Kusserow on Compliance: OIG reports on FDA generic drugs oversight and inspection

Congress requested the Office of Inspector General (OIG) conduct an evaluation of whether the FDA is achieving parity in inspections of foreign and domestic manufacturers. The expressed concern is related to the safety and quality of generic drugs produced by foreign manufacturers. Currently nearly 80 percent of all drug prescriptions filled in the United States were for generic drugs. Recalls of generic drugs in recent years have raised concerns about the adequacy of the FDA’s oversight of manufacturers, particularly those outside the United States. In their review, the OIG analyzed FDA data and conducted interviews of the staff to determine:

  • the number and types of inspections for manufacturers of generic drugs;
  • whether manufacturers listed on approved applications had registered with FDA as required; and
  • the extent to which it is progressing toward achieving parity in domestic and foreign inspections and more efficient processes for inspections.

 Findings

  • FDA has increased its preapproval inspections of manufacturers of generic drugs by 60 percent between 2011 and 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.
  • FDA did not conduct all of the preapproval inspections requested by its own generic drug application reviewers during this time period.
  • 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

Recommendations

The FDA should:

  • conduct outstanding preapproval inspections of manufacturers of generic drugs, which could lead to more timely approval of these drugs;
  • ensure compliance with the requirements of manufacturers of generic drugs to register with FDA as a complete and up-to-date registration database that would facilitate the implementation of their plans for conducting inspections; and
  • use its authority to request records in lieu or in advance of inspections which could increase their capacity for inspections and review of records in advance, which could, in turn, free up staff time during onsite portion of inspections.

The FDA concurred with all the OIG recommendations.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2015 Strategic Management Services, LLC. Published with permission.