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A new US Department of Health and Human Services (HHS) white paper outlines progress it has made toward preventing and lessening the impact of drug shortages—particularly the vulnerable generic injectable drugs used in hospitals—while acknowledging its efforts are only part of the solution.
"All across our Department, we are working to ensure that millions of Americans will have access to medication, treatment, and services that save lives and improve health outcomes," HHS Secretary Xavier Becerra said in a department press release.
"That's why advancing and implementing solutions to the nation’s drug shortages are so important, and why we want members of Congress and all actors in the supply chain to consider and act on the policy options presented in today’s white paper."
Authorities, resources needed to incentivize market
HHS and its agencies have been working to better track the drug supply chain and respond to disruptions, including:
- The establishment of a new supply chain resilience and shortage coordinator role to implement strategies to shore up supply chains for drugs and other medical products
- The publication of guidance to boost supply chain transparency and consider other long- and short-term solutions.
- A joint HHS and Federal Trade Commission request for information on how group purchasing organizations (GPOs) and drug wholesalers contribute to generic drug shortages.
- A $500 million Administration for Strategic Preparedness and Response (ASPR) investment to support domestic manufacturing of active pharmaceutical ingredients, as well as an exploration of how to return overseas manufacturing of essential medicines, medical countermeasures, and their ingredients to the United States.
- Proposals for policies to foster a diverse drug supply chain through Medicare payments.
Additional authorities and resources are needed to reward investment in supply chains through the development of a manufacturer resiliency assessment program and hospital resilient supply program, HHS adds.
Drug shortages have been a problem around the world for decades for reasons such as the interference of supply chain "middlemen" and a generic-drug price "race to the bottom" that provides little incentive for redundancy and resilient manufacturing, distribution, and purchasing.