Report Raises Concern over FDA’s Clinical Trial Investigations Program

October 5, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

A recent report conducted by The Department of Health and Human Services, Office of the Inspector General is stirring some concern over how the US Food and Drug Administration conducts inspections of clinical trials.

Washington, DC (Sept. 28)-A recent report conducted by the Department of Health and Human Services Office of the Inspector General (OIG) is stirring some concern over how the US Food and Drug Administration conducts inspections of clinical trials. Specifically the report, entitled “The Food and Drug Administration’s Oversight of Clinical Trials,” focuses on the agency’s bioresearch monitoring (BiMo) program between 2000 and 2005.

OIG estimates that FDA inspected only 1% of clinical trial sites during these five years.

The report states that FDA “is unable to identify all ongoing clinical trials and their associated trial sites.” This mismanagement of the BiMo program is a direct result of the lack of a complete clinical trial registry and the Office of Regulatory Affairs’s database “does not include complete information for inspection events that occur after it completes its inspection.”

The report also claims that the agency’s Centers also inconsistently classify “official action indicated” and “voluntary action indicated.” “FDA relies on voluntary compliance to correct violations of regulatory significance,” says the report. “Uncertainty of timing and lack of coordination impede FDA’s ability to conduct BiMo inspections.”

FDA reviewed the report and reports agreement to improve the program, including the development of an institutional review board registry. A copy of the report is available here.

Sen. Chuck Grassley (R-IA) wrote a letter to FDA Commissioner Andrew von Eschenbach requesting a meeting to discuss the OIG report. Grassley addressed his concerns about the OIG's findings, and asked FDA to arrange a meeting by Nov. 5 with the Senate Findings Committee. A copy of Grassley's letter is available here.