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''.
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.
{"src": "billsum_test", "title": "A bill to amend the Public Health Service Act to provide protections for first responders."}