Red pills in blister packs. (Photo: Oksana Kazykina/AdobeStock)

Despite efforts by the FDA to ensure essential drug supplies, the number of drug shortages has stubbornly plateaued since 2018. Supply chain shortages during the COVID-19 pandemic have highlighted the sometimes-precarious situation of essential drug manufacturing, and recent disruptions in China and Russia have only further tightened the market, according to FiercePharma. Now, the FDA is working to prevent future supply chain shortages by requiring certain manufacturers to prepare risk management plans. In a draft guidance released May 19th, the agency announced that its new rules would affect manufacturers of drugs that are used to treat rare diseases, can be used during a public health crisis, and drugs which lack alternatives.

Previous reports had recommended the creation of such a guidance, including a 2019 analysis from the Drug Shortages Task Force. Drug shortages can arise for a variety of reasons, including increases in demand and natural disasters, but as a 2019 FDA report showed, around 62% of all drug shortages between 2013 and 2017 were a result of quality issues.

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