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FDA identifies causes of drug shortages, recommends solutions Posted 22/11/2019

In response to growing concern over drug shortages, the US Food and Drug Administration (FDA) has released a report and accompanying statement regarding causes and solutions for the problem.

Drug shortages are a serious problem in the US, where scarcities of older generic drugs can cause delays to treatment or unplanned substitutions. In a recent study, over half of hospitals in the US reported changing patient care or delaying therapy due to shortages, and over a third said they had rescheduled procedures because of a lack of treatment options.

In response to this, FDA has now published a report ‘Drug Shortages: Root Causes and Potential Solutions’ exploring the factors responsible for drug shortages and recommending solutions to the problem.

The report was developed by the Drug Shortage Task Force, who analysed data on drug shortages between 2013 and 2017. This was the result of a request from Congress, from 31 US senators and 104 US congressional representatives, in June 2018.

The report is based on information from stakeholders, published research and economic analysis, and identifies three major causes for drug shortages:
1. A lack of incentives for manufacturers to produce less profitable, e.g. lower price, drugs
2. Lack of market reward for ‘mature quality systems’ that focus on early detection of supply chain issues
3. Logistical and regulatory challenges

The report also recommends solutions, including:
1. Creating shared understanding of the impact and causes of drug shortages
2. Developing a rating system to incentivize manufacturers to invest in mature quality systems
3. Promoting sustainable private sector contracts, for example, with payers, purchasers and group purchasing organizations

The report also describes recent proposals in the President’s budget for 2020 and initiatives planned by FDA to prevent and mitigate shortages.

In an accompanying statement, Acting Commissioner Ned Sharpless and Director of the Center for Drug Evaluation and Research Janet Woodcock describe drug shortages as a top priority for the US Administration and summarize the most important findings of the report.

The task force found that 163 drugs went into shortage between 2013 and 2017. These drugs were more likely to be low price and therefore financially unattractive to manufacturers. The task force also found a ‘broken marketplace’, where prices rarely rose after shortages began and production often did not increase sufficiently to restore supply to pre-shortage levels.

The statement elaborates on the report’s recommendations, which the administration hopes will mitigate the public health impact of drug shortages in the US.

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Source: US FDA

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