II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Bioterror and Pan5 demic Preparedness Protection Act’’. 

6 SEC. 2. LIABILITY PROTECTIONS FOR PANDEMICS, 

7 EPIDEMICS, AND COUNTERMEASURES. 

8 Part B of title III of the Public Health Service Act 

9 is amended by inserting after section 319F–2 (42 U.S.C. 

10 247d–6b) the following: 
2 

•S 1437 IS

1 ‘‘SEC. 319A–3. LIABILITY PROTECTIONS FOR PANDEMICS, 

2 EPIDEMICS, AND SECURITY COUNTER3 MEASURES. 

4 ‘‘(a) AUTHORITY.—The Secretary shall be solely and 

5 exclusively responsible for the administration of this sec6 tion. This section shall apply with respect to the design, 

7 development, clinical testing and investigation, manufac8 ture, labeling, distribution, sale, purchase, donation, dis9 pensing, administration, or use of a security counter10 measure or a qualified pandemic or epidemic product. 

11 ‘‘(b) LITIGATION MANAGEMENT.— 

12 ‘‘(1) FEDERAL CAUSE OF ACTION.— 

13 ‘‘(A) IN GENERAL.—There shall exist an 

14 exclusive Federal cause of action for all claims 

15 arising out of, relating to, or resulting from the 

16 design, development, clinical testing and inves17 tigation, manufacture, labeling, distribution, 

18 sale, purchase, donation, dispensing, adminis19 tration, and use of a qualified pandemic or epi20 demic product or a security countermeasure as 

21 provided for in clauses (i) and (ii) of paragraph 

22 (2)(B). 

23 ‘‘(B) ACTION.—With respect to the Fed24 eral cause of action provided in subparagraph 

25 (A)— 
3 

•S 1437 IS

1 ‘‘(i) an action may be commenced 

2 solely and exclusively against the United 

3 States for claims identified in subpara4 graph (A) that are against a manufac5 turer, distributor, or health care provider; 

6 ‘‘(ii) no cause of action shall be main7 tained against a manufacturer, distributor, 

8 or health care provider for claims identified 

9 in subparagraph (A); and 

10 ‘‘(iii) for products subject to designa11 tion by the Secretary as provided for in 

12 clause (ii) of paragraph (2)(B), the protec13 tions set forth in clauses (i) and (ii) shall 

14 apply to all claims identified in subpara15 graph (A) that involve products sold, pur16 chased, donated, dispensed, or adminis17 tered during the effective period set forth 

18 in the designation provided for in para19 graph (2)(F), regardless of the date of al20 leged injury. 

21 ‘‘(C) JURISDICTION.—The United States 

22 District Court for the District of Columbia shall 

23 have sole and exclusive jurisdiction over any 

24 claim for loss of property, personal injury, or 

25 death arising out of, relating to, or resulting 
4 

•S 1437 IS

1 from the design, development, clinical testing 

2 and investigation, manufacture, labeling, dis3 tribution, sale, purchase, donation, dispensing, 

4 administration, or use of a qualified pandemic 

5 or epidemic product or security countermeasure 

6 as provided for in clauses (i) and (ii) of para7 graph (2)(B). 

8 ‘‘(2) AFFIRMATIVE DEFENSE.— 

9 ‘‘(A) IN GENERAL.—There shall be a re10 buttable presumption that the Federal Govern11 ment is immune from liability in an action de12 scribed in subparagraph (B). 

13 ‘‘(B) ACTION DESCRIBED.—An action de14 scribed in this subparagraph is an action that 

15 is commenced against the United States for 

16 claims arising out of, relating to, or resulting 

17 from the design, development, clinical testing 

18 and investigation, manufacture, labeling, dis19 tribution, sale, purchase, donation, dispensing, 

20 administration, or use of— 

21 ‘‘(i) a security countermeasure that 

22 has been procured for the National Stra23 tegic Stockpile under section 319F–2 or a 

24 qualified pandemic or epidemic product 
5 

•S 1437 IS

1 that has been procured by the Secretary; 

2 or 

3 ‘‘(ii) a security countermeasure or 

4 qualified pandemic or epidemic product in 

5 anticipation of and preparation for, in de6 fense against, or in response or recovery to 

7 an actual or potential public health emer8 gency, that is a security countermeasure or 

9 is designated as a qualified pandemic or 

10 epidemic product by the Secretary after 

11 the Secretary declared a public health 

12 emergency as described in paragraph (1) 

13 or (2) of section 319(a). 

14 ‘‘(C) REBUTTABILITY.— 

15 ‘‘(i) IN GENERAL.—The presumption 

16 described in subparagraph (A) shall be 

17 overcome by a determination by the Sec18 retary as provided for in subparagraph 

19 (D). 

20 ‘‘(ii) INVESTIGATION BY SEC21 RETARY.—A party seeking a determination 

22 under subparagraph (D) may petition the 

23 Secretary to investigate claims against a 

24 manufacturer, distributor, dispenser, or 

25 health care provider arising out of, relating 
6 

•S 1437 IS

1 to, or resulting from the design, develop2 ment, clinical testing and investigation, 

3 manufacture, labeling, distribution, sale, 

4 purchase, donation, dispensing, administra5 tion, or use of products as provided for in 

6 clauses (i) and (ii) of subparagraph (B). 

7 The decision to undertake such investiga8 tion shall be within the Secretary’s discre9 tion and shall not be subject to judicial re10 view. 

11 ‘‘(D) DETERMINATION BY SECRETARY.— 

12 ‘‘(i) IN GENERAL.—In making a de13 termination under this subparagraph, the 

14 Secretary must find clear and convincing 

15 evidence that the manufacturer, dis16 tributor, or health care provider inten17 tionally or with willful disregard violated a 

18 provision of the Federal Food, Drug, and 

19 Cosmetic Act (21 U.S.C. 301 et seq.) or 

20 this Act and such violation— 

21 ‘‘(I) caused the product to 

22 present a significant risk to health; 

23 and 

24 ‘‘(II) proximately caused the in25 jury alleged by the petitioner. 
7 

•S 1437 IS

1 ‘‘(ii) NOTICE AND HEARING.—Prior to 

2 the Secretary’s making a determination 

3 under clause (i), the manufacturer, dis4 tributor, dispenser, or health care provider 

5 shall have notice and a right to a formal 

6 hearing in accordance with section 556 of 

7 title 5, United States Code. 

8 ‘‘(iii) JUDICIAL REVIEW.—At any time 

9 prior to the 90th day following a deter10 mination by the Secretary under clause (i) 

11 of this subparagraph, any manufacturer, 

12 distributor, or health care provider who 

13 will be adversely affected by such deter14 mination may file a petition with the 

15 United States Court of Appeals for the cir16 cuit wherein such person resides or has his 

17 principal place of business, for a judicial 

18 review of such determination. A copy of 

19 the petition shall be forthwith transmitted 

20 by the clerk of the court to the Secretary 

21 or other officer designated by the Sec22 retary for that purpose. The Secretary 

23 thereupon shall file in the court the record 

24 of the findings on which the Secretary 

25 based his or her determination. The filing 
8 

•S 1437 IS

1 of a petition under this clause shall auto2 matically stay the Secretary’s determina3 tion for the duration of the judicial pro4 ceeding. The sole parties to the judicial 

5 proceeding shall be the Secretary and the 

6 petitioner. Intervention by third parties in 

7 the judicial proceeding shall not be per8 mitted. No subpoenas shall be issued nor 

9 shall other compulsory process apply. The 

10 court’s review of a determination by the 

11 Secretary under this clause shall conform 

12 to the procedures for judicial review of ad13 ministrative orders set forth in paragraphs 

14 (2) through (6) of section 371(f) of title 

15 21, United States Code, to the extent con16 sistent with this section. 

17 ‘‘(E) SCOPE.—The presumption under 

18 subparagraph (A) shall apply regardless of 

19 whether the claim against the United States 

20 arises from the design, development, clinical 

21 testing and investigation, manufacture, labeling, 

22 distribution, sale, purchase, donation, dis23 pensing, administration, or use by the Federal 

24 Government or by non-Federal Government 

25 customers. 
9 

•S 1437 IS

1 ‘‘(F) DESIGNATION.—In any declaration of 

2 a public health emergency under section 319, 

3 the Secretary shall identify the pandemic, epi4 demic, or biological, chemical, nuclear agent, or 

5 toxin that presents, or may present, a public 

6 health emergency and shall designate the secu7 rity countermeasure(s) or qualified pandemic or 

8 epidemic product(s) to be sold by, purchased 

9 from, or donated by a manufacturer or drawn 

10 from the National Strategic Stockpile and shall 

11 specify in such designation the beginning and 

12 ending dates of such sale, purchase, donation, 

13 or use from the stockpile. The period so defined 

14 shall be the effective period of such qualifica15 tion for any products specified in the designa16 tion. The declaration shall subsequently be 

17 amended to reflect any additional sale, pur18 chase, or donation of products specified in the 

19 designation. 

20 ‘‘(c) DEFINITIONS.—In this section: 

21 ‘‘(1) HEALTH CARE PROVIDER.—The term 

22 ‘health care provider’ means a person, including a 

23 volunteer, who lawfully prescribes, administers, dis24 penses, or provides a facility to administer a security 

25 countermeasure or a qualified pandemic or epidemic 
10 

•S 1437 IS

1 product, including persons who prescribe, admin2 ister, or provide a facility to administer in accord3 ance with a designation under subsection (b)(2)(F). 

4 ‘‘(2) LOSS.—The term ‘loss’ means death, bod5 ily injury, or loss of or damage to property, includ6 ing business interruption loss. 

7 ‘‘(3) NON-FEDERAL GOVERNMENT CUS8 TOMERS.—The term ‘non-Federal Government cus9 tomers’ means any customer of a manufacturer that 

10 is not an agency or instrumentality for the United 

11 States Government with authority under Public Law 

12 85–804 to provide for indemnification under certain 

13 circumstances for third-party claims against its con14 tractors, including a State, a local authority, a pri15 vate entity, a health care provider, or an individual. 

16 ‘‘(4) QUALIFIED PANDEMIC OR EPIDEMIC PROD17 UCT.—The term ‘qualified pandemic or epidemic 

18 product’ means a drug (as such term is defined in 

19 section 201(g)(1) of the Federal Food, Drug, and 

20 Cosmetic Act (21 U.S.C. 321(g)(1))), biological 

21 product (as such term is defined by section 351(i) 

22 of this Act) or device (as such term is defined by 

23 section 201(h) of the Federal food, Drug and Cos24 metic Act (21 U.S.C. 321(h))) designed, developed, 

25 modified, or procured to diagnose, mitigate, prevent, 
11 

•S 1437 IS

1 treat, or cure a pandemic or epidemic or limit the 

2 harm such pandemic or epidemic might otherwise 

3 cause or a serious or life-threatening disease or con4 dition caused by such a product, that— 

5 ‘‘(A) is approved or cleared under chapter 

6 V of the Federal Food, Drug, and Cosmetic Act 

7 or licensed under section 351 of this Act; 

8 ‘‘(B) is a product for which the Secretary 

9 determines that sufficient and satisfactory clin10 ical experience or research data (including data, 

11 if available, from pre-clinical and clinical trials) 

12 support a reasonable conclusion that the coun13 termeasure will qualify for approval or licensing 

14 within 8 years after the date the Secretary de15 clares a public health emergency as described in 

16 paragraph (1) or (2) of section 319(a); or 

17 ‘‘(C) is authorized by the Secretary under 

18 this section, except that the Secretary may au19 thorize under this section the emergency use of 

20 a product only if, after consultation with the 

21 Director of the National Institutes of Health 

22 and the Director of the Centers for Disease 

23 Control and Prevention (to the extent feasible 

24 and appropriate given the circumstances of the 

25 emergency involved), the Secretary concludes— 
12 

•S 1437 IS

1 ‘‘(i) that an agent or toxin identified 

2 in a declaration described under subsection 

3 (b) can cause a serious or life-threatening 

4 disease or condition; 

5 ‘‘(ii) that, based on the totality of the 

6 scientific evidence available to the Sec7 retary, including data from adequate and 

8 well-controlled clinical trials, if available, it 

9 is reasonable to believe that— 

10 ‘‘(I) the product may be effective 

11 in diagnosing, mitigating, preventing, 

12 treating or curing— 

13 ‘‘(aa) a pandemic or epi14 demic; or 

15 ‘‘(bb) a serious or life16 threatening disease or condition 

17 caused by a product; and 

18 ‘‘(II) the known and potential 

19 benefits of the product, when used to 

20 diagnose, mitigate, prevent, treat or 

21 cure such disease or condition, out22 weigh the known and potential risks 

23 of the product; 

24 ‘‘(iii) that there is no adequate, ap25 proved, and available alternative to the 
13 

•S 1437 IS

1 product for diagnosing, mitigating, pre2 venting, treating or curing such disease or 

3 condition; and 

4 ‘‘(iv) that such other criteria as the 

5 Secretary may by regulation prescribe are 

6 satisfied. 

7 ‘‘(5) SECURITY COUNTERMEASURE.—The term 

8 ‘security countermeasure’ has the meaning given 

9 such term in section 319F–2(c)(1)(B).’’. 

10 SEC. 3. TECHNICAL AMENDMENT. 

11 Section 319(a)(1) of the Public Health Service Act 

12 (42 U.S.C. 247d (a)(1)) is amended by inserting ‘‘, or may 

13 present,’’ after ‘‘present’’. 

Æ