Bipartisan legislation targets increases to critical domestic medication supply, generics

Under the newly introduced Rolling Active Pharmaceutical Ingredient and Drug act, U.S. Sens. Gary Peters (D-MI), Marsha Blackburn (R-TN), and Sherrod Brown (D-OH) last week proposed fighting drug shortages with increased domestic supplies of critical medications.

The bill would front and center the Department of Health and Human Services (DHHS) in the fight, appointing it to award contracts to quality generic drug manufacturers either based in the United States or in a member country of the Organization for Economic Cooperation and Development (OECD). Under said contracts, manufacturers would work to build and maintain reserves of critical drugs and reduce reliance on overseas supply chains, particularly those linked to China.

“Active drug shortages are at their worst in nearly a decade and present serious health and national security concerns,” Peters said. “By awarding quality manufacturers contracts to help build reserves of critical medications and encourage facilities to increase production in emergency situations, we can strengthen our pharmaceutical supply chain, boost advanced domestic manufacturing and ensure health care providers have the medicine they need to care for their patients. This bipartisan bill would help ensure the U.S. is better prepared for future health threats and Americans can always access essential medications.”

With backers that include the Association for Clinical Oncology, Civica Inc. and Phlow Corp., the bill seeks to keep the U.S. from being flat footed when critical drugs and supplies are shorted, as seen recently during the COVID-19 pandemic. It would emphasize by overseeing an additional safety stock inventory within the supply chain, going so far as to allow other manufacturers to draw on reserves and surge production to meet demand when one manufacturer stumbles.Tapped manufacturers would need to build and maintain reserves of critical, generic medications and their key ingredients.

“The United States’ overreliance on Communist China for vital medications poses a threat to national security,” Blackburn said. “We must support domestic manufacturing of critical medications and work to prevent potential shortages during future national emergencies. The RAPID Reserve Act will help sustain sufficient reserves of medications as well as encourage companies to surge production during emergencies, ensuring Americans will always have access to the medication they need.”

In addition to the practical here and now side of production, the bill would also turn to the Government Accountability Office (GAO) to provide research for the future. GAO would be required to study current domestic manufacturing capacity and determine if it is underutilized, then analyze how the federal government can actively strengthen the domestic manufacturing capacity for both drug products and their key ingredients.