A Focus on Drug Shortages

November 07, 2023

The nation continues to grapple with shortages of nearly 130 over-the-counter and prescription medications, including Adderall, amoxicillin, and certain cancer treatments that have been in short supply this year.

The shortages have prompted a response from the Drug Enforcement Administration (DEA) and federal lawmakers as they look to address the causes of the supply issue. In a letter to the public last week, DEA Administrator Anne Milgram said the agency continues to take action to understand the shortage.

"As we said in our prior letter, there are still important issues that will need to be addressed through longer-term coordination by DEA, FDA, drug manufacturers, and other stakeholders to resolve these issues in the long term,” Milgram said.

Here’s what you need to know:

• Contributing factors:  In a letter to the FDA last week, leaders in the House Committee on Oversight and Accountability pointed to “pandemic supply chain delays, including an over-reliance on offshore manufacturing facilities, surging demand for pharmaceuticals, and diminishing manufacturing of generics.”
• Common shortages:  Shortages have been reported for medications commonly used to treat respiratory illnesses, heart failure, cancer, attention-deficit/hyperactivity disorder, infections, and other conditions.
  • Earlier this year, pediatricians reported issues sourcing children’s acetaminophen and ibuprofen, as well as the new therapies for Respiratory Syncytial Virus (RSV).
• Adderall shortage:  For amphetamines, manufacturers did not produce to their production quotas in 2022 and 2023, the DEA said, resulting in a shortfall of one billion doses that could have been produced but were not made or shipped.
• Next steps:  The DEA announced additional steps to ensure real-time data about the drug supply, including requiring drug manufacturers to submit production timelines and apply for quota allotments on a quarterly basis. The agency also plans to implement digital reporting for manufacturers and distributors and ask if a manufacturer's quota allotment is for domestic or export production.
• Quotable:  “It is of vital importance that the FDA monitor and prevent future drug shortages to maintain Americans’ health and quality of life,” the House Oversight Committee letter said.

HAP continues to monitor the drug supply shortages and provide updates to members.

The House Oversight Committee and DEA letters are available online.