I 118th CONGRESS 2d Session H. R. 7827 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. 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, methamphetamine, or alcohol use disorder (A) In general If a request is submitted under paragraph (1) for a vaccine to prevent, treat, or mitigate an opioid use disorder (including such a disorder related to fentanyl), a cocaine use disorder, a methamphetamine use disorder, or an alcohol use disorder, such vaccine is deemed to be a breakthrough therapy. (B) Sunset Subparagraph (A) shall cease to be effective on the date that is 10 years after the date of enactment of this paragraph. . (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, methamphetamine, or alcohol use disorder (A) In general If a request is submitted under paragraph (1) for a vaccine to prevent, treat, or mitigate an opioid use disorder (including such a disorder related to fentanyl), a cocaine use disorder, a methamphetamine 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 paragraph. . (c) Priority review (1) In general The Secretary of Health and Human Services shall give priority review to any application for a vaccine to prevent, treat, or mitigate an opioid use disorder (including such a disorder related to fentanyl), a cocaine use disorder, a methamphetamine use disorder, or an alcohol use disorder 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 Service Act ( 42 U.S.C. 262 ). (2) Sunset Paragraph (1) shall cease to be effective on the date that is 10 years after the date of enactment of this subsection. 2. X-prize for vaccine for opioid, cocaine, methamphetamine, or alcohol use disorder (a) Eligible new drug sponsor In this section, the term eligible new drug sponsor means the sponsor of a vaccine to prevent, treat, or mitigate an opioid use disorder (including such a disorder related to fentanyl), a cocaine use disorder, a methamphetamine use disorder, or an alcohol use disorder that— (1) is approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or is licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); and (2) is mass-produced. (b) Application An eligible new drug sponsor may submit to the Secretary of Health and Human Services an application for an award, to be known as the Vaccine X–Prize. (c) Award Subject to subsection (d), if the Secretary of Health and Human Services determines that an eligible new drug sponsor has submitted an application under subsection (b), the Secretary shall, subject to the availability of appropriations, pay the eligible new drug sponsor $1,000,000,000. (d) Single award The Secretary of Health and Human Services may not award more than 1 Vaccine X–Prize.