The U.S. Food and Drug Administration has issued a report after studying the issue of drug shortages.
At the request of Congress last year, the FDA convened an inter-agency Drug Shortages Task Force to study the problem, determine the root causes of drug shortages, and make recommendations for enduring solutions.
The findings are in the just issued report, “Drug Shortages: Root Causes and Potential Solutions.
The Task Force analyzed 163 drugs that went into shortage from 2013 to 2017 and compared these medicines to similar drugs that did not go into shortage.
Shortage drugs were more likely to be relatively low-price and financially unattractive drugs and were more likely to be sterile injectables.
Shortages often occurred as a result of disruption in supply due to a variety of factors. Importantly, prices rarely rose after shortages began, and during shortages, production typically did not increase enough to restore supply to pre-shortage levels.
The report made recommendations.
Steps must be taken to increase understanding of the impacts of drug shortages and companies’ contracting practices that may contribute to them.
Also develop a rating system to evaluate the robustness of a manufacturing facility’s quality system and its ability to deliver high-quality products reliably and without disruption.
New contracting approaches are recommended to help ensure a reliable supply of drugs.