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Manufacture Biosimilars

FDA Ups Generics Oversight

There have been a number of high-profile recalls of generic drugs in the US recently and with 80 percent of prescriptions in the country made up of generic drugs, the public and policy-makers alike are concerned. Following a request from Congress (1), the Office of Inspector General (OIG) of the US Department of Health & Human Services aimed to find out whether FDA oversight of generics manufacturers – particularly of those outside the US – is increasing in line with 2012’s FDA Safety and Innovation Act (FDASIA).

After analyzing FDA data and interviewing staff, the OIG concluded that progress had been made towards parity in inspections of domestic and foreign manufacturers, and inspections of facilities producing generic drugs were up 60 percent from 2011 to 2013. However, there were areas where the FDA fell short; in particular, failing to carry out 24 percent of pre-approval inspections requested FDA staff within that timeframe. “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,” said the report.

The backlog should be cleared, says the OIG, and greater emphasis placed on preapproval inspections. They also recommended that the FDA puts in place measures to make sure that all generic manufacturers complete FDA registration. This has been a legal requirement since 2013, but the OIG’s study suggested that registration data is currently incomplete. A third recommendation relates to the authority granted in FDASIA for inspectors to request records prior to or in lieu of an on-site inspection. The FDA agrees, noting that this “could lead to efficiencies by allowing inspectors to target time spent on site and potentially increase FDA’s capacity for inspections.”

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  1. Department of Health and Human Services Office of Inspector General “FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs”, (2015). oig.hhs.gov/oei
About the Author
Charlotte Barker

As an Editor at Texere, I’m working closely with our audience to create vibrant, engaging content that reflects the hard work and passion that goes into bringing new medicines to market. I got my start in biomedical publishing as a commissioning editor for healthcare journals and have spent my career covering everything from early-stage research to clinical medicine, so I know my way around. And I can’t think of a more interesting, challenging or important area to be working in.

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