AHA Letter of Support for the Drug Shortage Prevention Act of 2023

August 4, 2023

Dear Senator Klobuchar, Senator Collins and Senator Smith:

On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, the American Hospital Association (AHA) writes to express support for the Drug Shortage Prevention Act.

America’s hospitals and health systems have long been gravely concerned about shortages of a wide range of drugs to treat patients. Shortages of essential medications continue to rise — especially shortages of generic sterile injectable drugs used in hospitals.

The Drug Shortage Prevention Act would require manufacturers to notify the Food and Drug Administration (FDA) of increased demand of covered drugs. The AHA believes the requirement that manufacturers notify the FDA of increased demand for critical drugs will be an integral tool for shoring up the supply chain. Increased demand in the supply chain can create prolonged acquisition difficulties for providers. Avoiding these disruptions before they occur and pursuing opportunities to mitigate their effects when they do happen will allow providers to better serve their patients.

This legislation would also revise manufacturer notification requirements to include additional information related to discontinuances or interruptions in the manufacturing of excipients or any other input required for the final dosage form of a drug that would likely lead to a meaningful supply disruption of the drug or its active pharmaceutical ingredients (API). In addition, manufactures would be required to provide more frequent and detailed reporting, specifically adding important details about their suppliers of API and other materials used in the production of their medications. Providing such additional, essential information to the FDA will help the agency to better predict, mitigate and address interruptions in the supply of critical drugs.

Over the past two decades, the drug supply chain has become longer, more complex, and more fragmented as companies have located more production overseas and increased the use of contract manufacturers. By giving the FDA greater insight into critical drug shortages and more information from manufacturers, the Drug Shortage Prevention Act will help pave the way for additional improvements to the U.S. drug supply chain, which will, in turn, improve patient access and care.

We appreciate your leadership on this important issue and look forward to working together to strengthen the pharmaceutical supply chain for providers and patients.

Sincerely,

/s/

Lisa Kidder Hrobsky
Senior Vice President, Advocacy and Political Affairs