US Codex
Bill
Notes

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.

H.R. 7827 · 118th Congress · Mar 26, 2024 · Lineage

A BILL

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, 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.

Sec. 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.