FDA inspection of generic manufacturers up, but could be more thorough OIG finds

WASHINGTON - The Office of the Inspector General of the U.S. Department of Health and Human Services last week reported that the Food and Drug Administration has increased its preapproval inspections of manufacturers of generic drugs by 60% between 2011 and 2013. However, it did not conduct all of the preapproval inspections requested by its own generic drug application reviewers during this time period. 

 

The OIG made three recommendations to the agency, including that the agency, first, conduct outstanding preapproval inspections of manufacturers of generic drugs, where appropriate, which could lead to more timely approval of these drugs; second, ensure compliance with the requirement for manufacturers of generic drugs to register with FDA as a complete and up-to-date registration database would facilitate the implementation of the agency's plans for conducting inspections; and, third, use 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.

 

The FDA concurred with all three recommendations, the OIG reported. 

 

The OIG conducted the study after receiving a Congressional request expressing concerns about the safety and quality of generic drugs produced by foreign manufacturers and requesting that OIG evaluate whether FDA is achieving parity in inspections of foreign and domestic manufacturers. In 2012, nearly 80% of prescriptions filled in the United States were for generic drugs. But in recent years, several recalls of generic drugs have raised concerns about FDA's oversight of manufacturers

 

The OIG analyzed FDA data for inspections and registered manufacturers of generic drugs for 2011-2013 to determine the number and types of inspections. The Office also analyzed FDA data to determine whether manufacturers listed on approved applications had registered with FDA as required and analyzed FDA records and interviewed FDA staff to determine the extent to which it is progressing toward achieving parity in domestic and foreign inspections and more efficient processes for inspections.

 

In 2013, FDA conducted surveillance inspections of all generic manufacturers that it had identified as high risk. FDA also reported progress towards achieving parity in inspections of foreign and domestic manufacturers of generic drugs and ensuring compliance with generic manufacturer registration. Finally, FDA has created some policies and procedures to request manufacturer records in lieu or in advance of an inspection, but has not yet used these procedures to request records.