FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs

WHY WE DID THIS STUDY

OIG received 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 percent 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

HOW WE DID THIS STUDY

We analyzed FDA data for inspections and registered manufacturers of generic drugs for 2011-2013 to determine the number and types of inspections. We also analyzed FDA data to determine whether manufacturers listed on approved applications had registered with FDA as required. We also 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.

WHAT WE FOUND

FDA increased its preapproval inspections of manufacturers of generic drugs by 60 percent 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 graphic below illustrates the distribution of generic manufacturers and surveillance inspections worldwide (for more information, ).

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.

WHAT WE RECOMMEND

FDA should:

• Conduct outstanding preapproval inspections of manufacturers of generic drugs, where appropriate, which could lead to more timely approval of these drugs.
• 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.
• 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.

FDA concurred with all three recommendations.