While there is nothing like being together, the COVID pandemic has kept us apart and so it is for the AAM conference. Getting used to the format was easy but it ain’t the same! While there were some minor technical glitches, the conference went off without a major hitch.
Dan Leonard, the new President and CEO of AAM, opened the meeting with his take on where AAM is today and the importance of the work they and the FDA are doing. Dr Stephen Hahn, commissioner of the Food and Drug Administration, likewise gave an overview of the actions relating to the pandemic and the Agency’s current status relative to its mission.
Dr. Patricia Cavazzoni, Acting Director of CDER, provided a detailed overview of CDER activities and challenges under the pandemic. She spoke of the need to increase patient’s access to critical medicines by expediting applications, using enforcement discretion, or issuance of emergency use authorizations to mitigate drug shortages, as well as providing guidance to compounding pharmacies for certain drugs used in critical care settings for COVID. She also discussed a need to protect consumers and patients from unscrupulous firms by issuing Warning Letters to firms for making fraudulent claims or for distributing unapproved products. She noted that 35 firms were placed on Import Alert to protect violative products from entering the US marketplace and cited the Agency seeking voluntary recalls of some 150 hand sanitizing products that posed a potential safety issue.
She noted that, while the overall workload was heavier, the additional COVID work has not impacted the regular workstream, even as FDA’s generic drug program expedited 341 supplements to make certain that critical changes could be made for COVID-related products.
The Agency is continuing to work to assure that all firms required to register their establishments are complying with the drug listing of their products and she noted that, during the COVID emergency, there were already 257 new facilities registered. FDA is also working to continue to assure drug product quality and compliance in the face of all in-person inspections stopping in March 2020 by using alternate methods of assuring compliance. FDA has evolved to include records review, virtual inspections, and increased cooperation with foreign regulatory bodies through reliance on Mutual Recognition Agreements albeit some domestic inspections have resumed beginning in July (see below for Comments from Office of Regulatory Affairs).
FDA is working hard to maintain a vibrant generic drug industry and developing paths to bring complex generic products to market. In that regard, FDA has issued over 1900 product-specific bioequivalence (PSG) recommendations with 258 (108 new and 150 revised guidances) in 2020 alone. Of these, FDA has issued 38 new and 94 revised PSGs for complex generic products and 32 that provided a more efficient way of demonstrating bioequivalence (i.e., in vitro methods and characterization rather than in vivo studies).
Dr. Cavazzoni also discussed drug quality issues relative to nitrosamine contamination and drug shortage issues as the occurrence may have a dramatic impact on patient and health care provider’s acceptance of generic drugs and erode their confidence in the review and approval process.
Biosimilar work has also kept pace, including virtual outreach and education programs, guidance and policy issuance and development, and biosimilar development and submission activity continues. To date, the Agency has approved 28 biosimilars that represent 9 different reference products. But based on the “patent dance” and other challenges by innovators, thus far, only 18 of the 28 biosimilars approved are being marketed.
Elizabeth Miller, PharmD., Assistant Commissioner for Medical Products and Tobacco Operations, Office of Regulatory Affairs (ORA) further discussed ORA’s actions during the pandemic. She noted that FDA has continued to conduct mission critical inspections (MCI) and, since March, has conducted 200 MCIs. In July, FDA began prioritization of in-person domestic surveillance inspections by creating a COVID-19 Advisory Rating System to determine where geographically it is safe to perform inspections by using real time data on the number of COVID cases in the local area to best protect the FDA staff and the employees of the facilities to be inspected. These inspections, at this time, are preannounced to further ensure safety. There is also assurance of the provision of personal protective equipment to all employees. In addition, Dr. Miller discussed the FDA’s advanced voluntary records request program to obtain the necessary information to inform FDA’s assessment of the firm and make appropriate regulatory decisions in the virtual environment.
It was a jam-packed morning for sure. More to come as the conference proceeds.