OCTOBER 10, 2024
Originally published by our sister publication Specialty Pharmacy Continuum
By Gina Shaw
The FDA is facing challenges in the process of inspecting pharmaceutical manufacturing facilities, and that could have an impact on drug shortages, said industry experts from IQVIA at the NASP 2024 Annual Meeting in Nashville, Tenn.
“We have seen that the number of reported drug shortages has slowed in 2024 compared with the previous two years. However, almost 60% of the current shortages have been going
Originally published by our sister publication Specialty Pharmacy Continuum
By Gina Shaw
The FDA is facing challenges in the process of inspecting pharmaceutical manufacturing facilities, and that could have an impact on drug shortages, said industry experts from IQVIA at the NASP 2024 Annual Meeting in Nashville, Tenn.
“We have seen that the number of reported drug shortages has slowed in 2024 compared with the previous two years. However, almost 60% of the current shortages have been going on for more than two years, which is concerning,” said Scott Biggs, the director of supplier services. “And the challenges that the FDA is facing in the inspection process could cause problems here.”
Mr. Biggs noted that FDA inspections for the current year continue a downward trend; from a peak of nearly 2,200 in 2011, only 575 pharmaceutical manufacturing facilities have been inspected so far in 2024. (In 2023, 893 were inspected.) Inspections of facilities in China increased slightly, from 37 in 2023 to 100 so far in 2024, although inspections in India and other countries also declined.
“Of course, inspections went down dramatically during the pandemic,” he said. “Nobody was getting out and looking at these sites. While there has been some slight pickup since 2020-2021, there has not been a return to pre-pandemic levels. Last year’s inspection numbers were still down almost 40% from pre-pandemic.”
He pointed to a September 2024 report from the Associated Press that found roughly 2,000 pharmaceutical facilities have not been inspected since before the COVID-19 pandemic.
“While the majority of those are in the United States, more than 340 are in India and China. Some of the biggest challenges that they’re facing is that they have a strong number of resignations,” he said. “About 225 vacancies are currently available in the FDA for these inspection jobs. And the AP’s tally of the overdue plans does not include any new facilities that have registered since COVID-19, but they haven’t even yet had an initial inspection. And their internal list of sites inspection has increased by 14% over the last five years.”
That raises a concern: What happens when these overdue inspections take place? “They need to ensure that the quality of the medicine that we put in patients’ hands is good and safe,” Mr. Biggs said. “Are we going to see some more shortages of critical drugs like carboplatin and cisplatin? Are we going to see the number of shortages increase because they have to shut some of these facilities down?”
Doug Long, the vice president of industry relations, concurred. “I have heard that there are currently only two FDA inspectors in China, and China wants to be a big player on the global map,” he said. “Another factor is DSCSA [the Drug Supply Chain Security Act]. When that is fully implemented, there might be some players saying no more, and getting out. So that could create drug shortages as well.”
Messrs. Biggs and Long reported no relevant financial disclosures.
