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FDA /CDERWarning Letters 2008-Bioresearch monitoring program

For purposes of thinking about trends, I found it interesting to take a look at the last 6 months of FDA/CDER Warning Letters resulting from inspections in regard to its Bioresearch Monitoring Program. The Warning Letters show recent and 'real' fact patterns which reveal particular aspects about how certain law/regulations are being applied/enforced. These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office. (1) This page only covers Division of Drug Marketing and Communications and Headquarters Warning Letters. For District Office Warning Letters see the Main FDA FOI Warning Letters Page. Some of the letters have been redacted or edited to remove confidential information.
FDA's Biomonitoring Research program includes inspections designed to evaluate the conduct of research and to ensure that the rights, safety and welfare of the human subjects of those studies have been protected. Based on the Inspection Reports that were issued, these 2008 particular "Warning Letters" frequently cite to a failure to follow investigational plans and protocols. Noteworthy however, are the cites in the letters concerning deficiencies of obtaining informed consent from the human subjects participating in the clinical study for an investigational drug.
Other letters reflect concerns such as:
-a failure to excuse member from participating in the initial review of a project in which a member had a conflicting interest except to provide info. requested by the IRB,
-failure to provide additional safeguards for children in clinical investigations
-failure to maintain records showing financial interests,
-failure to protect the rights, safety and welfare of subjects under care,
-deficiencies relating to promotional materials.
Read more on the deficiencies below the fold.

Deficiencies resulting from a failure to obtain informed consent included: failure to provide subjects with a written description of any reasonable foreseeable risks or discomforts, failure to use an understandable language, failure to document it by the use of a written consent form approved by the IRB.
One Warning Letter resulted from an inspection that focused specifically on whether an institution's IRB was incompliance with the regulations governing IRBs and those governing the protections of human subjects participating in clinical trials [Title 21 of the Codes of Federal Regulations Parts 56 and 50--these regulations apply to clinical investigations of products regulated by the FDA]. Some of these deficiencies noted related to:
-failure to follow expedited review procedures,
-failure to maintain minutes of meetings in sufficient detail to indicate actions by the IRB.
FDA Inspections of manufacturing establishments abroad (Japan,China respectively), resulted in 2 Warning Letters issued concerning deficiencies in the respective establishment's compliance of law and regulations of US Current Good Manufacturing Practices in the manufacture of active pharmaceutical ingredients (API). (read more about FDA establishing offices in foreign countries and their manufacture/distribution/supply chain initiative on their website)

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This page contains a single entry from the blog posted on July 10, 2008 6:50 AM.

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