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# Drug Shortage Causes, Solutions
- URL: https://www.fdaweb.com/drug-shortage-causes-solutions/
- Published: 2019-10-29T12:00:00.000Z
- Updated: 2026-09-15T01:59:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145366

An interagency drug shortage task force led by FDA has identified three root causes for drug shortages and “enduring solutions” to address such shortages. The [report](https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions?ref=fdaweb.com) relies on information from stakeholders, published research, and economic analysis of market conditions affecting drug shortages, FDA says.

The three root causes identified are: 

- lack of incentives for manufacturers to produce less profitable drugs;
- failure of the market to 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 that make it difficult for the market to recover from a disruption.

The recommended solutions include: 

- 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 (with payers, purchasers, and group purchasing organizations) to make sure there is a reliable supply of medically important drugs.

During a media briefing, FDA acting commissioner **Ned Sharpless** cited some examples of drugs with lengthy shortages, including at least one product indicated to treat cancer in children that has been in and out of shortage for decades. He said the task force found that the number of ongoing shortages has increased and that the impact of the shortages has been greater than anticipated.

Referring to the economic analysis performed as part of the task force study, FDA senior advisor **Randall Lutter** said that between 2013 and 2017, some 163 different drugs went into shortage. He reported that during shortages, drug supply is typically 20%-40% of pre-shortage levels.

According to the analysis, 62% of drug shortages are due to quality issues, 63% of drugs in shortage are injectables, and 67% of the drugs in shortage have a generic form on the market.

After a shortage, Lutter says, the market rarely sees a price increase or a production increase in the shortage drugs.

The report also describes legislative proposals in the president’s FY 2020 budget 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.