Yesterday the OIG posted a report entitled "FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs" in response to a Congressional request expressing concerns about the safety and quality of generic drugs produced by foreign manufacturers. Key findings from the report include the following:

  • FDA increased its preapproval inspections of manufacturers of generic drugs by 60% between 2011 and 2013, but it did not conduct all of the preapproval inspections requested by its own generic drug application reviewers during this time period.
  • FDA conducted surveillance inspections in 2013 of all generic manufacturers that it had identified as high risk.
  • FDA reported progress towards achieving parity in inspections of foreign and domestic manufacturers of generic drugs and ensuring compliance with generic manufacturer registration, as illustrated by this table detailing the distribution of generic manufacturers and surveillance inspections in FY 2013:
Source: OIG analysis of FDA FACTS data and FDA database of manufacturers of generic drugs, FY 2013.
Country or Region Number of Manufacturers Number of Surveillance Inspections

Asia

 624 (41%) 180 (31%) 

Europe

 396 (26%)  126 (21%) 

Canada

 45 (3%) 20 (3%) 

Other

 46 (3%)  11 (2%) 

United States

 403 (27%)  252 (43%) 

Total*

 1,514  589 
  • FDA has created certain policies and procedures to request manufacturer records in lieu or in advance of an inspection, but it has not yet used these procedures.

In response to its findings, the OIG recommends that FDA:

  • Conduct outstanding preapproval inspections of manufacturers of generic drugs, where appropriate, which the OIG observes could lead to more timely approval of these drugs.
  • Ensure compliance with the requirement for manufacturers of generic drugs to register with FDA, since the OIG believes a complete and up-to-date registration database would facilitate implementation of the FDA's plans for conducting inspections.
  • Use its authority to request records in lieu or in advance of an inspection, which OIG states could increase FDA's capacity for inspections and free up staff time during the onsite portion of the inspection.

FDA concurred with these recommendations. The full report is available here.

This article is presented for informational purposes only and is not intended to constitute legal advice.