Sen. Grassley Requests OIG Review Of Clinical Trial Oversight
This article was originally published in The Pink Sheet Daily
Executive Summary
A letter to OIG asks whether "administrative, regulatory, and/or legislative corrective actions in this area are needed."
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Senate Finance Committee Chairman Charles Grassley (R-Iowa) has asked the HHS Office of the Inspector General to perform a review of clinical trial oversight. "I ask that you assess the previous work undertaken by your office in this area and determine appropriate issues related to institutional review boards that your office can address, including, but not limited to, FDA oversight of clinical trials," Grassley's Nov. 8 letter to HHS Inspector General Daniel Levinson states. "Please advise whether or not administrative, regulatory, and/or legislative corrective actions in this area are needed," the letter requests. The request was precipitated by a Bloomberg Markets December 2005 report on deficiencies in domestic clinical trials. OIG is tasked with providing its response to the committee by Nov. 29. The letter requests that OIG forward a comprehensive list of its past recommendations to the appropriate agencies of jurisdiction, including FDA, along with a status report on the recommendations. These include "strengthening institutional review boards, improving recruiting practices for human research subjects, and strengthening FDA oversight of clinical investigations." Grassley will also ask HHS, FDA and NIH to "provide an accounting to this Committee of their actions taken in response to the OIG reports released in 1995, 1998, 2000 and 2001." The request demonstrates Grassley's continuing desire for greater domestic clinical trial oversight. "We must take every possible step to ensure that our clinical trial system is in fact the 'Gold Standard' that we expect it to be," the letter states. Grassley also called attention to the state of domestic clinical trials in an August letter to the Department of Justice and the Securities & Exchange Commission. The Finance Committee Chair requested a review of allegations of possible disclosures of information from ongoing clinical trials (1 (Also see "Sen. Grassley Considering Tighter Securities Laws To Prevent Clinical Trial Disclosure" - Pink Sheet, 8 Aug, 2005.)). -John Rancourt |