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Commissioner Stephen Hahn evaluates the agency’s response to COVID-19 and how it affected non-COVID related initiatives in 2020.
In an FDA Voices blog post, FDA Commissioner, Stephen M. Hahn, MD, presented a review of the agency’s accomplishments during the difficult year that was 2020. The COVID-19 pandemic, according to Hahn, dominated the agency’s focus and increased FDA’s workload.
In 2020, FDA conducted cross-agency initiatives that included adaptations in operations and communications, using lessons learned from the pandemic. “For instance, we launched the COVID-19 Pandemic Recovery and Preparedness Plan—or PREPP—to support real-time adjustments on the basis of rapidly evolving data, to scale and sustain the FDA’s response, and to increase our capacity and resilience to respond to future health emergencies,” Hahn said.
FDA prioritized its work to optimize inspections and used alternative inspectional approaches during the pandemic. A COVID-19 Advisory Rating system was implemented that used real-time data to decide where and when domestic inspections were possible.
The combat against fraudulent products was also impacted by the pandemic, with new products claiming to treat or prevent COVID-19. The agency launched Operation Quack Hack in March 2020 and has identified more than 1100 fraudulent COVID-19 products. “This is in addition to our normal enforcement efforts by our Office of Criminal Investigations, which last year initiated more than 600 criminal investigations targeting violations related to FDA-regulated products,” said Hahn.
FDA continued to approve new brand and generic drugs in 2020, with 53 novel drugs approved and 800 generic drugs either approved or tentatively approved. “We’ve also made numerous decisions to address drug shortages. For example, we facilitated manufacturers’ extensions of expiration dates, prioritized review and approval of many generic drugs to help ease shortages, and issued guidance on the production of alcohol-based hand sanitizer to help boost supply,” stated Hahn. In addition to its work on COVID-19 treatments and vaccines, the Center for Biologics Evaluation and Research approved treatments for refractory mantle cell lymphoma, invasive meningococcal disease, hemophilia A or B, and peanut allergies.
“Throughout 2020, we continued to optimize our regulatory policies and procedures. For example, we streamlined many processes to make it easier for developers and scientists to send inquiries and requests related to the pandemic response and facilitated the timely availability of guidance documents for industry. We also continue to modernize how clinical trials can be designed and conducted to expand the data sources to aid our evaluation of medical products,” said Hahn. “I commend the entire FDA team for working so hard on behalf of the American public. I know this same focus and diligence will lead us into a successful and productive 2021.”