S-4635 : Still Just a Bill

The Pharmaceutical Risk Assessment and Mitigation Act of 2024 (S. 4635) requires the Under Secretary of Defense for Acquisition and Sustainment to take the following actions within two years of the bill's enactment:

• Submit a report to the Committees on Armed Services of the Senate and the House of Representatives that includes:
  • Information on existing streams within the Federal Government for excipients and key starting materials of drugs, to assess the Department of Defense's reliance on high-risk foreign suppliers.
  • Analysis of active pharmaceutical ingredients, final drug products, and their respective excipients and key starting materials produced by each manufacturer in a high-risk foreign country, as determined by the Secretary of Defense.
  • Identification of any limitations on the Secretary's ability to obtain or analyze the information, or to use data analytics to monitor vulnerabilities in the pharmaceutical supply chain.
  • Plans to address any identified limitations.
  • Recommendations to address those limitations.
• Update risk management guidance developed under section 860(a)(1) of the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 to incorporate relevant findings from the report.

The Department of Defense must rely on determinations made by the Food and Drug Administration (FDA) regarding excipients and key starting materials for final drug products, or align with FDA regulations.