With drugmakers clamoring, FDA looks to restart facility inspections delayed by COVID-19
The FDA halted most on-site inspections of foreign and domestic drug manufacturers in early March. (Pixabay)
The FDA abruptly shut down its on-site facility inspections in March, hoping to keep its employees safe during the novel coronavirus pandemic. More than two months into that moratorium, drugmakers are calling for relief—and with some new guidance, the FDA shows it might be willing to accommodate.
The agency is working with the U.S. Centers for Disease Control and Prevention to develop a "phased approach" to restarting inspections of domestic and foreign drug manufacturing facilities, the administration said in a statement Monday.
While the FDA was slim on details on how that rollout would work, experts told Cowen & Co. analysts the plan would likely continue the agency's focus on high-priority inspections taken on a "case-by-case" basis, the firm said in a Tuesday investor note.
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So far, the FDA has used volunteer teams to conduct inspections for facilities deemed "mission critical," according to Cowen. In lieu of widespread facility checks, the agency has ramped up alternative quality control methods, such as examining physical product at the border, reviewing facilities' compliance records and sharing inspection information with foreign governments.
The FDA's willingness to consider resuming on-site inspections could offer a respite for foreign manufacturers that have pleaded for an avenue to bringing their drugs and active pharmaceutical ingredients to the U.S. market.