Another IRB, Another FDA Warning Letter


FDA Warning Letter IRB

FDA Sends Warning Letter to IRB

FDA is keeping up its scrutiny of IRBs with a Warning Letter to the Burzynski Research Institute IRB. This is a publicly traded, for profit company who decided to run their own Institutional Review Board and dispense with the formalities, and expense, of an independent IRB. The result is a length 8 item Warning Letter listing many serious problems. They include “Failure to determine risks for subjects were minimized and risks to subjects were reasonabable in relation to anticipated benefits.”

I’ve actually never seen this charge before (if my poor memory isn’t failing me) and its a pretty big deal. BRI is a large operation and this is not a very good practice, approving studies of your own research institute that is a for-profit enterprise. I discussed the Warning Letter with a colleague familiar with the operations of IRBs who said, “I’ve never seen FDA look into the details of the (IRB) board’s operations before.” And I haven’t seen the Center for Drugs write so many Warning Letters to IRBs before. Very interesting. (See previous post on the Centra and Teneo Warning Letters.)

The Burzynski IRB Chair, Carlton F. Hazlewood, Ph.D., is also a director of the for-profit research institute, raising concerns about conflicts of interest. In fact, “The IRB failed to ensure that no member participated in the initial or continuing review of a project in which the member had a conflicting interest,” is the fourth charge in the Warning Letter. The IRB would also allow non-members to vote if a board member had a conflict. Thats another big problem. There are very specific rules about the membership of an IRB.

The company is run by physician and researcher Stanislaw Burzynski, MD, PhD who has been the President and Chairman of the Board of Directors of the Burzynski Research Institute since its inception in 1984. Read the Warning Letter for yourself. Here is the URL, (WordPress isn’t letting me insert a link):

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm

2 Responses to Another IRB, Another FDA Warning Letter

  1. dhanraj jadhav says:

    Ques: Can IEC Gives Expedited Approval in below mentioned case of BA/BE Studies?

    Case:

    IEC approved (full review approval) research proposal/ protocol (Suppose A) with study design as two period, two treatment, two sequence (one test and one reference formulation) for the Drug X.

    Then after 2 months, sponsor wants to change study design after the completion of above study

    from two treatment, two period to three treatment, three period (with two test and one reference formulation) study designs with same Drug X from the same manifacturing company with differance of just batch no. of two Test formulations.

    Can IEC gives Expedited Approval rather than giving full review approval to this research praposal with the change in study design?

    Kindly provide your valuable suggestions.

    • GxP Perspectives says:

      No, there cannot be an expedited approval. A change in study design needs a full board approval. See ICH E6 Section 3 and 21 CFR Part 56.

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