FDA prevented record number of drug shortages in 2021

Regulatory NewsRegulatory News | 22 June 2022 |  By 

The US Food and Drug Administration (FDA) prevented 317 drug shortages in 2021, the highest number since the agency began tracking drug shortages in 2012, according to a recent report released by the agency.
 
The agency’s Center for Drug Evaluation and Research (CDER) has been tracking drug shortages since the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed in 2012, which requires FDA to release an annual report to Congress; FDA’s Center for Biologics Evaluation and Research (CBER) has been tracking drug shortages together with CDER since 2016. In its report for calendar year 2021, FDA said that while a record number of new drug shortages were prevented, “Shortages continue to pose a real challenge to public health.”
 
“This is especially the case when the shortage involves a critical drug to treat cancer, to provide parenteral nutrition, or to address another serious medical condition, such as a shortage of blood pressure medications,” FDA wrote.
 
Although 41 new shortages occurred in 2021, FDA said that number is much lower than the 251 new shortages observed in 2011 and continues the trend of significantly fewer drug shortages occurring since 2013.
 
FDA said it has taken a number of actions to prevent shortages, including assessing the extent of the shortage and whether other manufacturers can fill the need, and expediting inspections and reviews of existing manufacturers intending to restore production as well as for competitors looking to begin manufacturing products in shortage.
 
FDA also has the authority to establish communication channels with stakeholders, work with manufacturers to assess root causes of drug shortages, be flexible with regulations around sourcing new medically necessary drugs, and develop a risk mitigation plans to allow individual drug batches to be released that have not met quality assurance requirements. The agency has also used the Defense Production Act (DPA) together with the Assistant Secretary for Preparedness and Response (ASPR) to produce more COVID-19 vaccines and therapeutics during the pandemic. In total, FDA said it exercised regulatory flexibility 104 times in 2021 across 59 products.
 
The agency also highlighted several unique challenges in preventing drug shortages because of continued supply chain disruptions or shortages due to the COVID-19 pandemic. A sudden demand for COVID-19 drugs led to a shortage in drugs treating hospitalized or critically ill patients with COVID-19, and FDA has asked manufacturers to investigate their entire supply chain to identify any potential issues, emphasizing early communication.
 
“FDA understands the significant impact this can have on patient care and is doing everything within its authority to help prevent and alleviate these disruptions and shortages. As a result of presidential, congressional, and Agency actions, manufacturers are notifying FDA earlier than in the past about certain manufacturing interruptions and discontinuances that can lead to shortages,” the agency wrote. “These early notifications give FDA additional time to work with manufacturers and other stakeholders to identify ways to maintain treatment options and prevent a shortage.”
 
To preempt shortages in 2021, FDA said CDER expedited nearly 100 original abbreviated new drug applications (ANDAs) and supplements, assessments of manufacturing supplements, and “exercised regulatory flexibility and discretion” to increase medication supplies in 15 cases. FDA also approved 35 original ANDAs and 86 supplemental ANDAs for drug products used as COVID-19 treatments in hospitals in 2021.
 
“These approvals help ensure the adequate supply of these essential products during this time of heightened demand and represent the dedicated efforts of review staff from many offices within FDA,” the agency wrote.
 
Future issues FDA plans to work on include addressing interruptions or problems in the drug supply chain and improving supply chain resilience. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), signed into law at the beginning of the COVID-19 pandemic, empowers FDA to “identify, prevent, and mitigate possible drug shortages by, among other things, enhancing FDA’s visibility into drug supply chains,” and FDA intends to use their authority to gain greater insight into these issues.
 
“Drug shortages remain a significant public health issue in the United States and a top priority for FDA, particularly during the COVID-19 pandemic. While important progress has been made in preventing many drug shortages from occurring, FDA continues to work to ensure that patients in the United States have access to the medicines they need and continue to work towards a more robust supply chain,” the agency concluded.
 
Drug Shortages for Calendar Year 2021

 

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