Identifying drugs vulnerable to shortage or fraudulent activity and proactively addressing barriers to outsourcing facility production of drugs to prevent shortages

The American Society of Health-System Pharmacists Inc. (ASHP) received a $3.0 million Project Grant from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research under the Food and Drug Administration Research program (CFDA 93.103), awarded September 25, 2025, with completion scheduled for August 31, 2028. The grant funds a comprehensive initiative to identify drugs vulnerable to supply-chain shortages or fraudulent activity and develop mitigation strategies through outsourcing facility production. ASHP will conduct a two-phase expert panel review process that applies supply-chain vulnerability assessments and shortage clinical impact analyses to prioritize drugs with shortage histories, older approval dates, essential medicine designation, or fraud risk. The assessment will evaluate factors including previous shortage duration, market consolidation, single/multi-source availability, product sales volume, therapeutic alternatives, and health outcome impacts.

The project deliverables include a matrix categorizing drugs into four priority quadrants based on vulnerability and clinical impact levels, with prioritized drugs forwarded to a second expert panel. This panel, composed of specialists in sterile compounding, outsourcing facility good manufacturing practices, and pharmacy operations, will determine feasibility for production by outsourcing facilities while considering production scale capabilities and the needs of special populations such as pediatric patients. The initiative directly addresses FDA's regulatory science mission by providing actionable intelligence to prevent critical drug shortages and reduce supply-chain vulnerabilities that could compromise patient access to essential medications.

Abstract

Drugs with a history of shortage according to the FDA or the american society of health-system pharmacists (ashp) drug shortage lists will be reviewed to identify products approved before 2000, on the 2020 FDA list of essential medicines, or subject to fraudulent activity. An expert panel of clinicians and supply chain specialists will apply both a supply-chain vulnerability assessment and shortage clinical impact analysis to develop a matrix score for each drug identified. The supply-chain vulnerability assessment will include data such as history and duration of previous shortages, market consolidation, single- or multi-source availability of a product, and risk of fraud or counterfeit activity. The shortage clinical impact analysis will include the volume of drug sales, the availability of other dosage forms or therapeutic alternatives, and the likelihood of poorer health outcomes due to shortage. The goal of the matrix will be to categorize drugs into four quadrants: high vulnerability / high clinical impact, high vulnerability / low clinical impact, low vulnerability / high clinical impact, and low vulnerability / low clinical impact. Drugs most susceptible to supply-chain disruption with a higher risk of clinical impact will be prioritized for review by a second panel. The second panel, comprised of experts in sterile compounding, outsourcing facility good manufacturing practices, and pharmacy operations, will review the list of prioritized drugs to determine which drugs and dosage forms are most feasible for production by outsourcing facilities, including consideration for the production scale of outsourcing facilities. Production scale evaluation will also consider the needs of special populations (e.g., pediatric patients) where an outsourcer may have the capabilities to meet the needs of a specific population. Drug candidates will also be compared against the most recent FDA outsourcing facility product report for current availability. The panel will develop a request-for-proposal (RFP) process and solicit proposals from outsourcing facilities for each drug prioritized. The panel will evaluate RFP submissions using a rubric that includes consideration for the outsourcing facility's capacity, quality assurance practices, the number of states where the facility is licensed, completion of the ashp outsourcing sterile products vendor assessment tool, and other relevant information as determined by the expert panel. Sub-grants will be awarded to proactively develop formulations of high-risk, highly impactful drugs so that they can more quickly respond in the event of a supply-chain disruption. Depending on the sales volume data and matrix score for a drug, multiple outsourcing facilities may be awarded sub-grants for specific drug and dosage form combinations.