Us Congress Senate Bill SB1122

Us Congress 2023-2024 Regular Session

• Introduced: 3/30/23
• Refer: 3/30/23

Caption

Prioritizing Medical Countermeasures for National Security Act of 2023

Impact

The proposed legislation amends existing provisions in the Federal Food, Drug, and Cosmetic Act, thereby expanding the definition of eligible medical countermeasures to include a broader range of biological threats. The Secretary of Health and Human Services is tasked with establishing and maintaining a list of medical countermeasures that are necessary for national security, which could significantly streamline the regulatory process for drug developers. This reform is anticipated to accelerate the availability of critical drugs to combat emerging threats, thereby enhancing the nation’s preparedness and response capabilities in public health crises.

Summary

Senate Bill 1122, officially titled the 'Prioritizing Medical Countermeasures for National Security Act of 2023', aims to enhance the ability of the federal government to expedite the review of human drug applications that are critical for national security. The bill emphasizes the priority review process for drugs used to prevent or treat diseases caused by potential threats such as chemical, biological, radiological, or nuclear agents. This effort seeks to ensure timely access to essential medical treatments that could mitigate public health emergencies with significant national implications.

Contention

While the bill's intent is largely seen as a proactive measure, there may be contentions surrounding the potential implications for drug approval processes and the definitions of urgency in the context of national security. Stakeholders in the pharmaceutical industry may express concerns about the adequacy of safeguards to prevent the misuse of expedited reviews for non-essential drugs. Moreover, discussions may arise about balancing public health with ensuring rigorous scientific vetting of drugs that enter the market under expedited conditions.