Earlier this year, a bipartisan duo in the United States House of Representatives reintroduced legislation to create an essential medicines strategic stockpile. Representatives Buddy Carter (R-GA) and Lisa Blunt Rochester (D-DE) introduced H.R. 2870 – Essential Medicines Strategic Stockpile Act of 2021 – which would require the United States Department of Health and Human Services (HHS) to develop a pilot program with private entities to test the effectiveness of acquiring, maintaining, managing, and distributing a state-based stockpile of generic drugs at risk of shortage, as a backup to the federal stockpile.
Under the proposed program, entities would create contracts of up to three years for a six-month stockpile of up to fifty generic drugs. These contracts would be annually evaluated by the Government Accountability Office. While the United States Food and Drug Administration (FDA) currently keeps a list of drugs in short supply, HHS would have to take it a step further, creating a separate list of at least fifty essential medicines, in collaboration with healthcare stakeholders and other governmental agencies.
Should the legislation pass Congress and become law, effective January 1, 2022, the HHS Secretary would need to “award contracts to eligible entities to each implement and test the effectiveness of acquiring, maintaining, managing and distributing a stockpile” that consisted of generic drugs at risk of shortage. The stockpile would need to be “of sufficient quantity to ensure that customers in the United States have access to such drugs for at least 6 months (as specified by the Secretary based on the historic demand for those drugs.”
If a contract is awarded to an eligible entity under the legislation, the entity does not need to stockpile all fifty drugs listed but would be responsible for the drugs listed in the contract. The entity would need to ensure that each drug maintained in the stockpile has an expiration date at least one year beyond the current date and if the drugs in the stockpile are sold through normal commercia channels, the drugs would need to be replaced. If there is no commercial market for a drug in the stockpile and the expiration date is less than one year in the future, the entity will need to dispose of the drug and report the disposal to the HHS Secretary.
Additionally, for each generic drug on the list, the HHS Secretary shall specify the quantity that is required to ensure all consumers in the United States have access to the drug for at least six months. The HHS Secretary can, on an annual basis, request a physical audit count of the inventories of all eligible entities with a contract to validate that each entity is maintaining the appropriate amount of stockpiled inventory.
All eligible entities that have a contract under the legislation will need to submit reports “at such time and in such manner as the Secretary may require” regarding current inventory levels of stockpiled drugs, indicators of current inventory levels of stockpiled drugs relative to acceptable minimums, and any other matters the Secretary deems appropriate.
The HHS Secretary will pay monthly fees to eligible entities for the management of the stockpile.
When reintroducing the bill – originally introduced in October 2020 – Carter and Rochester noted that the COVID-19 pandemic highlighted the need to “have a redundancy in our stockpiles.” The HHS Assistant Secretary for Preparedness and Response is currently reviewing the bill, which is currently siting in the House Committee on Energy and Commerce.