the person or
for public health reasons.''.
SEC. 403. USE OF DATA RELATING TO PREMARKET APPROVAL.
(a) In General.--Section 520(h)(4) (21 U.S.C. 360j(h)(4))
is amended to read as follows:
``(4)(A) Any information contained in an application for
premarket approval filed with the Secretary pursuant to
section 515(c) (including information from clinical and
preclinical tests or studies that demonstrate the safety and
effectiveness of a device, but excluding descriptions of
methods of manufacture and product composition) shall be
available, 6 years after the application has been approved by
the Secretary, for use by the Secretary in--
``(i) approving another device;
``(ii) determining whether a product development protocol
has been completed, under section 515 for another device;
``(iii) establishing a performance standard or special
control under this Act; or
``(iv) classifying or reclassifying another device under
section 513 and subsection (l)(2).
``(B) The publicly available detailed summaries of
information respecting the safety and effectiveness of
devices required by paragraph (1)(A) shall be available for
use by the Secretary as the evidentiary basis for the agency
action described in subparagraph (A).''.
(b) Conforming Amendment.--Section 517(a) (21 U.S.C.
360g(a)) is amended--
(1) in paragraph (8), by adding ``or'' at the end;
(2) in paragraph (9), by striking ``, or'' and inserting a
comma; and
(3) by striking paragraph (10).
SEC. 404. CONSIDERATION OF LABELING CLAIMS FOR PRODUCT
REVIEW.
(a) Premarket Approval.--Section 515(d)(1)(A) (21 U.S.C.
360e(d)(1)(A)) is amended by adding at the end the following
flush sentences:
``In making the determination whether to approve or deny the
application, the Secretary shall rely on the conditions of
use included in the proposed labeling as the basis for
determining whether or not there is a reasonable assurance of
safety and effectiveness, if the proposed labeling is neither
false nor misleading. In determining whether or not such
labeling is false or misleading, the Secretary shall fairly
evaluate all material facts pertinent to the proposed
labeling.''.
(b) Premarket Notification.--Section 513(i)(1) (21 U.S.C.
360c(i)(1)) is amended by adding at the end the following:
``(C) Whenever the Secretary requests information to
demonstrate that the devices with differing technological
characteristics are substantially equivalent, the Secretary
shall only request information that is necessary to make a
substantial equivalence determination. In making such a
request, the Secretary shall consider the least burdensome
means of demonstrating substantial equivalence and shall
request information accordingly.
``(D) The determinations of the Secretary under this
section and section 513(f)(1) with respect to the intended
use of a device shall be based on the intended use included
in proposed labeling of the device submitted in a report
under section 510(k).''.
[[Page S9137]]
SEC. 405. DEFINITION OF A DAY FOR PURPOSES OF PRODUCT REVIEW.
Section 201 (21 U.S.C. 321) is amended by adding at the end
the following:
``(ii) In any provision relating to a review of any
application or submission (including a petition,
notification, and any other similar form of request), made
under this Act with respect to an article that is a new drug,
device, biological product, new animal drug, an animal feed
bearing or containing a new animal drug, color additive, or
food additive, that is submitted to the Secretary to obtain
marketing approval, to obtain classification of a device
under section 513(f)(1), or to establish or clarify the
regulatory status of the article--
``(1) the term `day' means a calendar day in which the
Secretary has responsibility to review such an application or
submission; and
``(2) a reference to a date relating to the receipt of such
an application or submission by the Secretary shall be deemed
to be a reference to the date on which the Secretary receives
a complete application or submission within the meaning of
this Act and the regulations promulgated under this Act.''.
SEC. 406. CERTAINTY OF REVIEW TIMEFRAMES.
(a) Clarification on the 90-Day Timeframe for Premarket
Notification Reviews.--Section 510(k) (21 U.S.C. 360) is
amended by adding at the end the following flush sentence:
``The Secretary shall review the notification required by
this subsection and make a determination under section
513(f)(1) not later than 90 days after receiving the
notification.''.
(b) Certainty of 180-Day Review Timeframe.--Section 515(d)
(21 U.S.C. 360e(d)), as amended by section 302, is amended by
inserting after paragraph (2) the following:
``(3) Except as provided in paragraph (1), the period for
the review of an application by the Secretary under this
subsection shall be not more than 180 days. Such period may
not be restarted or extended even if the application is
amended.''.
SEC. 407. LIMITATIONS ON INITIAL CLASSIFICATION
DETERMINATIONS.
Section 510 (21 U.S.C. 360) is amended by adding at the end
the following:
``(m) The Secretary may not withhold a determination of the
initial classification of a device under section 513(f)(1)
because of a failure to comply with any provision of this Act
that is unrelated to a substantial equivalence decision,
including a failure to comply with the requirements relating
to good manufacturing practices under section 520(f).''.
SEC. 408. CLARIFICATION WITH RESPECT TO A GENERAL USE AND
SPECIFIC USE OF A DEVICE.
Not later than 270 days after the date of enactment of this
section, the Secretary of Health and Human Services shall
promulgate a final regulation specifying the general
principles that the Secretary of Health and Human Services
will consider in determining when a specific intended use of
a device is not reasonably included within a general use of
such device for purposes of a determination of substantial
equivalence under section 513(f)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)).
SEC. 409. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL
INVESTIGATIONS FOR APPROVAL.
(a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C.
360c(a)(3)(A)) is amended by striking ``clinical
investigations'' and inserting ``1 or more clinical
investigations''.
(b) New Drugs.--Section 505(d) (21 U.S.C. 355(d)) is
amended by adding at the end the following: ``Substantial
evidence may, as appropriate, consist of data from 1 adequate
and well-controlled clinical investigation and confirmatory
evidence (obtained prior to or after such investigation), if
the Secretary determines, based on relevant science, that
such data and evidence are sufficient to establish
effectiveness.''.
SEC. 410. PROHIBITED ACTS.
Section 301(l) (21 U.S.C. 331(l)) is repealed.
TITLE V--IMPROVING ACCOUNTABILITY
SEC. 501. AGENCY PLAN FOR STATUTORY COMPLIANCE AND ANNUAL
REPORT.
Section 903(b) (21 U.S.C. 393(b)), as amended by section
201, is further amended by adding at the end the following:
``(4) Agency plan for statutory compliance.--
``(A) In general.--Not later than 180 days after the date
of enactment of this paragraph, the Secretary, after
consultation with relevant experts, health care
professionals, representatives of patient and consumer
advocacy groups, and the regulated industry, shall develop
and publish in the Federal Register a plan bringing the
Secretary into compliance with each of the obligations of the
Secretary under this Act and other relevant statutes. The
Secretary shall biannually review the plan and shall revise
the plan as necessary, in consultation with such persons.
``(B) Objectives of agency plan.--The plan required by
subparagraph (A) shall establish objectives, and mechanisms
to be used by the Secretary, acting through the Commissioner,
including objectives and mechanisms that--
``(i) minimize deaths of, and harm to, persons who use or
may use an article regulated under this Act;
``(ii) maximize the clarity of, and the availability of
information about, the process for review of applications and
submissions (including petitions, notifications, and any
other similar forms of request) made under this Act,
including information for potential consumers and patients
concerning new products;
``(iii) implement all inspection and postmarket monitoring
provisions of this Act by July 1, 1999;
``(iv) ensure access to the scientific and technical
expertise necessary to ensure compliance by the Secretary
with the statutory obligations described in subparagraph (A);
``(v) establish a schedule to bring the Administration into
full compliance by July 1, 1999, with the time periods
specified in this Act for the review of all applications and
submissions described in clause (ii) and submitted after the
date of enactment of this paragraph; and
``(vi) reduce backlogs in the review of all applications
and submissions described in clause (ii) for any article with
the objective of eliminating all backlogs in the review of
the applications and submissions by January 1, 2000.
``(5) Annual report.--
``(A) Contents.--The Secretary shall prepare and publish in
the Federal Register and solicit public comment on an annual
report that--
``(i) provides detailed statistical information on the
performance of the Secretary under the plan described in
paragraph (4);
``(ii) compares such performance of the Secretary with the
objectives of the plan and with the statutory obligations of
the Secretary;
``(iii) analyzes any failure of the Secretary to achieve
any objective of the plan or to meet any statutory
obligation;
``(iv) identifies any regulatory policy that has a
significant impact on compliance with any objective of the
plan or any statutory obligation; and
``(v) sets forth any proposed revision to any such
regulatory policy, or objective of the plan that has not been
met.
``(B) Statistical information.--The statistical information
described in subparagraph (A)(i) shall include a full
statistical presentation relating to all applications and
submissions (including petitions, notifications, and any
other similar forms of request) made under this Act and
approved or subject to final action by the Secretary during
the year covered by the report. In preparing the statistical
presentation, the Secretary shall take into account the date
of--
``(i) the submission of any investigational application;
``(ii) the application of any clinical hold;
``(iii) the submission of any application or submission
(including a petition, notification, and any other similar
form of request) made under this Act for approval or
clearance;
``(iv) the acceptance for filing of any application or
submission described in clause (iii) for approval or
clearance;
``(v) the occurrence of any unapprovable action;
``(vi) the occurrence of any approvable action; and
``(vii) the approval or clearance of any application or
submission described in clause (iii).''.
TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES
SEC. 601. MINOR MODIFICATIONS.
(a) Action on Investigational Device Exemptions.--Section
520(g) (21 U.S.C. 360j(g)) is amended by adding at the end
the following:
``(6)(A) The Secretary shall, not later than 120 days after
the date of enactment of this paragraph, by regulation modify
parts 812 and 813 of title 21, Code of Federal Regulations to
update the procedures and conditions under which a device
intended for human use may, upon application by the sponsor
of the device, be granted an exemption from the requirements
of this Act.
``(B) The regulation shall permit developmental changes in
a device (including manufacturing changes) in response to
information collected during an investigation without
requiring an additional approval of an application for an
investigational device exemption or the approval of a
supplement to such application, if the sponsor of the
investigation determines, based on credible information,
prior to making any such changes, that the changes--
``(i) do not affect the scientific soundness of an
investigational plan submitted under paragraph (3)(A) or the
rights, safety, or welfare of the human subjects involved in
the investigation; and
``(ii) do not constitute a significant change in design, or
a significant change in basic principles of operation, of the
device.''.
(b) Action on Application.--Section 515(d)(1)(B) (21 U.S.C.
360e(d)(1)(B)) is amended by adding at the end the following:
``(iii) The Secretary shall accept and review data and any
other information from investigations conducted under the
authority of regulations required by section 520(g), to make
a determination of whether there is a reasonable assurance of
safety and effectiveness of a device subject to a pending
application under this section if--
``(I) the data or information is derived from
investigations of an earlier version of the device, the
device has been modified during or after the investigations
(but prior to submission of an application under subsection
(c)) and such a modification of the device does not
constitute a significant change in the design or in the basic
principles of operation of the device that would invalidate
the data or information; or
``(II) the data or information relates to a device approved
under this section, is available for use under this Act, and
is relevant to the design and intended use of the device for
which the application is pending.''.
(c) Action on Supplements.--Section 515(d) (21 U.S.C.
360e(d)), as amended by section 302, is further amended by
adding at the end the following:
``(6)(A)(i) A supplemental application shall be required
for any change to a device subject to an approved application
under this subsection that affects safety or effectiveness,
unless such change is a modification in a manufacturing
procedure or method of manufacturing and the holder of the
approved application submits a written notice to the
Secretary that describes in detail the change, summarizes the
data or information supporting the change, and informs the
Secretary that the change has been made under the
requirements of section 520(f).
[[Page S9138]]
``(ii) The holder of an approved application who submits a
notice under clause (i) with respect to a manufacturing
change of a device shall not distribute the device for a
period of 14 days after the date on which the Secretary
receives the notice.
``(B)(i) Subject to clause (ii), in reviewing a supplement
to an approved application, for an incremental change to the
design of a device that affects safety or effectiveness, the
Secretary shall approve such supplement if--
``(I) nonclinical data demonstrate that the design
modification creates the intended additional capacity,
function, or performance of the device; and
``(II) clinical data from the approved application and any
supplement to the approved application provide a reasonable
assurance of safety and effectiveness for the changed device.
``(ii) The Secretary may require, when necessary,
additional clinical data to evaluate the design modification
to provide a reasonable assurance of safety and
effectiveness.''.
SEC. 602. ENVIRONMENTAL IMPACT REVIEW.
Chapter VII (21 U.S.C. 371 et seq.), as amended by section
402, is further amended by adding at the end the following:
``SEC. 742. ENVIRONMENTAL IMPACT REVIEW.
``Notwithstanding any other provision of law, no action by
the Secretary pursuant to this Act shall be subject to an
environmental assessment, an environmental impact statement,
or other environmental consideration unless the Secretary
demonstrates, in writing--
``(1) that there is a reasonable probability that the
environmental impact of the action is sufficiently
substantial and within the factors that the Secretary is
authorized to consider under this Act; and
``(2) that consideration of the environmental impact will
directly affect the decision on the action.''.
SEC. 603. EXEMPTION OF CERTAIN CLASSES OF DEVICES FROM
PREMARKET NOTIFICATION REQUIREMENT.
(a) Class I and Class II Devices.--Section 510(k) (21
U.S.C. 360(k)) is amended by striking ``intended for human
use'' and inserting ``intended for human use (except a device
that is classified into class I under section 513 or 520
unless the Secretary determines such device is intended for a
use that is of substantial importance in preventing
impairment of human health or such device presents a
potential unreasonable risk of illness or injury, or a device
that is classified into class II under section 513 or 520 and
is exempt from the requirements of this subsection under
subsection (l))''.
(b) Publication of Exemption.--Section 510 (21 U.S.C. 360)
is amended by inserting after subsection (k) the following:
``(l)(1) Not later than 30 days after the date of enactment
of this subsection, the Secretary shall publish in the
Federal Register a list of each type of class II device that
does not require a notification under subsection (k) to
provide reasonable assurance of safety and effectiveness.
Each type of class II device identified by the Secretary not
to require the notification shall be exempt from the
requirement to provide notification under subsection (k) as
of the date of the publication of the list in the Federal
Register.
``(2) Beginning on the date that is 1 day after the date of
the publication of a list under this subsection, the
Secretary may exempt a class II device from the notification
requirement of subsection (k), upon the Secretary's own
initiative or a petition of an interested person, if the
Secretary determines that such notification is not necessary
to assure the safety and effectiveness of the device. The
Secretary shall publish in the Federal Register notice of the
intent of the Secretary to exempt the device, or of the
petition, and provide a 30-day comment period for public
comment. Within 120 days after the issuance of the notice in
the Federal Register, the Secretary shall publish an order in
the Federal Register that sets forth the final determination
of the Secretary regarding the exemption of the device that
was the subject of the notice.''.
SEC. 604. EVALUATION OF AUTOMATIC CLASS III DESIGNATION.
Section 513(f) (21 U.S.C. 360c(f)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (B), by striking ``paragraph (2)'' and
inserting ``paragraph (3)''; and
(B) in the last sentence, by striking ``paragraph (2)'' and
inserting ``paragraph (2) or (3)'';
(2) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively; and
(3) by inserting after paragraph (1) the following:
``(2)(A) Any person who submits a report under section
510(k) for a type of device that has not been previously
classified under this Act, and that is classified into class
III under paragraph (1), may request, within 30 days after
receiving written notice of such a classification, the
Secretary to classify the device into class I or II under the
criteria set forth in subparagraphs (A) through (C)
subsection (a)(1). The person may, in the request, recommend
to the Secretary a classification for the device. The request
shall describe the device and provide detailed information
and reasons for the recommended classification.
``(B)(i) Not later than 60 days after the date of the
submission of the request under subparagraph (A) for
classification of a device under the criteria set forth in
subparagraphs (A) through (C) of subsection (a)(1), the
Secretary shall by written order classify the device. Such
classification shall be the initial classification of the
device for purposes of paragraph (1) and any device
classified under this paragraph into class I or II shall be a
predicate device for determining substantial equivalence
under paragraph (1).
``(ii) A device that remains in class III under this
subparagraph shall be deemed to be adulterated within the
meaning of section 501(f)(1)(B) until approved under section
515 or exempted from such approval under section 520(g).
``(C) Within 30 days after the issuance of an order
classifying a device under this paragraph, the Secretary
shall publish a notice in the Federal Register announcing
such classification.''.
SEC. 605. SECRETARY'S DISCRETION TO TRACK DEVICES.
(a) Release of Information.--Section 519(e) (21 U.S.C.
360i(e)) is amended by adding at the end the following flush
sentence:
``Any patient receiving a device subject to tracking under
this section may refuse to release, or refuse permission to
release, the patient's name, address, social security number,
or other identifying information for the purpose of
tracking.''.
(b) Publication of Certain Devices.--Not later than 180
days after the date of enactment of this Act, the Secretary
of Health and Human Services shall develop and publish in the
Federal Register a list that identifies each type of device
subject to tracking under section 519(e)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)(1)). Each
device not identified by the Secretary of Health and Human
Services under this subsection or designated by the Secretary
under section 519(e)(2) shall be deemed to be exempt from the
mandatory tracking requirement under section 519 of such Act.
The Secretary of Health and Human Services shall have
authority to modify the list of devices exempted from the
mandatory tracking requirements.
SEC. 606. SECRETARY'S DISCRETION TO CONDUCT POSTMARKET
SURVEILLANCE.
(a) In General.--Section 522 (21 U.S.C. 360l) is amended by
striking ``Sec. 522.'' and all that follows through ``(2)
Discretionary surveillance.--The'' and inserting the
following:
``Sec. 522. (a) Discretionary Surveillance.--The''.
(b) Surveillance Approval.--Section 522(b) (21 U.S.C.
360l(b)) is amended to read as follows:
``(b) Surveillance Approval.--
``(1) In general.--Each manufacturer that receives notice
from the Secretary that the manufacturer is required to
conduct surveillance of a device under subsection (a) shall,
not later than 30 days after receiving the notice, submit for
the approval of the Secretary, a plan for the required
surveillance.
``(2) Determination.--Not later than 60 days after the
receipt of the plan, the Secretary shall determine if a
person proposed in the plan to conduct the surveillance has
sufficient qualifications and experience to conduct the
surveillance and if the plan will result in the collection of
useful data that can reveal unforeseen adverse events or
other information necessary to protect the public health and
to provide safety and effectiveness information for the
device.
``(3) Limitation on plan approval.--The Secretary may not
approve the plan until the plan has been reviewed by a
qualified scientific and technical review committee
established by the Secretary.''.
(c) Duration of Surveillance.--Section 522 (21 U.S.C.
360l), as amended by subsection (b), is further amended by
adding at the end the following:
``(c) Duration of Surveillance.--
``(1) In general.--Each manufacturer required to conduct
surveillance of a device under subsection (a) shall be
required to conduct such surveillance for not longer than 24
months.
``(2) Extension of the period of surveillance.--If the
Secretary determines that additional surveillance is needed
to identify the incidence of adverse events documented during
the initial period of surveillance that were not foreseen at
the time of approval or classification of the device, the
Secretary may extend the period of surveillance for such time
as may be necessary after providing the person required to
conduct such surveillance an opportunity for an informal
hearing to determine whether or not additional surveillance
is appropriate and to determine the appropriate period, if
any, for such surveillance.''.
SEC. 607. REPORTING.
(a) Reports.--Section 519 (21 U.S.C. 360i) is amended--
(1) in subsection (a)--
(A) in the first sentence by striking ``make such reports,
and provide such information,'' and inserting ``and submit
such samples and components of devices (as required by
paragraph (10)),''; and
(B) by inserting after the first sentence the following:
``Every person who is a manufacturer or importer of a device
intended for human use shall make reports, and provide such
information, as the Secretary may by regulation reasonably
require to assure that such device is not adulterated or
misbranded and to assure the safety and effectiveness of such
device.'';
(C) in the last sentence by striking ``sentence'' and
inserting ``sentences'';
(D) in paragraph (8), by striking ``; and'' and inserting a
semicolon; and
(E) by striking paragraph (9) and inserting the following:
``(9) shall require distributors to keep records and make
such records available to the Secretary upon request; and'';
(2) by striking subsection (d); and
(3) in subsection (f), by striking ``, importer, or
distributor'' each place it appears and inserting ``or
importer''.
(b) Registration.--Section 510(g) (21 U.S.C. 360(g)) is
amended--
(1) by redesignating paragraph (4) as paragraph (5);
(2) by inserting after paragraph (3), the following:
``(4) any distributor who acts as a wholesale distributor
of devices, and who does not manufacture, repackage, process,
or relabel a device; or''; and
(3) by adding at the end the following flush sentence:
[[Page S9139]]
``In this subsection, the term `wholesale distributor' means
any person who distributes a device from the original place
of manufacture to the person who makes the final delivery or
sale of the device to the ultimate consumer or user.''.
SEC. 608. PILOT AND SMALL-SCALE MANUFACTURE.
Section 505(c) (21 U.S.C. 355(c)) is amended by adding at
the end the following:
``(4) A new drug manufactured in a pilot or other small
facility may be used to demonstrate the safety and
effectiveness of the new drug and to obtain approval of the
new drug prior to scaling up to a larger facility, unless the
Secretary determines that a full scale production facility is
necessary to ensure the safety or effectiveness of the new
drug.''.
SEC. 609. 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 designed for diagnosis and monitoring of
diseases and conditions. 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 (but
not be limited to) 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
intended to be used for diagnostic or monitoring purposes,
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, 1 or more disease states.
(b) Definition.--In this section, the term
``radiopharmaceutical'' means--
(1) an article--
(A) that is intended for use in the diagnosis or monitoring
of a disease or a manifestation of a disease in humans; and
(B) that exhibits spontaneous disintegration of unstable
nuclei with the emission of nuclear particles or photons; or
(2) any nonradioactive reagent kit or nuclide generator
that is intended to be used in the preparation of any such
article.
SEC. 610. MODERNIZATION OF REGULATION OF BIOLOGICAL PRODUCTS.
(a) Licenses.--
(1) In general.--Section 351(a) of the Public Health
Service (42 U.S.C. 262(a)) is amended to read as follows:
``(a)(1) Except as provided in paragraph (4), 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 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.
``(3) A biologics license application shall be approved
only 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).
``(4) The Secretary shall prescribe requirements under
which a biological product undergoing investigation shall be
exempt from the requirements of paragraph (1).''.
(2) Elimination of existing license requirement.--Section
351(d) of the Public Health Service Act (42 U.S.C. 262(d)) is
amended--
(A) by striking ``(d)(1)'' and all that follows through
``of this section.'';
(B) in paragraph (2)--
(i) by striking ``(2)(A) Upon'' and inserting ``(d)(1)
Upon;'' and
(ii) by redesignating subparagraph (B) as paragraph (2);
and
(C) in paragraph (2) (as so redesignated by subparagraph
(B)(ii))--
(i) by striking ``subparagraph (A)'' and inserting
``paragraph (1)''; and
(ii) by striking ``this subparagraph'' each place it
appears and inserting ``this paragraph''.
(b) Labeling.--Section 351(b) of the Public Health Service
Act (42 U.S.C. 262(b)) is amended to read as follows:
``(b) No person shall falsely label or mark any package or
container of any biological product or alter any label or
mark on the package or container of the biological product so
as to falsify the label or mark.''.
(c) Inspection.--Section 351(c) of the Public Health
Service Act (42 U.S.C. 262(c)) is amended by striking
``virus, serum,'' and all that follows and inserting
``biological product.''.
(d) Definition; Application.--Section 351 of the Public
Health Service Act (42 U.S.C. 262) is amended by adding at
the end the following:
``(i) In this section, the term `biological product' means
a virus, therapeutic serum, toxin, antitoxin, vaccine, blood,
blood component or derivative, allergenic product, analogous
product, or arsphenamine or derivative of arsphenamine (or
any other trivalent organic arsenic compound), applicable to
the prevention, treatment, or cure of a disease or condition
of human beings.''.
(e) Conforming Amendment.--Section 503(g)(4) (21 U.S.C.
353(g)(4)) is amended--
(1) in subparagraph (A)--
(A) by striking ``section 351(a)'' and inserting ``section
351(i)''; and
(B) by striking ``262(a)'' and inserting ``262(i)''; and
(2) in subparagraph (B)(iii), by striking ``product or
establishment license under subsection (a) or (d)'' and
inserting ``biologics license application under subsection
(a)''.
(f) Special Rule.--The Secretary of Health and Human
Services shall take measures to minimize differences in the
review and approval of products required to have approved
biologics license applications under section 351 of the
Public Health Service Act (42 U.S.C. 262) and products
required to have approved full new drug applications under
section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(b)(1)).
SEC. 611. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED
PRODUCTS.
(a) Performance Standards.--Not later than 180 days after
the date of enactment of this section, the Secretary of
Health and Human Services shall publish in the Federal
Register performance standards for the prompt review of
supplemental applications submitted for approved articles
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321
et seq.).
(b) Guidance to Industry.--Not later than 180 days after
the date of enactment of this section, the Secretary of
Health and Human Services shall issue final guidances to
clarify the requirements for, and facilitate the submission
of data to support, the approval of supplemental applications
for the approved articles described in subsection (a). The
guidances shall--
(1) clarify circumstances in which published matter may be
the basis for approval of a supplemental application;
(2) specify data requirements that will avoid duplication
of previously submitted data by recognizing the availability
of data previously submitted in support of an original
application; and
(3) define supplemental applications that are eligible for
priority review.
(c) Responsibilities of Centers.--The Secretary of Health
and Human Services shall designate an individual in each
center within the Food and Drug Administration (except the
Center for Food Safety and Applied Nutrition) to be
responsible for--
(1) encouraging the prompt review of supplemental
applications for approved articles; and
(2) working with sponsors to facilitate the development and
submission of data to support supplemental applications.
(d) Collaboration.--The Secretary of Health and Human
Services shall implement programs and policies that will
foster collaboration between the Food and Drug
Administration, the National Institutes of Health,
professional medical and scientific societies, and other
persons, to identify published and unpublished studies that
may support a supplemental application, and to encourage
sponsors to make supplemental applications or conduct further
research in support of a supplemental application based, in
whole or in part, on such studies.
SEC. 612. HEALTH CARE ECONOMIC INFORMATION.
Section 502 (21 U.S.C. 352) is amended by adding at the end
the following:
``(u) In the case of a health care economic statement that
is included in labeling or advertising provided to a
formulary committee, managed care organization, or similar
entity with responsibility for drug selection decisions
(other than the label or approved physician package insert)
relating to an indication approved under section 505 or 351
of the Public Health Service Act (42 U.S.C. 262), if the
health care economic statement is not based on competent and
reliable scientific evidence. The only requirements
applicable to any such statement under this Act shall be the
requirements of this paragraph. In this paragraph, the term
`health care economic statement' means any statement that
identifies, measures, or compares the costs (direct,
indirect, and intangible) and health care consequences of a
drug to another drug, to another health care intervention for
the same indication, or to no intervention, where the primary
endpoint is an economic outcome.''.
SEC. 613. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS.
(a) In General.--Chapter V (21 U.S.C. 351 et seq.), as
amended by section 102, is further amended by adding at the
end the following:
``Subchapter E--Fast Track Drugs
``SEC. 561. FAST TRACK DRUGS.
``(a) Designation of Drug as a Fast Track Drug.--
``(1) In general.--The Secretary shall facilitate
development, and expedite review and approval of new drugs
and biological products
[[Page S9140]]
that are intended for the treatment of serious or life-
threatening conditions and that demonstrate the potential to
address unmet medical needs for such conditions. In this Act,
such products shall be known as `fast track drugs'.
``(2) Request for designation.--The sponsor of a drug
(including a biological product) may request the Secretary to
designate the drug as a fast track drug. 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)(4) of the
Public Health Service Act.
``(3) Designation.--Within 30 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 drug and
shall take such actions as are appropriate to expedite the
development and review of the drug.
``(b) Approval of Application for a Fast Track Drug.--
``(1) In general.--The Secretary may approve an application
for approval of a fast track drug under section 505(b) or
section 351 of the Public Health Service Act (21 U.S.C. 262)
upon a determination that the drug has an effect on a
surrogate endpoint that is reasonably likely to predict
clinical benefit.
``(2) Limitation.--Approval of a fast track drug 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 clinical benefit of the drug; and
``(B) that the sponsor submit copies of all promotional
materials related to the fast track drug during the
preapproval review period and following approval, at least 30
days prior to dissemination of the materials for such period
of time as the Secretary deems appropriate.
``(3) Expedited withdrawal of approval.--The Secretary may
withdraw approval of a fast track drug using expedited
procedures (as prescribed by the Secretary in regulations)
including a procedure that provides 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 drug fails to
verify clinical benefit of the fast track drug;
``(C) other evidence demonstrates that the fast track drug
is not safe or effective under conditions of use of the drug;
or
``(D) the sponsor disseminates false or misleading
promotional materials with respect to the fast track drug.
``(c) Review of Incomplete Applications for Approval of a
Fast Track Drug.--
``(1) In general.--If preliminary evaluation by the
Secretary of clinical efficacy data for a fast track drug
under investigation shows evidence of effectiveness, the
Secretary shall evaluate for filing, and may commence review
of portions, of an application for the approval of the drug
if the applicant provides a schedule for submission of
information necessary to make the application complete and
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 widely disseminate to physicians, patient
organizations, pharmaceutical and biotechnology companies,
and other appropriate persons a comprehensive description of
the provisions applicable to fast track drugs established
under this section; and
``(2) establish an ongoing program to encourage the
development of surrogate endpoints that are reasonably likely
to predict clinical benefit for serious or life-threatening
conditions for which there exist significant unmet medical
needs.''.
(b) Guidance.--Within 1 year after the date of enactment of
this Act, the Secretary of Health and Human Services shall
issue guidance for fast track drugs that describes the
policies and procedures that pertain to section 561 of the
Federal Food, Drug, and Cosmetic Act.
SEC. 614. MANUFACTURING CHANGES FOR DRUGS AND BIOLOGICS.
(a) In General.--Chapter VII (21 U.S.C. 371 et seq.), as
amended by section 602, is further amended by adding at the
end the following:
``Subchapter E--Manufacturing Changes
``SEC. 751. MANUFACTURING CHANGES.
``(a) In General.--A change in the manufacture of a new
drug, including a biological product, may be made in
accordance with this section.
``(b) Changes.--
``(1) Validation.--Before distributing a drug made after a
change in the manufacture of the drug from the manufacturing
process established in the approved new drug application
under section 505, or license application under section 351
of the Public Health Service Act, the applicant shall
validate the effect 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.
``(2) Reports.--The applicant shall report the change
described in paragraph (1) to the Secretary and may
distribute a drug made after the change as follows:
``(A) Major manufacturing changes.
``(i) In general.--Major manufacturing changes, which are
of a type determined by the Secretary to have substantial
potential to adversely affect the identity, strength,
quality, purity, or potency of the drug as the identity,
strength, quality, purity, and potency may relate to the
safety or effectiveness of a drug, shall be submitted to the
Secretary in a supplemental application and drugs made after
such changes may not be distributed until the Secretary
approves the supplemental application.
``(ii) Definition.--In this subparagraph, the term `major
manufacturing changes' means--
``(I) changes in the qualitative or quantitative
formulation of a drug or the specifications in the approved
marketing application for the drug (unless exempted by the
Secretary from the requirements of this subparagraph);
``(II) changes that the Secretary determines by regulation
or issuance of guidance require completion of an appropriate
human study demonstrating equivalence of the drug to the drug
manufactured before such changes; and
``(III) other changes that the Secretary determines by
regulation or issuance of guidance have a substantial
potential to adversely affect the safety or effectiveness of
the drug.
``(B) Other manufacturing changes.--
``(i) In general.--As determined by the Secretary,
manufacturing changes other than major manufacturing changes
shall--
``(I) be made at any time and reported annually to the
Secretary, with supporting data; or
``(II) be reported to the Secretary in a supplemental
application.
``(ii) Distribution of the drug.--In the case of changes
reported in accordance with clause (i)(II)--
``(I) the applicant may distribute the drug 30 days after
the Secretary receives the supplemental application unless
the Secretary notifies the applicant within such 30-day
period that prior approval of such supplemental application
is required; and
``(II) the Secretary shall, after making the notification
to the applicant under subclause (I), approve or disapprove
each such supplemental application.
``(iii) Special rule.--The Secretary may determine types of
manufacturing changes after which distribution of a drug may
commence at the time of submission of such supplemental
application.''.
(b) Existing Law.--The requirements of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) and the Public
Health Service Act (42 U.S.C. 201 et seq.) that are in effect
on the date of enactment of this Act with respect to
manufacturing changes shall remain in effect--
(1) for a period of 24 months after the date of enactment
of this Act; or
(2) until the effective date of regulations promulgated by
the Secretary of Health and Human Services implementing
section 751 of the Federal Food, Drug, and Cosmetic Act,
whichever is sooner.
SEC. 615. DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS.
Within 12 months after the date of enactment of this Act,
the Secretary of the 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 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) 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. 616. FOOD CONTACT SUBSTANCES.
(a) Food Contact Substances.--Section 409(a) (21 U.S.C.
348(a)) is amended--
(1) in paragraph (1)--
(A) by striking ``subsection (i)'' and inserting
``subsection (j)''; and
(B) by striking at the end ``or'';
(2) by striking the period at the end of paragraph (2) and
inserting ``; or'';
(3) by inserting after paragraph (2) the following:
``(3) in the case of a food additive as defined in this Act
that is a food contact substance, there is--
``(A) in effect, and such substance and the use of such
substance are in conformity with, a regulation issued under
this section prescribing the conditions under which such
additive may be safely used; or
``(B) a notification submitted under subsection (h) that is
effective.''; and
(4) by striking the matter following paragraph (3) (as
added by paragraph (2)) and inserting the following flush
sentence:
``While such a regulation relating to a food additive, or
such a notification under subsection (h) relating to a food
additive that is a food contact substance, is in effect, and
has not been revoked pursuant to subsection (i), a food shall
not, by reason of bearing or containing such a food additive
in accordance with the regulation or notification, be
considered adulterated under section 402(a)(1).''.
(b) Notification for Food Contact Substances.--Section 409
(21 U.S.C. 348), as amended by subsection (a), is further
amended--
(1) by redesignating subsections (h) and (i), as
subsections (i) and (j), respectively;
(2) by inserting after subsection (g) the following:
``Notification Relating to a Food Contact Substance
``(h)(1) Subject to such regulations as may be promulgated
under paragraph (3), a manufacturer or supplier of a food
contact substance may, at least 120 days prior to the
introduction or delivery for introduction into interstate
commerce of the food contact substance, notify the
[[Page S9141]]
Secretary of the identity and intended use of the food
contact substance, and of the determination of the
manufacturer or supplier that the intended use of such food
contact substance is safe under the standard described in
subsection (c)(3)(A). The notification shall contain the
information that forms the basis of the determination, the
fee required under paragraph (5), and all information
required to be submitted by regulations promulgated by the
Secretary.
``(2)(A) A notification submitted under paragraph (1) shall
become effective 120 days after the date of receipt by the
Secretary and the food contact substance may be introduced or
delivered for introduction into interstate commerce, unless
the Secretary makes a determination within the 120-day period
that, based on the data and information before the Secretary,
such use of the food contact substance has not been shown to
be safe under the standard described in subsection (c)(3)(A),
and informs the manufacturer or supplier of such
determination.
``(B) A decision by the Secretary to object to a
notification shall constitute final agency action subject to
judicial review.
``(C) In this paragraph, the term `food contact substance'
means the substance that is the subject of a notification
submitted under paragraph (1), and does not include a similar
or identical substance manufactured or prepared by a person
other than the manufacturer identified in the notification.
``(3)(A) The process in this subsection shall be utilized
for authorizing the marketing of a food contact substance
except where the Secretary determines that submission and
review of a petition under subsection (b) is necessary to
provide adequate assurance of safety, or where the Secretary
and any manufacturer or supplier agree that such manufacturer
or supplier may submit a petition under subsection (b).
``(B) The Secretary is authorized to promulgate regulations
to identify the circumstances in which a petition shall be
filed under subsection (b), and shall consider criteria such
as the probable consumption of such food contact substance
and potential toxicity of the food contact substance in
determining the circumstances in which a petition shall be
filed under subsection (b).
``(4) The Secretary shall keep confidential any information
provided in a notification under paragraph (1) for 120 days
after receipt by the Secretary of the notification. After the
expiration of such 120 days, the information shall be
available to any interested party except for any matter in
the notification that is a trade secret or confidential
commercial information.
``(5)(A) Each person that submits a notification regarding
a food contact substance under this section shall be subject
to the payment of a reasonable fee. The fee shall be based on
the resources required to process the notification including
reasonable administrative costs for such processing.
``(B) The Secretary shall conduct a study of the costs of
administering the notification program established under this
section and, on the basis of the results of such study,
shall, within 18 months after the date of enactment of the
Food and Drug Administration Modernization and Accountability
Act of 1997, promulgate regulations establishing the fee
required by subparagraph (A).
``(C) A notification submitted without the appropriate fee
is not complete and shall not become effective for the
purposes of subsection (a)(3) until the appropriate fee is
paid.
``(D) Fees collected pursuant to this subsection--
``(i) shall not be deposited as an offsetting collection to
the appropriations for the Department of Health and Human
Services;
``(ii) shall be credited to the appropriate account of the
Food and Drug Administration; and
``(iii) shall be available in accordance with appropriation
Acts until expended, without fiscal year limitation.
``(6) In this section, the term `food contact substance'
means any substance intended for use as a component of
materials used in manufacturing, packing, packaging,
transporting, or holding food if such use is not intended to
have any technical effect in such food.'';
(3) in subsection (i), as so redesignated by paragraph (1),
by adding at the end the following: ``The Secretary shall by
regulation prescribe the procedure by which the Secretary may
deem a notification under subsection (h) to no longer be
effective.''; and
(4) in subsection (j), as so redesignated by paragraph (1),
by striking ``subsections (b) to (h)'' and inserting
``subsections (b) to (i)''.
(c) Effective Date.--Notifications under section 409(h) of
the Federal Food, Drug, and Cosmetic Act, as added by
subsection (b), may be submitted beginning 18 months after
the date of enactment of this Act.
SEC. 617. HEALTH CLAIMS FOR FOOD PRODUCTS.
Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by
adding at the end the following:
``(C) Notwithstanding the provisions of clauses (A)(i) and
(B), a claim of the type described in subparagraph (1)(B)
that is not authorized by the Secretary in a regulation
promulgated in accordance with clause (B) shall be authorized
and may be made if--
``(i) an authoritative scientific body of the Federal
Government with official responsibility for public health
protection or research directly relating to human nutrition
(such as the National Institutes of Health or the Centers for
Disease Control and Prevention), the National Academy of
Sciences, or a subdivision of the scientific body or the
National Academy of Sciences, has published an authoritative
statement, which is currently in effect, about the
relationship between a nutrient and a disease or health-
related condition to which the claim refers;
``(ii) a person has submitted to the Secretary at least 90
days before the first introduction of a food into interstate
commerce a notice of the claim, including a concise
description of the basis upon which such person relied for
determining that the requirements of subclause (i) have been
satisfied;
``(iii) the claim and the food for which the claim is made
are in compliance with clause (A)(ii), and are otherwise in
compliance with paragraph (a) and section 201(n); and
``(iv) the claim is stated in a manner so that the claim is
an accurate representation of the authoritative statement
referred to in subclause (i) and so that the claim enables
the public to comprehend the information provided in the
claim and to understand the relative significance of such
information in the context of a total daily diet.
For purposes of this paragraph, a statement shall be regarded
as an authoritative statement of such a scientific body
described in subclause (i) only if the statement is published
by the scientific body and shall not include a statement of
an employee of the scientific body made in the individual
capacity of the employee.
``(D) A claim meeting the requirements of clause (C) may be
made until--
``(i) such time as the Secretary issues a final regulation
under clause (B) prohibiting or modifying the claim, and the
regulation has become effective; or
``(ii) a district court of the United States in an
enforcement proceeding under chapter III has determined that
the requirements of clause (C) have not been met.''.
SEC. 618. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.) is amended by inserting after section 505
the following:
``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
``(a) Market Exclusivity for New Drugs.--If, prior to
approval of an application that is submitted under section
505(b)(1) the Secretary determines that information relating
to the use of a drug in the pediatric population may produce
health benefits in that population, the Secretary makes a
written request for pediatric studies (which may 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 completed
within any such timeframe and the reports thereof are
accepted in accordance with subsection (d)(3)--
``(1)(A) the period during which an application may not be
submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii)
of section 505 shall 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 section 505 to four years, to forty-
eight months, and to seven and one-half years shall be deemed
to be four and one-half years, fifty-four months, and eight
years, respectively; or
``(B) the period of market exclusivity under subsections
(c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of
section 505 shall be three years and six months rather than
three years; and
``(2)(A) if the drug is the subject of--
``(i) a listed patent for which a certification has been
submitted under section 505(b)(2)(A)(ii) or section
(j)(2)(A)(vii)(II) 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 section 505(b)(2)(A)(iii) or section
505(j)(2)(A)(vii)(III),
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
section 505(b)(2)(A)(iv) or section 505(j)(2)(A)(vii)(IV),
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 this
section, the Secretary, after consultation with experts in
pediatric research (such as the American Academy of
Pediatrics, the Pediatric Pharmacology Research Unit Network,
and the United States Pharmacopoeia) 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 for pediatric studies
(which may include a timeframe for completing such studies)
concerning a drug identified in the list described in
subsection (b) to the holder of an approved application under
section 505(b)(1) for the drug, the holder agrees to the
request, and the studies are completed within any such
timeframe and the reports thereof submitted in accordance
with subsection (d)(2) or completed within any such timeframe
and the reports thereof accepted in accordance with
subsection (d)(3)--
``(1)(A) the period during which an application may not be
submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii)
of section 505 shall 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 section 505 to four years, to forty-
eight months, and to seven and one-half years shall be deemed
to be four
[[Page S9142]]
and one-half years, fifty-four months, and eight years,
respectively; or
``(B) the period of market exclusivity under subsections
(c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of
section 505 shall be three years and six months rather than
three years; and
``(2)(A) if the drug is the subject of--
``(i) a listed patent for which a certification has been
submitted under section 505(b)(2)(A)(ii) or
(j)(2)(A)(vii)(II) 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 section 505(b)(2)(A)(iii) or section
505(j)(2)(A)(vii)(III),
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 section
505(b)(2)(A)(iv) or section 505(j)(2)(A)(vii)(IV), 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 for studies, 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 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.
``(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, whether
such studies have been conducted in accordance with commonly
accepted scientific principles and protocols, and whether
such studies have been reported in accordance with the
requirements of the Secretary for filing.
``(e) Delay of Effective Date for Certain Applications;
Period of Market Exclusivity.--If the Secretary determines
that the acceptance or approval of an application under
section 505(b)(2) or 505(j) for a 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 market exclusivity
protection, 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), respectively, until the
determination under subsection (d) is made, but such delay
shall not exceed 90 days. In the event that requirements of
this section are satisfied, the applicable period of market
exclusivity referred to in 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 section 505(b)(2) or (j) 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 1 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) Limitation.--The holder of an approved application
for a new drug that has already received six months of market
exclusivity under subsection (a) or (c) may, if otherwise
eligible, obtain six months of market exclusivity under
subsection (c)(1)(B) for a supplemental application, except
that the holder is not eligible for exclusivity under
subsection (c)(2).
``(i) Sunset.--No period of market exclusivity shall be
granted under this section based on studies commenced after
January 1, 2004. The Secretary shall conduct a study and
report to Congress not later than January 1, 2003 based on
the experience under the program. 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; and
``(4) any suggestions for modification that the Secretary
deems appropriate.''.
SEC. 619. POSITRON EMISSION TOMOGRAPHY.
(a) Regulation of Compounded Positron Emission Tomography
Drugs Under the Federal Food, Drug, and Cosmetic Act.--
(1) Definition.--Section 201 (21 U.S.C. 321), as amended by
section 405, is further amended by adding at the end the
following:
``(jj) The term `compounded positron emission tomography
drug' means a drug that--
``(1) exhibits spontaneous disintegration of unstable
nuclei, including the emission of positrons;
``(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 any such drug; and
``(3)(A) has been compounded in a State in accordance with
State law for a patient or for research, teaching, or quality
control by or on the order of a practitioner licensed by that
State to compound or order such a drug; or
``(B) has been compounded in a Federal facility in a State
in accordance with the law of the State in which the facility
is located.''.
(b) Regulation as a Drug.--Section 501(a)(2) (21 U.S.C.
351(a)(2)) 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, which it purports or is represented
to possess; or (3)''.
(c) Regulation as a New Drug.--Section 505 (21 U.S.C. 355)
is amended by adding at the end the following:
``(n) The provisions of subsections (a) and (j) shall not
apply to the preparation of a compounded positron emission
tomography drug.''.
(d) Revocation of Certain Inconsistent Documents.--Not
later than 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 revoking--
(1) a notice entitled ``Regulation of Positron Emission
Tomographic Drug Products: Guidance; Public Workshop'',
published in the Federal Register of February 27, 1995;
(2) a notice entitled ``Guidance for Industry: Current Good
Manufacturing Practices for Positron Emission Tomographic
(PET) Drug Products'', published in the Federal Register of
April 22, 1997; and
(3) a final rule entitled ``Current Good Manufacturing
Practice for Finished Pharmaceuticals; Positron Emission
Tomography'', published in the Federal Register of April 22,
1997.
TITLE VII--FEES RELATING TO DRUGS
SEC. 701. SHORT TITLE.
This title may be cited as the ``Prescription Drug User Fee
Reauthorization Act of 1997''.
SEC. 702. 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 title
will be dedicated toward expediting the drug development
process and the review of human drug applications as set
forth in the goals identified in the letters of
______________, and ______________, 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 at ____ Cong. Rec. ________ (daily ed. __________,
1997).
SEC. 703. 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 or biological product that is
not distributed commercially. Such term does include an
application for licensure, as described in subparagraph (D),
of a large volume biological product intended for single dose
injection for intravenous use or infusion.'';
(2) in the second sentence of paragraph (3)--
(A) by striking ``Service Act, and'' and inserting
``Service Act,''; and
(B) by striking ``September 1, 1992.'' and inserting the
following: ``September 1, 1992, does not include a biological
product that is licensed
[[Page S9143]]
for further manufacturing use only, and does not include a
drug or biological product 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) in paragraph (7)(A)--
(A) by striking ``employees under contract'' and all that
follows through ``Administration,'' 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,'';
(5) 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'';
(B) by striking subparagraph (B) and inserting the
following:
``(B) 1 plus the total percentage increase for such fiscal
year since fiscal year 1997 in basic pay under the General
Schedule in accordance with section 5332 of title 5, United
States Code, as adjusted by any locality-based comparability
payment pursuant to section 5304 of such title for Federal
employees stationed in the District of Columbia.''; and
(C) by striking the second sentence; and
(6) 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) 1 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. 704. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is
amended--
(1) by striking ``Beginning in fiscal year 1993'' and
inserting ``Beginning in fiscal year 1998'';
(2) in paragraph (1)--
(A) by striking subparagraph (B) and inserting the
following:
``(B) Payment.--The fee required by subparagraph (A) shall
be due upon submission of the application or supplement.'';
(B) in subparagraph (D)--
(i) in the subparagraph heading, by striking ``not
accepted'' and inserting ``refused'';
(ii) by striking ``50 percent'' and inserting ``75
percent'';
(iii) by striking ``subparagraph (B)(i)'' and inserting
``subparagraph (B)''; and
(iv) by striking ``not accepted'' and inserting
``refused''; and
(C) by adding at the end the following:
``(E) Exception for designated orphan drug or indication.--
A person that submits 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, or a
supplement proposing to include a new indication for a rare
disease or condition pursuant to section 526, shall not be
assessed a fee under subparagraph (A), unless the human drug
application includes indications for other than rare diseases
or conditions.
``(F) Exception for applications and supplements for
pediatric indications.--A person that submits a human drug
application or supplement that includes an indication for use
in pediatric populations shall be assessed a fee under
subparagraph (A) only if--
``(i) the application is for initial approval for use in a
pediatric population; or
``(ii) the application or supplement is for approval for
use in pediatric and non-pediatric populations.
``(G) Refund of fee if application withdrawn.--If an
application or supplement is withdrawn after the application
or supplement is filed, the Secretary may waive and 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 waive and refund a fee or a portion of
the fee under this subparagraph. A determination by the
Secretary concerning a waiver or refund under this paragraph
shall not be reviewable.'';
(3) in paragraph (2)(A), by striking ``505(j), and'' and
inserting the following: ``505(j) 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, or a product approved under an
application filed under section 507 that is abbreviated,
and''; 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
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), 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, or is a product approved
under an application filed under section 507 that is
abbreviated.''.
(b) Fee Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is
amended to read as follows:
``(b) Fee Amounts.--Except as provided in subsections (c),
(d), (f), and (g), the fees required under subsection (a)
shall be determined and assessed as follows:
``(1) Application and supplement fees.--
``(A) Full fees.--The application fee under subsection
(a)(1)(A)(i) shall be $250,704 in fiscal year 1998, $256,338
in each of fiscal years 1999 and 2000, $267,606 in fiscal
year 2001, and $258,451 in fiscal year 2002.
``(B) Other fees.--The fee under subsection (a)(1)(A)(ii)
shall be $125,352 in fiscal year 1998, $128,169 in each of
fiscal years 1999 and 2000, $133,803 in fiscal year 2001, and
$129,226 in fiscal year 2002.
``(2) 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 during the past fiscal year 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 1 or more fees assessed under subsection
(a) where the Secretary finds that--'';
(3) in subparagraph (C) (as so redesignated by paragraph
(1)), by striking ``, or'' and inserting a comma;
(4) in subparagraph (D) (as so redesignated by paragraph
(1)), by striking the period and inserting ``, or'';
(5) by inserting after subparagraph (D) (as so redesignated
by paragraph (1)) the following:
``(E) the applicant 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 within the meaning of section 735(6).'';
[[Page S9144]]
(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 is authorized
to be appropriated for fees under this section--
``(A) $106,800,000 for fiscal year 1998;
``(B) $109,200,000 for fiscal year 1999;
``(C) $109,200,000 for fiscal year 2000;
``(D) $114,000,000 for fiscal year 2001; and
``(E) $110,100,000 for fiscal year 2002,
as adjusted to reflect adjustments in the total fee revenues
made under this section and changes in the total amounts
collected by application, supplement, establishment, and
product fees.
``(4) Offset.--Any amount of fees collected for a fiscal
year which 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 appropriation Acts for a subsequent fiscal
year.''.
(g) Requirement for Written Requests for Waivers,
Reductions, and Fees.--Section 736 (21 U.S.C. 379h) is
amended--
(1) by redesignating subsection (i) as subsection (j); and
(2) by inserting after subsection (h) the following:
``(i) Written Requests for Waivers, Reductions, and
Refunds.--To qualify for consideration for a waiver or
reduction under subsection (d), or for a refund, of any fee
collected in accordance with subsection (a), a person shall
submit to the Secretary a written request for such waiver,
reduction, or refund not later than 180 days after such fee
is due.''.
(h) Special Rule for Waiver, Refunds, and Exceptions.--Any
requests for waivers, refunds, or exceptions for fees paid
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.
SEC. 705. ANNUAL REPORTS.
(a) First 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 letter described in section
702(4) during such fiscal year and the future plans of the
Food and Drug Administration for meeting the goals.
(b) Second Report.--Beginning with fiscal year 1998, not
later than 120 days after the end of each fiscal year during
which fees are collected under the part described in
subsection (a), the Secretary of Health and Human Services
shall prepare and submit to the Committee on Commerce of the
House of Representatives and the Committee on Labor and Human
Resources of the Senate a report on the implementation of the
authority for such fees during such fiscal year and the use,
by the Food and Drug Administration, of the fees collected
during such fiscal year for which the report is made.
SEC. 706. EFFECTIVE DATE.
The amendments made by this title shall take effect October
1, 1997.
SEC. 707. TERMINATION OF EFFECTIVENESS.
The amendments made by sections 703 and 704 cease to be
effective October 1, 2002 and section 705 ceases to be
effective 120 days after such date.
TITLE VIII--MISCELLANEOUS
SEC. 801. REGISTRATION OF FOREIGN ESTABLISHMENTS.
Section 510(i) (21 U.S.C. 360(i)) is amended to read as
follows:
``(i)(1) Any establishment within any foreign country
engaged in the manufacture, preparation, propagation,
compounding, or processing of a drug or a device that is
imported or offered for import into the United States shall
register with the Secretary the name and place of business of
the establishment and the name of the United States agent for
the establishment.
``(2) The establishment shall also provide the information
required by subsection (j).
``(3) The Secretary is authorized to enter into cooperative
arrangements with foreign countries to ensure that adequate
and effective means are available for purposes of
determining, from time to time, whether drugs or devices
manufactured, prepared, propagated, compounded, or processed
by an establishment described in paragraph (1), if imported
or offered for import into the United States, shall be
refused admission on any of the grounds set forth in section
801(a).''.
SEC. 802. 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
(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. 803. CLARIFICATION OF SEIZURE AUTHORITY.
Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended--
(1) in paragraph (1), in the fifth sentence, by striking
``paragraphs (1) and (2) of section 801(e)'' and inserting
``subparagraphs (A) and (B) of section 801(e)(1)''; and
(2) by inserting after the fifth sentence the following:
``Any person seeking to export an imported article pursuant
to any of the provisions of this subsection shall establish
that the article was intended for export at the time the
article entered commerce.''.
SEC. 804. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.
Chapter IX (21 U.S.C. 391 et seq.), as amended by section
203, is further amended by adding at the end the following:
``SEC. 907. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.
``(a) In General.--The Secretary, acting through the
Commissioner of Food and Drugs, may, directly or through
grants, contracts, or cooperative agreements, conduct and
support intramural research training in regulatory scientific
programs by predoctoral and postdoctoral scientists and
physicians, including the support through the use of
fellowships.
``(b) Limitation on Participation.--A recipient of a
fellowship under subsection (a) may not be an employee of the
Federal Government.
``(c) Special Rule.--The Secretary, acting through the
Commissioner of Food and Drugs, may support the provision of
assistance for fellowships described in subsection (a)
through a Cooperative Research and Development Agreement.''.
SEC. 805. DEVICE SAMPLES.
(a) Recall Authority.--
(1) In general.--Section 518(e)(2) (21 U.S.C. 360h(e)(2))
is amended by adding at the end the following:
``(C) If the Secretary issues an amended order under
subparagraph (A), the Secretary may require the person
subject to the order to submit such samples of the device and
of components of the device as the Secretary may reasonably
require. If the submission of such samples is impracticable
or unduly burdensome, the requirement of this subparagraph
may be met by the submission of complete information
concerning the location of 1 or more such devices readily
available for examination and testing.''.
(2) Technical amendment.--Section 518(e)(2)(A) (21 U.S.C.
360h(e)(2)(A)) is amended by striking ``subparagraphs (B) and
(C)'' and inserting ``subparagraph (B)''.
(b) Records and Reports on Devices.--Section 519(a) (21
U.S.C. 360i(a)) is amended by inserting after paragraph (9)
the following:
``(10) may reasonably require a manufacturer, importer, or
distributor to submit samples of a device and of components
of the device that may have caused or contributed to a death
or serious injury, except that if the submission of such
samples is impracticable or unduly burdensome, the
requirement of this paragraph may be met by the submission of
complete information concerning the location of 1 or more
such devices readily available for examination and
testing.''.
SEC. 806. INTERSTATE COMMERCE.
Section 709 (21 U.S.C. 379a) is amended by striking ``a
device'' and inserting ``a device, food, drug, or cosmetic''.
SEC. 807. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND
COSMETICS.
Chapter VII (21 U.S.C. 371 et seq.), as amended by section
614, is further amended by adding at the end the following:
``Subchapter F--National Uniformity for Nonprescription Drugs for Human
Use and Cosmetics
``SEC. 761. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND
COSMETICS.
``(a) In General.--Except as provided in subsection (b),
(c)(1), or (d), no State or political subdivision of a State
may establish or continue in effect any requirement--
``(1) that relates to the regulation of a drug intended for
human use that is not subject to the requirements of section
503(b)(1) or a cosmetic; and
``(2) that is different from or in addition to, or that is
otherwise not identical with, a requirement of this Act, the
Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et
seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451
et seq.).
``(b) Exemption.--Upon application of a State, the
Secretary may by regulation, after notice and opportunity for
written and oral presentation of views, exempt from
subsection (a), under such condition as may be prescribed in
such regulation, a State requirement that--
``(1) protects an important public interest that would
otherwise be unprotected;
``(2) would not cause any drug or cosmetic to be in
violation of any applicable requirement or prohibition under
Federal law; and
``(3) would not unduly burden interstate commerce.
``(c) Scope.--For purposes of subsection (a), a requirement
that relates to the regulation of a drug or cosmetic--
[[Page S9145]]
``(1) shall not include any requirement that relates to the
practice of pharmacy or any requirement that a drug be
dispensed only upon the prescription of a practitioner
licensed by law to administer such drug; and
``(2) shall be deemed to include any requirement relating
to public information or any other form of public
communication relating to the safety or effectiveness of a
drug or cosmetic.
``(d) No Effect on Product Liability Law.--Nothing in this
section shall be construed to modify or otherwise affect any
action or the liability of any person under the product
liability law of any State.''.
SEC. 808. 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
(2) by inserting after subsection (i), the following:
``(j)(1) The Secretary, acting through the Director of the
National Institutes of Health and subject to the availability
of appropriations, shall establish, maintain, and operate a
program with respect to information on research relating to
the treatment, detection, and prevention of serious or life-
threatening diseases and conditions. The program shall, with
respect to the agencies of the Department of Health and Human
Services, be integrated and coordinated, and, to the extent
practicable, coordinated with other data banks containing
similar information.
``(2)(A) 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, the Secretary shall, in carrying out
paragraph (1), establish a data bank of information on
clinical trials for drugs, and biologicals, for serious or
life-threatening diseases and conditions.
``(B) In carrying out subparagraph (A), the Secretary shall
collect, catalog, store and disseminate the information
described in such subparagraph. 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 sections 505 and 520 of the Federal
Food, Drug, and Cosmetic Act that provides a description of
the purpose of each experimental drug or biological protocol,
either with the consent of the protocol sponsor, or when a
trial to test efficacy begins. Information provided shall
consist of eligibility criteria, 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 must be forwarded to the Data Bank by the sponsor
of the trial not later than 21 days after the approval by the
Food and Drug Administration.
``(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 Food and Drug
Administration pursuant to part 312 of title 21, Code of
Federal Regulations; or
``(ii) as a Group C cancer drug.
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 certified to the
Secretary that disclosure of such information would
substantially interfere with the timely enrollment of
subjects in the investigation.
``(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 (21 U.S.C. 379h) shall not
be authorized or appropriated for use in carrying out this
subsection.''.
(b) Collaboration and Report.--
(1) In general.--The Secretary of Health and Human
Services, the Director of the National Institutes of Health,
and the Commissioner of Food and Drugs shall collaborate to
determine the feasibility of including device investigations
within the scope of the registry requirements set forth in
subsection (j) of section 402 of the Public Health Service
Act.
(2) Report.--Not later than 2 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 that shall
consider, among other things--
(A) the public health need, if any, for inclusion of device
investigations within the scope of the registry requirements
set forth in subsection (j) of section 402 of the Public
Health Service Act; and
(B) 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.
SEC. 809. APPLICATION OF FEDERAL LAW TO THE PRACTICE OF
PHARMACY COMPOUNDING.
Section 503 (21 U.S.C. 353) is amended by adding at the end
the following:
``(h)(1) Sections 501(a)(2)(B), 502(f)(1), 502(l), 505, and
507 shall not apply to a drug product if--
``(A) the drug product is compounded for an identified
individual patient, based on a medical need for a compounded
product--
``(i) by a licensed pharmacist in a State licensed pharmacy
or a Federal facility, or a licensed physician, on the
prescription order of a licensed physician or other licensed
practitioner authorized by State law to prescribe drugs; or
``(ii) by a licensed pharmacist or licensed physician in
limited quantities, prior to the receipt of a valid
prescription order for the identified individual patient, and
is compounded based on a history of the licensed pharmacist
or licensed physician receiving valid prescription orders for
the compounding of the drug product that have been generated
solely within an established relationship between the
licensed pharmacist, or licensed physician, and--
``(I) the individual patient for whom the prescription
order will be provided; or
``(II) the physician or other licensed practitioner who
will write such prescription order; and
``(B) the licensed pharmacist or licensed physician--
``(i) compounds the drug product using bulk drug
substances--
``(I) that--
``(aa) comply with the standards of an applicable United
States Pharmacopeia monograph; or
``(bb) in a case in which such a monograph does not exist,
are drug substances that are covered by regulations issued by
the Secretary under paragraph (3);
``(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;
``(ii) compounds the drug product using ingredients (other
than bulk drug substances) that comply with the standards of
an applicable United States Pharmacopeia monograph and the
United States Pharmacopeia chapter on pharmacy compounding;
``(iii) only advertises or promotes the compounding service
provided by the licensed pharmacist or licensed physician and
does not advertise or promote the compounding of any
particular drug, class of drug, or type of drug;
``(iv) 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;
``(v) does not compound a drug product that is identified
by the Secretary in regulation as presenting demonstrable
difficulties for compounding that reasonably demonstrate an
adverse effect on the safety or effectiveness of that drug
product; and
``(vi) does not distribute compounded drugs outside of the
State in which the drugs are compounded, unless the principal
State agency of jurisdiction that regulates the practice of
pharmacy in such State has entered into a memorandum of
understanding with the Secretary (based on the adequate
regulation of compounding performed in the State) that
provides for appropriate investigation by the State agency of
complaints relating to compounded products distributed
outside of the State.
``(2)(A) The Secretary shall, after consultation with the
National Association of Boards of Pharmacy, develop a
standard memorandum of understanding for use by States in
complying with paragraph (1)(B)(vi).
``(B) Paragraph (1)(B)(vi) shall not apply to a licensed
pharmacist or licensed physician, who does not distribute
inordinate amounts of compounded products outside of the
State, until--
``(i) the date that is 180 days after the development of
the standard memorandum of understanding; or
``(ii) the date on which the State agency enters into a
memorandum of understanding under paragraph (1)(B)(vi),
whichever occurs first.
``(3) The Secretary, after consultation with the United
States Pharmacopeia Convention Incorporated, shall promulgate
regulations limiting compounding under paragraph
(1)(B)(i)(I)(bb) to drug substances that are components of
drug products approved by the Secretary and to other drug
substances as the Secretary may identify.
``(4) The provisions of paragraph (1) shall not apply--
``(A) to compounded positron emission tomography drugs as
defined in section 202(jj); or
``(B) to radiopharmaceuticals.''.
The Senate proceeded to consider the bill.
Mr. JEFFORDS addressed the Chair.
The PRESIDING OFFICER. The Senator from Vermont.
Amendment No. 1130
(Purpose: To provide a complete substitute)
Mr. JEFFORDS. Mr. President, I send a modification of the committee
amendment to the desk.
The PRESIDING OFFICER. The clerk will report the amendment.
The legislative clerk read as follows:
The Senator from Vermont [Mr. Jeffords] proposes an
amendment numbered 1130.
[[Page S9146]]
Mr. JEFFORDS. Mr. President, I ask unanimous consent that further
reading of the amendment be dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
(The text of the amendment is printed in today's Record under
``Amendments Submitted.'')
Mr. LOTT addressed the Chair.
The PRESIDING OFFICER. The majority leader.
Mr. LOTT. Will the Senator yield?
Mr. JEFFORDS. I certainly yield to the majority leader.
Mr. LOTT. Mr. President, this will be just very brief. I know you
have your statements. Senator Kennedy has another event at 3 or 4 that
he may attend. I have a conflict with other events, too.
Cloture Motion
Mr. LOTT. Mr. President, I send a cloture motion to the desk and ask
the clerk to report.
The PRESIDING OFFICER. The cloture motion having been presented under
rule XXII, the Chair directs the clerk to read the motion.
The legislative clerk read as follows:
Cloture Motion
We the undersigned Senators, in accordance with the
provisions of rule XXII of the Standing Rules of the Senate,
do hereby move to bring to a close debate on the substitute
amendment to Calendar No. 105, S. 830, the FDA reform bill:
Trent Lott, James M. Jeffords, Pat Roberts, Kay Bailey
Hutchison, Tim Hutchinson, Conrad Burns, Chuck Hagel,
Jon Kyl, Rod Grams, Pete Domenici, Ted Stevens,
Christopher S. Bond, Strom Thurmond, Judd Gregg, Don
Nickles, and Paul Coverdell.
Mr. JEFFORDS addressed the Chair.
The PRESIDING OFFICER. The Senator from Vermont.
Mr. JEFFORDS. Mr. President, the amendment that I sent to the desk is
a modification of the committee amendment, and it is the amendment we
desire to move forward on.
The PRESIDING OFFICER. Amendment No. 1130 is a modification of the
committee substitute, and cloture has been filed on that amendment.
Mr. JEFFORDS. Thank you, Mr. President.
First, filing a cloture motion sort of indicates a serious situation
which requires its action. I am pleased to report that I am more
optimistic now than I have been at any time that a vote will not be
necessary to have cloture and that we are all working very long and
hard upon resolving the remaining questions. The most difficult one
that we were facing appears to be resolved. So it is my firm belief
that by the time we come before this body again, other than today's
debate, we will have an opportunity to expeditiously pass an FDA bill
for the Food and Drug Administration to ensure that we have it passed
in time to prevent the problems which might occur by failing to do so.
Legislation to reform and modernize the Food and Drug Administration
has been under consideration by Congress for over 3 years. At least six
hearings have been held over the past 2 years in the Senate.
Last year, our measure was reported out of committee but never
reached the floor for full consideration. This year, we have held
hearings and worked through months of negotiations with my colleague
from Massachusetts and with the administration.
S. 830 passed out of the Labor Committee on a vote of 14-4, a strong
statement as to the bipartisan support this moderate measure enjoys.
Last week we had a vote on the motion to proceed, and the vote was 89-5
that we begin consideration of this measure. We are here today to do
that. The Senate spoke loud and clear last week: ``Let's move on the
bill. Let's consider amendments. And let us vote.'' We have now had
over 15 hours of debate on this measure stretching back to before the
August recess.
Most recently, we spent a good part of Friday and Monday debating
essentially 6 pages out of the 152-page bill. The time to move forward
on this measure is now. I urge Senators to examine this measure, and I
believe they will agree with me that it provides moderate, incremental
but important improvements to the FDA while continuing the agency's
``gold standard'' of public safety.
I have never worked harder on a bill, and I say the same for the
members of the committee, than we have on this one. The number of hours
that have been spent bringing about consensus is incredible. I thank my
ranking member and our staff for their cooperation and for placing us
in a position where I believe we can expeditiously pass this next week
without the necessity of having to invoke cloture.
So at this point, Mr. President, I yield the floor.
Mr. KENNEDY addressed the Chair.
The PRESIDING OFFICER. The Senator from Massachusetts.
Mr. KENNEDY. Mr. President, as I have on other occasions, I pay
tribute to my friend and colleague from Vermont, Senator Jeffords, who
has been shepherding this very complicated but enormously important
health policy issue through the Senate. As he has correctly stated,
there has been broad agreement on a number of the very important
aspects of the bill that relate to the drug and medical device
provisions.
We have made considerable progress on one other aspect of the
legislation, and that deals with an amendment which was added by the
Senator from New Hampshire, which I will address momentarily. There are
still some very important issues that are still being considered by
Members. All of us are hopeful that we will have a positive outcome,
but we are not quite there yet.
Mr. President, just on another item, I want to identify myself with
the excellent remarks of my friend and colleague from Iowa, Senator
Harkin, on the vote that was taken just an hour or so ago about the
block granting of various education programs.
I think all of us have understood that the role of the Federal
Government is very limited in terms of its help and assistance to local
communities in terms of education. We have a much more profound
responsibility in the areas of higher education. But our
responsibilities in the elementary and secondary education respects
that education is a local function but also an important State
responsibility.
That is why for every dollar that is expended, only about 6 cents of
that dollar really comes from the Federal Government. The targeting of
those programs has been in the areas where there has been, as he
pointed out and others have recognized, general recognition nationwide
of very important national objectives, and that is with the most
disadvantaged students, primarily in the areas of basic skills--basic
skills--math and science programs in the title I programs across this
country, the neediest children in the most disadvantaged areas. It is a
very important program. It has been evaluated, has had broad support.
That is one of the very important areas.
There have been adjustments about what programs will be in and what
programs will be out, but you cannot get away from the fact that these
programs that have been included are targeted and by and large go to
local communities where there is wide discretion. If you take the Goals
2000, 90 percent of that fund is spent at the local level. You can't
get any more in terms of local control than what we have at the present
time.
You find that there is 2 percent administrative costs by the
Department of Education in the overall programming, 6 percent at the
State level of all of these various programs. A great percent of that 6
percent is technical assistance, goes to local communities that are
trying to deal perhaps with special-needs children. Maybe it is a small
community that has two or three members of a class that have special
needs. They do not develop a whole program, but there are other
schools, other school districts that have similar kinds of needs.
This technical assistance helps and assists those local communities:
the School to Work Program has had strong bipartisan support--we still
remember the strong Republican support to try to help young people move
from school into the employment programs and into employment--the drug-
free schools to try to do something about the problems of drug
addiction and violence in our various school districts.
Now, we do not know. There is no accountability in this particular
program. There is no requirement for reporting on how the money is
expended. It bypassed even the States, so the States will not have an
understanding of how these resources are going to be spent. We do not
know which States
[[Page S9147]]
are going to be advantaged, which disadvantaged or communities
advantaged or disadvantaged.
So I join in expressing strong reservations. I want to say very
clearly that if this comes back, this particular provision, we are
going to take some time on the floor of the U.S. Senate to really make
sure that not only every Member of this body understands it but all
Americans understand it. If the local States want to expend additional
resources, let them go out and tax their local communities to do so. If
they want it, let them do it. But if we are going to commit ourselves
to trying to raise resources to meet targeted needs for the neediest
children in this country, we ought to be able to do it. If you are
going to take that and block grant it and send it back to the States
and just use the Federal tax system to raise these funds, that ought to
be done in a different forum. We will have a longer time to debate it
if it comes back. But we should not permit a vote in support of the
general appropriations to go by without some comment.
Now, Mr. President, I am pleased that we have achieved an important
compromise on one of the most important issues in the FDA reform
legislation, the issue of Federal preemption of State regulation of
over-the-counter drugs and cosmetics.
I compliment Senator Gregg, Secretary Shalala, and others involved in
working out this responsible agreement. It will assure that States have
the ability to step in to protect consumers from cosmetics when
necessary while also providing companies reasonable guarantees that
when the FDA has acted effectively to protect consumers, they will not
be subjected to conflicting and potentially duplicative labeling
requirements.
Under the agreement, the Federal Government will not preempt State
regulation of the safety of a cosmetic. This is appropriate. If a State
feels strongly enough about a particular ingredient or a product to ban
it or to take similar actions, it should be free to do so. States
virtually never use this authority. But even though it is rarely used,
it should be preserved.
In the critical realm of packaging and labeling where States have
been most active in ensuring consumers receive the information they
need to protect themselves, this amendment strikes a fair balance. The
reason preserving States' ability to act is so important is that FDA
regulation has been weak. Under this agreement, States would continue
to have the ability to act to protect their consumers except in those
cases where the FDA has already taken appropriate action in a specific
area.
The compromise reached in section 762, which relates to the
preemption of the State regulation for the packaging and labeling of
cosmetics, will assure that the States retain full authority to
regulate cosmetics in those circumstances when the FDA has not acted.
As you know, I think it is essential for the States to be able to
regulate the labeling and packaging of cosmetics whenever the FDA has
not acted. This is especially important because there is so little FDA
regulation in the area of cosmetics.
Section 762 would preempt a State labeling and packaging requirement
only when FDA has specifically acted on the same aspect of the labeling
or packaging of that cosmetic. Thus, if FDA issues a regulation that
requires cosmetic manufacturers to include a specific warning about an
aspect of an ingredient in a cosmetic, a State cannot require a
different warning about the same aspect of that ingredient.
For example, if the FDA required a warning label for a particular
product regarding its use by pregnant women, the State would be
prohibited from requiring a different warning label for the same hazard
and product. On the other hand, where the FDA has not taken action, the
States would be free to fill the gap. So, if we are going to breathe
new life into the FDA to take on more and more kinds of
responsibilities to assure the public in terms of some of these health
hazards, as a result of the debates we have had in the past days, they
are free to do so.
On the other hand, if a State wants to require a warning on a
cosmetic and FDA has not acted, the State can require that warning. For
example, Minnesota has required a caution statement on flammable
products. This provision would not preempt that requirement because FDA
has not acted.
Similarly, if FDA requires a warning about a specific ingredient
contained in a cosmetic, ingredient A, and a State wants to require a
warning about another ingredient in the same cosmetic, ingredient B,
the State would not be preempted. Likewise, if FDA requires a warning
about a certain aspect of an ingredient for example, ingredient A
causes cancer, a State can require a warning about a different aspect
of the same ingredient for example, ingredient A causes birth defects.
The bottom line is that the States are preempted only when FDA has
acted on the same ingredient and the same health concern.
Finally, this provision does not in any way affect the State's
ability to regulate the safety of cosmetics. Thus, if FDA has a
specific labeling requirement for a cosmetic ingredient about a
particular concern, the State may take additional steps, such as a ban
on the ingredient, to protect the public health, although the State
cannot require additional labeling about the concern for that
ingredient.
This may very well be an invitation to give the FDA the authority and
the resources to adequately regulate cosmetics, but if they do not do
it, which is the condition today, we are not going to be interfering
with the States. That is very, very important.
The debate on this issue has highlighted the potential hazards that
cosmetics pose to consumers, especially women, which are too often
underestimated.
A study by the respected, nonpartisan General Accounting Office
reported that more than 125 ingredients available for use in cosmetics
are suspected in causing cancer. Other cosmetics may cause adverse
effects on the nervous system, including convulsions. Still other
ingredients are suspected of causing birth defects. And a carefully
controlled study found that 1 in 60 users suffered a cosmetic-related
injury identified by a physician.
The fact is, Mr. President, there are enormous numbers of new
compounds, an enormous expansion of the use of various products,
including toxic products, that are being utilized in cosmetics. We want
to make sure that the States, through their own public health agencies
or through various studies or through their research, are going to be
able to raise health concerns necessary to protect their consumers.
Mr. President, we have outlined at other times on the floor various
items which raise some important concerns--alpha-hydroxy acid, feminine
hygiene products, and talcum powder. We have heard from Dr. Wallinga, a
physician at the Natural Resource Defense Council. He points out the
dangers of these products citing studies in prestigious medical
journals.
We have in this compromise preserved the right of the States to
protect the public.
We have seen recently the impact of State laws on public health. In
California, for example, action has been taken against Grecian Formula
and toluene in nail polish.
We also know of other States that have introduced legislation aimed
at further regulation of cosmetics. New York, for example, is pursuing
expiration dating of certain cosmetics. Ohio and Texas are also
considering additional regulation of cosmetics. My own State of
Massachusetts is pursuing a consumer right-to-know law similar to that
in California.
Nothing in this legislation will infringe upon these or similar
activities by the States to protect the public.
The agreement we have reached today is a very reasonable one. I
commend Senator Gregg for his hard work in making it a reality. The
fact is neither the Food and Drug Administration nor the States are
doing enough to protect women from the dangers posed by cosmetics. This
issue deserves to be a high priority. I intend to see that it is.
Mr. President, regarding remaining issues in the legislation, I hope
we can have the same hard work and accommodation in addressing these
issues before we turn to the legislation. They deal with important
questions about the procedures of the Food and Drug Administration in
reviewing medical devices. We want to make sure that the medical
devices that are going to be used on the American public are safe
[[Page S9148]]
and effective. We want to make sure that FDA reviewers look at data on
the use of a medical device that is clearly indicated by the technical
design of the device--whether or not it is on the label. Under the
current language, FDA would be unable to make a complete review of the
device. The public would be deprived of assurances they have today that
devices are truly safe and effective. We talked about this previously
on the floor of the U.S. Senate. We will have further opportunity to
address this issue. It is an extremely important one.
A second item we hope to address is ensuring that FDA can consider
certain manufacturing practices that produce an unsafe product in
clearing a medical device for marketing. The language requires FDA to
allow a new device on the market even if the manufacturer is producing
defective devices. This provision endangers the public health by
putting unsafe products on the market. It also requires the Food and
Drug Administration to spend its resources chasing after unsafe medical
devices already on the market rather than simply requiring that the
device be produced safely in the first place.
These are important items and in my full statement, to a considerable
degree, I expand on them.
There are environment considerations, the effective removal of the
environmental impact statements under NEPA. I do not remember
considering this provision as part of our hearings on this legislation.
I do not feel that we should start taking various agencies and
exempting them from considering the environmental impact of their
actions. I think this is an issue that we should address.
My colleagues have raised other questions in terms of the ethical
issues that surround the payment of third party reviewers. These
individuals are going to be reviewing products that are manufactured by
the same companies that are paying them. This raises important ethical
issues. I will have an opportunity to debate and take action on some of
those.
I thank very much, Mr. President, the chairman of the committee, for
his continued cooperation, and the other Members for their help and
assistance. I am particularly grateful to Senator Gregg for his
cooperation in helping us work out a satisfactory resolution of the
amendment on cosmetics.
Consumers have suffered painful, permanent injuries from hair
treatment products that have caught fire. They have suffered serious
urinary tract infections from bubble bath. They have suffered life-
threatening allergic reactions to hair dyes, and severe chemical burns
from skin creams and sun tan lotions. The GAO concluded that
``cosmetics are being marketed in the United States which may pose a
serious hazard to the public.''
And these are only the acute injuries that require immediate medical
care. The poisons in cosmetics can also cause long-term injuries and
illnesses that do not develop for years after exposure.
Three specific products highlight the risks consumers face. Alpha-
hydroxy acid is one of the hottest selling cosmetic products on the
market, with sales of roughly a billion dollars a year. It is sold to
erase fine lines and tighten the skin. FDA has received numerous
complaints of adverse effects from the use of these products. Alpha-
hydroxy acids have been linked to severe redness, burning, blistering,
bleeding, rash, itching, and skin discoloration. Most troubling, there
is concern that alpha-hydroxy may promote skin cancer by increasing
sensitivity to sun exposure. Yet these products are in the
marketplace--with no warning labels and no limits on the concentrations
that may be sold. Under this bill, every State would be prohibited from
requiring these sensible warnings.
I ask unanimous consent that I may put a fact sheet laying the issues
on alpha-hydroxy in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Who Will Act to Protect the Public From Hazardous Products in Cosmetics
If S. 830 Passes? No One Will!
(Statement of David Wallinga, MD, MPA, Senior Scientist, Public Health
Program, Natural Resources Defense Council, September 10, 1997)
People often assume that government is there to protect
them. They figure that if a consumer product is sold at the
corner drug or department store, it must some passed some
sort of regulatory scrutiny. People would especially like to
believe that cosmetics--the products they put on their hair,
lips, faces and underarms each day--have been adequately
tested and found to be safe.
They couldn't be more wrong. As a physician, I couldn't
believe it when it first learned how powerless the Food and
Drug Administration is to regulate cosmetics in a way that
ensures their safety. FDA's lack of regulatory authority is
based on a law from 1938--a time when scientists knew very
little about the potential health effects of the chemicals
found in cosmetics. This law only lets FDA act if a cosmetic
has been adulterated or misbranded. What's even more amazing
is that the law has absolutely no requirement that cosmetic
products be tested for safety.
That means the thousands of chemicals currently found in
cosmetics: Do not have to be tested to see if they are
absorbed through the skin and in the blood; do not have to be
tested to see if the cause cancer; do not have to be tested
to see if they cause allergies or infections; do not have to
be tested for effects on the brain or nervous system; do not
have to be tested to see if they affect fertility or the
reproductive organs; and do not have to be tested for their
effects on infants and children, who can be more susceptible
to the toxic effects of certain chemicals.
It is outrageous that products which people put on their
faces, their underarms and other parts of their body each day
are not even adequately tested for safety. Testing of the
pesticide in your dog's flea collar is more extensive than
that for cosmetics. This, despite the fact that cosmetics are
often used by pregnant women, and women of reproductive age.
Since many chemicals in cosmetics are fat-soluble, or are
organic solvents, it means they can penetrate the skin--and
possibly enter the fetus where they may cause reproductive
harm.
It gets worse. The Senate is now proposing to strip the
states of much of their regulatory authority over cosmetics
as well. In particular, the Senate would limit the states
ability to provide consumers with product warnings and other
information, including adequate labeling. This will extend
FDA's ignorance about potentially-toxic cosmetic products to
consumers. It will also strip consumers of their only
conceivable protection against these products. In this
regulatory magic act, science will have been frozen solid.
FDA is already frozen into the science of the 1930s; now, we
are freezing out states from acting on any new scientific
information. This might be great news for a $20 billion
dollar-a-year industry, but its pretty lousy news for public
health.
Each year, around 1000 new cosmetic products enter the
consumer market. In perfumes and fragrances alone, there are
at least 1500 different chemicals. How many of these are
safe? No one knows. But because of the FDA's impotence, it is
certain that the vast majority have not been broadly tested
for health effects, and are not well understood from a
scientific standpoint.
There are some cosmetics, however, whose safety we already
have good reason to question. Skin-peeling creams, for
example, are extremely popular. But they contain alpa-
hydroxyacids which have been shown to greatly increase the
skin's susceptibility to ultraviolent light. Someone who has
used one of these creams recently would want to be careful
about sun exposure, to prevent sunburn and avoid the
increased risk of skin cancer. How will the consumer know to
use sun screen or avoid sun exposure after using these
creams? The short answer is, they won't.
FDA not only lacks the authority to require safety testing,
it also has very weak authority to require product labels
that reflect health and safety concerns about cosmetics. Even
worse, the proposed bill would deny individual states the
authority to require such labels. It doesn't seem like much
to ask: a label that would tell people to avoid sun or use
sunscreen. It's not a product ban, it's not changing the
formulation . . . it's just an advisory label. But it will be
forbidden by this law. We will instead just have to hope that
industry voluntarily labels its products so that people use
them correctly.
There's more. In medicine we know about a disease called
``talcosis'' which occurs from inhaling talcum powder.
Mostly, that's a problem in talc workers. But what about a
recent study from Yale University, a study that confirmed
earlier research finding an association between the use of
talcum powder on the genital region and ovarian cancer in
women? Scientists have shown that talc particles can enter
the body and accumulate in ovarian tissue. There, they are
associated with a 40% increased risk of ovarian cancer.
Ovarian cancer is hard to diagnose, hard to treat
effectively, and is often fatal. It is something which is
much better to prevent than to try and treat once it occurs.
Yet if a state wanted to notify women that talcum powder
should not be used regularly in the genital region, that
would be illegal under this new law.
These are only two examples of the many, many potential
hazards from the thousands of chemicals in cosmetic products.
There are more: hair dyes and shampoos which contain coal
tars which are known to cause cancer; feminine hygiene
products associated with infertility, ectopic pregnancy, and
an increased risk of pelvic inflammatory disease; lipstick
and hair dyes which contain lead,
[[Page S9149]]
used by pregnant women, and particularly dangerous for
fetuses; and numerous products which contain immune system
sensitizers, such as cinnamates, which can cause severe
allergic reactions, skin rashes, or asthma.
Currently, we have an empty law regulating these cosmetics,
a law directing the FDA into empty regulation. Until we have
a better system in place at the federal level, we should
certainly not interfere with the right of states to act on
these hazards, and to protect the health of their citizens,
independently. Our best hope as consumers, as patients, and
as health care professionals, is to let states fill this
regulatory gap.
____
Fact Sheet: FDA Reform Bill and Preemption of Cosmetic Regulation by
the States
The regulation of health and safety has traditionally
rested in the hands of the States.
Cosmetics pose substantial threats to the health and safety
of consumers.
There is no substantial Federal regulatory presence in
cosmetics (see below), but proposed cosmetic preemption would
completely bar the States from exercising their traditional
regulation of cosmetic labeling, packaging and consumer
information and would severely limit states ability to
regulate these products in other ways.
background
Traditionally, preemption only takes place in areas where
the Federal government has a strong presence, or has
``occupied that field.''
FDA currently employs less than 30 people to regulate the
$20 billion cosmetics industry. Only 2 employees actually
regulate cosmetic packaging and labeling.
FDA has no authority to approve cosmetic products or review
ingredients, require companies to register, or to even report
cosmetic-related injuries.
Nor can FDA require products be tested for safety or the
results of safety testing be made available to the FDA or the
public. It has no legal access to manufacturers' records. Nor
can it require a product recall--cosmetic recalls are
voluntary.
The basic Federal law regulating cosmetics has not been
amended since 1938.
A 1978 General Accounting Office (GAO) study found that
more than 125 cosmetic ingredients were suspected of causing
cancer. Twenty ingredients were believed to cause central
nervous system disorders, ranging from headaches and
drowsiness to convulsions. Twenty-five were believed to cause
birth defects The industry adds approximately 1,000 new
chemicals annually, with no requirement to show that these
chemicals are safe.
The GAO concluded that ``cosmetics are being marketed in
the United States which may pose a serious hazard to the
public'' and recommended that additional Federal authorities
be granted to FDA to protect the public.
S. 830 and state preemption
There is no public record, hearings, testimony, studies or
otherwise, from the 104th or 105th Congresses which
substantively addresses the issue of cosmetic preemption.
The cosmetics preemption provision was not in the
Chairman's original mark, nor was it subject to hearings.
States will be completely barred from regulating cosmetic
labeling and packaging under S. 830. States will also be
barred from establishing any requirements for communicating
the safety and effectiveness of a drug or cosmetic to the
public.
States will also be barred from other forms of safety
regulation if the Federal government has acted in that area,
even if the Federal regulation is outdated, narrow, or vague.
The industry cannot cite one example of a burdensome state
regulation that this law preempts.
others opposed to s. 830 preemption provision
The Administration position states, ``if the bill were
maintained in its present form, and the outstanding issues
were not addressed, I would be forced to recommend to the
President that he veto this legislation.''
A broad coalition of state officials, women's
organizations, environmental advocates, and others concerned
about public health opposes this provision (see attached
letters)
examples of cosmetic injuries
A six year old girl in Oakland, California had her mother
apply a hair product to her head, which resulted in second
degree burns to the child's ears and neck.
A 59-year old California woman almost died from an allergic
reaction to hair dye.
A 47-year old woman had her cornea destroyed by a mascara
wand.
Still another woman's hair caught fire as the result of an
inflammable hair treatment gel.
In fact, a carefully controlled three month study found
that one in 60 users of cosmetics experienced adverse
reactions.
dangers of widely used products
The attached fact sheets highlight possible dangers from
three widely used cosmetic products: skin creams containing
alpha-hydroxy products--skin irritation and burns, long-term
risk of skin cancer associated with greater sun sensitivity;
feminine hygiene products--pelvic inflammatory disease,
ectopic pregnancy, and infertility; and talc and talcum
powder--ovarian cancer.
international standards
The European Union requires full ingredient listing on
packaging, documentary proof of good manufacturing practice
and similar proof that extensive testing has been carried
out.
____
Fact Sheet: Hazards of Skin Care Products Containing Alpha-Hydroxy
what are alpha-hydroxy acids?
Alpha-hydroxy acids are naturally occurring acids that have
recently been included in skin care products. Alpha-hydroxy
products promise to erase wrinkles and acne, restore skin
elasticity and firmness, and produce younger-looking,
smoother skin. They are used both in skin creams intended for
daily use and ``skin peels'' that are sometimes described as
chemical face lifts.
Products containing alpha-hydroxy acids working by
penetrating the upper-layer of skin, breaking apart the bonds
that hold the skin cells together. The skin then sloughs off
these cells.
Alpha-hydroxy products include Avon Anew Face Cream, Ponds'
Age Defying Complex, Alpha Hydrox Face Cream, Murad, and
MDForte.
Products containing alpha-hydroxy acids are among the
hottest-selling cosmetics, used by millions of women, with
sales of roughly a billion dollars a year.
what are the concerns about cosmetics containing alpha-hydroxy acids?
There is very little data on the effects of alpha-hydroxy
acids. Researcher suggests that they can cause skin
irritation and increased sensitivity to UV radiation, with
the potential for increasing risk of skin cancer. There have
been no long-term studies of the safety of the product.
FDA reported that between 1989 and 1996, there were likely
``many thousands'' of complaints associated with alpha-
hydroxy acids, including ``severe redness, swelling
(especially in the area of the eyes), burning, blistering,
bleeding, rash, itching, and skin discoloration. Many of the
products involved are the lower concentration, mass market
products.'' (February 23, 1996 letter from Dr. John E. Bailey
(Acting Director, Office of Cosmetics and Colors, FDA) to Dr.
F. Alan Andersen (Scientific Coordinator and Director,
Cosmetic Ingredient Review). At least one major manufacturer
has discontinued one of its alpha-hydroxy products because of
the high volume of complaints.
In fact, FDA was sufficiently concerned about alpha-hydroxy
acids that it designated them as their highest priority for
review by the National Toxicology Program--a rare occurrence
for a cosmetic.
A June 1997 report sponsored by the cosmetics industry
found that more study is needed to determine if the use of
alpha-hydroxy acids to remove the epidermis causes the skin
to be more UV sensitive and increasingly susceptible to skin
cancer. In the meantime, the report noted that ``some steps
should be taken to minimize the potential that use a alpha-
hydroxy acid ingredients would result in increased sun
sensitivity. Accordingly, the Expert Panel admonished
producers of leave-on cosmetics containing alpha-hydroxy acid
ingredients to either formulate to avoid increasing sun
sensitivity or to provide directions for use that include the
daily use of sun protection.'' (Final Report: June 6, 1997
Cosmetic Ingredient Review, pg. 131). The report also made
safety recommendations regarding maximum acceptable levels
for alpha-hydroxy acids in both products for daily use and
products used for skin peels by cosmeticians or health
professionals.
There are no binding requirements assuring that
manufacturers abide by the safety recommendations of the
advisory committee with regard to tolerance levels or provide
any safety information on the product. Manufacturers'
packaging typically includes no warnings on the need to use
sunscreen in conjunction with use of the product, no warning
on the potential danger of skin cancer from use of the
product, no information on risks of skin damage or
irritation. Nor are the manufacturers required to list on the
package the concentration of alpha-hydroxy acids in the
product, or inform users if the other ingredients strengthen
or weaken its effectiveness.
Under S. 830, States would be prohibited from requiring
warning labels or other consumer information about alpha-
hydroxy acids.
____
Fact Sheet: Adverse Health Effects of Feminine Hygiene Products
Over one third of all women regularly use feminine hygiene
products--generating roughly $100 million a year in sales.
These products have been shown to cause upper reproductive
tract infections, pelvic inflammatory disease, ectopic
pregnancies and infertility in women.\1\
Analyses has shown that use of these products increased the
overall risk of pelvic inflammatory disease by 73% and the
risk of ectopic pregnancy by 76%.\2\
The current literature also suggests an increased risk in
cervical cancer.\3\
Researchers at University of Washington, Brigham and
Women's Hospital, Harvard Medical School, Mount Sinai School
of Medicine and Centers for Disease Control and Prevention
have all published data regarding the adverse effects of
feminine hygiene products.\4\
[[Page S9150]]
The National Women's Health Network testified that the FDA
needs to do more to educate women and recommended that
feminine hygiene product labeling information on their severe
adverse effects.\5\
Under S. 830, States would be prohibited from requiring
warning labels or other consumer information on feminine
hygiene products.
footnotes
1. J Zhang, AG Thomas, and E Leybovich. ``Vaginal douching
and adverse health effects: a meta-analysis.'' American
Journal of Public Health. 1997 Jul; 87(7): 1207-1211.
2. Ibid.
3. Gardner JW, KL Shuman, ML Slattery, JS Sanborn, TM Abbott,
and JC Overall Jr. ``Is vaginal douching related to cervical
carcinoma?'' American Journal of Epidemiology. 1991 Feb;
133(4): 368-375.
4. Baird DD, CR Weinberg, LF Voight and JR Daling. ``Vaginal
douching and reduced fertility'' American Journal of Public
Health 1996 June: 86(6):844-850. Kendrick JS, HK Atrash, LT
Strauss, PM Garguiullo and YW Ahn. ``Vaginal Douching and the
risk of ectopic pregnancy among black women.'' American
Journal of Obstetrics and Gynecology. 1997 May; 176(5):991-
997. Onderdonk AB, ML Delaney, PL Hinkson and Am DuBois.
``Quantitative and qualitative effects of douche preparations
on vaginal microflora.'' Obstetrics and Gynecology. 1992
Sept; 803 Pt 1):333-8.; Phillips RS, RE Tuomala, PJ Feldblum,
J Schachter, MJ Rosenberg, and MD Aronson, ``The effects of
cigarette smoking, Chlamydia trachomatis infection, and
vaginal douching on ectopic pregnancy.'' Obstetrics and
Gynecology. 1992 Jan; 79(1): 85-90, and Zhang J, p 1207-1211.
5. Cox, Lisa. National Women's Health Network testimony
before FDA Nonprescription Drugs Advisory Committee hearing,
15 Apr 1997.
____
Fact Sheet: Talc May Pose A Risk of Ovarian Cancer
Talc, or talcum powder, is widely used in popular bath and
cosmetic products, and is applied directly to the body,
typically after bathing. Common products with talc include
baby powders and sanitary napkins.
A relationship between talc exposure and ovarian cancer has
been investigated by a number of prominent epidemiologists
and physicians for years.
A recent study by the Yale School of Public Health
confirmed that talc exposure may lead to an increased risk of
developing ovarian cancer.\1\
---------------------------------------------------------------------------
\1\ Footnotes at end of factsheet.
---------------------------------------------------------------------------
Dr. Harvey Risch in the Yale study, states that, ``Several
lines of evidence support the argument for an association
between talc usage and ovarian carcinoma.'' \2\
In the United States, approximately 26,000 women develop
ovarian cancer annually.\3\
Due to its chemical similarity to asbestos, talc has long
been suspected as a lung and ovarian carcinogen.\4\
A technique used to extract ovarian tumor material found
talc particles in approximately 75% of ovarian tumors
examined. Subsequent evaluations have appeared to support the
contention of an association between talc exposure and
ovarian carcinoma.\5\
The Cancer Prevention Coalition has submitted a citizen's
petition to FDA expressing their concern about the possible
health risks posed by talc and requested the agency establish
regulations to require carcinogen warning labels on cosmetics
containing talc as an ingredient.
Under S. 830, States would be prohibited from requiring
warning labels or other consumer information about the
possible hazards of talc.
footnotes
1. Chang, Stella and Risch, Harvey. ``Perineal Talc Exposure
and Risk of Ovarian Carcinoma,'' Cancer. Vol. 79, No. 12,
June 15, 1997.
2. Ibid.
3. Ibid.
4. Herbst AL. ``The Epidemiology of Ovarian Carcinoma and the
Current Status of Tumor Markers to Detect Disease,'' American
Journal of Obstetrics and Gynecology. Vol. 170, 1994.
5. Hederson, WJ, et al. ``Talc and Carcinoma of the Ovary and
Cervix,'' Journal of Obstetrics and Gynecology for the
British Commonwealth. Vol. 78, 1971.
Mr. KENNEDY. Mr. President, a critical point is that an industry-
appointed panel itself set out safety tolerance levels for use of the
product with regard to short-term effects and warned that the product
should not be used without sunscreen. Yet, there is absolutely no
binding requirement that manufacturers follow these recommendations--
and virtually none of the products carry the information or warnings
developed by the industry's own committee that would enable consumers
to help protect their own safety. And, in point of fact, there has been
no truly independent evaluation of the work of the industry panel. In
fact, the FDA is so concerned about the safety of alpha-hydroxy acid
that it has chosen it has its top priority for review by the
prestigious National Toxicology Program.
A second example is feminine hygiene products, which have sales of
$100 million a year. More than one-third of women use them--but they
pose serious health hazards. They have been shown to cause upper
reproductive tract infections, pelvic inflammatory disease, ectopic
pregnancies, and infertility. They may place women at additional hazard
for cervical cancer. Women using these products should have the right
to warning labels informing them of these hazards. But the FDA has done
little to protect or warn women against these dangers.
There are a substantial number of studies on the safety of these
products. The evidence that they are dangerous seems incontrovertible--
but this legislation would prevent States from acting to simply warn
women of the dangers. How outrageous it is that women should face
illness and sterility without being warned of the danger of a seemingly
harmless and beneficial product.
A third example is talc, or talcum powder is widely used in popular
bath and cosmetic products. But it is chemically similar to asbestos,
and it has long been suspected of causing cancer. A number of studies
have suggested the possibility of a link to ovarian cancer, which
afflicts 26,000 women annually--but there are no warning labels on
these products. American women deserve better protection from their
Government.
These three issues have been carefully analyzed by Dr. David
Wallinga, a physician and the senior scientist at the Natural Resources
Defense Council. He points out the dangers of each of these three
products based on studies in prestigious medical journals from
researchers at institutions like Yale and the Mount Sinai Hospital in
New York. I ask unanimous consent to enter his comments in the Record,
along with the articles analyzing these issues.
Federal oversight of this $20 billion industry today is extremely
limited. The basic Federal law regulating cosmetics has not been
updated since 1938. The FDA has less than 30 employees overseeing this
huge industry--and only two employees dealing with the critical issues
of packaging, labeling, and consumer warnings. The FDA has no authority
to require manufacturers to register their plants and products. It
cannot require manufacturers to file data on the ingredients in their
products. It cannot compel manufacturers to file reports on cosmetic-
related injuries. It cannot require that products be tested for safety
or that the results of safety testing be made available to the agency.
It does not have the right of access to manufacturers' records. It
cannot require recall of a product.
In the Federal Food, Drug and Cosmetic Act there are 126 pages
devoted to the regulation of drugs and devices; 55 pages are devoted to
foods regulation. A full eight pages of the act is dedicated to
definitions. But less than two pages are devoted to cosmetic
regulation.
In 1938, there was no requirement that industry show safety of drugs,
medical devices, food additives, or cosmetics before they were
marketed. Today, the public demands higher standards of protection, and
they have been established for drugs, for medical devices, and for food
additives--but not for cosmetics.
The agreement we have reached today is a highly reasonable one. I
especially commend Senator Gregg for his hard work to make it a
reality. But the fact is that neither the FDA and the States are doing
enough to protect women from these dangers. This is an issue that
deserves a higher priority, and I intend to do all I can to see that it
gets it.
There are important remaining issues in this legislation, and I hope
that with the same hard work and spirit of accommodation we can reach
agreement on these issues before we return to consideration of this
legislation on Tuesday.
Two changes in the regulation of devices in particular put consumers
at unacceptable and unnecessary risk. They should be removed in this
bill before it goes forward--and the administration has made it clear
that they put the whole bill at risk of a veto.
A great deal of negotiation has taken place on the medical device
provisions of this bill, and I compliment Senator Jeffords, Senator
Coats, and my other colleagues on the committee for resolving most of
the device provisions in a way that is consistent with protection of
the public health. But there are at least two medical device provisions
in the bill which still raise substantial concerns. They could be
corrected very simply and with negligible effect to the basic purpose
and intent of this bill. Yet these corrections have not been made and
my colleagues deserve a clear description of the hazards they pose.
A brief explanation of how the FDA regulates and clears medical
devices for marketing may first be in order. Under current law,
manufacturers of
[[Page S9151]]
new class I and class II devices can get their products onto the market
by showing that they are substantially equivalent to devices already on
the market. For example, the manufacturer of a new laser can get that
laser onto the market if it can show FDA that the laser is
substantially equivalent to a laser that is already on the market.
Similarly, the manufacturer of a new biopsy needle can get that
biopsy needle onto the market by showing that it is substantially
equivalent to a biopsy needle already on the market. And the
manufacturer of new patient examination gloves can get those gloves
onto the market by showing that they are substantially equivalent to
patent gloves already on the market.
Mr. President, these manufacturers are obliged to demonstrate
substantial equivalence to the FDA by showing that the new product has
the same intended use as the old product and that the new product has
the same technological characteristics as the old product. If the new
product has different technological characteristics, these
characteristics must not raise new types of safety and effectiveness
questions in order for the product to still be substantially equivalent
to the older product.
The logic of this process for bringing medical devices onto market is
quite simple: if a product is very much like an existing product, it
can get to market quickly. If it raises new safety or effectiveness
questions, those questions should be answered before the product can be
marketed.
This process for getting new medical devices on the market, commonly
known as the 510(k) process, is considered by most to be the easier
route to the market. Devices that are not substantially equivalent to a
class I or class II device already on the market must go through a full
premarket review. Thus, device manufacturers have an incentive to get
new products on the market through the 510(k) process. And in fact,
well over 90 percent of all new devices get on the market through the
submission of a 510(k) application.
This legislation seriously compromises the FDA's ability to protect
the public health through its regulation of medical devices that are
marketed through the 510(k) process. Of the dozens of provisions that
we have negotiated and discussed which affect medical devices in this
bill, these two still raise fundamental public health problems.
Although few in number, these provisions raise substantial risks to the
public health which simply cannot be ignored.
The first problem raised by this bill relating to medical devices is
its prohibition on the FDA from considering how a new device will be
used if the manufacturer has not included that use in its proposed
labeling.
You may think that this approach makes sense--why should the Agency
consider the use of a device if the manufacturer has not specified that
use on the label? I'll tell you why--because that proposed label may be
false or misleading. How would the FDA know that? Because the design of
the new device may make it perfectly clear that the new device is
intended for a different use.
Let me provide my colleagues with a few examples. Let's talk about
the biopsy needle I mentioned before, which is used on breast lesions.
Most biopsy needles for breast lesions currently on the market take a
tissue sample that is about the size of the tip of pencil lead. Let's
assume the manufacturer of a new biopsy needle comes to the FDA with a
510(k) submission. But this new biopsy needle takes a tissue sample
that is 50 times as big--the size of a 1-inch piece of a hot dog.
The manufacturer of this new needle has proposed labeling that says
that the needle will be used like the old, marketed needles to biopsy
breast lesions. But FDA knows that the chunk of tissue being biopsied
will usually exceed the size of the lesion. This makes it clear to
FDA--and to any impartial observer--that the new needle will in most
cases be used to remove the lesion.
Under these circumstances the FDA should be able to ask the
manufacturer to provide information on this new use. Is it safe to
remove lesions? Does it really work? The bill, however, categorically
bars FDA from asking these essential questions. This means that the FDA
would be unable to make a complete review of the device and the public
would be deprived of existing assurances that devices are truly safe
and effective.
The proponents of this provision have argued that the FDA could
simply say that the change in device design or technology--such as the
change in size of the biopsy needle--renders the new product
unequivalent to the old product. But that is not always true. The
manufacturer could argue that there are no new questions of safety or
effectiveness for the purpose claimed on the label. In the case of the
biopsy needle, Mr. President, there are times where a large sample is
needed--a sample larger than a pencil tip.
So long as the larger needle is safe and effective for removing a
sample, FDA would still be barred from obtaining data about the new use
of removing lesions--and to the extent the needle is used for the new
use, women could be put at risk for an effective or unsafe treatment of
breast cancer.
Another good example is surgical lasers. Lasers have been used for
decades to remove tissue. Several years ago, a manufacturer added a
side-firing mechanism to their laser to improve its use in prostate
patients. While the manufacturer did not include this specific use in
its proposed labeling, it was transparently clear that the new side-
firing design was intended solely for this purpose of treating prostate
patients.
As a result, FDA required the manufacturer to submit data
demonstrating the laser's safety and effectiveness in treating prostate
patients. This is precisely how the device review process should work.
Manufacturers must prove their devices live up to their claims, while
patients and doctors receive all of the information needed to make the
best possible treatment choices.
But under this bill, FDA would be prohibited from getting adequate
safety data on the laser's use on prostate patients--even though that
would be the product's primary use. This defies common sense yet this
is the result of one troubling and indefensible provision.
Other examples in the way that this provision could allow unsafe and
ineffective devices abound. A stent designed to open the bile duct for
gallstones could be modified in a way that clearly was designed to make
it a treatment for blockages of the carotid artery.
Without adequate testing, it could put patients at risk of stroke or
death. But under this bill, the FDA would be prohibited from looking
behind the label to the actual intended use of the device. A laser to
use to excise warts could have its power raised so that it was also
possible to use it in smoothing facial wrinkles. But without FDA's
ability to assure adequate testing, the use of the laser for this
purpose could lead to irreversible scarring.
Most companies, of course, will not try to bypass the process in this
way. But some bad actors will. And this legislation should not force
the FDA to fight those bad actors with one hand tied behind it. This
provision is like asking a policeman to accept a known armed robber's
assurance that the only reason he is wearing a mask and carrying a gun
is that he is going to a costume party.
The second way this bill undercuts the FDA's ability to protect the
public health and adequately regulate medical devices is the way it
forces the FDA to clear a new device for marketing even if the Agency
knows that the manufacturer cannot manufacture a safe device.
Let me repeat that statement. It sounds frankly preposterous but it
is true. One of the bill's provisions actually requires the FDA to
allow a new device onto the market even if the manufacturer is
producing defective devices. Surprisingly, the proponents of this
provision freely admit that this is true.
Under current law, let's assume that a maker of new examination
gloves submits a 510(k) to the FDA and claims that the new gloves are
substantially equivalent to gloves already on the market. If the FDA
knows for a fact from its inspectors that the company uses a
manufacturing process that often results in these gloves having holes,
FDA would simply not clear the gloves for marketing. FDA would find
[[Page S9152]]
that these gloves are not substantially equivalent to gloves on the
market because gloves on the market don't have holes. That's common
sense, and fortunately, that's also the law.
In contrast, this bill would force FDA to clear the gloves for
marketing. At this point, these defective gloves would be sold to
hospitals, clinics, and HMO's, where they will be used routinely by
doctors, nurses, paramedics, and other health professionals every
single day. Every single glove would expose these professionals
needlessly to the risk of fatal blood-borne diseases like AIDS and
hepatitis.
Here is the response of the provision's supporters. They argue that
once these defective gloves are in the market and being used by health
professionals, FDA can simply institute an enforcement action to remove
them from the market. But when hundreds or thousands of defective
devices have been distributed, and when dozens or hundreds of
facilities may be using these devices, an enforcement action entails
far more than blowing a whistle or picking up the phone to place a
simple call.
In reality, the FDA must coordinate with the U.S. Attorney's office,
the U.S. Marshal's Service and persuade the court of jurisdiction to
issue the appropriate papers. As any attorney or law enforcement
professional can tell you that this takes precious time. And in the
case of a defective device which is exposing people to unnecessary
risks, time is absolutely critical. The sooner a defective glove is
pulled from the market, the sooner the public is protected.
But all this makes absolutely no sense when the FDA today can prevent
this situation from ever arising. If this provision becomes law, the
debater's point distinguishing between different forms of FDA authority
will ultimately be paid for in the health and safety of American
consumers placed at needless risk of death and injury. In fact, even
the regulated industry is willing to compromise on this provision,
because they recognize that it is so unreasonable.
So I hope we can continue to work to compromise these important
devices issues over the weekend. We have been successful on so many
other issues in this bill. These should be resolvable as well.
The last unacceptable element of this bill is an assault on basic
environmental protections contained in the National Environmental
Protection Act. The National Environmental Protection Act of 1969 is a
key Federal environmental statute which regulates the Government's own
actions through environmental impact statements. Under NEPA, Federal
agencies must undertake a comprehensive environmental planning process
for every major action they take. This law is a crucial statutory
assurance that the work of the Government and the actions of regulated
industries are consistent with the guiding principle of environmental
protection.
Section 602 of the bill broadly exempts the FDA's activities from
environmental impact assessments under NEPA. In fact, the provision
even precludes the FDA from taking environmental considerations into
account in its work. The administration unequivocally opposes this
provision. This week, I spoke with the Vice President, who expressed
his serious personal concerns about this provision. In just a few
sentences, this bill opens the door to weakening our environmental
protections and lays a welcome mat down for future exemptions and
future attacks on an effective and essential environmental statute.
This is a terrible precedent, but it also directly affects the
environment. The FDA regulates products which constitute a quarter of
our gross domestic product. When it makes decisions on food containers,
or manufacturing plant approvals, or handling and disposal of medical
supplies, it can have an immense impact on the environment.
Ironically, this antienvironmental extremism is not even demanded by
the regulated industry, which regards the reforms of the NEPA process
recently announced by the Clinton administration as fair and balanced.
We all agree on the importance of FDA reform. The reauthorization of
the Prescription Drug User Fee Program is tremendously important to
assure that the FDA will have adequate resources to review new drugs
and biological products quickly and effectively. This legislation
contains many significant reforms that can streamline the regulatory
process and codify improvements that FDA has already taken
administratively. I compliment Senator Jeffords, the chairman of our
committee, and many other colleagues who have worked hard on this bill
and have been willing to work together to eliminate many other
troublesome provisions in the bill as originally introduced. Let us now
move to complete this work by fixing the remaining contentious issues
included in this legislation.
The PRESIDING OFFICER. The Senator from Vermont is recognized.
Mr. JEFFORDS. Mr. President, this legislation is the result of a
well-considered process to consult with all points of view and to
benefit from the expertise needed to craft legislation on this complex
matter. The substitute before us today stands on the shoulders of four
hearings and a committee markup of a comprehensive Food and Drug
Administration reform bill in the 104th Congress.
This year we held two more hearings, taking testimony from Food and
Drug Administration, industry experts, physicians, and consumer
groups--and I emphasize ``and consumer groups.'' Staff held dozens of
meetings with Food and Drug Administration, experts and patient groups,
discussing in detail every issue of this bill. The negotiation process
with Food and Drug Administration, and the minority started in the
drafting phase of the bill and continued up to and right through the
markup, and has continued right up to this moment. This has been a
process marked by openness and consultation.
The philosophy of this bill is to codify recent efforts of the self-
reform of the Food and Drug Administration, and a great deal of that is
self-reform which we are codifying, and to provide the Food and Drug
Administration with the tools to do even better in certain areas.
We recognize that Congress cannot micromanage an agency like the Food
and Drug Administration, nor do we want to. But we must set realistic
performance goals to ensure the public is protected and well served and
that the industry is fairly treated. In an era of flat or declining
resources, we must give the Food and Drug Administration the management
tools it needs to manage an increasing workload without the expectation
of ever-increasing appropriations to assist them.
The first title of S. 830 establishes in statute that the mission of
the Food and Drug Administration is to protect the public health,
promptly and efficiently review clinical research, and take appropriate
action on the marketing of regulated products in a manner that does not
unduly impede innovation or product availability.
From the 1906 Food and Drugs Act through the 1990 Safe Medical
Devices Act, food and drug law has emphasized the duty of the Food and
Drug Administration is to protect the public against unsafe or
ineffective products. This legislation, as reflected in the mission
statement, strengthens protection of the public from unsafe or
ineffective products and provides a better balance in the law by
ensuring timely access to safe and effective products. It is simple:
Safe and effective products can be made available more quickly--and
they should be. That is what this bill does.
The legislation reauthorizes the Prescription Drug User Fee Act of
1992, commonly referred to as PDUFA, to allow the continued collection
of user fees from prescription drug manufacturers for 5 additional
years. PDUFA I represented a consensus among the Food and Drug
Administration, the prescription drug industry, and Congress that the
industry would pay user fees to augment the resources of the Food and
Drug Administration devoted to the review of human drug applications.
PDUFA I has succeeded in substantially reducing review times for human
drug applications, bringing those drugs to the market sooner than
before.
At some point in the debate I would like to engage a colloquy with
Senator Mikulski, a cosponsor of S. 830, to discuss the importance of
the performance enhancements that PDUFA will bring to the drug review
process. We have all
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benefited from Senator Mikulski's determination to bring the Food and
Drug Administration into the 21st century for the benefit of her own
constituents who work at the FDA, for the betterment of the burgeoning
biotechnology sector in Maryland, and for the parties throughout
America who are served by the technologies developed by those
companies.
Title VII of S. 830, or PDUFA II, would build on the
original legislation by codifying new commitments from FDA to implement
more ambitious and comprehensive improvements in the regulatory
process. PDUFA I focused on reducing the length of time taken by FDA in
reviewing an application. The committee commends FDA for successfully
meeting, and at times exceeding, the performance goals established at
PDUFA I. However, while review times for submitted applications have
improved, the period of time taken to get the drug through the drug
development phase has recently increased from 5 to 7 years.
Appropriately, PDUFA II will focus on shortening overall development
time.
It will streamline interaction with the FDA during the highly
regulated drug development phase and also establish new performance
levels and procedures for FDA that are designed to reduce the time
required to show that a drug is ready for FDA review.
The bill provides improved access to new treatments and important
information needed by patients. Section 102 establishes a statutory
right for any person, acting through a physician, to request an
investigational drug, biological product, or device for diagnosis of a
serious disease or condition. This provision builds upon current FDA
programs that have proved so successful for aids and cancer drugs, and
this is an area that is critical to all of us.
This section of the bill includes modifications urged by the FDA and
patient groups, that codify important patient protections. These
provide patient access under their physician's supervision, to
unapproved therapies, under the existing emergency use, and
investigational device and drug treatment exemption programs.
Another important provision advocated by the patient groups as one of
their top priorities is section 808, which establishes a registry of
clinical trials, both publicly or privately funded, of experimental
drugs and biological or serious life-threatening medical conditions.
Registry information must be understandable to the general public and
include the purpose of experimental protocol, trial eligibility
criteria, and sites and contact points for people wishing to enroll in
a clinical trial. It is critical that those people who are suffering
from the diseases of this nature be able to find out how they can get
involved and be able to take part in a program which is designed to
bring them back to health. Patients, health care providers,
researchers, and the public would access the registry through toll-free
telephone communications and other informational systems. This
provision was included in the bill as an amendment offered by Senator
Dodd, based on legislation introduced by Senator Snowe and Senator
Feinstein. We are all grateful for their leadership in this area. I
should add that Senator Dodd, who is a cosponsor of S. 830, must be
recognized for his early and unflagging support for enacting broad-
based reform this year. He has worked incredibly hard and has been one
of the most steadfast leaders in bringing forth a bipartisan bill.
Yet another provision designed to speed new drugs to patients who
need them is section 613. The FDA currently has a number of mechanisms
aimed at streamlining the development and approval process for new
therapies for serious and life-threatening conditions. Section 613
establishes a statutory mechanism for identifying breakthrough drugs
early in the product development phase. It provides sponsors of such
drugs a reasonable opportunity for early interaction with the agency to
further help streamline the development and approval process for such
drugs.
This provision is intended to clarify and to coordinate some of FDA's
mechanisms for new drugs and biological products that are intended for
the treatment of serious and life-threatening conditions and that
demonstrate the potential to address unmet medical needs for such
conditions. It defines and clarifies a process pursuant to which
sponsors of these drugs may interact with the FDA, and includes
provisions that will ensure that these processes are well known and
well understood.
I want to mention other changes made in the substitute that have been
the subject of discussion between the committee markup and floor
consideration.
I want to make sure that everyone has an opportunity to know what we
will be voting on and that they will have an opportunity to review this
and, hopefully, fully understand it. Certainly, my staff, and I am sure
Senator Kennedy's staff is available to enlighten them if they have
questions. I urge all members to take a look at the bill that is now
before the Senate.
The third-party review provision has undergone substantial revision
since its was first debated in the 104th Congress. This provision has
been developed under the leadership of Senator Coats, who has played an
important role in advancing FDA modernization throughout this process.
This year, he has played a special role in the development of S. 830
from its inception and provided wise counsel on how to achieve the best
possible reform at the FDA. The third-party review pilot in this bill
moves important expansion to the current FDA third-party review program
for medical devices.
I should mention that two amendments to the provision on third-party
review for medical devices offered by Senator Harkin in committee,
which were not agreed to, did form the basis for subsequent compromise
reflected in the substitute now before the Senate. To meet the
Senator's concerns and the concerns of others, the bill sponsors have
agreed to statutory language establishing the right of FDA to review
records related to compensation arrangements, and excluding from third-
party review class III products, products that are implanted for more
than 1 year, products that are life sustaining or life supporting, and
products that are of substantial importance in the prevention of
impairment to human health.
This was an important provision which brought peace of mind to many
and allowed us to come forward with the bill in the form we have
now. These changes in scope and the additional safeguards to protect
against conflict of interest broaden public confidence in this pilot
and provide FDA with a needed tool to manage an increasing workload of
medical device reviews.
Two other critical provisions to improve the medical device review
program will make the review process more efficient and collaborative
for high-technology products--those which offer the greatest benefit
for patients and which also experience the longest review times at FDA.
Senator Wellstone is the sponsor of legislation to reform the medical
device approval process that includes these two provisions and others
in S. 830, and I applaud his leadership on these issues. Section 301
creates the opportunity for a manufacturer to meet with FDA to
establish the type of scientific evidence necessary to demonstrate
effectiveness for a device. FDA had earlier concerns about binding
determinations of device data requirements needed to show efficacy. In
response to the FDA, the provision has been modified to ensure that the
agency will receive sufficient information to make such a determination
and is provided authority to modify the determination where
appropriate.
Manufacturers should not have to spend months wondering if their
application is still on track in the review process. Section 302
requires the agency to meet with manufacturers 100 days after a
premarket approval application is submitted to discuss deficiencies and
any additional information required for approval. This provision, too,
was modified to address FDA's concerns that the agency only be required
to identify deficiencies known at the time of the 100-day meetings. And
FDA would only be required to identify information needed to correct
those deficiencies.
In recognition that the mandatory postmarket surveillance authority
established in the 1990 Safe Medical Devices Act was overbroad and
inconsistently applied, S. 830 made the current mandatory postmarketing
surveillance discretionary and limited surveillance to a 24-month
period, unless FDA
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showed that longer time is needed to track device after marketing.
Concerns of the FDA and patient group are further addressed in the
substitute by striking the portions of the provision establishing new
duration and scope limitations on postmarket surveillance--under the
agreement the only change to the existing surveillance authority is to
make it discretionary, allowing FDA the flexibility to impose
surveillance requirements as appropriate without leaving itself or
companies in technical violation of the law.
Another area of disagreement prior to markup was the manner in which
S. 830 proposed to handle certain types of manufacturing changes for
medical devices. Senate bill 830 proposed to allow these changes to
proceed on the basis of a notification rather than a full supplemental
application.
The substitute modifies the provision in the manufacturing changes
section so that FDA may in some cases still require the submission of a
supplement for a manufacturing change, and such supplement must be
approved prior to implementation of the change. These manufacturing
change supplements shall be reviewed in 135 days. This compromise will
still allow many, if not most, manufacturing changes to proceed under a
streamlined process.
Senator Gregg, who worked very, very hard on this bill, has been
certainly one of those who deserves a great deal of credit for bringing
it to the body in the form it is in, which I believe is most
satisfactory. He is to be also commended for his proposals to
streamline the FDA process for the consideration of health claims based
on Federal research and his amendments to establish uniformity for
over-the-counter [OTC] drugs and cosmetics.
He has modified this provision to exempt California's proposition 65
and allow States to regulate cosmetic labeling and packaging issues
where FDA has not acted. Senate bill 830 authorizes truthful,
nonmisleading health claims for food products that are based on
published authoritative statements of scientific bodies of the U.S.
Government such as the National Institutes of Health. FDA expressed
concern regarding the length of time the agency had to assess these
proposed claims and the mechanism by which they might prevent a
particular claim from going forward. Agreement with FDA was reached on
the basis that FDA is given 30 additional days to review a health claim
under the provision, for a total of 120 days to review a health claim.
FDA is able to prevent the claim from being used in the marketplace by
issuing an interim final regulation. FDA may also block a claim from
going forward, if the conditions established under the provision
governing claims are not met. Again, I thank the Senator for his
excellent work in crafting this provision and reaching agreement with
the FDA.
The committee adopted an amendment by Senator Frist which conforms
the statute with FDA's current practice and today's science with regard
to the quality of data required to show drug efficacy. I am especially
grateful to Dr. Frist, a cosponsor of the S. 830, whose medical
expertise has lent credibility to the decisions we have made in the
complex area of medical technology regulation.
Senator DeWine, joined by Senator Dodd, offered an important
amendment to establish incentives for the conduct of research into
pediatric uses for existing and new drugs.
The bill was improved by Senator Hutchinson's amendment, to establish
a rational framework for pharmacy compounding, which respects the State
regulation of pharmacy while allowing an appropriate role for FDA. I
look forward to participating in a colloquy with the Senator and the
ranking minority member on this topic.
The ranking minority member, Senator Kennedy, has played a vital role
in bringing this compromise to the floor. In markup, he offered two
important amendments adopted by the committee. One amendment, developed
in consultation with Senator Gregg, improved a provision from last
year's legislation governing the regulation of radiopharmaceuticals.
The second improved the bill's provision setting forth a streamlined
process for the review of supplemental applications for new uses of
approved drugs.
I commend the Senator for his hard work and willingness to compromise
on a number of issues which threatened to hold up proceeding on the
bill. We reached agreement on the distribution of health care economic
information. This data is the essential information ingredient in the
drug selection process in the growing managed care sector of the health
insurance marketplace. We agreed to require pharmaceutical companies to
report annually on their efforts to comply with postapproval studies.
This is essential information needed to provide the assurance that
these studies will in fact be completed. Again, I thank the Senator for
his willingness to work out these and other compromises.
Finally, I would like to comment on the involvement of patient and
consumer groups: They testified at one of our committee hearings. Also,
our staff met a dozen times with representatives of these groups to
discuss their proposals, share our ideas and drafts, and debate policy
issues. Representatives of these groups were in key meetings with
industry, FDA, and bipartisan staff to discuss the resolution of issues
they identified as critical--pharmacoeconomics and the requirement of
drug companies to comply with postapproval, or phase four, study
requirements are examples of where we relied heavily on their advice
and were pleased to have their information.
The bill reflects changes to address their concerns: Companies must
report on their compliance with phase four studies; FDA is given
express authority to inspect compensation records of third-party
reviewers; patients will have access to a registry of clinical trials
information; and additional safeguards were built into the provision
allowing expanded access to products under clinical investigation. It
is clear that these groups have played an active and important role in
drafting this bill.
Mr. President, I stand before the body today with a sense of relief
because, for the first time, I feel we are really, without any further
delays, coming toward completion. It is also still my purpose and my
goal to ensure that all Members will still have an opportunity to
express themselves, and that when we come back next time, I hope that
we will have an agreement or unanimous consent that we can proceed
without the necessity of invoking cloture, and have amendments
established to be considered in reasonable lengths of time, so that
this bill can move forward. Certainly, I ask those who are desiring to
propose amendments, when we come back here next week, to get in touch
with us today, tomorrow, and during the weekend and the first of the
week so we can try to accommodate all Members who desire to have
amendments that they desire to have expeditiously considered.
I urge all of the body to recognize that this is an important piece
of legislation. It has to be acted upon yet by the House. They are
anxiously awaiting us to move, so hopefully the bills can be as close
together as possible, so that we can have the bill signed into law
expeditiously, within a month.
With that, Mr. President, I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. HARKIN. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. HARKIN. Mr. President, I yield 10 minutes to the Senator from
Minnesota.
The PRESIDING OFFICER (Mr. Allard). The Senator from Minnesota.
Mr. WELLSTONE. Mr. President, I come to the floor to speak about S.
830, the FDA Modernization Reform Act of 1997.
I guess there are a couple of things I would like to say about this
piece of legislation.
First of all, I would like to thank my colleagues who have worked
very hard on this. Senator Jeffords, Senator Kennedy, Senator Coats,
Senator Gregg, Senator Harkin, and many others as well.
I also would like to thank Linda Degutis, who is going to be on the
floor with me who has been a fellow with our office. These fellow
programs are wonderful programs. I think many of us are always looking
for additional support and expertise. She has done a marvelous job.
[[Page S9155]]
This bill has traveled an interesting journey. It was in committee
markup about maybe a year ago, or thereabouts. I voted against it then.
That was a difficult vote for me because it never really came to the
floor. But I said then that there was much in this bill that I
approved. I wanted to see some changes. But I thought the bill went too
far.
It was frustrating because on the medical device part of this bill
our office had put much work into it. We spent about a year and a half,
and I think other Senators know what this is like--writing a lot of the
provisions. But I thought the legislation went too far.
There were a number of things in it that are technical sounding. I
will not go into all of it. But it was an overreach. It went too far
trying to privatize FDA. The one thing you don't want to do is throw
the baby out with the bathwater. I really have to keep the consumer
protection part. It is quite one thing to say that you want more
predictability and more timeliness and more focus in the regulatory
process. I am all for that. It is one thing to say that we have to get
these products to the market in a timely fashion. I am all for that.
But they have to be safe and effective.
Then we came back to committee. The second time around it was close
again because there were some provisions in the bill that I did not
agree with. I voted for it. I have tried to work real hard with lots of
different people here. I don't think I need to talk about myself
because that is not important. I think this has been a pretty darned
important collaborative effort.
We are almost there. I thank Senator Gregg for his cooperation. I
think the provisions dealing with cosmetics and preemption of State
standards, which would have affected my State in a very negative way,
was a mistake. I think that has been worked out. We still may have some
work to do yet with NEPA in terms of how this affects environmental
impact statements. I believe that will be worked out. There are a
couple of other problems that I think we are working on right now.
But, Mr. President, let me just say that it is my belief that we can
do better--that we can provide medical products to consumers in a more
timely manner through the provisions in this bill while retaining
significant consumer protection. It is my belief as a Senator that this
legislation would improve the predictability and the timeliness and the
focus of the regulatory process for medical products.
Mr. President, next week when we bring this bill up, I am going to
talk about what all of this means in specifics because this has been
about 2\1/2\ years of work for me as a Senator from Minnesota. But as
long as we are just kind of setting the stage here, if you will, I
think the mood here in the Senate is very positive.
I say to Senator Jeffords again, Senator Jeffords has done a really
fine job of bringing people together. I actually think that we brought
together not only Democrats and Republicans but others, a lot of people
who have been involved with this. I will give full credit to a lot of
the consumer organizations who have not agreed with everything in the
bill, and they have been fighting hard and they continue to fight hard.
They certainly have let me know when they have not agreed with
positions I have taken, but they have done it with class, and they have
been tough. They should be tough, and they should be critical. And they
have been.
By the same token, I want to make it clear that I think the business
community, the industry has been very responsible. At one point in time
when the Congress first started talking about FDA reform, I think there
were some--this now goes back probably 2 years or so--who really looked
at this as an opportunity to privatize FDA, roll back the really
important consumer protection provisions.
I think that is over. It is over for a lot of different reasons. It
is over because I think people now in the Congress hopefully understand
that people in the country are not interested in not having strong
consumer protection. They view FDA as extremely important to them and
the regulation that FDA does as being very important to their lives and
to their children's lives.
I also think people have pulled back from that because the of
industry--and I want to give a lot of credit to the industry. There are
a lot of people in the industry--and I know more about the medical
device industry--who have basically every step along the way made it
clear that, no, this goes too far; we are willing to compete with the
gold standard; we are just asking to get our products to the market in
a more timely fashion, but we don't want to give any ground. These
products have to be safe and effective.
To say that there ought to be more predictability, to say that when
you have a protocol and you have waited for a year or you have waited
more than a year and then all of a sudden you are told the protocol is
no good, you had a right to learn about that earlier, you would like to
at least have conversation with the agency, is very reasonable.
Now, we had some provisions in the bill, including when I voted for
it in the committee, that I thought still needed to be worked on,
changes needed to be made. Again, Senator Jeffords, Senator Kennedy,
and a number of people worked very hard and I think we have really
worked very diligently, and a lot of those problems I think we have
dealt with.
So what we have here, Mr. President, I think is an important piece of
legislation. We will undoubtedly have that, when we bring this bill to
the floor--I say to my colleague, Tuesday, probably, is that correct?
Mr. JEFFORDS. That is correct.
Mr. WELLSTONE. There will be discussion. Some of us are still working
on improvements. But overall what this piece of legislation does, I
will summarize--and I will talk about it in specifics later. I will
talk about it in a fairly technical way next week. But if I had to
summarize, I do believe now after tough negotiation, after a lot of
people in the country being involved with this on all sides, after
Democrats and Republicans I think pulled together on this, with Senator
Jeffords--and I am not just saying this because he is in the Chamber--
really providing key leadership, Senator Kennedy being in there
fighting, with Senator Coats as well, being willing to negotiate; I am
proud of our office's roll and other people as well, what we have is a
piece of legislation which says essentially, look, there will be more
predictability, there will be more timeliness, more focus on FDA's
regulatory action, we can get products to the market in a timely
fashion, which is important to families and consumers, but we can do it
in such a way that we do not sacrifice consumer protection.
We are almost there, and I think this is going to be a very important
reform bill, and I am very proud to be a part of it.
I thank my colleague for his work.
Mr. JEFFORDS. Mr. President, I will yield on my time. I thank the
Senator for all the work he has put into this bill. I know he is
probably one of the strongest consumer advocates this Senate has ever
seen. I would like to chat with the Senator just a bit because there is
some concern of consumer advocates in my State who say how come we are
getting all these editorials? And I would have to say in fairness to
this committee they are based upon information which may have been true
a month or 2 months or 3 months ago, but we have gone out of our way to
put on the web pages--in fact, the most recent agreement which we have
reached on cosmetics is now, or will be this afternoon, on the web
pages so that all they have to do is tune in and they can see the exact
wording.
So I urge those who are still nervous about what is in the bill to
find out. It is available. In the modern age of being able to have
information available, it is available instantly around the country. I
hope that we would continue to work on the basis of what the bill is
instead of what it used to be.
I acknowledge the Senator's contribution to this effort entirely. The
Senator has been instrumental in proposing innovative ideas and finding
solutions. He has done an outstanding job in helping myself and Senator
Kennedy bring this bill to where it is. The Senator is looked upon by
many as a person they can trust to protect the interests of the
consumer. So I thank the Senator for his very active participation in
this bill.
Mr. WELLSTONE. Mr. President, I thank my colleague, and I think he is
right about the time lag on information that has gotten to people. We
have
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continued to be in tough negotiations and a good number of these
problems have been resolved. I guess my style would be to say to the
strong consumer organizations, keep on pushing hard to the very end. I
think this is emerging as a real solid piece of work, and I am proud to
be a part of it.
I thank the Senator very much for the very gracious remarks. Linda
Degutis, again, I thank very much for her help. She has been helpful in
this in a big way.
I thank the Chair.
Mr. DODD. Mr. President, I want to begin by thanking my colleagues
for their overwhelming support last week for cloture on the motion to
proceed with this bill. Some 89 Senators very loudly and very clearly
told us last week that they were ready to move forward to reauthorize
PDUFA and to begin debating the other critical reforms this bill
contains.
There is no Federal agency with a more direct and significant impact
on the lives of the American people than the Food and Drug
Administration. The foods we serve our family, the medicines we take
when we're sick, even the drugs we give our pets, are all approved and
monitored by the FDA.
We must not lose the opportunity that we have before us now to enact
legislation that ensures the FDA has the authorities it needs to bring
safe and effective products to the American people quickly and
efficiently.
I would like to again thank both Senator Jeffords and Senator Kennedy
for their perseverance on this issue. Time after time they have been
willing to return to the bargaining table after many others would have
just walked away. With open minds and in good faith, they've
extensively negotiated this bill, line by line.
We have come to a point where issues on which Members were previously
completely polarized--third party review of medical devices, off-label
dissemination of information, health claims for food products, the
number of clinical trials needed for drug approval, and just today
national uniformity of cosmetics--we've now reached agreement.
I don't know that any of us would have thought unanimity possible on
these provisions even 2 months ago--yet here we are with full agreement
on all but a handful of issues.
I know we have a better bill for all of the arduous negotiations that
have occurred.
Just as an example of how far we've come, let's talk about third
party review of medical devices. The bill would expand the pilot
program currently administered by the FDA.
This is a program, I should note, that is supported by the FDA as a
way to make more efficient use of its resources.
In last years debate, which many of you will remember as being much
more acrimonious, we were told this provision was a nonstarter, no room
to compromise, subject closed.
This year, I am pleased to say, a spirit of bipartisanship and
compromise prevailed. Senator Harkin, Senator Kennedy, and Senator
Coats worked diligently to draft language that ensures that higher risk
devices aren't inappropriately included in this pilot program and that
strong conflict of interest protections are in place.
And just last night, again on an issue that appeared unresolvable--
national uniformity for cosmetics, we have reached agreement. Senator
Gregg has offered what I think is a very reasonable compromise. In the
area of safety requirements, States can continue to regulate where the
FDA has not acted.
Conflicting State requirements that could confuse consumers will be
removed. But where the FDA has not chosen to act, where it does not
have either the manpower or the authority to protect the public, States
can contain to play their historic role in regulating cosmetics.
This is the kind of effort made over and over again on this bill--
some 30 times just since markup 2 months ago we have made improvements
to this bill. A great many of us take pride in the product that has
been created--a bill that will speed lifesaving drugs and devices to
patients and that clearly retains the FDA as the undisputed arbiter of
the safety effectiveness of these products.
Mr. President, I would like to speak for a moment about some of the
positive reforms contained in this bill.
At the heart of this bill is the 5-year reauthorization of PDUFA, the
Prescription Drug User Fee Act--a piece of legislation remarkable for
the fact that there is unanimous agreement that it really works.
PDUFA has set up a system of user fees which drug companies pay to
the FDA. These fees have enabled the Agency to hire more staff. As a
result, drug approval times have been cut almost in half, getting new
and life-saving therapies to patients more quickly.
In addition, by improving the certainty and clarity of the product
review process, S. 830 encourages U.S. companies to continue to develop
and manufacture their products in the United States. The legislation
emphasizes collaboration early on between the FDA and industry during
the product development and product approval phases. This will prevent
misunderstandings about Agency expectations and should result in even
quicker development and approval times.
In addition, S. 830 establishes or expands upon several mechanisms to
provide patients and other consumers with greater access to information
and to life-saving products.
For example, S. 830 will give individuals with life-threatening
illness greater access to information about the location of on-going
clinical trials of drugs.
Based on a bill originally championed by Senators Snowe and
Feinstein. I offered an amendment in committee, which I was pleased to
see adopted, to expand an existing aids database to include trials for
all serious or life-threatening diseases.
Experimental trials offer hope for patients who have not benefited
from treatments currently on the market. Currently, patients' ability
to access experimental treatments is dependent upon their spending
large amounts of time and energy contacting individual drug
manufacturers just to discover the existence of trials.
This is not a burden that we should place on individuals already
struggling with chronic and debilitating diseases. This database will
provide ``one-stop-shopping'' for patients seeking information on the
location of and eligibility criteria for studies of promising
treatments.
Mr. President, I am particularly pleased that this bill incorporates
the Better Pharmaceuticals for Children Act, legislation originally
introduced by our former colleague from Kansas, Senator Kassebaum, and
now cosponsored by myself and Senator DeWine, along with Senators
Kennedy, Mikulski, Hutchinson, Collins, and Cochran.
This provision addresses the problem of the lack of information about
how drugs work on children, a problem that just last month President
Clinton recognized publicly as a national crisis.
According to the American Academy of Pediatrics, only one-fifth of
all drugs on the market have been tested for their safety and
effectiveness in children. This legislation provides a fair and
reasonable market incentive for drug companies to make the extra effort
needed to test their products for use by children. It gives the
Secretary of Health and Human Services the authority to request
pediatric clinical trials for new drug applications and for drugs
currently on the market. If the manufacturer successfully conducts the
additional research, 6 extra months of market exclusivity would be
given.
I recognize that there are few matters still unresolved on this bill
despite the best efforts of all involved. And those we will need to
simply address though the traditional process of holding votes on the
issues.
One issue, which I plan to discuss further when we debate the bill on
Tuesday involves section 404 of the bill, which relates to the FDA's
review of medical devices. This provision, the so-called labeling
claims provision clarifies current law by stating that when reviewing a
device for approval, FDA should look at safety and efficacy issues
raised by the use for which the product was developed and for which it
will be marketed.
Again, this is current law. Unfortunately, in a few instances, the
FDA has inappropriately expanded the scope of its review by requiring
manufacturers to submit data on potential uses of product.
Some have raised concerns that under this provision a manufacturer
[[Page S9157]]
could propose a very narrowly worded label for a device and that the
FDA would be barred from asking for information on other obvious uses.
This is simply not the case. The FDA retains its current authority to
not approve a device if based on a fair evaluation of all material
facts, the labeling is false or misleading. Clearly, if a bad actor
device manufacturer attempted to get a misleading label past the FDA,
the Agency would have full authority to disapprove the product.
I was pleased to join Senator Jeffords as the first Democratic
cosponsor of this bill. I would thank him again for the hard work and
long hours that he and his staff, as well, as Senator kennedy, Senator
Mikulski, Senator Wellstone, Senator Coats, Senator Gregg, and others,
have contributed.
I look forward to further debate on and to joining my colleague next
week in enacting this legislation.
Mr. JEFFORDS. Mr. President, I make a point of order that a quorum is
not present and ask unanimous consent that it be evenly divided between
the minority and majority.
The PRESIDING OFFICER. Without objection, it is so ordered. The clerk
will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. JEFFORDS. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. JEFFORDS. The minority representative and myself are sitting
here. There is some time left. However, we also want to move the
calendar forward as best we can. I just want to alert all Members,
minority and majority, if we do not receive a communication from a
Member or staff within 10 minutes, it is our intention to yield back
the remainder of our time in order that we may move the process of the
Senate forward. I just let everyone know that. We will be sitting here,
awaiting the news.
I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. JEFFORDS. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. JEFFORDS. Mr. President, speaking on behalf of the leader, I ask
unanimous consent that the cloture vote with respect to FDA occur at 10
a.m. on Tuesday, September 16, the mandatory quorum call under rule
XXII be waived, and the time between 9:30 and 10 a.m. be equally
divided for debate, prior to the vote.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. JEFFORDS. Therefore, under rule XXII, all first-degree amendments
must be filed at the desk by 1 p.m. on Monday, September 15. I ask
unanimous consent that all second-degree amendments may be filed up to
the time of the vote on Tuesday.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. JEFFORDS. Mr. President, at this time, and I have the permission
of the minority, I will yield back the remainder of our time, both
minority and majority time; and I so do.
The PRESIDING OFFICER. All time is yielded back.
Mr. JEFFORDS. Mr. President, I make a point of order a quorum is not
present.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. INHOFE. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. INHOFE. I ask unanimous consent that I be recognized for 5
minutes as if in morning business.
The PRESIDING OFFICER. Without objection, it is so ordered.
____________________