FDA focuses on efforts made to avert drug shortages in 2020
New drug shortages in the US decreased in 2020, in part because of the US Food and Drug Administration’s (FDA’s) use of enforcement discretion to ensure an uninterrupted supply of critical medical products during the COVID-19 public health crisis.Yet, the agency’s new drug shortages report to Congress said that while these actions helped avert shortages in the short-term, more work is needed to improve supply chain resiliency.
This report summarizes the agency’s actions during calendar year (CY) 2020 to prevent or mitigate drug shortages; these annual reports are mandated by Congress under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.
The report notes that the number of new drug shortages has stayed relatively constant over the past several years, hovering around the 50-item mark. In 2020, the number of new drug shortages was 43, a slight decrease from the 52 shortages reported in 2018 and 2019 but well under the record number of 250 shortages in 2011.
In 2011, the high number of shortages caught the attention of then-President Barack Obama, who released an executive order requiring FDA to create an early-warning system for drug shortages. (RELATED: 2011 drug shortages soar to record highs, Regulatory Focus 4 January 2012).
Using regulatory discretion to prevent shortages
The agency “leveraged all its regulatory tools” in 2020 to avert drug shortages and ensure patients’ access to critically needed medicines.
For example, FDA’s Center for Drug Evaluation and Research (CDER) expedited reviews for more than 100 original abbreviated new drug applications for drugs to treat patients with COVID-19, also speedingthe assessment of more than 150 ANDA supplements. The agency also expedited assessments of supplements to facilitate manufacturing capacity for COVID-19 biologics.
FDA also exercised discretion in 45 cases to increase supplies of heparin, albuterol, etomidate, midazolam andpropofol, as well as other essential medicines for treatment of hospitalized patients with COVID-19. (RELATED: 2020 Drug Safety: CDER spotlights COVID-19 activities, nitrosamine contamination, Regulatory Focus, 18 February 2021),
The agency also issued six guidances granting temporary enforcement discretion for compounded drugs needed to treat hospitalized COVID-19 patients. (RELATED: FDA allows compounding of needed hospital drugs for COVID-19, Regulatory Focus 16 April 2020; FDA expands COVID-19 drug compounding policy to smaller pharmacies, Regulatory Focus 21 April 2020)
Challenging year
Despite the progress made to avert shortages, 2020 was still a “challenging” year; “ongoing work is needed to gain better insight into the supply chain,” according to the FDA report.
Increasing supply chain redundancy, rather than relying on a sole manufacturer or geographic region to supply a drug can help avoid potential drug shortages. “For example, if a manufacturing facility needs to temporarily close or its operations are curtailed by factors such as travel restrictions, quarantines, or social distancing requirements, it is important to have alternative facilities available to manufacture the drug or its API,” wrote FDA in the report.
The medical shortage issue continues to be a top priority for the agency. FDA’s FY 2022 budget request to Congress prioritizes resources to avert shortages for such medical devices as personal protective equipment. (RELATED: FDA’s FY 22 budget priorities: boost inspections, surveillance; avert device shortages, Regulatory Focus, 8 June 2021).
FDA drug shortages report
