Drug Shortages: Root Causes and Potential Solutions, published in October 2019, examines the underlying factors responsible for drug shortages and recommends enduring solutions. The inter-agency Drug Shortage Task Force, which was led by FDA, oversaw the analysis of drug shortage data and development of recommendations in response to a request from 31 U.S. senators and 104 U.S. congressional representatives in June 2018.
The recommendations were based on insights gleaned from public and private stakeholders at a November 2018 Drug Shortages Task Force Public MeetingExternal Link Disclaimer, a docket for comments, and listening sessions with stakeholders, as well as FDA data analysis and published research.
The report identifies three root causes for drug shortages:
- Lack of incentives for manufacturers to produce less profitable drugs;
- The market does not recognize and reward manufacturers for “mature quality systems” that focus on continuous improvement and early detection of supply chain issues; and
- Logistical and regulatory challenges make it difficult for the market to recover from a disruption.
The report also recommends enduring solutions:
- Creating a shared understanding of the impact of drug shortages on patients and the contracting practices that may contribute to shortages;
- Developing a rating system to incentivize drug manufacturers to invest in quality management maturity for their facilities; and
- Promoting sustainable private sector contracts (e.g., with payers, purchasers, and group purchasing organizations) to make sure there is a reliable supply of medically important drugs.