Legislation Would Help Build Reserves of Critical Medications with Vulnerable Supply Chains While Bolstering Domestic Manufacturing Capacity
WASHINGTON, D.C. – U.S. Senators Gary Peters (D-MI), Ranking Member of the Senate Homeland Security and Governmental Affairs Committee, Marsha Blackburn (R-TN), Tim Kaine (D-VA), and Ted Budd (R-NC) have reintroduced the bipartisan Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act to help increase supply chain resiliency for critical generic drugs and their key ingredients by bolstering supply reserves and domestic production capacity through federal contracts. The RAPID Reserve Act would help reduce drug shortages, enhance preparedness, and mitigate national security threats from U.S. overreliance on China for critical medications and their key ingredients.
Drug shortages are lasting longer and continue to impact patients, hospitals, and health care providers, increasing the risk of medication errors, rationing, and delays in patient care. In a 2023 report, Peters found that at least 15 critical medications remained in shortage for over a decade. Many of the life-saving generic drug products that regularly experience shortages are complex to manufacture and cost pennies on the dollar. The legislation builds on recommendations from Peters’ prior investigative reports in 2019 and 2023, which found that generic drug manufacturers’ ability to surge production and store supplies are often limited because they regularly operate at or near full capacity.
“Every American should be able to get the medicine they need when they need it. Increasing domestic and reliable manufacturing capacity for our critical, lifesaving medications is essential to addressing drug shortages that can compromise patient care,” said Senator Peters. “This bipartisan bill will help ensure Americans receive the essential medications they need while strengthening our ability to respond to future public health crises.”
“The United States faces a national security threat from its overreliance on Communist China for vital drugs and pharmaceutical ingredients,” said Senator Blackburn. “We must boost domestic manufacturing of active pharmaceutical ingredients and help sustain sufficient reserves of medications. The RAPID Reserve Act would ensure Americans will always have access to the medication they need.”
“While we’ve taken a lot of steps to increase domestic manufacturing of critical medicines and key ingredients, we still have more to do,” said Senator Kaine. “This bipartisan legislation would reduce our reliance on foreign countries, encourage drug manufacturers to increase domestic production, and help prevent drug shortages.”
“For far too long, America has faced a drug shortage that not only threatens patients’ health but poses a national security risk by forcing us to rely on Communist China’s supply chains for essential medications,” said Senator Budd. “I am proud to join my colleagues in introducing the bipartisan RAPID Reserve Act to bring drug manufacturing back to the U.S., prioritize sufficient medication reserves, and support increased production in emergencies to reliably meet patient demand.”
The RAPID Reserve Act would direct the Department of Health and Human Services (HHS) to award contracts to quality manufacturers of critical generic drug products who are based in the United States or in a country that is a member of the Organization for Economic Cooperation and Development (OECD) in order to maintain reserves of critical medications and their key ingredients while building the capacity to surge production when needed. Through these contracts, which would prioritize domestic manufacturers, the RAPID Reserve Act would help strengthen vulnerable supply chains by ensuring that when there is a disruption in supply, manufacturers can draw on reserves and surge production to meet demand.
Senators Peters, Blackburn, Budd, and Kaine have also sent a letter to the Government Accountability Office (GAO) requesting the agency examine underutilized domestic manufacturing capacity and federal efforts to invest in advanced manufacturing capabilities.
The RAPID Reserve Act is supported by the Association for Clinical Oncology (ASCO), the American Society of Health-System Pharmacists (ASHP), the Healthcare Distribution Alliance (HDA), and Phlow. Below are quotes in support of the senators’ legislation:
“Getting the right treatment at the right time is an essential part of achieving the best possible outcome for anyone with a cancer diagnosis” said Association for Clinical Oncology (ASCO), Board Chair Eric P. Winer, MD, FASCO. “ASCO supports the RAPID Reserve Act, because it would take steps to ensure that critical cancer drug treatments are available when our patients need them.”
“ASHP strongly supports the RAPID Reserve Act. By establishing reserves of both active pharmaceutical ingredients and finished products, the legislation creates greater resiliency in the U.S. pharmaceutical supply chain and reduces the harmful impacts of shortages on patient care,” said Tom Kraus, Vice President of ASHP Government Relations.
“HDA is pleased to support the RAPID Reserve Act. This bill is an important step forward in supply chain resilience. By creating solutions that build more capacity and redundancy in the system, the nation will be more prepared for disasters and disease outbreaks in the future.” – Nicolette Louissaint, PhD, Chief Policy Officer, Healthcare Distribution Alliance
“Americans must have reliable access to critical essential medicines and the ingredients to make them, produced right here on U.S. soil. This access is not merely a convenience; it’s a national imperative to safeguard public health in the face of future public health emergencies, trade disruptions, conflicts with adversarial nations, or natural disasters. This bill represents a vital and long-overdue first step toward building a resilient, secure domestic pharmaceutical industrial base, one that will finally put an end to the persistent shortages of essential medicines that have long jeopardized the healthcare of every American,” said Dr. Eric Edwards, CEO and Founder of Phlow Corp.
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