FDA avoided record number of drug shortages in 2021

Regulatory newsRegulatory news

Posted on June 22, 2022 | By Jeff Craven

FDA avoided record number of drug shortages in 2021

2803


The U.S. 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 by the agency.

The agency’s Center for Drug Evaluation and Research (CDER) has been monitoring drug shortages for Food and Drug Administration Safety and Innovation Act (FDASIA) was passed in 2012, which requires the FDA to publish an annual report to Congress; The FDA’s Center for Biologics Evaluation and Research (CBER) has been tracking drug shortages with CDER since 2016. In its report for calendar year 2021, the FDA said that while a record number of new drug shortages were avoided, “shortages continue to be a real public health challenge.

“This is especially the case when the shortage involves a drug essential to treat cancer, to provide parenteral nutrition, or to treat another serious medical condition, such as a shortage of blood pressure medication,” the FDA wrote.

Although 41 new shortages occurred in 2021, the FDA said that number is much lower than the 251 new shortages seen in 2011 and continues the trend of a significant decrease in drug shortages since 2013.

The FDA said it has taken a number of steps 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 seeking to begin manufacturing. shortage products.

The FDA also has the authority to establish communication channels with stakeholders, work with manufacturers to assess the root causes of drug shortages, be flexible with regulations regarding the supply of new medically necessary drugs, and to develop risk mitigation plans to allow the release of individual drug batches that have failed to meet quality assurance requirements. The agency also used the Defense Production Act (DPA) with the Assistant Secretary for Preparedness and Response (ASPR) to produce more COVID-19 vaccines and treatments during the pandemic. In total, the FDA said it exercised regulatory flexibility 104 times in 2021 on 59 products.

The agency also highlighted several unique challenges in preventing drug shortages due to ongoing supply chain disruptions or shortages due to the COVID-19 pandemic. A sudden demand for COVID-19 drugs has resulted in a shortage of drugs treating hospitalized or critically ill patients with COVID-19, and the FDA has asked manufacturers to investigate their entire supply chain to identify any potential problem, with an emphasis on early communication.

“The FDA understands the significant impact this can have on patient care and is doing everything in its power to help prevent and mitigate these disruptions and shortages. As a result of Presidential, Congressional, and Agency actions, manufacturers are notifying the FDA earlier than in the past of certain manufacturing disruptions and interruptions that may lead to shortages,” the agency wrote. “These early notifications give the FDA more time to work with manufacturers and other stakeholders to identify ways to maintain treatment options and avoid a shortage.”

To anticipate shortages in 2021, the FDA said CDER expedited nearly 100 original abbreviated new drug applications (ANDAs) and supplements, assessed supplement manufacturing, and “exercised regulatory flexibility and discretion” to increase the drug supply in 15 cases. The FDA also approved 35 original ANDAs and 86 additional ANDAs for drug products used as COVID-19 treatments in hospitals in 2021.

“These approvals help ensure the adequate supply of these critical products during this time of increased demand and represent the dedicated efforts of review staff in many FDA offices,” the agency wrote.

Future issues the FDA plans to work on include addressing disruptions or issues in the drug supply chain and improving supply chain resilience. The Coronavirus Aid, Relief and Economic Security Act (CARES Act), enacted at the start of the COVID-19 pandemic, empowers the FDA to “identify, prevent, and mitigate potential drug shortages by, among other things, improving FDA visibility into drug supply chains “, and the FDA intends to use their authority to better understand these issues.

“Drug shortages remain a significant public health issue in the United States and a top priority for the FDA, especially during the COVID-19 pandemic. Although significant progress has been made to prevent many drug shortages, the FDA continues to work to ensure that patients in the United States have access to the drugs they need and continues to work for a stronger supply chain. “, concluded the agency.

Drug shortages for calendar year 2021

© 2022 Society of Regulatory Affairs Professionals.