CDER Outlines Drug Safety Measures Taken in 2020

“The past year was an unprecedented one,” says Patrizia Cavazzoni, MD, acting director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA), in a new report on the center’s activities in 2020. She notes CDER “collaborated closely with colleagues across the [FDA] as well as other federal and international partners to engage in activities to respond to the COVID–19 situation and to protect our nation’s public health during these challenging times.”

Although significant effort in 2020 was spent battling the pandemic, CDER continued to complete its critical work to ensure the safety of the medicines on which millions of patients rely, the report says. However, the focus of the agency’s efforts was confronting COVID-19.

For example, the FDA created a special emergency program for possible coronavirus therapies, the Coronavirus Treatment Acceleration Program. The program uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.

To protect and promote public health during the pandemic, the FDA:

  • Reviewed safety data including adverse event reports and observational studies, as part of the overall benefit-risk assessment for products submitted for Emergency Use Authorization and New Drug Application approval.
  • Conducted surveillance on case reports in the FDA Adverse Event Reporting System, medical literature, National Poison Data System, prescription and non-retail sales, and other data sources, and evaluated newly identified safety concerns and medication errors related to products used to treat or prevent COVID–19.
  • Conducted searches and reviews of observational study literature on the impact of drugs used to treat or prevent COVID–19.
  • Reviewed and provided feedback on the quality and feasibility of proposals for real-world data analyses to inform the effectiveness of COVID–19 therapies.
  • Developed pandemic-related guidances, such as the “Policy for Certain REMS Requirements During the COVID–19 Public Health Emergency” and “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.”

Edited by Michael Causey