What’s Next to Solve our Nation’s Drug Shortages?

New white paper looks at the future of generic sterile injectables

January 26, 2024

The Senate Finance Committee and other elected leaders are expected to consider key policy solutions to address the ongoing drug shortages that have plagued health care.

Last year, the U.S. experienced shortages for critical cancer treatments and other injectable drugs (morphine, saline) that impacted patient care. Federal figures show the nation had its highest level of shortages since 2014, and there were 77 generic sterile injectables (GSI) in short supply.

Lawmakers in the U.S. Senate Finance Committee published a new white paper Thursday with potential policy approaches to relieve shortages in generic drugs, including sterile injectables that represent one of the most vulnerable drug classes.

“Shortages can delay or deny necessary care for patients or force prescribers to turn to second-line alternatives, which sometimes prove less effective or pose additional risks compared to the drug in shortage,” the paper notes.

Here are a few takeaways:

• The issue:  GSIs are critical in emergency rooms, ICUs, cancer centers, surgery, and other settings but have “high rates of manufacturer market exits, and are often more expensive to produce.”
  • “Intense pressure to reduce prices” and more stringent manufacturing standards for sterile products contribute to turnover in manufacturers and supply instability.
• By the numbers:  From 2013 through 2017, sterile injectables accounted for 63 percent of drugs in shortage and had a median price of $11.05 per unit before going into shortage, the report notes.
• Policy proposals:  The white paper includes proposals in four areas related to Medicare Part A and B payment reforms; incentives for hospitals to create shortage and mitigation plans; Medicare Part D programs for “shortage mitigation, quality, and drug supply chain resilience”; and Medicaid Drug Rebate Program changes targeting generic medicines.
• The paradox:  “The least expensive (i.e., lowest-cost) generic drugs appear to have the highest shortage risk,” the report notes.

HAP continues to monitor the latest on the nation’s drug shortages and provide updates to members. The white paper is available to review online.