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.
Impact
The bill proposes to classify vaccines targeting these substance use disorders as 'breakthrough therapies', which would grant them expedited pathways for development and review by the FDA. This acceleration in getting effective treatments to market is critical, especially in light of the ongoing opioid epidemic and rising instances of overdoses related to various substances. The bill is designed to foster innovation in the pharmaceutical industry by offering not only expedited review processes but also significant financial awards to incentivize developers.
Summary
House Bill 7827 aims to amend the Federal Food, Drug, and Cosmetic Act in order to encourage the development of vaccines that could prevent, treat, or mitigate substance use disorders associated with opioids, cocaine, methamphetamine, and alcohol. A significant part of the bill includes the establishment of a monetary incentive, known as the Vaccine X-Prize, amounting to $1 billion, which would be awarded to a drug sponsor that successfully develops such vaccines. This initiative highlights a proactive approach to tackle the growing issues of substance abuse and dependence in the United States.
Contention
While the intent behind Bill HB7827 is to mitigate the impact of drug addiction and improve public health outcomes, potential debate centers around the effectiveness of vaccines as a viable treatment for substance use disorders. Critics may question whether vaccines can truly address the complexities of addiction or whether alternative treatment strategies should be prioritized. Furthermore, the allocation of public funds for such a high-stakes prize could lead to discussions on resource management and prioritization of public health funding in Congress.
To nullify modifications made by the Food and Drug Administration on January 3, 2023, to the risk evaluation and mitigation strategy under section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) for mifepristone, and for other purposes.
No Vaccine Passports Act This bill prohibits certain actions related to vaccine passports and proof of COVID-19 vaccination. Specifically, a federal agency may not issue a vaccine passport, vaccine pass, or other standardized documentation for the purpose of certifying the COVID-19 vaccination status of a U.S. citizen to a third party, or otherwise publish or share any COVID-19 vaccination record of a U.S. citizen or similar health information. Additionally, proof of COVID-19 vaccination shall not be required to access federal or congressional property or services.