Sponsors, CROs and study sites and other involved in drug trials should prepare for increased scrutiny under new US legislation say legal experts.
The Consolidated Appropriations Act 2023 – which was enacted by US President Joe Biden late last year – significantly enhanced the US Food and Drug Administration’s (FDA) ability to analyze clinical trials and inspect sites according to experts from law firm Hogan Lovells.
“The Act grants FDA broader authority to inspect a wider range of parties involved in clinical research, such as consultants and vendors,” they write, adding that the Act authorizes the FDA to inspect a broad range of records and trial related information.
The authors point to the FDA’s Bioresearch Monitoring (BIMO) program – a program of on-site inspections and data audits designed to monitor all aspects of a drug trial – as an example of an area where changes have been made.
“Study sponsors, CROs, vendors, and clinical trial sites should take renewed care in ensuring compliance with FDA rules given this expanded BIMO authority and the post-pandemic return of on-site inspections.”
According to the authors the new law makes clear that BIMO inspections are designed to ensure the accuracy and reliability of studies as well as to assess compliance with applicable legal requirements.
They also point out that the law empowers the agency to oversee the activities of “sites and facilities,” “persons,” and “studies and submissions,” including sites involved in analyzing study data.
The enhanced oversight powers also cover a wider range of documents associated with the trial.
According to the report authors the “FDA BIMO inspections extend to all records and other information related to studies and submissions. This includes records and other information related to the conduct, results, and analysis of studies, as well as the protection of human and animal trial participants.”
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