I 

108TH CONGRESS 

2D SESSION H. R. 5404 

To prohibit price gouging during a shortage of a covered vaccine. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 19, 2004 

Mr. KUCINICH introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To prohibit price gouging during a shortage of a covered 

vaccine. 

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 ‘‘Fair Vaccine Price 

5 Act of 2004’’. 

6 SEC. 2. PROHIBITION AGAINST PRICE GOUGING DURING A 

7 SHORTAGE OF A COVERED VACCINE. 

8 (a) PROHIBITION.—No person shall introduce or de9 liver for introduction into interstate commerce any covered 

10 vaccine with a price in violation of this section. 
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1 (b) UNLAWFUL PRICE.—The price of a covered vac2 cine is in violation of this section if— 

3 (1) at the time the vaccine is offered for sale 

4 at such price— 

5 (A) there is in effect a declaration of a 

6 shortage of the vaccine under subsection (c); or 

7 (B) the seller knows or has substantial 

8 reason to believe there will be a shortage of the 

9 vaccine within a period of 60 days, and not 

10 later than the end of such period there is in ef11 fect a declaration of a shortage of the vaccine 

12 under subsection (c); and 

13 (2) the price of the vaccine per dose is at least 

14 150 percent of the baseline price of the vaccine per 

15 dose (as determined under subsection (d)). 

16 (c) DECLARATION OF VACCINE SHORTAGE.—For any 

17 period for which the Secretary of Health and Human 

18 Services determines there will be a shortage of a covered 

19 vaccine, the Secretary may declare a shortage of that vac20 cine for purposes of this Act. 

21 (d) BASELINE PRICE DETERMINATION.— 

22 (1) IN GENERAL.—Subject to paragraph (2), 

23 the baseline price of a covered vaccine per dose is— 

24 (A) the average price of the brand of vac25 cine per dose offered for sale by the seller on 
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1 the date that is 60 days before the effective 

2 date of the applicable declaration under sub3 section (c); 

4 (B) if the seller did not offer for sale the 

5 brand of vaccine on the date described in sub6 paragraph (A), the average price of the brand 

7 of vaccine per dose offered by the seller during 

8 the 12-month period preceding such date; or 

9 (C) if the seller did not offer for sale the 

10 brand of vaccine on the date described in para11 graph (1)(A) or during the period described in 

12 paragraph (1)(B), the price determined by the 

13 Secretary under paragraph (3). 

14 (2) EXCEPTION.—If the Secretary finds that 

15 the average price of a covered vaccine is substan16 tially different at the time of a declaration of a 

17 shortage of that vaccine under subsection (c) than 

18 the average price of the vaccine during the 12-month 

19 period preceding such declaration because of factors 

20 wholly unrelated to the causes of the shortage, the 

21 Secretary may determine an appropriate baseline 

22 price of the vaccine. 

23 (3) TIMING OF DETERMINATIONS BY SEC24 RETARY.—At the time of declaring a shortage of a 

25 covered vaccine under subsection (c), the Secretary 
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1 shall determine an appropriate baseline price of the 

2 vaccine per dose for purposes of paragraph (1)(C) 

3 and, if applicable, for purposes of paragraph (2). 

4 (e) PENALTIES.— 

5 (1) IN GENERAL.—Any person who violates 

6 subsection (a) shall be imprisoned for not more than 

7 30 days, fined in the amount described in paragraph 

8 (2), or both. Each violation of subsection (a) re9 specting a separate dose of a covered vaccine con10 stitutes a separate offense. 

11 (2) AMOUNT.—The amount of a fine under 

12 paragraph (1) shall be, for each dose of covered vac13 cine sold at a price in violation of this section, 3 

14 times the amount of the difference between such 

15 price and the applicable baseline price. 

16 (f) CITIZEN SUITS.— 

17 (1) IN GENERAL.—Except as provided in para18 graph (2), any person may commence a civil action 

19 on his own behalf to compel compliance with sub20 section (a) against any person (including the United 

21 States and any other governmental instrumentality 

22 or agency to the extent permitted by the Eleventh 

23 Amendment to the Constitution) for any alleged vio24 lation of subsection (a). The United States district 

25 courts shall have jurisdiction, without regard to the 
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1 amount in controversy or the citizenship of the par2 ties, to compel compliance with such subsection. 

3 (2) NOTICE REQUIRED.—No action may be 

4 commenced under this subsection— 

5 (A) prior to 30 days after the plaintiff has 

6 given notice of the alleged violation (in such 

7 manner as the Secretary may require) to the 

8 Secretary and to each alleged violator of sub9 section (a); or 

10 (B) if the Secretary or the Attorney Gen11 eral of the United States has commenced and 

12 is diligently prosecuting a criminal or civil ac13 tion in a court of the United States to require 

14 each such alleged violator to comply with sub15 section (a), but in any such civil action in a 

16 court of the United States any person may in17 tervene as a matter of right. 

18 (3) INTERVENTION.—In any action under this 

19 subsection, the Secretary or the Attorney General of 

20 the United States, if not a party, may intervene as 

21 a matter of right. 

22 (4) AWARD OF COSTS.—The court, in issuing 

23 any final order in any action brought under this sub24 section, may award costs of litigation (including rea25 sonable attorney and expert witness fees) to any 
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1 party whenever the court determines such an award 

2 is appropriate. 

3 (g) ACTION FOR DAMAGES.—If a person purchases 

4 a covered vaccine at a price in violation of this section, 

5 the person may bring a civil action against the seller of 

6 the vaccine in a district court of the United States to re7 cover— 

8 (1) the amount that is 3 times the amount of 

9 the difference between such price and the applicable 

10 baseline price; and 

11 (2) the costs of the action (including reasonable 

12 attorney and expert witness fees). 

13 (h) NO PREEMPTION.—Nothing in this Act shall be 

14 construed as— 

15 (1) affecting the authority of a State to regu16 late the distribution and sale of vaccines; or 

17 (2) restricting the right of any person (or class 

18 of persons) under any statute or common law to 

19 seek enforcement of a requirement relating to the 

20 distribution or sale of a vaccine or to seek any other 

21 relief. 

22 (i) DEFINITIONS.—For purposes of this Act: 

23 (1) The term ‘‘covered vaccine’’ means a vac24 cine intended to prevent or mitigate the effects of in25 fluenza or any biological terrorist agent. 
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1 (2) The term ‘‘Secretary’’ means the Secretary 

2 of Health and Human Services. 

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