Legislation introduced to reduce prescription drug shortages

A bipartisan group of lawmakers has introduced bicameral legislation to help reduce the “prevalence and severity” of prescription drug shortages.

The End Drug Shortages Act was introduced in the House and Senate on Thursday by U.S. Sens. Tim Kaine, D-Va., and Tom Cotton, R-Ark., and U.S. Reps. Abigail Spanberger, D-Va., and Adrian Smith, R-Neb.

The lawmakers say drug shortages “adversely affect clinical care and patient outcomes,” which they say can lead to delayed care, substandard treatment and medication errors. The group says that as of September, the Food and Drug Administration listed 275 active drug shortages.

Kaine warns of the negative impacts on individuals when life-saving drugs are unavailable.

“Drug shortages can have tragic consequences for patients and force providers to ration life-saving medications,” Kaine said. “We must do more to ensure that Americans have access to the treatment they need.”

If approved, the legislation would improve communication between drug manufacturers, the FDA and pharmacies to provide health care providers with more accurate and prompt information related to drug supplies.

It would require drug manufacturers to “notify the FDA when there is a surge in demand of a drug that is likely to lead to a disruption” of the drug supply. It would also take information reported by patients, health care providers and manufacturers to the FDA when examining drug shortages.

In addition, the legislation 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.”

Spanberger underscored the importance of opening the line of communication between pharmacies, health care providers and the FDA in preventing prescription drug rationing.

“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,” Spanberger said. “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 Improved communication between patients, health care professionals, and drug manufacturers can shore up our supply chains and help prevent Americans from going without their medications.”

Several major health care providers, health care associations and medical schools support the bipartisan legislation.