US FDA Inspections Delayed by COVID-19... Negative Impact on K-Bio as Well

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Chunhee Lee] As the COVID-19 pandemic prolongs, it has been revealed that it is having a significant impact on new drug development. The essential on-site inspections related to product approval by the U.S. Food and Drug Administration (FDA), which are crucial for entering the world's largest market, the United States, have not been conducted. Consequently, domestic new drugs that were initially expected to receive rapid approval are facing continuous delays.

According to the Korea Bio Association's Bio Economy Research Center on the 13th, from March to October 2020, the FDA conducted overseas inspections only three times. After that, until April 2021, inspections were conducted only 18 times, mainly focused on China. Compared to 2019, when the FDA conducted a total of 1,671 inspections?977 for overseas production facilities and 694 for domestic U.S. production facilities?inspections have effectively come to a halt.

Currently, the FDA conducts three types of overseas inspections related to pharmaceuticals. First, pre-approval inspections are conducted before the approval of new drugs and generic drugs to verify that the manufacturing sites specified in the drug application can continuously produce safe drugs and that the submitted manufacturing records and data are accurate. Regular inspections are also conducted after drug approval, and special inspections occur if there are specific issues such as consumer complaints or quality problems. However, due to COVID-19 and the U.S. government's travel restrictions abroad, these inspections have hardly been conducted.

With inspections for drug approval not being conducted, domestic new drug developers are also suffering setbacks. GC Green Cross received a Complete Response Letter (CRL) last month from the FDA regarding its immunoglobulin preparation 'ALYGLO (IVIG-SN 10%)'. The final approval, initially scheduled for the 26th of last month (local time), was not granted.

The decisive factor for the approval delay was the lack of on-site inspections. GC Green Cross submitted the Biologics License Application (BLA) for ALYGLO to the FDA in February last year, but on-site inspections could not be conducted due to COVID-19. As a last resort, a remote evaluation of the Ochang production facility was conducted in the fourth quarter of last year, but the FDA deemed an on-site inspection necessary and, as the approval deadline approached, ultimately requested additional information. A GC Green Cross official explained that the lack of on-site inspection was "the sole reason for this approval delay." They expect that once inspections resume, the review process will proceed promptly.

Additionally, drugs such as Mezzion's 'Udenafil', with an approval deadline at the end of this month, and Hanmi Pharmaceutical's 'Poziotinib', with an approval deadline at the end of the year, are also facing delays due to the lack of on-site inspections.

Currently, the FDA is conducting information sharing of inspections with overseas regulatory agencies, drug sampling and testing, and teleconferences to substitute for overseas inspections, but the necessity of on-site inspections remains significant. An industry insider stated, "However, the FDA announced in November last year that it plans to resume overseas inspections starting this year," adding, "Since the Omicron variant's spread has peaked globally, if inspections resume, approvals could be granted in a short period."