Smith, Cotton, Kaine, and Spanberger Introduce Bipartisan, Bicameral End Drug Shortages Act

Washington, D.C.- Today, Rep. Adrian Smith (R-NE), Sen. Tom Cotton (R-AR), Sen. Tim Kaine (D-VA), and Rep. Abigail Spanberger (D-VA) introduced the End Drug Shortages Act, bipartisan, bicameral legislation to help reduce the prevalence and severity of drug shortages. Drug shortages can adversely affect clinical care and patient outcomes-and in the most severe of cases, can lead to delayed care, inferior treatment, and medication errors. As of September 2024, there were over 275 active drug shortageslisted on the Food and Drug Administration's (FDA) drug shortage list.

The members released the following statements:

"Timely information sharing is critical to addressing our drug shortage crisis and empowering providers to connect patients with the treatments they need, thereby improving health outcomes," said Rep. Smith. "This bill would enhance access to critical medicines Americans depend on by streamlining communication among providers and the FDA when supply chain needs are anticipated. I thank my Senate colleagues, Sens. Cotton and Kaine, and Rep. Spanberger for working with me to introduce this legislation."

"When Americans are consistently unable to fill a prescription at their local pharmacy or when hospitals are rationing lifesaving medications, it's clear that there is a breakdown along our pharmaceutical supply chain. By requiring drug manufacturers to notify FDA when demand for a drug is surging, pharmacies and health systems can more quickly prepare for a potential shortage," said Rep. Spanberger. "Improved communication between patients, healthcare professionals, and drug manufacturers can shore up our supply chains and help prevent Americans from going without their medications. I'm proud to lead this bipartisan legislation alongside my friend and fellow Virginian, Senator Kaine, as well as Representative Smith and Senator Cotton - because Congress must do more to make sure Virginians and Americans across our country can access the medications on which they rely."

"Shortages in the medical supply chain are a matter of life and death. Our bill will enhance communication processes, support hospitals, and strengthen health systems to ensure that Americans have access to the medicines that they need," said Sen. Cotton.

"Drug shortages can have tragic consequences for patients and force providers to ration life-saving medications," said Sen. Kaine. "We must do more to ensure that Americans have access to the treatment they need. That's why I'm introducing this bipartisan legislation to help prevent and limit the impacts of these dangerous shortages."

Specifically, the End Drug Shortages Act would:

• Improve communication between drug manufacturers, the FDA, and pharmacies that support hospitals and health systems to ensure more accurate and timely information regarding the supply of prescription drugs by:
• Requiring drug manufacturers to notify the FDA when there is a surge in demand of a drug that is likely to lead to a disruption in the supply of the drug.
• Establishing a definition of the term "surge."
• Ensuring that the FDA considers information reported by patients, health care professionals, and manufacturers when designating a drug shortage.
• Instruct the FDA to finalize October 2021 guidance for hospital and health system pharmacies and ensure that such guidance is consistent with the most current research and best clinical practices.

The legislation is supported by: American Hospital Association, American Society of Health System Pharmacists, Angels for Change, Alliance for Pharmacy Compounding, Association of American Medical Colleges, Children's Hospital Association, Federation of American Hospitals, Inova, Kaiser Permanente, National Community Pharmacists Association, UVA Health, Virginia Commonwealth University, and Vizient.

"Angels for Change applauds Senator Kaine, Senator Cotton, Representative Spanberger, and Representative Smith for their bipartisan leadership in taking on the drug shortage crisis and advancing this vital work. We are proud to support the End Drug Shortages Act, which will implement critical transparency measures and flexibility for compounding pharmacies to help fill the gaps in times of shortage. Nearly 50% of all shortages in 2023 came from an increase in demand, so it is vital that we have the tools to give patients access to lifesaving medications during shortages, whether they are caused by decreases in manufacturing supply or surges in demand," said Laura Bray, Founder and Chief Change Maker, Angels for Change.

"ASHP strongly supports the End Drug Shortages Act. By expanding criteria for reporting drug shortages, and reporting interruptions and discontinuances, this legislation can help ensure Americans have continuous access to essential medicines," said Tom Kraus, Vice President of ASHP Government Relations.

"By improving communication between drug manufacturers, the FDA, and healthcare providers, the End Drug Shortages Act will significantly mitigate the frequency and impact of drug shortages, including those caused by a surge," said Shoshana Krilow, senior vice president of public policy and government relations for Vizient. "We deeply appreciate the leadership of Sens. Tim Kaine and Tom Cotton and Reps. Abigail Spanberger and Adrian Smith for their decisive action in addressing drug shortages through the bipartisan End Drug Shortages Act."

Full text of the End Drug Shortages Act isavailable here.

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