FDA Hits ICON with Warning Letter for J & J Studies

ICON Gets Warning Letter for J&J Study

FDA posted a new Warning Letter on its website to ICON Clinical Research, the CRO responsible for many of
the activities that led to the Johnson & Johnson sponsor Warning Letter last August (see previous posts). The heavily redacted document lists J & J only as “(B) (4)” but it is easy to compare the two and see that they are related. This is the first time in Years, someone correct me if I’m wrong, that FDA has gone after a CRO for their contracted responsibilities with a sponsor of clinical trials. It was ICON that performed the monitoring responsibilities that led to both Warning Letters. The Warning Letter was issued by Center for Drugs, Division of Scientific Investigations (DSI).

Up until now it looked like FDA would only go after the sponsor when things went wrong at a clinical site. In the Sanofi Aventis Warning Letter of October 2007 the CRO was mentioned but no Warning Letter followed.

UPDATE: The Warning Letter to ICON was sent out over three months ago and this continues to be the most visited post on this Blog. Obviously many people are interested in CRO oversight. It is an important issue and people involved with clinical research need to know that CROs are doing their job. Here is an article that can assist in reviewing your clinical trial vendors:

http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2fSponsor+Articles/Vendor-Quality-Assurance-Audits-A-Formula-for-Succ/ArticleStandard/Article/detail/424921

FDA is holding both sponsors and CROs accountable

In the J & J Warning Letter the CRO, ICON, was redacted out and you could not determine who the CRO was. It took four months for FDA to write a Warning Letter to ICON. However, now that it is out, it is quite a doozy. FDA states that CROs need to adhere to their regulatory responsibilities. The Warning Letter states, in part:

“FDA regulations require that sponsors, or CROs to whom such responsibilities have been transferred, ensure proper monitoring of clinical investigations. Our investigation found that ICON failed to properly ensure monitoring of the studies referenced above. Inadequate monitoring resulted in deficiencies in recordkeeping with respect to case histories and drug accountability by clinical investigators participating in the above-referenced studies.”

Failure to monitor the progress of the investigation has for years been the number one violation of sponsor responsibilities. Now it appears that FDA is reviewing CROs that have assumed that responsibility. Read the Warning Letter for yourself:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm193156.htm

Read about the J & J Warning Letter:

https://carl1anderson.wordpress.com/2009/08/19/fda-sends-jj-a-warning-letter-for-clinical-trial-failures-as-a-sponsor/

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