Bioterror and Pandemic Preparedness Protection Act - Amends the Public Health Service Act to establish an exclusive federal cause of action for all claims relating to a qualified pandemic or epidemic product or a security countermeasure.
Restricts all causes of action for such claims against a manufacturer, distributor, or health care provider and instead provides for sole and exclusive action against the United States. Gives jurisdiction over such an action to the U.S. District Court for the District of Columbia.
Establishes a rebuttable presumption of immunity for the federal government in any such action concerning: (1) a security countermeasure that has been procured for the National Strategic Stockpile; (2) a qualified pandemic or epidemic product that has been procured by the Secretary of Health and Human Services; or (3) a security countermeasure or designated qualified pandemic or epidemic product relating to an actual or potential public health emergency.
Allows a party to petition the Secretary to investigate claims against a manufacturer, distributor, dispenser, or heath care provider. Disallows judicial review of the Secretary's decision as to whether to undertake such an investigation.
Declares that the immunity presumption shall be overcome by a determination by the Secretary, by finding clear and convincing evidence, that the manufacturer, distributor, or health care provider intentionally or with willful disregard violated the Federal Food, Drug, and Cosmetic Act or this Act and that such violation: (1) caused the product to present a significant health risk; and (2) proximately caused the injury alleged by the petitioner.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1437 Introduced in Senate (IS)]
109th CONGRESS
1st Session
S. 1437
To amend the Public Health Service Act to provide protections for first
responders.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 20, 2005
Mr. Gregg introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide protections for first
responders.
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 ``Bioterror and Pandemic Preparedness
Protection Act''.
SEC. 2. LIABILITY PROTECTIONS FOR PANDEMICS, EPIDEMICS, AND
COUNTERMEASURES.
Part B of title III of the Public Health Service Act is amended by
inserting after section 319F-2 (42 U.S.C. 247d-6b) the following:
``SEC. 319A-3. LIABILITY PROTECTIONS FOR PANDEMICS, EPIDEMICS, AND
SECURITY COUNTERMEASURES.
``(a) Authority.--The Secretary shall be solely and exclusively
responsible for the administration of this section. This section shall
apply with respect to the design, development, clinical testing and
investigation, manufacture, labeling, distribution, sale, purchase,
donation, dispensing, administration, or use of a security
countermeasure or a qualified pandemic or epidemic product.
``(b) Litigation Management.--
``(1) Federal cause of action.--
``(A) In general.--There shall exist an exclusive
Federal cause of action for all claims arising out of,
relating to, or resulting from the design, development,
clinical testing and investigation, manufacture,
labeling, distribution, sale, purchase, donation,
dispensing, administration, and use of a qualified
pandemic or epidemic product or a security
countermeasure as provided for in clauses (i) and (ii)
of paragraph (2)(B).
``(B) Action.--With respect to the Federal cause of
action provided in subparagraph (A)--
``(i) an action may be commenced solely and
exclusively against the United States for
claims identified in subparagraph (A) that are
against a manufacturer, distributor, or health
care provider;
``(ii) no cause of action shall be
maintained against a manufacturer, distributor,
or health care provider for claims identified
in subparagraph (A); and
``(iii) for products subject to designation
by the Secretary as provided for in clause (ii)
of paragraph (2)(B), the protections set forth
in clauses (i) and (ii) shall apply to all
claims identified in subparagraph (A) that
involve products sold, purchased, donated,
dispensed, or administered during the effective
period set forth in the designation provided
for in paragraph (2)(F), regardless of the date
of alleged injury.
``(C) Jurisdiction.--The United States District
Court for the District of Columbia shall have sole and
exclusive jurisdiction over any claim for loss of
property, personal injury, or death arising out of,
relating to, or resulting from the design, development,
clinical testing and investigation, manufacture,
labeling, distribution, sale, purchase, donation,
dispensing, administration, or use of a qualified
pandemic or epidemic product or security countermeasure
as provided for in clauses (i) and (ii) of paragraph
(2)(B).
``(2) Affirmative defense.--
``(A) In general.--There shall be a rebuttable
presumption that the Federal Government is immune from
liability in an action described in subparagraph (B).
``(B) Action described.--An action described in
this subparagraph is an action that is commenced
against the United States for claims arising out of,
relating to, or resulting from the design, development,
clinical testing and investigation, manufacture,
labeling, distribution, sale, purchase, donation,
dispensing, administration, or use of--
``(i) a security countermeasure that has
been procured for the National Strategic
Stockpile under section 319F-2 or a qualified
pandemic or epidemic product that has been
procured by the Secretary; or
``(ii) a security countermeasure or
qualified pandemic or epidemic product in
anticipation of and preparation for, in defense
against, or in response or recovery to an
actual or potential public health emergency,
that is a security countermeasure or is
designated as a qualified pandemic or epidemic
product by the Secretary after the Secretary
declared a public health emergency as described
in paragraph (1) or (2) of section 319(a).
``(C) Rebuttability.--
``(i) In general.--The presumption
described in subparagraph (A) shall be overcome
by a determination by the Secretary as provided
for in subparagraph (D).
``(ii) Investigation by secretary.--A party
seeking a determination under subparagraph (D)
may petition the Secretary to investigate
claims against a manufacturer, distributor,
dispenser, or health care provider arising out
of, relating to, or resulting from the design,
development, clinical testing and
investigation, manufacture, labeling,
distribution, sale, purchase, donation,
dispensing, administration, or use of products
as provided for in clauses (i) and (ii) of
subparagraph (B). The decision to undertake
such investigation shall be within the
Secretary's discretion and shall not be subject
to judicial review.
``(D) Determination by secretary.--
``(i) In general.--In making a
determination under this subparagraph, the
Secretary must find clear and convincing
evidence that the manufacturer, distributor, or
health care provider intentionally or with
willful disregard violated a provision of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) or this Act and such violation--
``(I) caused the product to present
a significant risk to health; and
``(II) proximately caused the
injury alleged by the petitioner.
``(ii) Notice and hearing.--Prior to the
Secretary's making a determination under clause
(i), the manufacturer, distributor, dispenser,
or health care provider shall have notice and a
right to a formal hearing in accordance with
section 556 of title 5, United States Code.
``(iii) Judicial review.--At any time prior
to the 90th day following a determination by
the Secretary under clause (i) of this
subparagraph, any manufacturer, distributor, or
health care provider who will be adversely
affected by such determination may file a
petition with the United States Court of
Appeals for the circuit wherein such person
resides or has his principal place of business,
for a judicial review of such determination. A
copy of the petition shall be forthwith
transmitted by the clerk of the court to the
Secretary or other officer designated by the
Secretary for that purpose. The Secretary
thereupon shall file in the court the record of
the findings on which the Secretary based his
or her determination. The filing of a petition
under this clause shall automatically stay the
Secretary's determination for the duration of
the judicial proceeding. The sole parties to
the judicial proceeding shall be the Secretary
and the petitioner. Intervention by third
parties in the judicial proceeding shall not be
permitted. No subpoenas shall be issued nor
shall other compulsory process apply. The
court's review of a determination by the
Secretary under this clause shall conform to
the procedures for judicial review of
administrative orders set forth in paragraphs
(2) through (6) of section 371(f) of title 21,
United States Code, to the extent consistent
with this section.
``(E) Scope.--The presumption under subparagraph
(A) shall apply regardless of whether the claim against
the United States arises from the design, development,
clinical testing and investigation, manufacture,
labeling, distribution, sale, purchase, donation,
dispensing, administration, or use by the Federal
Government or by non-Federal Government customers.
``(F) Designation.--In any declaration of a public
health emergency under section 319, the Secretary shall
identify the pandemic, epidemic, or biological,
chemical, nuclear agent, or toxin that presents, or may
present, a public health emergency and shall designate
the security countermeasure(s) or qualified pandemic or
epidemic product(s) to be sold by, purchased from, or
donated by a manufacturer or drawn from the National
Strategic Stockpile and shall specify in such
designation the beginning and ending dates of such
sale, purchase, donation, or use from the stockpile.
The period so defined shall be the effective period of
such qualification for any products specified in the
designation. The declaration shall subsequently be
amended to reflect any additional sale, purchase, or
donation of products specified in the designation.
``(c) Definitions.--In this section:
``(1) Health care provider.--The term `health care
provider' means a person, including a volunteer, who lawfully
prescribes, administers, dispenses, or provides a facility to
administer a security countermeasure or a qualified pandemic or
epidemic product, including persons who prescribe, administer,
or provide a facility to administer in accordance with a
designation under subsection (b)(2)(F).
``(2) Loss.--The term `loss' means death, bodily injury, or
loss of or damage to property, including business interruption
loss.
``(3) Non-federal government customers.--The term `non-
Federal Government customers' means any customer of a
manufacturer that is not an agency or instrumentality for the
United States Government with authority under Public Law 85-804
to provide for indemnification under certain circumstances for
third-party claims against its contractors, including a State,
a local authority, a private entity, a health care provider, or
an individual.
``(4) Qualified pandemic or epidemic product.--The term
`qualified pandemic or epidemic product' means a drug (as such
term is defined in section 201(g)(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as
such term is defined by section 351(i) of this Act) or device
(as such term is defined by section 201(h) of the Federal food,
Drug and Cosmetic Act (21 U.S.C. 321(h))) designed, developed,
modified, or procured to diagnose, mitigate, prevent, treat, or
cure a pandemic or epidemic or limit the harm such pandemic or
epidemic might otherwise cause or a serious or life-threatening
disease or condition caused by such a product, that--
``(A) is approved or cleared under chapter V of the
Federal Food, Drug, and Cosmetic Act or licensed under
section 351 of this Act;
``(B) is a product for which the Secretary
determines that sufficient and satisfactory clinical
experience or research data (including data, if
available, from pre-clinical and clinical trials)
support a reasonable conclusion that the countermeasure
will qualify for approval or licensing within 8 years
after the date the Secretary declares a public health
emergency as described in paragraph (1) or (2) of
section 319(a); or
``(C) is authorized by the Secretary under this
section, except that the Secretary may authorize under
this section the emergency use of a product only if,
after consultation with the Director of the National
Institutes of Health and the Director of the Centers
for Disease Control and Prevention (to the extent
feasible and appropriate given the circumstances of the
emergency involved), the Secretary concludes--
``(i) that an agent or toxin identified in
a declaration described under subsection (b)
can cause a serious or life-threatening disease
or condition;
``(ii) that, based on the totality of the
scientific evidence available to the Secretary,
including data from adequate and well-
controlled clinical trials, if available, it is
reasonable to believe that--
``(I) the product may be effective
in diagnosing, mitigating, preventing,
treating or curing--
``(aa) a pandemic or
epidemic; or
``(bb) a serious or life-
threatening disease or
condition caused by a product;
and
``(II) the known and potential
benefits of the product, when used to
diagnose, mitigate, prevent, treat or
cure such disease or condition,
outweigh the known and potential risks
of the product;
``(iii) that there is no adequate,
approved, and available alternative to the
product for diagnosing, mitigating, preventing,
treating or curing such disease or condition;
and
``(iv) that such other criteria as the
Secretary may by regulation prescribe are
satisfied.
``(5) Security countermeasure.--The term `security
countermeasure' has the meaning given such term in section
319F-2(c)(1)(B).''.
SEC. 3. TECHNICAL AMENDMENT.
Section 319(a)(1) of the Public Health Service Act (42 U.S.C. 247d
(a)(1)) is amended by inserting ``, or may present,'' after
``present''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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