Regulatory Focus™ > News Articles > Federal Health Auditors Gear up for Investigation of FDA's Generic Drug Inspections

Federal Health Auditors Gear up for Investigation of FDA's Generic Drug Inspections

Posted 03 February 2014 | By Alexander Gaffney, RAC

The Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) plans to investigate the US Food and Drug Administration's (FDA) track record of inspecting generic pharmaceutical manufacturers in the coming year, the group said.


OIG is DHHS' investigative body, and serves to audit agency programs and make recommendations as to how they can improve. Often times their reports are also used by members of Congress to push for changes.

OIG's proposal to audit FDA's inspections of generic drug manufacturers, contained within its 2014 Work Plan, comes after the agency was granted new resources and authority to inspect generic drug manufacturing facilities under the Food and Drug Administration Safety and Innovation Act (FDASIA). The law contained provisions to allow for the collection of user fees from generic drug companies, including active pharmaceutical ingredient (API) manufacturers.

For years, FDA has expressed the challenge of inspecting generic companies, as many of them are foreign-based and therefore more difficult and expensive to inspect. Without access to user fees to support inspections, FDA simply lacked the resources to inspect as many companies as it wished, it argued.

But flush with new funding from FDASIA, FDA is already showing signs of being more aggressive with its inspections of foreign-based generic manufacturers, and especially those based in India.

Eye on FDA's Generic Inspections

According to OIG's Work Plan, several aspects of FDA's generic facility inspections will be subject to its close scrutiny.

OIG inspectors will describe "the extent to which FDA conducts inspections … the results of such inspections and the enforcement actions taken by FDA in response to shortcomings or deficiencies found."

OIG said its report is driven by general concerns about generic manufacturers' compliance with current good manufacturing practices and how deficiencies could affect the bioequivalence of manufactured drugs, but did not cite any specific practices or events.

Which is not to say that recent concerns are not to blame for the new interest. In addition to the new FDASIA money and authorities, FDA recently obtained a guilty plea from the Indian generic drug manufacturer Ranbaxy related to serious manufacturing deficiencies and data fraud. Those concerns have continued to plague the company as well as other Indian generic drug manufacturers. The products of several of those companies are now banned from entering the US.

OIG said it expects to release its report within the 2014 calendar year.


2014 Work Plan

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