Biodefense and Pandemic Vaccine and Drug Development Act of 2006 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to develop and make public a strategic plan to integrate biodefense and emerging infectious disease requirements with the advanced research and development, strategic initiatives for innovation, and the procurement of qualified countermeasures and qualified pandemic or epidemic products.
Establishes the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (HHS).
Requires the Secretary to: (1) coordinate and oversee the acceleration of countermeasure and product advanced research and development; and (2) delegate to the Director of BARDA any necessary functions and authorities.
Establishes the Biodefense Medical Countermeasure Development Fund.
Requires the Secretary to establish the National Biodefense Science Board to provide expert advice and guidance to the Secretary on matters relating to current and future chemical, biological, nuclear, and radiological agents.
Amends the Federal Food, Drug, and Cosmetic Act to extend the period of market exclusivity from seven years to ten years for certain new drugs, antibiotics, or anti-infective drugs to treat a rare disease or condition caused by a biological agent, toxin, chemical, radiological, or nuclear agent that is deemed by the Secretary to be a material threat to the United States.
Provides an antitrust exemption for: (1) meetings and consultations held by the Secretary among persons engaged in the development of countermeasures or pandemic or epidemic products; and (2) agreements resulting from such meetings.
Prohibits payment on a security countermeasure procurement contract until the delivery of an acceptable portion of such product to the Secretary unless advance payment is necessary to ensure the success of the project.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 2564 Introduced in Senate (IS)]
109th CONGRESS
2d Session
S. 2564
To prepare and strengthen the biodefenses of the United States against
deliberate, accidental, and natural outbreaks of illness, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 6, 2006
Mr. Burr (for himself, Mr. Frist, Mr. Enzi, Mr. Gregg, Mr. Alexander,
and Mrs. Dole) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To prepare and strengthen the biodefenses of the United States against
deliberate, accidental, and natural outbreaks of illness, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Biodefense and Pandemic Vaccine and
Drug Development Act of 2006''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Biomedical Advanced Research and Development Authority;
National Biodefense Science Board.
Sec. 4. Clarification of countermeasures covered by Project BioShield.
Sec. 5. Orphan drug market exclusivity for countermeasure products.
Sec. 6. Technical assistance.
Sec. 7. Collaboration and coordination.
Sec. 8. Procurement.
Sec. 9. Rule of construction.
SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY;
NATIONAL BIODEFENSE SCIENCE BOARD.
(a) In General.--Title III of the Public Health Service Act (42
U.S.C. 241 et seq.) is amended by inserting after section 319K the
following:
``SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.
``(a) Definitions.--In this section:
``(1) BARDA.--The term `BARDA' means the Biomedical
Advanced Research and Development Authority.
``(2) Fund.--The term `Fund' means the Biodefense Medical
Countermeasure Development Fund established under subsection
(d).
``(3) Other transactions.--The term `other transactions'
means transactions, other than procurement contracts, grants,
and cooperative agreements, such as the Secretary of Defense
may enter into under section 2371 of title 10, United States
Code.
``(4) Qualified countermeasure.--The term `qualified
countermeasure' has the meaning given such term in section
319F-1.
``(5) Qualified pandemic or epidemic product.--The term
`qualified pandemic or epidemic product' has the meaning given
the term in section 319F-3.
``(6) Advanced research and development.--
``(A) In general.--The term `advanced research and
development' means, with respect to a product that is
or may become a qualified countermeasure or a qualified
pandemic or epidemic product, activities that
predominantly--
``(i) are conducted after basic research
and preclinical development of the product; and
``(ii) are related to manufacturing the
product on a commercial scale and in a form
that satisfies the regulatory requirements
under the Federal Food, Drug, and Cosmetic Act
or under section 351 of this Act.
``(B) Activities included.--The term under
subparagraph (A) includes--
``(i) testing of the product to determine
whether the product may be approved, cleared,
or licensed under the Federal Food, Drug, and
Cosmetic Act or under section 351 of this Act
for a use that is or may be the basis for such
product becoming a qualified countermeasure or
qualified pandemic or epidemic product, or to
help obtain such approval, clearance, or
license;
``(ii) design and development of tests or
models, including animal models, for such
testing;
``(iii) activities to facilitate
manufacture of the product on a commercial
scale with consistently high quality, as well
as to improve and make available new
technologies to increase manufacturing surge
capacity;
``(iv) activities to improve the shelf-life
of the product or technologies for
administering the product; and
``(v) such other activities as are part of
the advanced stages of testing, refinement,
improvement, or preparation of the product for
such use and as are specified by the Secretary.
``(7) Security countermeasure.--The term `security
countermeasure' has the meaning given such term in section
319F-2.
``(8) Research tool.--The term `research tool' means a
device, technology, biological material (including a cell line
or an antibody), reagent, animal model, computer system,
computer software, or analytical technique that is developed to
assist in the discovery, development, or manufacture of
qualified countermeasures or qualified pandemic or epidemic
products.
``(9) Program manager.--The term `program manager' means an
individual appointed to carry out functions under this section
and authorized to provide project oversight and management of
strategic initiatives.
``(10) Person.--The term `person' includes an individual,
partnership, corporation, association, entity, or public or
private corporation, and a Federal, State, or local government
agency or department.
``(b) Strategic Plan for Countermeasure Research, Development, and
Procurement.--
``(1) In general.--Not later than 6 months after the date
of enactment of the Biodefense and Pandemic Vaccine and Drug
Development Act of 2006, the Secretary shall develop and make
public a strategic plan to integrate biodefense and emerging
infectious disease requirements with the advanced research and
development, strategic initiatives for innovation, and the
procurement of qualified countermeasures and qualified pandemic
or epidemic products.
``(2) Content.--The strategic plan under paragraph (1)
shall guide--
``(A) research and development, conducted or
supported by the Department of Health and Human
Services, of qualified countermeasures and qualified
pandemic or epidemic products against possible
biological, chemical, radiological, and nuclear agents
and to emerging infectious diseases;
``(B) innovation in technologies that may assist
advanced research and development of qualified
countermeasures and qualified pandemic or epidemic
products (such research and development referred to in
this section as `countermeasure and product advanced
research and development'); and
``(C) procurement of such qualified countermeasures
and qualified pandemic or epidemic products by such
Department.
``(c) Biomedical Advanced Research and Development Authority.--
``(1) Establishment.--There is established within the
Department of Health and Human Services the Biomedical Advanced
Research and Development Authority.
``(2) In general.--Based upon the strategic plan described
in subsection (b), the Secretary shall coordinate and oversee
the acceleration of countermeasure and product advanced
research and development by--
``(A) facilitating collaboration among the
Department of Health and Human Services, other Federal
agencies, relevant industries, academia, and other
persons, with respect to such advanced research and
development;
``(B) promoting countermeasure and product advanced
research and development;
``(C) facilitating contacts between interested
persons and the offices or employees authorized by the
Secretary to advise such persons regarding requirements
under the Federal Food, Drug, and Cosmetic Act and
under section 351 of this Act; and
``(D) promoting innovation to reduce the time and
cost of countermeasure and product advanced research
and development.
``(3) Director.--The BARDA shall be headed by a Director
(referred to in this section as the `Director') who shall be
appointed by the Secretary and to whom the Secretary shall
delegate such functions and authorities as necessary to
implement this section.
``(4) Duties.--
``(A) Collaboration.--To carry out the purpose
described in paragraph (2)(A), the Secretary shall--
``(i) facilitate and increase the
expeditious and direct communication between
the Department of Health and Human Services and
relevant persons with respect to countermeasure
and product advanced research and development,
including by--
``(I) facilitating such
communication regarding the processes
for procuring such advanced research
and development with respect to
qualified countermeasures and qualified
pandemic or epidemic products of
interest; and
``(II) soliciting information about
and data from research on potential
qualified countermeasures and qualified
pandemic or epidemic products and
related technologies;
``(ii) at least annually--
``(I) convene meetings with
representatives from relevant
industries, academia, other Federal
agencies, international agencies as
appropriate, and other interested
persons;
``(II) sponsor opportunities to
demonstrate the operation and
effectiveness of relevant biodefense
countermeasure technologies; and
``(III) convene such working groups
on countermeasure and product advanced
research and development as the
Secretary may determine are necessary
to carry out this section; and
``(iii) carry out the activities described
in section 7 of the Biodefense and Pandemic
Vaccine and Drug Development Act of 2006.
``(B) Support advanced research and development.--
To carry out the purpose described in paragraph (2)(B),
the Secretary shall--
``(i) conduct ongoing searches for, and
support calls for, potential qualified
countermeasures and qualified pandemic or
epidemic products;
``(ii) direct and coordinate the
countermeasure and product advanced research
and development activities of the Department of
Health and Human Services;
``(iii) establish strategic initiatives to
accelerate countermeasure and product advanced
research and development and innovation in such
areas as the Secretary may identify as priority
unmet need areas; and
``(iv) award contracts, grants, cooperative
agreements, and enter into other transactions,
for countermeasure and product advanced
research and development.
``(C) Facilitating advice.--To carry out the
purpose described in paragraph (2)(C) the Secretary
shall--
``(i) connect interested persons with the
offices or employees authorized by the
Secretary to advise such persons regarding the
regulatory requirements under the Federal Food,
Drug, and Cosmetic Act and under section 351 of
this Act related to the approval, clearance, or
licensure of qualified countermeasures or
qualified pandemic or epidemic products; and
``(ii) ensure that, with respect to persons
performing countermeasure and product advanced
research and development funded under this
section, such offices or employees provide such
advice in a manner that is ongoing and that is
otherwise designated to facilitate expeditious
development of qualified countermeasures and
qualified pandemic or epidemic products that
may achieve such approval, clearance, or
licensure.
``(D) Supporting innovation.--To carry out the
purpose described in paragraph (2)(D), the Secretary
may award contracts, grants, and cooperative
agreements, or enter into other transactions, such as
prize payments, to promote--
``(i) innovation in technologies that may
assist countermeasure and product advanced
research and development;
``(ii) research on and development of
research tools and other devices and
technologies; and
``(iii) research to promote strategic
initiatives, such as rapid diagnostics, broad
spectrum antimicrobials, and vaccine
manufacturing technologies.
``(5) Transaction authorities.--
``(A) Other transactions.--In carrying out the
functions under subparagraph (B) or (D) of paragraph
(4), the Secretary shall have authority to enter into
other transactions for countermeasure and product
advanced research and development.
``(B) Expedited authorities.--
``(i) In general.--In awarding contracts,
grants, and cooperative agreements, and in
entering into other transactions under
subparagraph (B) or (D) of paragraph (4), the
Secretary shall have the expedited procurement
authorities, the authority to expedite peer
review, and the authority for personal services
contracts, supplied by subsections (b), (c),
and (d) of section 319F-1.
``(ii) Application of provisions.--
Provisions in such section 319F-1 that apply to
such authorities and that require institution
of internal controls, limit review, provide for
Federal Tort Claims Act coverage of personal
services contractors, and commit decisions to
the discretion of the Secretary shall apply to
the authorities as exercised pursuant to this
paragraph.
``(iii) Authority to limit competition.--
For purposes of applying section 319F-
1(b)(1)(D) to this paragraph, the phrase
`BioShield Program under the Project BioShield
Act of 2004' shall be deemed to mean the
countermeasure and product advanced research
and development program under this section.
``(iv) Availability of data.--The Secretary
shall require that, as a condition of being
awarded a contract, grant, cooperative
agreement, or other transaction under
subparagraph (B) or (D) of paragraph (4), a
person make available to the Secretary on an
ongoing basis, and submit upon request to the
Secretary, all data related to or resulting
from countermeasure and product advanced
research and development carried out pursuant
to this section.
``(C) Advance payments; advertising.--The authority
of the Secretary to enter into contracts under this
section shall not be limited by section 3324(a) of
title 31, United States Code, or by section 3709 of the
Revised Statutes of the United States (41 U.S.C. 5).
``(D) Milestone-based payments allowed.--In
awarding contracts, grants, and cooperative agreements,
and in entering into other transactions, under this
section, the Secretary may use milestone-based awards
and payments.
``(E) Foreign nationals eligible.--The Secretary
may under this section award contracts, grants, and
cooperative agreements to, and may enter into other
transactions with, highly qualified foreign national
persons outside the United States, alone or in
collaboration with American participants, when such
transactions may inure to the benefit of the American
people.
``(F) Establishment of research centers.--The
Secretary may establish one or more federally-funded
research and development centers, or university-
affiliated research centers in accordance with section
303(c)(3) of the Federal Property and Administrative
Services Act of 1949 (41 U.S.C. 253(c)(3)).
``(6) Vulnerable populations.--In carrying out the
functions under this section, the Secretary may give priority
to the advanced research and development of qualified
countermeasures and qualified pandemic or epidemic products
that are likely to be safe and effective with respect to
children, pregnant women, and other vulnerable populations.
``(7) Personnel authorities.--
``(A) Specially qualified scientific and
professional personnel.--In addition to any other
personnel authorities, the Secretary may--
``(i) without regard to those provisions of
title 5, United States Code, governing
appointments in the competitive service,
appoint highly qualified individuals to
scientific or professional positions in BARDA,
such as program managers, to carry out this
section; and
``(ii) compensate them in the same manner
in which individuals appointed under section
9903 of such title are compensated, without
regard to the provisions of chapter 51 and
subchapter III of chapter 53 of such title
relating to classification and General Schedule
pay rates.
``(B) Special consultants.--In carrying out this
section, the Secretary may--
``(i) appoint special consultants pursuant
to section 207(f); and
``(ii) accept voluntary and uncompensated
services.
``(d) Fund.--
``(1) Establishment.--There is established the Biodefense
Medical Countermeasure Development Fund, which shall be
available to carry out this section.
``(2) Funds.--
``(A) First fiscal year.--
``(i) Authorization and appropriation.--
There are authorized to be appropriated and
there are appropriated to the Fund $340,000,000
to carry out this section for fiscal year 2007.
Such funds shall remain available until
expended.
``(ii) Authorization of appropriations.--
There are authorized to be appropriated, in
addition to the amounts appropriated under
clause (i), $160,000,000 to carry out this
section for fiscal year 2007. Such funds shall
remain available until expended.
``(B) Subsequent fiscal years.--
``(i) In general.--There are authorized to
be appropriated to carry out this section--
``(I) $500,000,000 for fiscal year
2008; and
``(II) such sums as may be
necessary for fiscal years 2009 through
2012.
``(ii) Availability of funds.--Such sums
authorized under clause (i) shall remain
available until expended.
``(e) Inapplicability of Certain Provisions.--
``(1) Disclosure.--
``(A) In general.--The Secretary shall withhold
from disclosure under section 552 of title 5, United
States Code, specific technical data or scientific
information that is created or obtained during the
countermeasure and product advanced research and
development funded by the Secretary that reveal
vulnerabilities of existing medical or public health
defenses against biological, chemical, nuclear, or
radiological threats. Such information shall be deemed
to be information described in section 552(b)(3) of
title 5, United States Code.
``(B) Oversight.--Information subject to
nondisclosure under subparagraph (A) shall be reviewed
by the Secretary every 5 years to determine the
relevance or necessity of continued nondisclosure.
``(2) Federal advisory committee act.--Section 14 of the
Federal Advisory Committee Act (5 U.S.C. App.) shall not apply
to a working group of BARDA or to the National Biodefense
Science Board under section 319M.
``SEC. 319M. NATIONAL BIODEFENSE SCIENCE BOARD AND WORKING GROUPS.
``(a) In General.--
``(1) Establishment and function.--The Secretary shall
establish the National Biodefense Science Board (referred to in
this section as the `Board') to provide expert advice and
guidance to the Secretary on scientific, technical and other
matters of special interest to the Department of Health and
Human Services regarding current and future chemical,
biological, nuclear, and radiological agents, whether naturally
occurring, accidental, or deliberate.
``(2) Membership.--The membership of the Board shall be
comprised of individuals who represent the Nation's preeminent
scientific, public health, and medical experts, as follows--
``(A) such Federal officials as the Secretary may
determine are necessary to support the functions of the
Board;
``(B) four individuals representing the
pharmaceutical, biotechnology, and device industries;
``(C) four individuals representing academia; and
``(D) five other members as determined appropriate
by the Secretary.
``(3) Term of appointment.--A member of the Board described
in subparagraph (B), (C), or (D) of paragraph (2) shall serve
for a term of 3 years, except that the Secretary may adjust the
terms of the initial Board appointees in order to provide for a
staggered term of appointment for all members.
``(4) Consecutive appointments; maximum terms.--A member
may be appointed to serve not more than 3 terms on the Board
and may serve not more than 2 consecutive terms.
``(5) Duties.--The Board shall--
``(A) advise the Secretary on current and future
trends, challenges, and opportunities presented by
advances in biological and life sciences,
biotechnology, and genetic engineering with respect to
threats posed by naturally occurring infectious
diseases and chemical, biological, radiological, and
nuclear agents;
``(B) at the request of the Secretary, review and
consider any information and findings received from the
working groups established under subsection (b); and
``(C) at the request of the Secretary, provide
recommendations and findings for expanded, intensified,
and coordinated biodefense research and development
activities.
``(6) Meetings.--
``(A) Initial meeting.--Not later than one year
after the date of enactment of the Biodefense and
Pandemic Vaccine and Drug Development Act of 2006, the
Secretary shall hold the first meeting of the Board.
``(B) Subsequent meetings.--The Board shall meet at
the call of the Secretary, but in no case less than
twice annually.
``(7) Vacancies.--Any vacancy in the Board shall not affect
its powers, but shall be filled in the same manner as the
original appointment.
``(8) Chairperson.--The Secretary shall appoint a
chairperson from among the members of the Board.
``(9) Powers.--
``(A) Hearings.--The Board may hold such hearings,
sit and act at such times and places, take such
testimony, and receive such evidence as the Board
considers advisable to carry out this subsection.
``(B) Postal services.--The Board may use the
United States mails in the same manner and under the
same conditions as other departments and agencies of
the Federal Government.
``(10) Personnel.--
``(A) Employees of the federal government.--A
member of the Board that is an employee of the Federal
Government may not receive additional pay, allowances,
or benefits by reason of the member's service on the
Board.
``(B) Other members.--A member of the Board that is
not an employee of the Federal Government may be
compensated at a rate not to exceed the daily
equivalent of the annual rate of basic pay prescribed
for level IV of the Executive Schedule under section
5315 of title 5, United States Code, for each day
(including travel time) during which the member is
engaged in the actual performance of duties as a member
of the Board.
``(C) Travel expenses.--Each member of the Board
shall receive travel expenses, including per diem in
lieu of subsistence, in accordance with applicable
provisions under subchapter I of chapter 57 of title 5,
United States Code.
``(D) Detail of government employees.--Any Federal
Government employee may be detailed to the Board with
the approval for the contributing agency without
reimbursement, and such detail shall be without
interruption or loss of civil service status or
privilege.
``(b) Other Working Groups.--The Secretary may establish a working
group of experts, or may use an existing working group or advisory
committee, to--
``(1) identify innovative research with the potential to be
developed as a qualified countermeasure or a qualified pandemic
or epidemic product;
``(2) identify accepted animal models for particular
diseases and conditions associated with any biological,
chemical, radiological, or nuclear agent, any toxin, or any
potential pandemic infectious disease, and identify strategies
to accelerate animal model and research tool development and
validation; and
``(3) obtain advice regarding supporting and facilitating
advanced research and development related to qualified
countermeasures and qualified pandemic or epidemic products
that are likely to be safe and effective with respect to
children, pregnant women, and other vulnerable populations, and
other issues regarding activities under this section that
affect such populations.
``(c) Definitions.--Any term that is defined in section 319L and
that is used in this section shall have the same meaning in this
section as such term is given in section 319L.
``(d) Authorization of Appropriations.--There are authorized to be
appropriated $1,000,000 to carry out this section for fiscal year 2007
and each fiscal year thereafter.''.
(b) Offset of Funding.--The amount appropriated under the
subheading ``Biodefense Countermeasures'' under the heading ``Emergency
Preparedness and Response'' in title III of the Department of Homeland
Security Appropriations Act, 2004 (Public Law 108-90) shall be
decreased by $340,000,000.
SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED BY PROJECT BIOSHIELD.
(a) Qualified Countermeasure.--Section 319F-1(a) of the Public
Health Service Act (42 U.S.C. 247d-6a(a)) is amended by striking
paragraph (2) and inserting the following:
``(2) Definitions.--In this section:
``(A) Qualified countermeasure.--The term
`qualified countermeasure' means a drug (as that term
is defined by section 201(g)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))),
biological product (as that term is defined by section
351(i) of this Act (42 U.S.C. 262(i))), or device (as
that term is defined by section 201(h) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), that
the Secretary determines to be a priority (consistent
with sections 302(2) and 304(a) of the Homeland
Security Act of 2002) to--
``(i) diagnose, mitigate, prevent, or treat
harm from any biological agent (including
organisms that cause an infectious disease) or
toxin, chemical, radiological, or nuclear agent
that may cause a public health emergency
affecting national security; or
``(ii) diagnose, mitigate, prevent, or
treat harm from a condition that may result in
adverse health consequences or death and may be
caused by administering a drug, biological
product, or device that is used as described in
this subparagraph.
``(B) Infectious disease.--The term `infectious
disease' means a disease potentially caused by a
pathogenic organism (including a bacteria, virus,
fungus, or parasite) that is acquired by a person and
that reproduces in that person.''.
(b) Security Countermeasure.--Section 319F-2(c)(1)(B) is amended by
striking ``treat, identify, or prevent'' each place it appears and
inserting ``diagnose, mitigate, prevent, or treat''.
(c) Limitation on Use of Funds.--Section 510(a) of the Homeland
Security Act of 2002 (6 U.S.C. 320(a)) is amended by adding at the end
the following: ``None of the funds made available under this subsection
shall be used to procure countermeasures to diagnose, mitigate,
prevent, or treat harm resulting from any naturally occurring
infectious disease.''.
SEC. 5. ORPHAN DRUG MARKET EXCLUSIVITY FOR COUNTERMEASURE PRODUCTS.
(a) In General.--Section 527 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360cc) is amended by adding at the end the
following:
``(c) Market Exclusivities for Countermeasures, Antibiotics, and
Antiinfectives.--
``(1) In general.--Except as provided in paragraph (2),
with respect to a drug that is designated under section 526 for
a rare disease or condition, the period referred to in this
section is deemed to be 10 years in lieu of 7 years if--
``(A) such rare disease or condition is directly
caused by a--
``(i)(I) biological agent (including an
organism that causes infectious disease);
``(II) toxin; or
``(III) chemical, radiological, or nuclear
agent; and
``(ii) such biological agent (including an
organism that causes an infectious disease),
toxin, or chemical, radiological or nuclear
agent, is identified as a material threat under
subsection (c)(2)(A)(ii) of section 319F-2 of
the Public Health Service Act;
``(B) such drug is determined by the Secretary to
be a security countermeasure under subsection (c)(1)(B)
of such section 319F-2 with respect to such agent or
toxin;
``(C) no active ingredient (including a salt or
ester of the active ingredient) of the drug has been
approved under an application under section 505(b)
prior to the submission of the request for designation
of the new drug under section 526; and
``(D) notice respecting the designation of a drug
under section 526 has been made available to the
public.
``(2) Application of provision.--Paragraph (1) shall apply
with respect to an antibiotic drug or antiinfective drug
designated under section 526 only if--
``(A) no active ingredient (including a salt or
ester of the active ingredient) of such drug has been
approved as a feed or water additive for an animal in
the absence of any clinical sign of disease in the
animal for growth promotion, feed efficiency, weight
gain, routine disease prevention, or other routine
purpose;
``(B) no active ingredient (including a salt or
ester of the active ingredient) of such drug has been
approved for use in humans under section 505 or
approved for human use under section 507 (as in effect
prior to November 21, 1997) prior to the submission of
the request for designation of the new drug under
section 526;
``(C) the Secretary has made a determination that--
``(i) such drug is not a member of a class
of antibiotics that is particularly prone to
creating antibiotic resistance;
``(ii) sufficient antibiotics do not
already exist in the same class;
``(iii) such drug represents a significant
clinical improvement over other antibiotic
drugs;
``(iv) such drug is for a serious or life-
threatening disease or conditions; and
``(v) such drug is for a countermeasure
use; and
``(D) notice respecting the designation of a drug
under section 526 has been made available to the
public.
``(3) Rule of construction.--With respect to a drug to
which this subsection applies, and which is also approved for
additional uses to which this subsection does not apply,
nothing in section 505(b)(2) or 505(j) shall prohibit the
Secretary from approving a drug under section 505(b)(2) or
505(j) with different or additional labeling for the drug as
the Secretary deems necessary to ensure that the drug is safe
and effective for the uses to which this subsection does not
apply.
``(4) Study and report.--Not later than January 1, 2011,
the Comptroller General of the United States shall conduct a
study and submit to Congress a report concerning the effect of
and activities under this subsection. Such study and report
shall examine all relevant issues including--
``(A) the effectiveness of this subsection in
improving the availability of novel countermeasures for
procurement under section 319F-2 of the Public Health
Service Act;
``(B) the effectiveness of this subsection in
improving the availability of drugs that treat serious
or life threatening diseases or conditions and offer
significant clinical improvements;
``(C) the continued need for additional incentives
to create more antibiotics and antiinfectives;
``(D) the economic impact of the section on
taxpayers and consumers, including--
``(i) the economic value of additional
drugs provided for under this subsection,
including the impact of improved health care
and hospitalization times associated with
treatment of nosocomial infections; and
``(ii) the economic cost of any delay in
the availability of lower cost generic drugs on
patients, the insured, and Federal and private
health plans;
``(E) the adequacy of limits under subparagraphs
(A) and (B) of paragraph (2) to maximize the useful
period during which antibiotic drugs or antiinfective
drugs remain therapeutically useful treatments; and
``(F) any recommendations for modifications to this
subsection that the Comptroller determines to be
appropriate.
``(5) Effective date.--This subsection shall apply only to
products for which an applicant has applied for designation
under section 526 after the date of enactment of the Biodefense
and Pandemic Vaccine and Drug Development Act of 2006.
``(6) Sunset.--This subsection shall not apply with respect
to any designation of a drug under section 526 made by the
Secretary on or after October 1, 2011.''.
SEC. 6. TECHNICAL ASSISTANCE.
Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the
following:
``SEC. 565. TECHNICAL ASSISTANCE.
``The Secretary, in consultation with the Commissioner of Food and
Drugs, shall establish within the Food and Drug Administration a team
of experts on manufacturing and regulatory activities (including
compliance with current Good Manufacturing Practice) to provide both
off-site and on-site technical assistance to the manufacturers of
qualified countermeasures (as defined in section 319F-1 of the Public
Health Service Act), security countermeasures (as defined in section
319F-2 of such Act), or vaccines, at the request of such a manufacturer
and at the discretion of the Secretary, if the Secretary determines
that a shortage or potential shortage may occur in the United States in
the supply of such vaccines or countermeasures and that the provision
of such assistance would be beneficial in helping alleviate or avert
such shortage.''.
SEC. 7. COLLABORATION AND COORDINATION.
(a) Limited Antitrust Exemption.--
(1) Meetings and consultations to discuss security
countermeasures, qualified countermeasures, or qualified
pandemic or epidemic product development.--
(A) Authority to conduct meetings and
consultations.--The Secretary of Health and Human
Services (referred to in this subsection as the
``Secretary''), in coordination with the Attorney
General and the Secretary of Homeland Security, may
conduct meetings and consultations with persons engaged
in the development of a security countermeasure (as
defined in section 319F-2 of the Public Health Service
Act (42 U.S.C. 247d-6b)) (as amended by this Act), a
qualified countermeasure (as defined in section 319F-1
of the Public Health Service Act (42 U.S.C. 247d-6a))
(as amended by this Act), or a qualified pandemic or
epidemic product (as defined in section 319F-3 of the
Public Health Service Act (42 U.S.C. 247d-6d)) for the
purpose of the development, manufacture, distribution,
purchase, or storage of a countermeasure or product.
The Secretary may convene such meeting or consultation
at the request of the Secretary of Homeland Security,
the Attorney General, the Chairman of the Federal Trade
Commission (referred to in this section as the
``Chairman''), or any interested person, or upon
initiation by the Secretary. The Secretary shall give
prior notice of any such meeting or consultation, and
the topics to be discussed, to the Attorney General,
the Chairman, and the Secretary of Homeland Security.
(B) Meeting and consultation conditions.--A meeting
or consultation conducted under subparagraph (A)
shall--
(i) be chaired or, in the case of a
consultation, facilitated by the Secretary;
(ii) be open to persons involved in the
development, manufacture, distribution,
purchase, or storage of a countermeasure or
product, as determined by the Secretary;
(iii) be open to the Attorney General, the
Secretary of Homeland Security, and the
Chairman;
(iv) be limited to discussions involving
covered activities; and
(v) be conducted in such manner as to
ensure that no national security, confidential
commercial, or proprietary information is
disclosed outside the meeting or consultation.
(C) Limitation.--The Secretary may not require
participants to disclose confidential commercial or
proprietary information.
(D) Transcript.--The Secretary shall maintain a
complete verbatim transcript of each meeting or
consultation conducted under this subsection, which
shall not be disclosed under section 552 of title 5,
United States Code, unless such Secretary, in
consultation with the Attorney General and the
Secretary of Homeland Security, determines that
disclosure would pose no threat to national security.
The determination regarding possible threats to
national security shall not be subject to judicial
review.
(E) Exemption.--
(i) In general.--Subject to clause (ii), it
shall not be a violation of the antitrust laws
for any person to participate in a meeting or
consultation conducted in accordance with this
paragraph.
(ii) Limitation.--Clause (i) shall not
apply to any agreement or conduct that results
from a meeting or consultation and that is not
covered by an exemption granted under paragraph
(4).
(2) Submission of written agreements.--The Secretary shall
submit each written agreement regarding covered activities that
is made pursuant to meetings or consultations conducted under
paragraph (1) to the Attorney General and the Chairman for
consideration. In addition to the proposed agreement itself,
any submission shall include--
(A) an explanation of the intended purpose of the
agreement;
(B) a specific statement of the substance of the
agreement;
(C) a description of the methods that will be
utilized to achieve the objectives of the agreement;
(D) an explanation of the necessity for a
cooperative effort among the particular participating
persons to achieve the objectives of the agreement; and
(E) any other relevant information determined
necessary by the Attorney General, in consultation with
the Chairman and the Secretary.
(3) Exemption for conduct under approved agreement.--It
shall not be a violation of the antitrust laws for a person to
engage in conduct in accordance with a written agreement to the
extent that such agreement has been granted an exemption under
paragraph (4), during the period for which the exemption is in
effect.
(4) Action on written agreements.--
(A) In general.--The Attorney General, in
consultation with the Chairman, shall grant, deny,
grant in part and deny in part, or propose
modifications to an exemption request regarding a
written agreement submitted under paragraph (2), in a
written statement to the Secretary, within 15 business
days of the receipt of such request. An exemption
granted under this paragraph shall take effect
immediately.
(B) Extension.--The Attorney General may extend the
15-day period referred to in subparagraph (A) for an
additional period of not to exceed 10 business days.
(C) Determination.--An exemption shall be granted
regarding a written agreement submitted in accordance
with paragraph (2) only to the extent that the Attorney
General, in consultation with the Chairman and the
Secretary, finds that the conduct that will be exempted
will not have any substantial anticompetitive effect
that is not reasonably necessary for ensuring the
availability of the countermeasure or product involved.
(5) Limitation on and renewal of exemptions.--An exemption
granted under paragraph (4) shall be limited to covered
activities, and such exemption shall be renewed (with
modifications, as appropriate, consistent with the finding
described in paragraph (4)(C)), on the date that is 3 years
after the date on which the exemption is granted unless the
Attorney General in consultation with the Chairman determines
that the exemption should not be renewed (with modifications,
as appropriate) considering the factors described in paragraph
(4).
(6) Authority to obtain information.--Consideration by the
Attorney General for granting or renewing an exemption
submitted under this section shall be considered an antitrust
investigation for purposes of the Antitrust Civil Process Act
(15 U.S.C. 1311 et seq.).
(7) Limitation on parties.--The use of any information
acquired under an agreement for which an exemption has been
granted under paragraph (4), for any purpose other than
specified in the exemption, shall be subject to the antitrust
laws and any other applicable laws.
(8) Report.--Not later than one year after the date of
enactment of this Act and biannually thereafter, the Attorney
General and the Chairman shall report to Congress on the use of
the exemption from the antitrust laws provided by this
subsection.
(b) Sunset.--The applicability of this section shall expire at the
end of the 6-year period that begins on the date of enactment of this
Act.
(c) Definitions.--In this section:
(1) Antitrust laws.--The term ``antitrust laws''--
(A) has the meaning given such term in subsection
(a) of the first section of the Clayton Act (15 U.S.C.
12(a)), except that such term includes section 5 of the
Federal Trade Commission Act (15 U.S.C. 45) to the
extent such section 5 applies to unfair methods of
competition; and
(B) includes any State law similar to the laws
referred to in subparagraph (A).
(2) Countermeasure or product.--The term ``countermeasure
or product'' refers to a security countermeasure, qualified
countermeasure, or qualified pandemic or epidemic product (as
those terms are defined in subsection (a)(1)).
(3) Covered activities.--
(A) In general.--Except as provided in subparagraph
(B), the term ``covered activities'' includes any
activity relating to the development, manufacture,
distribution, purchase, or storage of a countermeasure
or product.
(B) Exception.--The term ``covered activities''
shall not include, with respect to a meeting or
consultation conducted under subsection (a)(1) or an
agreement for which an exemption has been granted under
subsection (a)(4), the following activities involving 2
or more persons:
(i) Exchanging information among
competitors relating to costs, profitability,
or distribution of any product, process, or
service if such information is not reasonably
necessary to carry out covered activities--
(I) with respect to a
countermeasure or product regarding
which such meeting or consultation is
being conducted; or
(II) that are described in the
agreement as exempted.
(ii) Entering into any agreement or
engaging in any other conduct--
(I) to restrict or require the
sale, licensing, or sharing of
inventions, developments, products,
processes, or services not developed
through, produced by, or distributed or
sold through such covered activities;
or
(II) to restrict or require
participation, by any person
participating in such covered
activities, in other research and
development activities, except as
reasonably necessary to prevent the
misappropriation of proprietary
information contributed by any person
participating in such covered
activities or of the results of such
covered activities.
(iii) Entering into any agreement or
engaging in any other conduct allocating a
market with a competitor that is not expressly
exempted from the antitrust laws under
subsection (a)(4).
(iv) Exchanging information among
competitors relating to production (other than
production by such covered activities) of a
product, process, or service if such
information is not reasonably necessary to
carry out such covered activities.
(v) Entering into any agreement or engaging
in any other conduct restricting, requiring, or
otherwise involving the production of a
product, process, or service that is not
expressly exempted from the antitrust laws
under subsection (a)(4).
(vi) Except as otherwise provided in this
subsection, entering into any agreement or
engaging in any other conduct to restrict or
require participation by any person
participating in such covered activities, in
any unilateral or joint activity that is not
reasonably necessary to carry out such covered
activities.
(vii) Entering into any agreement or
engaging in any other conduct restricting or
setting the price at which a countermeasure or
product is offered for sale, whether by bid or
otherwise.
SEC. 8. PROCUREMENT.
Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b)
is amended--
(1) in the section heading, by inserting ``and security
countermeasure procurements'' before the period; and
(2) in subsection (c)--
(A) in the subsection heading, by striking
``Biomedical'';
(B) in paragraph (5)(B)(i), by striking ``to meet
the needs of the stockpile'' and inserting ``to meet
the stockpile needs'';
(C) in paragraph (7)(B)--
(i) by striking the subparagraph heading
and all that follows through ``Homeland
Security Secretary'' and inserting the
following: ``Interagency agreement; cost.--The
Homeland Security Secretary''; and
(ii) by striking clause (ii);
(D) in paragraph (7)(C)(ii)--
(i) by amending clause (I) to read as
follows:
``(I) Payment conditioned on
delivery.--The contract shall provide
that no payment may be made until
delivery of a portion, acceptable to
the Secretary, of the total number of
units contracted for, except that,
notwithstanding any other provision of
law, the contract may provide that, if
the Secretary determines (in the
Secretary's discretion) that an advance
payment, partial payment for
significant milestones, or payment to
increase manufacturing capacity is
necessary to ensure success of a
project, the Secretary shall pay an
amount, not to exceed 10 percent of the
contract amount, in advance of
delivery. The Secretary shall, to the
extent practicable, make the
determination of advance payment at the
same time as the issuance of a
solicitation. The contract shall
provide that such advance payment is
required to be repaid if there is a
failure to perform by the vendor under
the contract. The contract may also
provide for additional advance payments
of 5 percent each for meeting the
milestones specified in such contract.
Provided that the specified milestones
are reached, these advanced payments of
5 percent shall not be required to be
repaid. Nothing in this subclause shall
be construed as affecting the rights of
vendors under provisions of law or
regulation (including the Federal
Acquisition Regulation) relating to the
termination of contracts for the
convenience of the Government.''; and
(ii) by adding at the end the following:
``(VII) Sales exclusivity.--The
contract may provide that the vendor is
the exclusive supplier of the product
to the Federal Government for a
specified period of time, not to exceed
the term of the contract, on the
condition that the vendor is able to
satisfy the needs of the Government.
During the agreed period of sales
exclusivity, the vendor shall not
assign its rights of sales exclusivity
to another entity or entities without
approval by the Secretary. Such a sales
exclusivity provision in such a
contract shall constitute a valid basis
for a sole source procurement under
section 303(c)(1) of the Federal
Property and Administrative Services
Act of 1949 (41 U.S.C. 253(c)(1)).
``(VIII) Surge capacity.--The
contract may provide that the vendor
establish domestic manufacturing
capacity of the product to ensure that
additional production of the product is
available in the event that the
Secretary determines that there is a
need to quickly purchase additional
quantities of the product. Such
contract may provide a fee to the
vendor for establishing and maintaining
such capacity in excess of the initial
requirement for the purchase of the
product. Additionally, the cost of
maintaining the domestic manufacturing
capacity shall be an allowable and
allocable direct cost of the contract.
``(IX) Contract terms.--The
Secretary, in any contract for
procurement under this section, may
specify--
``(aa) the dosing and
administration requirements for
countermeasures to be developed
and procured;
``(bb) the amount of
funding that will be dedicated
by the Secretary for
development and acquisition of
the countermeasure; and
``(cc) the specifications
the countermeasure must meet to
qualify for procurement under a
contract under this section.'';
and
(E) in paragraph (8)(A), by adding at the end the
following: ``Such agreements may allow other executive
agencies to order qualified and security
countermeasures under procurement contracts or other
agreements established by the Secretary. Such ordering
process (including transfers of appropriated funds
between an agency and the Department of Health and
Human Services as reimbursements for such orders for
countermeasures) may be conducted under the authority
of section 1535 of title 31, United States Code, except
that all such orders shall be processed under the terms
established under this section for the procurement of
countermeasures.''.
SEC. 9. RULE OF CONSTRUCTION.
Nothing in this Act, or any amendment made by this Act, shall be
construed to affect any law that applies to the National Vaccine Injury
Compensation Program under title XXI of the Public Health Service Act
(42 U.S.C. 300aa-1 et seq.), including such laws regarding--
(1) whether claims may be filed or compensation may be paid
for a vaccine-related injury or death under such Program;
(2) claims pending under such Program; and
(3) any petitions, cases, or other proceedings before the
United States Court of Federal Claims pursuant to such title.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S3222-3227)
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