May 22, 2020
ASA-Endorsed Drug Shortages Legislation Introduced in U.S. Senate
On May 20, U.S. Senator Gary Peters (D-MI) introduced ASA-endorsed legislation, the Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act which would address drug shortages by identifying vulnerabilities in the medical supply chain and increase capacity for domestic advanced manufacturing of critical drugs and medical devices in the United States.
The PART Act would identify the extent of U.S. reliance on foreign drug and medical supply manufacturersand encourage investments in domestic manufacturing by expanding reporting requirements for manufacturers and require quarterly disclosures to the Food and Drug Administration (FDA) on critical data such as which medications and the amount, including active pharmaceutical ingredients, are produced domestically and abroad. Manufacturers would also be required to report any increased demand or export restriction to proactively address potential shortages. The FDA would be required to share the data with the Department of Defense (DOD) and the Assistant Secretary for Preparedness and Response (ASPR).
ASA has long raised concerns about the nation’s dependency on overseas manufacturing and foreign-made active pharmaceutical ingredients. The ongoing COVID-19 outbreak has highlighted the vulnerabilities and deficiencies in our regulatory oversight of the global supply chains. ASA believes the PART Act would help us better understand the extent of America’s dependence on foreign manufacturers and shore up domestic supply chains.
ASA applauds the efforts in the Senate to prevent further drug shortages and will continue to work with Congress to advance legislation that addresses this critical issue impacting patient care.