…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.”

To read the rest of the article by Kyle Blankenship, click here.