FDA Releases Report on Underlying Causes of Drug Shortages

FDA released a report on Oct. 29, 2019 that detailed the underlying factors responsible for drug shortages and its recommendations regarding solutions for the problem.

According to a press release, the report focuses on information from stakeholders, published research, and economic analysis of market conditions from an analysis of drug shortage data and development of recommendations by the inter-agency Drug Shortage Task Force led by FDA. The analysis was conducted in June 2018 after requests from 31 US senators and 104 US congressional representatives.

The report outlines three main causes for the drug shortages:

• The need for incentives for manufacturers to make less profitable drugs

• The market not recognizing and rewarding manufacturers for quality systems that center on continuous improvement and early detection of supply chain issues

• Logistical and regulatory issues that make it challenging for the market to recover from a disruption.

Additionally, the report addressed possible solutions for the shortages:

• Establishing a mutual understanding of the significance of drug shortages on patients and the countering practices that may contribute to shortages

• Promoting a rating system to help manufacturers invest in quality management maturity for their facilities

• Encouraging sustainable private sector contracts to ensure there is a supply of medically important drugs. 

The report also discussed legislative proposals in the President’s full year 2020 budget regarding mitigating shortages. The proposals deal with improved data sharing, risk management, lengthened expiration dates for drugs, and internationally harmonized guidelines for a pharmaceutical quality system, according to the release.

Source: FDA