HHS Adopts ASHP Recommendations on Drug Shortages, But Proposes Concerning Penalties

The Department of Health and Human Services (HHS) released a new white paper, Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States, which sets out a series of recommendations for addressing drug shortages.

ASHP was pleased to see that the white paper incorporates a number of ideas from our most recent set of drug shortage recommendations. Specifically, the white paper acknowledges the need for greater transparency and supply chain diversity, and highlights shortages of generic sterile injectable products as a key risk area. Like ASHP’s drug shortage recommendations, the white paper includes policy suggestions for incentivizing manufacturer quality and purchasing from reliable suppliers to ensure a more stable, secure supply chain.

Unfortunately, the HHS proposal misses the mark by suggesting penalties against hospitals that do not adopt HHS-required inventory and purchasing practices. Hospitals are often hit hard by drug shortages. We are deeply concerned that HHS proposes to impose financial penalties on hospitals that may be least able to take steps, such as investing in buffer inventories, to prevent shortages. This risks further disadvantaging hospitals with limited resources to manage shortages.

The white paper includes policy proposals but is not itself a law or regulation. HHS and Congress need to take additional action to operationalize any of the suggestions included in the white paper.

“The white paper includes some key solutions to address drug shortages, but more work needs to be done before these policies are adopted,” said Tom Kraus, ASHP vice president of government relations. “ASHP will continue to work closely with HHS and Congress to tailor policy proposals to best enhance the supply chain and protect patients and providers.”