In an APhA2022 education session presented titled "FDA Update," Lindsay Wagner, PharmD, BCPS, branch chief, FDA, and Beth F. Fritsch, PharmD, MBA, BCPS, senior advisor, FDA, apprised attendee of the latest important regulatory updates while providing insight into the agency's current priorities while fulfilling its mission of promoting and protecting public health.
Not surprisingly, chief among the FDA's activities during the past year were those related to the COVID-19 pandemic, many of which affected pharmacy practice. Specifically, Drs. Wagner and Fritsch detailed the fast-tracked, life-saving vaccines and treatments for COVID-19, describing how the vaccines changed the course of the pandemic. An overwhelming amount of work was performed by CDER between January 2020 and September 2021, Dr. Wagner said. During this period, she added, "CDER approved over 1,000 original and supplemental NDAs for generic COVID-19-related treatments and therapies."
Drug shortages, Dr. Wagner added, have been a major concern throughout the pandemic, and CDER's drug shortages team has reached out to more than 180 manufacturers of both COVID-19 and non-COVID-19 treatments to address these shortages.
The CDER has also been busy policing health fraud during the pandemic, taking action against sellers of fraudulent COVID-19 products and sending out more 120 warning letters. She noted that CDER has fielded more than 23,000 COVID-19-related inquiries from the public.
To obtain the latest information related to the pandemic, Dr. Wagner recommends that people visit the agency's COVID-19 information page (www.fda.gov/coronavirus).
The FDA has created a program for possible COVID-19 treatments called the Coronavirus Treatment Acceleration Program, noting that as of January 31, 2022, there were 680 drug-development programs in planning stages and 470 clinical trials were reviewed by FDA.
Looking ahead, Dr. Fritch described the FDA's priorities for 2022 and beyond, including the COVID-19 pandemic; countering misinformation about science and FDA; opioid and stimulant crisis; tobacco harm, including e-cigarettes; food supply safety and public health nutrition education; veterinary products, and antimicrobial resistance; and enhanced ability to collect and analyze the best available science and rigorous data.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
« Click here to return to APhA Conference Connect.
Published March 24, 2022