Bill Would Help Mitigate Drug Shortages and Strengthen Preparedness Through Improved Coordination, Data Analytics, and Public-Private Partnerships
WASHINGTON, D.C. –U.S. Senators Gary Peters (D-MI), James Lankford (R-OK), Joni Ernst (R-IA), Tom Cotton (R-AR), Tim Kaine (D-VA), Angus King (I-ME), and Rick Scott (R-FL) have introduced bipartisan legislation to improve federal coordination and visibility for our essential medicine supply chains – from key ingredients needed to manufacture essential medicines to their distribution in hospitals and pharmacies. The Mapping America’s Pharmaceutical Supply (MAPS) Act will help ensure our nation is well positioned to mitigate drug shortages and respond to future health emergencies by proactively identifying and addressing supply chain weaknesses that could lead to shortages or other challenges in future public health crises.
“As we learned during the COVID-19 pandemic, federal agencies lack the visibility needed to effectively identify and respond to supply chain chokepoints,” said Senator Peters. “This bipartisan legislation will help ensure we have the tools necessary to proactively identify vulnerabilities in our essential medicine supply chains and reduce our dependence on foreign sources. Every American should have access to essential medicines.”
“US dependence on pharmaceutical drugs and products from other countries, like communist China, is a major concern for our national security,” said Senator Lankford. “China can cut off supplies at their will, as we saw during the first months of the COVID pandemic when China withheld PPE from OK healthcare providers and families. We should have transparency and diversity in our pharma supply chain, so we are never vulnerable to a communist nation for our healthcare needs.”
“Depending on China for critical pharmaceutical ingredients poses a national security threat,” said Senator Ernst. “Through our bipartisan action, we can identify essential medicines to strengthen the supply chain and reduce our reliance on our adversary. By taking action now, we can protect the health of our citizens in the future.”
“Drug shortages can force Americans to ration or even go without the medications they need – leading to tragic and preventable consequences,” said Senator Kaine. “I’m proud to introduce this bipartisan legislation to proactively identify gaps in the supply chain, which will decrease the frequency and severity of future drug shortages.”
“I’m proud to support the bipartisan MAPS Act to strengthen our essential medicine supply chains and reduce America’s dangerous overreliance on Communist China for critical drug ingredients,” said Senator Scott. This legislation will enhance federal coordination and supply chain visibility so we can better protect patients, prevent drug shortages, and ensure our national security isn’t compromised by foreign adversaries.”
“As we work to protect our communities from a future public health emergency, researching and understanding the prescription drug supply chain is a simple way to help Americans stay healthy and safe – since access to medication is such a critical component to modern care,” said Senator King. “The bipartisan Mapping America’s Pharmaceutical Supply (MAPS) Act would help prevent prescription drug shortages, ensure that our country is reducing its dependence on foreign adversaries for essential medicines, while also protecting the American public from the effects of a future pandemic. I am grateful to my colleagues in both parties for putting the safety and health of the American people first.”
The bill directs the Department of Health and Human Services (HHS), in coordination with relevant agencies and the private sector, to regularly update, maintain, and publish a list of essential medicines. Using the Essential Medicines List, the federal government would be required to conduct a comprehensive risk assessment of these supply chains to assess the key ingredients needed to manufacture essential medicines, overreliance on high-risk foreign sources, sole-sourced products, current domestic manufacturing capabilities, cybersecurity threats, and any other gaps that may reduce the federal government’s ability to identify health and national security risks related to our essential medicine supply chains. HHS, through public private partnerships, would also be required to map all our essential medicine supply chains – from the key ingredients needed to manufacture drug products to their distribution in hospitals and pharmacies – creating end-to-end visibility in these supply chains using data analytics to proactively assess vulnerabilities and threats. The bill would also require the Department of Defense (DoD) to submit reports to Congress on drug products that rely on China for critical inputs and finished dose forms.
The legislation builds on recommendations from two reports released by Peters in 2019 and 2023 that identified national security concerns related to our nation’s overdependence on foreign sources for critical drug products and their key ingredients, including insufficient visibility into U.S. pharmaceutical supply chains. Peters’ 2023 report found that both industry and the federal government lack visibility into entire pharmaceutical supply chains – from the key ingredients needed to make essential medicines to the distribution of those products, presenting both health and national security risks. The COVID-19 pandemic exacerbated many of these longstanding challenges, and a 2022 Peters report examining the federal pandemic response found that federal agencies struggled to obtain needed supply chain data in critical early months that could have informed federal actions to mitigate shortages.
The bill is supported by the American Society of Health-System Pharmacists (ASHP), American Society of Clinical Oncology (ASCO), Angels for Change, the Michigan Health & Hospital Association, United States Pharmacopeia, and CivicaRx. Below are statements in support of the bill.
“ASHP strongly supports the MAPS Act. By requiring the Department of Health and Human services to coordinate with other agencies and the private sector to map the pharmaceutical supply chain, threats to the U.S. pharmaceutical supply chain can be identified and addressed before they place patients at risk,” said Tom Kraus, Vice President of ASHP Government Relations.
“ASCO applauds the introduction of the MAPS Act, which would provide needed tools to gain better visibility into the supply of critical prescription drugs in the United States,” said Eric P. Winer, MD, FASCO, Board Chair of the Association for Clinical Oncology. “We support efforts to recognize potential drug shortages earlier and to relay information to stakeholders to help them prepare for and mitigate possible supply challenges. The bipartisan work of Senators Peters, Ernst, Cotton, Kaine, Lankford, King, and Scott on this important legislation, advances these efforts.”
“Angels for Change proudly supports the MAPS Act—a vital step toward ending drug shortages and protecting patients,” said Laura Bray, Founder and Chief Change Maker of Angels for Change. “This bipartisan legislation will strengthen transparency and coordination across the entire drug supply chain, helping to detect and prevent disruptions before they impact care. Building the reliable supply chain patients deserve will require collaboration across government and industry. We applaud Senators Peters, Lankford, Ernst, Cotton, Kaine, King, and Scott for their leadership in prioritizing the safeguarding of Essential Medicines that will benefit all US patients.”
“Having access to the right medication and treatment is crucial to achieve the best outcome for patients,” said Brian Peters, CEO, Michigan Health & Hospital Association (MHA) CEO. “Drug shortages are a challenge that hospitals navigate constantly. The MAPS Act is an important way for our country to ensure everyone in our country can access essential medications when they need it. We thank Sen. Peters and his Senate colleagues for understanding how important it is for the health and security of our country to address drug shortages.”
“Prolonged and persistent drug shortages over the past two decades are jeopardizing Americans’ access to critical treatments and increasing our vulnerability to disruptions from natural disasters, pandemics, and geopolitical instability,” said Ronald T. Piervincenzi, Ph.D., Chief Executive Officer, U.S. Pharmacopeia. “Building meaningful and lasting resilience across this complex supply chain requires comprehensive reform. The MAPS Act will improve our ability to leverage tools, like USP’s Medicine Supply Map, to detect risks, anticipate shortages, and safeguard national security. As we seek further insight on the sourcing of key starting materials and API for producing our most vulnerable medicines, these collaborations are critical for understanding our vulnerabilities, as well as unlocking innovative solutions, like advanced manufacturing and scalable synthesis technologies.”
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