I 

118TH CONGRESS 

2D SESSION H. R. 7827 

To amend the Federal Food, Drug, and Cosmetic Act to encourage the 

development of vaccines to prevent, treat, or mitigate opioid, cocaine, 

methamphetamine, or alcohol use disorder, to establish an x-prize for 

the development of such a vaccine, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 26, 2024 

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

Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

encourage the development of vaccines to prevent, treat, 

or mitigate opioid, cocaine, methamphetamine, or alcohol 

use disorder, to establish an x-prize for the development 

of such a vaccine, and for other purposes. 

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


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•HR 7827 IH

1 SECTION 1. ENCOURAGING DEVELOPMENT OF VACCINES 

2 FOR OPIOID, COCAINE, METHAMPHETAMINE, 

3 OR ALCOHOL USE DISORDER. 

4 (a) BREAKTHROUGH THERAPIES.—Section 506(a) of 

5 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

6 356(a)) is amended by adding at the end the following: 

7 ‘‘(4) VACCINES FOR OPIOID, COCAINE, METH8 AMPHETAMINE, OR ALCOHOL USE DISORDER.— 

9 ‘‘(A) IN GENERAL.—If a request is sub10 mitted under paragraph (1) for a vaccine to 

11 prevent, treat, or mitigate an opioid use dis12 order (including such a disorder related to 

13 fentanyl), a cocaine use disorder, a meth14 amphetamine use disorder, or an alcohol use 

15 disorder, such vaccine is deemed to be a break16 through therapy. 

17 ‘‘(B) SUNSET.—Subparagraph (A) shall 

18 cease to be effective on the date that is 10 

19 years after the date of enactment of this para20 graph.’’. 

21 (b) FAST TRACK PRODUCTS.—Section 506(b) of the 

22 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(b)) 

23 is amended by adding at the end the following: 

24 ‘‘(4) VACCINES FOR OPIOID, COCAINE, METH25 AMPHETAMINE, OR ALCOHOL USE DISORDER.— 


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•HR 7827 IH

1 ‘‘(A) IN GENERAL.—If a request is sub2 mitted under paragraph (1) for a vaccine to 

3 prevent, treat, or mitigate an opioid use dis4 order (including such a disorder related to 

5 fentanyl), a cocaine use disorder, a meth6 amphetamine use disorder, or an alcohol use 

7 disorder, such vaccine is deemed to be a fast 

8 track product. 

9 ‘‘(B) SUNSET.—Subparagraph (A) shall 

10 cease to be effective on the date that is 10 

11 years after the date of enactment of this para12 graph.’’. 

13 (c) PRIORITY REVIEW.— 

14 (1) IN GENERAL.—The Secretary of Health and 

15 Human Services shall give priority review to any ap16 plication for a vaccine to prevent, treat, or mitigate 

17 an opioid use disorder (including such a disorder re18 lated to fentanyl), a cocaine use disorder, a meth19 amphetamine use disorder, or an alcohol use dis20 order that is submitted under— 

21 (A) section 505 of the Federal Food, 

22 Drug, and Cosmetic Act (21 U.S.C. 355); or 

23 (B) section 351 of the Public Health Serv24 ice Act (42 U.S.C. 262). 


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•HR 7827 IH

1 (2) SUNSET.—Paragraph (1) shall cease to be 

2 effective on the date that is 10 years after the date 

3 of enactment of this subsection. 

4 SEC. 2. X-PRIZE FOR VACCINE FOR OPIOID, COCAINE, 

5 METHAMPHETAMINE, OR ALCOHOL USE DIS6 ORDER. 

7 (a) ELIGIBLE NEW DRUG SPONSOR.—In this section, 

8 the term ‘‘eligible new drug sponsor’’ means the sponsor 

9 of a vaccine to prevent, treat, or mitigate an opioid use 

10 disorder (including such a disorder related to fentanyl), 

11 a cocaine use disorder, a methamphetamine use disorder, 

12 or an alcohol use disorder that— 

13 (1) is approved under section 505 of the Fed14 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355) 

15 or is licensed under section 351 of the Public Health 

16 Service Act (42 U.S.C. 262); and 

17 (2) is mass-produced. 

18 (b) APPLICATION.—An eligible new drug sponsor 

19 may submit to the Secretary of Health and Human Serv20 ices an application for an award, to be known as the Vac21 cine X–Prize. 

22 (c) AWARD.—Subject to subsection (d), if the Sec23 retary of Health and Human Services determines that an 

24 eligible new drug sponsor has submitted an application 

25 under subsection (b), the Secretary shall, subject to the 


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1 availability of appropriations, pay the eligible new drug 

2 sponsor $1,000,000,000. 

3 (d) SINGLE AWARD.—The Secretary of Health and 

4 Human Services may not award more than 1 Vaccine X– 

5 Prize. 

Æ 


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