FDA issues report on root causes and potential solutions to drug shortages

FDA issues report on root causes and potential solutions to drug shortages

The U.S. Food and Drug Administration (FDA) inter-agency Drug Shortages Task Force has released a report, Drug Shortages: Root Causes and Potential Solutions, that examines the root causes of drug shortages and recommends enduring solutions. Drug shortages are a significant public health issue that can have serious effects on patients, who may experience treatment delays, receive alternative therapies that are not as effective or well-tolerated, or forgo treatment.

The report identifies three root causes for drug shortages: lack of incentives for manufacturers to produce less profitable drugs; limited recognition for manufacturers with “mature quality systems” that focus on continuous improvement and early detection of supply chain issues; and logistical and regulatory challenges that make it difficult for the market to recover from a shortage.

The report also discusses long-term solutions to address drug shortages. These solutions include creating a shared understanding of the impact of shortages on patient care and the contracting practices that contribute to shortages; developing a system to incentivize drug manufacturers to invest in quality management maturity for their facilities; and promoting sustainable contracting approaches (e.g., with payers, purchasers, and group purchasing organizations) to make sure there is a reliable supply of medically important drugs.

In addition, the report describes legislative proposals and planned FDA initiatives to prevent and mitigate shortages that look at improved data sharing, risk management, lengthened expiration dates for drugs, and internationally harmonized guidelines for a pharmaceutical quality system.

Drug Shortages: Root Causes and Potential Solutions was developed in response to a congressional request for the FDA to help address the issue of drug shortages. Upon receiving this request, the FDA convened an inter-agency Drug Shortages Task Force to study the problem, prepare a report on the root causes of drug shortages in the United States, and make recommendations for enduring solutions.