Recent FDA Metrics Show Increase in Reported Violations from BIMO Inspections
As background, FDA's BIMO program is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research. The agency established the program to assure the quality and integrity of data submitted to FDA in support of new product approvals, and to provide for protection of the rights and welfare of human subjects involved in FDA-regulated research. Consistent with all inspections, conclusions of BIMO inspections are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI). An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory action is warranted to address the establishment's lack of compliance with statute(s) or regulation(s).
According to the FY 2014 metrics, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) conducted fifteen percent more BIMO inspections in FY 2014 (986) over FY 2013 (833). Agency-wide, the most common FY 2014 inspections concerned clinical investigators. Five percent of these inspections resulted in an OAI classification, compared to two percent in FY 2013. The most common clinical investigator deficiencies included:
• Failure to follow the investigational plan and/or regulations;
• Protocol deviations;
• Inadequate recordkeeping;
• Inadequate accountability for the investigational product;
• Inadequate communication with the Institutional Review Board (IRB); and
• Inadequate subject protection – failure to report adverse events (AEs) and informed consent issues.
There were also increases in OAI classifications for inspections regarding sponsor/monitor/contract research organization (CROs), bioequivalence, and Good Laboratory Practices (GLP). In light of the agency’s heightened scrutiny of these issues, pharmaceutical and biotechnology companies should ensure that they are taking appropriate measures, including reinforcing BIMO compliance programs.
FDA’s BIMO inspection metrics for FY 2014, as well as previous years, is available here. For more information about BIMO inspections, please contact the authors or the Hogan Lovells lawyer with whom you work.
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