…with pledge to resume domestic inspections
The FDA’s usual facility inspections have been on hold for months because of COVID-19—and pharma isn’t happy. Now, after hearing calls from all levels of the drug industry, the agency says it will kick off inspections again. But it’s far from a full-scale restart.
The FDA will resume “prioritized” domestic manufacturing inspections the week of July 20 after a four-month moratorium on most on-site walkthroughs, FDA Commissioner Stephen Hahn, M.D., said in a release Friday.
However, a troubling uptick in new COVID-19 cases and deaths means the agency will weigh local virus activity when deciding which sites to inspect, and that fact had analysts questioning the FDA’s announcement.
…During a Senate Finance Committee hearing in early June, CEO David Light of independent testing lab Valisure warned that a slowdown in on-site inspections strained regulators’ ability to ensure the quality of U.S. medicines.
“Manufacturing problems that arise from the escalated production of drugs [tied to COVID-19] and a lack of FDA inspectors on the ground at foreign plants could produce a domino effect for years to come,” Light said. “The lifecycle of a drug in the supply chain is many years, and it could be many more before significant and serious issues are found, let alone addressed.”
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