Drug shortages: FDA to require risk management plans
62% of all drug shortages between 2013 and 2017 were a result of quality issues, an FDA report showed.
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 In a draft guidance released May 19th, the agency announced that its new rules would affect manufacturers of drugs that are used to treat rare diseases, can be used during a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.
Organizations like the End Drug Shortages Alliance have arisen to try to combat these issues. Aiming to anticipate and prevent essential drug shortages, the End Drug Shortages Alliance released its first report this month warning about possible shortages after the closing of a Teva Pharmaceuticals plant in Irvine, Calif. The plant was shut down by Teva after receiving multiple warnings from the FDA about quality issues, according to the University of Minnesota Center for Infectious Disease and Research Policy. The plant manufactured multiple drugs, including five essential medications for which Teva produced more than 15% of the market.
The EDSA has recommended that suppliers preemptively assess their supply chains in anticipation of ramping up production. They’ve also advised the FDA to fast-track approvals for imports or manufacturing of the affected drugs.
“Information shared in this report highlights the level of transparency that is required across the supply chain to successfully navigate drug shortages,” said Terri Lee Wilson, EDSA vice-chair, in a news release.
Drug companies wishing to file comments or suggestions about the FDA’s new guidance have 60 days to reach out.