U.S. FDA Increases Generic Preapproval Inspections, but Lags on Foreign Audits

The U.S. Food and Drug Administration increased its preapproval inspections of generics makers by 60 percent between fiscal years 2011 and 2013, but failed to conduct all of those requested by agency reviewers, a new report finds.

Preapproval inspections increased each year — from 149 in 2011 to 211 in 2012 and 243 in 2013, the Health and Human Services Office of Inspector General says. But 24 percent of preapproval inspections requested in 2011 had not been conducted as of Dec. 31, 2013, all of them for overseas generics makers.

The FDA attributed the failing to a lack of resources, staff availability and priority being given to preapproval inspections that could impact drug shortages, according to the report.

During the same period, the total number of overseas inspections grew from 101 in 2011 to 142 in 2013. However, the proportion of generic inspections of foreign manufacturers, compared with domestic firms, decreased — from 60 percent in 2011 to about 50 percent by the end of 2013, OIG says.

The report also looks at routine surveillance inspections conducted at generics facilities in fiscal 2013, finding that the FDA inspected all 283 prioritized as high risk.

Of those, 185, or 65 percent, were foreign, and 11 — two of them foreign — resulted in corrective actions. The FDA issued warning letters to four of the firms and held regulatory meetings with four others, OIG says.

Overall, the FDA conducted 589 surveillance inspections of generics companies, 57 percent of them foreign, resulting in 26 corrective actions. Twenty of the inspections were follow-ups on earlier enforcement actions, OIG says.

Regarding registration of generic firms, the FDA has made progress but the registry is incomplete, OIG says. For instance, 45 of the 432 companies with approved ANDAs in 2013 didn’t match entries in the agency’s registry of generics firms. Of those, 62 percent were foreign manufacturers.

The FDA also isn’t using its authority to request records in place of, or ahead of, an inspection, despite interim policies issued last October, OIG says. “By conducting this review in advance of visiting a facility, inspectors could focus their on-site time on observing and inspecting areas in need of attention, rather than on reviewing paperwork,” the report says.

Read the OIG report, including the FDA’s response, at www.fdanews.com/05-07-15-OIG-generics.pdf. — Jessica Grinspan

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