Premier Offers Congress Policy Solutions to Eliminate Drug Shortages

Premier provided detailed responses to a bicameral request for information (RFI) from House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Senate Finance Committee Ranking Member Mike Crapo (R-ID) on the causes of drug shortages, as well as potential policy solutions to address them. In its response to the RFI, Premier applauds Congress for its bipartisan and bicameral efforts to date to alleviate drug shortages, while calling for greater legislative, regulatory and oversight action to address persistent shortages.

In its comments, Premier identified the root causes of drug shortages and recommended sustainable policy solutions to decrease manufacturer barriers to entry, namely the time and cost to enter the marketplace, while maintaining the quality and safety of the product. Specifically, Premier urged Congress to:

• Hold the Food and Drug Administration (FDA) accountable for expeditiously implementing drug shortage provisions from the CARES Act in alignment with Congressional intent;
• Require manufacturers, including active pharmaceutical ingredient (API) manufacturers, to report the volume of product that is manufactured in each FDA-registered facility;
• Modernize the FDA’s data infrastructure to collect shortage signals from the private sector;
• Level the playing field for all FDA inspections;
• Expand drug shortage authorities to vaccines;
• Expand the FDA drug shortage list to include regional shortages as well as shortages based on strength and dosage form;
• Revisit Generic Drug User Fee Act (GDUFA) facility fees and their potential impact on drug shortages;
• Fund robust research to quantify the clinical and economic impact of drug shortages.
• Testing reimbursement models that create stability for drugs prone to shortages;
• Require the Drug Enforcement Agency (DEA) to establish aggregate production quotas (APQs) in terms of pharmaceutical dosage form for all CII controlled substances;
• Require entities who receive government grants for domestic manufacturing of drugs, vaccines, and API to manufacture drug shortage products when needed;
• Streamline the ability of 340B covered entities to purchase drug shortage items; and
• Require a report to Congress with recommendations on consumer notification of shortages.

As one of our major policy priorities, Premier will continue to advance bipartisan policy solutions to mitigate and prevent drug shortages.