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FDA Substantially Increasing its Inspections of Foreign Generic Drug Companies

Posted 06 May 2015 | By Alexander Gaffney, RAC

FDA Substantially Increasing its Inspections of Foreign Generic Drug Companies

The US Food and Drug Administration (FDA) has made substantial improvements to its inspections of foreign generic pharmaceutical manufacturers, a new report by the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) claims.


OIG's report, issued on 4 May 2015, was prompted by congressional concerns that FDA lacked sufficient resources to inspect generic pharmaceutical manufacturers, which now make up nearly 80% of the prescriptions filled in the US. Many of those drugs are manufactured—either in part or in whole—abroad, making FDA oversight more difficult.

In response to these concerns, Congress voted to give FDA a significant increase in resources to conduct these inspections under the Generic Drug User Fee Act (GDUFA) provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.

In addition to increasing FDA's funding for generic drug regulatory activities, the law also increased FDA's authority to conduct inspections, detain drugs thought to have been manufactured improperly, and required all manufacturers of generic drugs and active pharmaceutical ingredients to register their facilities with FDA.

Preapproval Inspections up Markedly

And as OIG's new report finds, those new authorities and resources are leading to big improvements in the way FDA inspects generic pharmaceutical manufacturers.

"FDA increased its preapproval inspections of manufacturers of generic drugs by 60 percent between 2011 and 2013," the report found. Those inspections are undertaken by FDA prior to a drug being approved by regulators. For example, in 2011 FDA conducted 169 preapproval inspections. In 2012, it conducted 226. And in 2013, the last year tracked by the report, FDA conducted 271 inspections.

However, even as the number of inspections increased, FDA conducted relatively fewer inspections outside the US. In 2011, nearly 60% of FDA's inspections of generic drug facilities were outside the US. In 2012 and 2013, the agency conducted only about half of all pre-approval inspections outside the US.

Even as the number of preapproval inspections has increased, the number of enforcement recommendations has remained relatively steady, OIG found. In all three years, 51-52% of firms passed the inspection, 41-43% of firms were asked to take voluntary action to resolve minor problems, and 6-7% of firms were required to take action to resolve problems ("Official Action Indication").

FDA has also launched a new type of "risk-based" inspection, OIG noted. In 2013, FDA "prioritized at least 283 manufacturers of generic drugs for routine surveillance inspections and conducted inspections at all of them," OIG wrote in its report. Of the 283 manufacturers identified, 65% of them were based outside the US.

Despite FDA's increased focus on international firms, there was no discernible difference between domestic and foreign manufacturers, OIG found.

Continuing Problems Identified

OIG's report also took note of several ongoing problems in need of correction.

For example, OIG investigators observed that nearly every single preapproval inspection request that had been requested by the Center for Drug Evaluation and Research (CDER) but not yet conducted by FDA's Office of Regulatory Affairs (ORA) was for a foreign manufacturer.

"FDA staff attributed outstanding preapproval inspections to a lack of resources and said that they expect the percentage of inspections conducted to improve with additional funding from user fees from manufacturers of generic drugs," OIG noted in its report.

In addition, OIG said FDA hasn't been using its authority to request records "in lieu or in advance of an inspection."

"Such requests could increase FDA's capacity for inspections, and review of records could be completed in advance, which could free up staff time during the onsite portion of the inspection," OIG wrote.


OIG Report

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