March 26, 2020
Agency responds to COVID-19 pandemic’s US arrival by suspending domestic surveillance inspections and non-critical for-cause and preapproval inspections.
The US Food and Drug Administration (FDA) announced a suspension of all domestic good manufacturing practice surveillance and non-critical for-cause and preapproval inspections for the duration of the COVID-19 public health crisis as part of decision to require all eligible employees to telework. The aim is to wind down all inspections by 3 April.
Exceptions will be made for inspections of facilities manufacturing medically necessary products, such as products to treat and prevent COVID-19 and breakthrough products such as new cancer treatments.
Image: iStock/Shidlovski
FDA Commissioner Stephen Hahn announced on 18 March that this ban on most domestic inspections is in keeping with the White House Coronavirus Task Force and cross-government guidance directing government employees to telework. The guidance is meant to “slow the spread of the crisis and help flatten the curve of the COVID-19 pandemic” through social distancing. He said that “we must ensure our workforce remains healthy to carry out the FDA’s critical public health mission to keep Americans safe.”
Hahn said the agency “postponed all domestic routine surveillance facility inspections.” He added that the FDA is evaluating all for-cause inspections and proceeding only if it deems them mission-critical.
This announcement follows up on the FDA’s 10 March decision to ban all foreign travel, including travel for meetings and inspections.
The FDA’s Alonza Cruse told a conference 18 March prior to the announcement that the agency is “scaling down and trying to wrap up surveillance inspections that are already in progress, and we are escalating those that are only the most critical for-cause and preapproval inspections.” He made these remarks at the PharmaLink conference sponsored by the FDA and Xavier University. The conference, held annually at the university in Cincinnati, OH, occurred in virtual-only mode this year due to COVID-19 safety concerns.
Cruse, director of the Office of Pharmaceutical Quality Operations in the FDA’s Office of Regulatory Affairs, said that the agency has been accused of being “tone deaf” in continuing to conduct inspections despite the epidemic gripping the nation. “We have a social responsibility to do whatever we can to reduce the transmission of COVID-19 and try to be socially responsible in our social distancing issues.”
Cruse also urged the pharmaceutical industry to adopt advanced manufacturing methods, which he said would help expedite the delivery of COVID-19 treatments once they are approved and for other breakthrough drugs as well. Such methods would include continuous manufacturing and 3D printing, which he said would help expedite the delivery of medically necessary drugs. Continuous manufacturing involves using agile technologies that can be rapidly scaled. Using these technologies also can speed the availability of therapies compared to batch processing.
He said that these technologies will “not only help us deal with supply shortages but will allow us the resilience to spread out [manufacturing] so that we are not dependent on just one or two sites to manufacture critically necessary drugs.”
He said that once COVID-19 vaccines start to show promise, “you will see that using advanced manufacturing to rapidly scale up some of these medical countermeasures will be important for the US and for global health.”
Cruse also described some of the activities being undertaken by the FDA in the enforcement area.
The agency is continuing its work in training compounders on GMPs as part of its pharmacy compounding quality center for excellence. The program was established in 2019.
A training session on sterile drugs was supposed to be held in late March but was postponed due to the coronavirus. The FDA as also scheduled a conference with the pharmacy community in September but that too may be postponed.
This article was first published on 9 March 2020 in The Pink Sheet.
Joanne Serpick Eglovitch is a senior editor for Pink Sheet where she writes about manufacturing quality issues. She can be contacted at [email protected].
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