U.S. Rep. Adrian Smith (R-NE) on Nov. 21 cosponsored a bipartisan, bicameral bill that aims to help reduce drug shortages, which can adversely affect clinical care and patient outcomes.
“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,” Rep. Smith said. “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.”
The congressman introduced the End Drug Shortages Act, H.R. 10239, with bill sponsor U.S. Rep. Abigail Spanberger (D-VA), while U.S. Sens. Tom Cotton (R-AR) and Tim Kaine (D-VA) introduced the same-named version in their chamber.
If enacted, the bill would amend the Federal Food, Drug, and Cosmetic Act to expand drug shortage notification practices to include surges in demand for a drug, according to the text of the bill.
Specifically, the measure would improve communication between drug manufacturers, the Food and Drug Administration (FDA), and pharmacies 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; and ensuring that the FDA considers information reported by patients, healthcare professionals, and manufacturers when designating a drug shortage.
Additionally, the bill would 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, according to a bill summary provided by the lawmakers.
“When Americans are consistently unable to fill a prescription at their local pharmacy or when hospitals are rationing life-saving medications, it’s clear that there is a breakdown along our pharmaceutical supply chain,” said Rep. Spanberger. “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.”
The legislation is supported by several entities, including the American Hospital Association, the American Society of Health System Pharmacists, the Children’s Hospital Association, Inova, Kaiser Permanente, the National Community Pharmacists Association, UVA Health, Virginia Commonwealth University, and Vizient, among others.