In an APhA2023 education session presented titled “FDA Update,” Lindsay Wagner, PharmD, BCPS, branch chief, FDA, and Connie Jung, RPh, PhD, senior advisor, FDA, apprised attendees of the latest important regulatory updates while providing insight into the agency’s current priorities to fulfill its mission of promoting and protecting public health.
There were several notable achievements for the FDA in 2022. One was the creation of the Accelerating Rare Disease Cures (ARC) Program. The ARC program drives scientific and regulatory innovation and engagement to accelerate the availability of treatments for patients with rare diseases. Dr. Wagner explained that the FDA’s vision for this program is “speed and increasing the development of effective and safe treatment options addressing the unmet needs of patients with rare diseases.”
Another new program is the Joint Information Center (JIC), established to increase collaboration between FDA centers/offices to streamline FDA-wide clearance process for COVID-19 communications. The JIC succeeded by issuing web pages, press releases, newsletters, consumer and stakeholder updates, infographics, videos, podcasts, and tweets to the public.
In 2022, the FDA authorized Moderna and Pfizer-BioNTech’s bivalent COVID-19 vaccine for use as booster dosing. The agency also permitted pharmacists to prescribe Paxlovid to patients, with certain limitations, which improved access for individuals at high risk for severe COVID-19.
There were 914 generic approvals last year, which, Dr. Wagner explained, saved Americans over $365 billion since this “created greater competition in the marketplace.” Quoting statistics from the 2022 U.S. Generic and Biosimilar Medicines Savings Report, she pointed out that 93% of the generic prescriptions filled in 2021 cost less than $20, with the average generic copay of $6.16 compared with the brand-name copay average of $56.12.
Dr. Wagner also spoke on drug recalls. She explained that last year there were 343 drug recalls, and these actions were broken down into three classes:
• Class I: 64 events totaling 99 drug products
• Class II: 218 events totaling 218 drug products
• Class III: 61 events totaling 114 drug products.
Looking ahead, Dr. Jung described the FDA’s priorities for 2023 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; antimicrobial resistance; and enhanced ability to collect and analyze the best available science and rigorous data.
To obtain the latest drug information, Dr. Jung recommended visiting the agency’s information page (www.fda.gov/drugs), or downloading the FDA, CUREID, DRUGS@FDA, Orange Book Express, and NDC mobile applications.
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