The coronavirus public health emergency may have ended last year, but its effects on the pharmaceutical industry continue to reverberate.
Like during the pandemic, drug and medical supply shortages continue to plague the industry. While the federal government investigates the issue, public and private entities continue to push for increased visibility and collaboration.
The lingering issues are part of why experts pointed to three main trends to watch in 2024: ongoing drug shortages, federal oversight and the Drug Supply Chain Security Act.
1. Lingering drug shortages
Drug shortages in the U.S. are going to get “a whole lot worse before they get better,” said Vimala Raghavendran, vice president of informatics product development at U.S. Pharmacopeia.
As of March, there were more than 200 drug shortages in the country, according to the American Society of Health-System Pharmacists. Medication shortages include cancer treatments, sterile injectables, generics, imaging agents and antimicrobials.
Shortages are driven by a variety of reasons, and could include a domestic manufacturing facility getting hit by a tornado, quality issues at overseas factories, or risks from single-sourced generic medications. Underlying issues expand beyond the supply chain to pricing and payment, further complicating solutions.
"I think there is a sense of urgency in D.C. that is palpable."
Vimala Raghavendran
Vice President of Informatics Product Development at U.S. Pharmacopeia
Public and private entities have made some efforts in the past year. Legislative efforts include a bill introduced to the U.S. House of Representatives last year that calls the Department of Health and Human Services to create a stockpile program for generic drugs at risk of shortage. President Biden also announced a $35 million investment for domestic production of sterile injectable medication starting materials.
Meanwhile, Mark Cuban’s Cost Plus Drugs, a pharmaceutical company, is positioned to produce drugs on the FDA’s shortage list, although the initiative’s timeline is still unclear.
Raghavendran lauded the efforts as a great move, saying increased domestic production would lessen the likelihood of shortages long term.
“I think there is a sense of urgency in D.C. that is palpable. It would be great if that led to some action,” Raghavendran said. “If not, things will get a lot worse for patients.”
2. Government efforts and coordination
Government bodies have been coordinating their own efforts and initiatives to combat the domestic drug supply shortage.
In November, the White House announced some pharmaceutical supply initiatives, including the Defense Production Act which promotes the domestic production of essential medicines to address drug shortages. The Department of Defense also plans to release a report on pharmaceutical supply chain resilience focused on reducing reliance on high-risk foreign suppliers.
The Department of Health and Human Services also designating a new Supply Chain Resilience and Shortage Coordinator to improve medical product resilience efforts and address shortages. This appointment will “give us more insight on the best way for the commercial market to engage with federal partners,” said Linda Rouse O’Neill, senior vice president for supply chain policy at the Health Industry Distributors Association.
Several other pharmaceutical and healthcare supply chain bills were introduced in 2023, including the MAPS Act, which would direct the Department of Health and Human Services to work with other public and private partners to identify supply chain vulnerabilities, and the FAST PASS Act which would create processes to expedite critical supplies in the case of a public emergency. Experts hope to see Congressional action on these bills in 2024.
Last year, HIDA developed a playbook in partnership with federal agencies, supporting the national preparedness response framework for the medical product supply chain. In 2024, the HIDA aims to work with federal partners to monitor early warning signals, Rouse O’Neill said.
3. Drug Supply Chain Security Act implementation
Many in the pharmaceutical supply chain felt relieved when the FDA delayed the final step of the Drug Supply Chain Security Act to Nov. 27, 2024. All U.S. prescription drug supply chain trading partners, including manufacturers, distributors and dispensers, now have more time to develop or fine tune their methods of electronically exchanging end-to-end drug traceability at the package level.
This year, “everybody is working on establishing electronic connections if they haven’t already done so already,” said Elizabeth Gallenagh, general counsel and senior vice president of supply chain integrity for the Healthcare Distribution Alliance. “This extra time has given the industry more time to work through these issues.” Some partners are ready now to send and receive data now, and some are starting to collect information on data errors.
Even with this delay, the Healthcare Distribution Alliance is asking the FDA to phase in the final DSCSA requirements in three stages by sector, to give clearer direction. However, the FDA has not indicated whether they would implement a phased approach. Industry organizations like the Healthcare Distribution Alliance continue to work with the trading partners to help prepare for the November deadline.
The current lack of coordination is a big problem as all hospitals make independent choices to optimize medication availability for their patients, and they operate in a vacuum.
“It will be interesting to see with this new coordinating function within the Department of Health and Human Services, how they might be able to harness the power of the federal government to address this problem,” said Raghavendran.
