FDA Lays Out Roadmap to Clear Inspection Backlog as Biomanufacturing Booms

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Biopharma manufacturing is booming, with companies opening new facilities across the globe to meet the demands of delivering medical products to patients in need. At the same time, the U.S. Food and Drug Administration (FDA) has a massive backlog of site inspections that has delayed some regulatory actions.

Earlier this month, the FDA released its “Resiliency Roadmap for FDA Inspectional Oversight” to outline its priorities to address the backlog, mainly due to the ongoing COVID-19 pandemic that prevented all but the most “mission critical” travel to prevent the spread of the virus. 

When the pandemic broke out across the U.S. in March 2020, the FDA paused most foreign and domestic inspections. By mid-July 2020, some domestic inspections resumed. 

“While FDA has continued many of our oversight activities, there is no doubt that the pandemic has had an impact on our inspectional work,” Acting FDA Commissioner Janet Woodcock said in a statement. 

Some of those postponed inspections delayed anticipated approvals, such as Bristol Myers Squibb’s liso-cel. That delay ended up hurting investors who held Contingent Value Rights (CVR) tickets from the Celgene acquisition.

The new roadmap details the agency’s inspection plans going forward and how it intends to address those postponed inspections. Woodcock said the FDA is committed to meeting its inspection goals as quickly as possible.

Since the pandemic first forced a shutdown in the U.S., the FDA said it received more than 13,500 medical product approval or authorization applications since March 2020. The agency determined that only 600 needed inspectional oversight of some type before action. Since that time, the FDA has completed approximately 440 application-based inspections, including mission-critical and prioritized inspections. 

An analysis of the FDA backlog conducted by GlobalData Healthcare notes that the FDA has a backlog of nearly 500 domestic pharma inspections alone. GlobalData Healthcare speculated the FDA would need to complete “at least an extra 457 inspections in the U.S. to account for the shortfall between 2019 (692 inspections) and last year (235 inspections).”

In its report, the FDA noted that it would need to complete 26,250 site inspections by the end of the fiscal year to catch up with its total backlog. The FDA said it had completed nearly 3000 of those since the end of March. The majority of those inspections that need to be completed are related to food. 

The FDA said mission-critical, meaning those related to COVID-19, will remain prioritized. Routine surveillance inspections will continue to be conducted. However, the agency said it would prioritize higher-tiered needs. For international inspections, FDA said it would lean on its international partners, such as the European Medicines Agency (EMA)

While the FDA looks to address its backlog, multiple companies have recently announced plans to open new manufacturing facilities across the globe. In the U.S., Thermo Fisher Scientific recently announced a partnership with the University of California, San Francisco to build a cell therapy manufacturing facility

Thermo Fisher will build the state-of-the-art 44,000 square-foot site on the college’s Mission Bay campus. The campus is a center of biotech and medical innovation. 

CDMO Tergus Pharma opened a new headquarters in Durham, N.C., and Australia-based Ellume is planning to build a large manufacturing facility in Maryland. 

Across the pond, Germany’s BioNTech announced plans for a Singapore facility, its first toehold in Asia, and Biogen announced its new Switzerland facility received a Good Manufacturing Practice (GMP) multi-product license from the Swiss Agency for Therapeutic Products. 

The Solothurn facility combines Biogen’s latest concepts for fed-batch cell culture technology and protein purification, enabling the large-scale production of biopharmaceuticals, the company said. Biogen anticipates that the Switzerland facility could produce aducanumab if approved by regulatory agencies.

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