WASHINGTON, D.C. – U.S. Senator Gary Peters (MI), Chairman of the Homeland Security and Governmental Affairs Committee, introduced bipartisan legislation to help increase the available supply of critical medications for the United States and help mitigate the national security threat posed by our nation’s overreliance on China for critical medications. The bill would require the Department of Health and Human Services (HHS) to award contracts to quality generic drug manufacturers, who are either based in the United States or in a country that is a member of the Organization for Economic Cooperation and Development (OECD), to build and maintain reserves of critical drugs. The legislation would require awardees to keep sufficient reserves of key ingredients and finished drug products on hand and bolster production capacity to help prevent potential shortages before they occur. The bill would also help encourage domestic production of these medications by ensuring that U.S.-based manufacturers are prioritized for federal contracts. The legislation builds on recommendations from two reports released by Peters in 2019 and 2023 which found that generic drug manufacturers’ ability to surge production and store supplies is often limited because they regularly operate at or near full capacity. 

“Active drug shortages are at their worst in nearly a decade and present serious health and national security concerns. 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 healthcare providers have the medicine they need to care for their patients,” said Senator Peters. “This bipartisan bill would help ensure the U.S. is better prepared for future health threats and Americans can always access essential medications.”    

The Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act would allow HHS to reward quality manufacturers of critical generic drug products with contracts to build and maintain reserves of critical medications and their key ingredients. It would also strengthen vulnerable supply chains, which for example, contributed to recent shortages of critical cancer drugs, and are a key driver of shortages, by ensuring that when one manufacturer experiences a disruption in supply, other manufacturers are able to draw on reserves and surge production to meet demand. The bill also requires the Government Accountability Office (GAO) to study whether current domestic manufacturing capacity is underutilized and assess how the federal government can strengthen domestic manufacturing capacity for both critical drug products and their key ingredients. 

This legislation follows Peters’ efforts to mitigate national security risks within the pharmaceutical industry. This Congress, he introduced a bipartisan bill to address the U.S. dependency on foreign drug manufacturers. Earlier this year, as Chairman of HSAGC, Peters convened a hearing on the national security risks presented by continued drug shortages.

Below are quotes in support of Peters’ legislation:

“Currently providers and patients are caught off guard when critical drugs go into shortage,” said Everett E. Vokes, MD, FASCO, Board Chair of the Association for Clinical Oncology. “The RAPID Reserve Act would provide patients and their doctors the certainty that critical cancer drugs are available when needed.”

“We applaud Senators Peters, Blackburn, and Brown for their efforts to combat the ongoing drug shortage crisis,” said Ned McCoy, President and CEO of Civica Inc. (Civica Rx). “In particular, the focus on creating additional safety stock inventory within the supply chain and on upgrading aging generic drug manufacturing infrastructure both of which have the potential to significantly reduce shortages.”

“Americans need a stronger pharmaceutical supply chain to be more self-sufficient in case of a future public health emergency, trade dispute with a foreign adversary, or natural disaster that threatens our essential medicine supply chain. This bill is a critical first step in securing a resilient supply chain free from essential medicine drug shortages that continue to threaten the healthcare for all Americans,” said Dr. Eric Edwards, CEO and Founder, Phlow Corp.

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