The coronavirus pandemic may have officially ended last year, but its impact on the pharmaceutical industry is far from over. As the nation continues to recover, the effects of the pandemic continue to be felt in the form of drug and medical supply shortages. While the federal government is taking steps to address the issue, both public and private entities are pushing for increased visibility and collaboration to find solutions.
These lingering issues have led experts to identify three main trends to watch in 2024: ongoing drug shortages, federal oversight, and the implementation of the Drug Supply Chain Security Act. Let’s take a closer look at each of these trends.
1. Lingering Drug Shortages
Drug shortages remain a major concern in the United States, with over 200 shortages reported as of March. These shortages impact a wide range of medications, including cancer treatments, sterile injectables, generics, imaging agents, and antimicrobials.
The root causes of these shortages are varied and complex, ranging from natural disasters to quality issues at overseas manufacturing facilities. Additionally, the risks associated with relying on single-source generic medications further exacerbate the problem. The underlying issues go beyond just the supply chain and also involve pricing and payment challenges, making it difficult to find solutions.
In the past year, both public and private entities have made efforts to address these shortages. For example, a bill was introduced in the U.S. House of Representatives to establish a stockpile program for generic drugs at risk of shortage. President Biden also announced a $35 million investment to increase domestic production of sterile injectable medication starting materials.
Furthermore, Mark Cuban’s Cost Plus Drugs, a pharmaceutical company, is poised to produce medications on the FDA’s shortage list, although the timeline for this initiative is still unclear. While these efforts are a step in the right direction, experts warn that without further action, shortages will continue to impact patients.
2. Government Efforts and Coordination
The government is also taking steps to address the domestic drug supply shortage. In November of last year, the White House announced several pharmaceutical supply chain initiatives, including the Defense Production Act, which promotes the domestic production of essential medicines to combat drug shortages. The Department of Defense also plans to release a report on pharmaceutical supply chain resilience with the goal of reducing reliance on high-risk foreign suppliers.
Additionally, the Department of Health and Human Services has designated a new Supply Chain Resilience and Shortage Coordinator to improve medical product resilience efforts and address shortages. This appointment will facilitate better collaboration between the government and the commercial market to find solutions.
Several pharmaceutical and healthcare supply chain bills were also introduced in 2023, including the MAPS Act, which would direct the Department of Health and Human Services to work with public and private partners to identify supply chain vulnerabilities, and the FAST PASS Act, which would create processes to expedite critical supplies in the event of a public emergency. Experts are hopeful that Congress will take action on these bills in 2024.
In 2023, the Health Industry Distributors Association (HIDA) developed a playbook in partnership with federal agencies to support the national preparedness response framework for the medical product supply chain. In 2024, the HIDA plans to work with federal partners to monitor early warning signals and continue to promote collaboration and coordination.
3. Drug Supply Chain Security Act Implementation
The final step of the Drug Supply Chain Security Act, which requires all U.S. prescription drug supply chain trading partners to electronically exchange end-to-end drug traceability at the package level, was initially set for November 2023. However, due to the ongoing challenges posed by the pandemic, the FDA has extended the deadline to November 2024.
This extra time has allowed the industry to work through potential issues and establish electronic connections for data exchange. Some trading partners are already equipped to send and receive data, while others are still working on collecting information on data errors. Despite the delay, the Healthcare Distribution Alliance is urging the FDA to phase in the final DSCSA requirements in three stages, based on sector, to provide clearer direction. However, the FDA has not yet indicated whether they will implement a phased approach.
In the meantime, industry organizations like the Healthcare Distribution Alliance continue to work with trading partners to ensure they are prepared for the November deadline. As the industry continues to navigate these challenges, the coordination and collaboration between all parties involved will be crucial to success.
Conclusion
The pharmaceutical industry is still feeling the impact of the coronavirus pandemic, with drug and medical supply shortages continuing to be a major concern. However, with ongoing efforts from both the government and private sector, there is hope for finding solutions to these challenges. As we move into 2024, the industry will be closely watching the progress on addressing drug shortages, increasing federal oversight, and implementing the Drug Supply Chain Security Act.
