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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. ENCOURAGING DEVELOPMENT OF VACCINES 
FOR OPIOID, COCAINE, METHAMPHETAMINE, 
OR ALCOHOL USE DISORDER. 
(a) BREAKTHROUGH THERAPIES.—Section 506(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356(a)) is amended by adding at the end the following: 
‘‘(4) VACCINES FOR OPIOID, COCAINE, METH-
AMPHETAMINE, OR ALCOHOL USE DISORDER.— 
‘‘(A) IN GENERAL.—If a request is sub-
mitted under paragraph (1) for a vaccine to 
prevent, treat, or mitigate an opioid use dis-
order (including such a disorder related to 
fentanyl), a cocaine use disorder, a meth-
amphetamine use disorder, or an alcohol use 
disorder, such vaccine is deemed to be a break-
through therapy. 
‘‘(B) SUNSET.—Subparagraph (A) shall 
cease to be effective on the date that is 10 
years after the date of enactment of this para-
graph.’’. 
(b) FAST TRACK PRODUCTS.—Section 506(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(b)) 
is amended by adding at the end the following: 
‘‘(4) VACCINES FOR OPIOID, COCAINE, METH-
AMPHETAMINE, OR ALCOHOL USE DISORDER.— 
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‘‘(A) IN GENERAL.—If a request is sub-
mitted under paragraph (1) for a vaccine to 
prevent, treat, or mitigate an opioid use dis-
order (including such a disorder related to 
fentanyl), a cocaine use disorder, a meth-
amphetamine use disorder, or an alcohol use 
disorder, such vaccine is deemed to be a fast 
track product. 
‘‘(B) SUNSET.—Subparagraph (A) shall 
cease to be effective on the date that is 10 
years after the date of enactment of this para-
graph.’’. 
(c) PRIORITY REVIEW.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall give priority review to any ap-
plication for a vaccine to prevent, treat, or mitigate 
an opioid use disorder (including such a disorder re-
lated to fentanyl), a cocaine use disorder, a meth-
amphetamine use disorder, or an alcohol use dis-
order that is submitted under— 
(A) section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355); or 
(B) section 351 of the Public Health Serv-
ice Act (42 U.S.C. 262). 
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