Bills of Congress by U.S. Congress

American Medicine Safety and Security Act

Summary

The American Medicine Safety and Security Act aims to establish conditions on employment and work arrangements at the Food and Drug Administration (FDA) to ensure the safety and security of drugs and devices. It restricts individuals who are nationals of 'countries of foreign concern' (China, Russia, and Iran) from working at the FDA. The bill also mandates reporting requirements for FDA employees with immediate family members who are nationals of these countries.

Expected Effects

This act will likely lead to changes in the FDA's hiring practices and potentially impact its workforce composition. It may also affect the agency's ability to collaborate with international researchers or experts from the specified countries. The act could also create additional administrative burdens for the FDA in terms of compliance and enforcement.

Potential Benefits

  • Enhanced security of drug and device approval processes.
  • Reduced risk of foreign influence or espionage within the FDA.
  • Increased public confidence in the FDA's regulatory decisions.
  • Strengthened protection of sensitive data related to drug and device development.
  • Greater accountability for FDA employees and contractors.

Potential Disadvantages

  • Potential for discrimination based on national origin.
  • Reduced access to qualified professionals and experts from certain countries.
  • Increased administrative burden and costs for the FDA.
  • Possible chilling effect on international collaboration and research.
  • Risk of unintended consequences, such as hindering the FDA's ability to address public health emergencies.

Constitutional Alignment

The bill's constitutionality is complex. While Congress has broad power to regulate immigration and national security, the restrictions on employment based on national origin could raise concerns under the Equal Protection Clause of the Fourteenth Amendment. The First Amendment implications could arise if the reporting requirements are viewed as infringing on freedom of association. Article I, Section 8 grants Congress the power to regulate commerce, which could be used to justify regulations related to drug and device safety.

Impact Assessment: Things You Care About

This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).