The FDA June 29 sent its annual report on drug shortages to Congress, summarizing the major actions the agency took in 2020 to prevent or mitigate shortages in the U.S.
Five takeaways from the report:
- The FDA said there were 43 new drug shortages in 2020 and that it successfully prevented 199 shortages. The peak number of drug shortages was 251 in 2011.
- Drugmakers are notifying the FDA earlier than they did in the past about manufacturing interruptions that could lead to shortages, which has given the FDA more time to mitigate drug shortages, the agency said.
- The closure of two manufacturing facilities in 2017 and 2018 by major drugmakers is continuing to affect the pharmaceutical supply chain and contribute to shortages, the FDA said. The agency didn't specify which drugmakers closed facilities.
- The report listed several actions the FDA took in 2020 to mitigate storages, including expediting reviews of more than 100 new drug applications and exercising regulatory flexibility to increase supplies of critically needed drugs, including heparin and propofol.
- The agency also highlighted changes needed to reduce shortages, including gaining better insight into the pharmaceutical supply chain and increasing the supply chain's resilience.
Read the full report here.