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  • 1.  ND closure and NDA discontinuation challenge question

    Posted 29-May-2019 21:59

    Imagine this scenario:  

    A company is contractually obligated, through the purchase of a marketed product developed by another company, if no longer willing or able to commercialize the product, to immediately cease ALL activity related to that product.  This includes closing down any and all post-market required (PMR) studies, phase IV studies, stability studies, etc.  Not honoring the contractual agreements will result in a lawsuit.

    There is an ongoing pediatric trial on this product which was required under PREA https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM077855.Pdf

    The company you work for is no longer interested in commercializing the product due to a change in corporate vision and strategic objectives.

    You are asked to close the IND, and discontinue the NDA until such time that all product is expired, or otherwise out of the distribution/supply chain.  At that time when the product is no longer available, you are to withdraw the NDA; estimated to be one year after initial discontinuation notice submission to the FDA.

    You submit the IND closure and NDA discontinuation as instructed.

    Upon receipt of the IND closure, the FDA contacts you and advises that if the required PMR study is intended to be closed down, it is required to withdraw the NDA and await the Federal Register notice of said withdrawal before the clinical study may be stopped.  Your clinical trial management group has already stopped the study and is in the process to close the sites, etc.  No clinical study report will be written.

    The Legal department insists that the plan to only withdraw the NDA after all product is expired, or otherwise out of the distribution/supply chain, stands as is regardless of FDA advice.

    As a responsible RA leader of this product, how would you strategically write a response to the FDA?  Or would you respond at all?   Why or why not?



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    Charlotte, NC
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  • 2.  RE: ND closure and NDA discontinuation challenge question

    Posted 30-May-2019 06:50
    My advice is have the legal department offer the response to the FDA. 

    The Clinical Study Group, even if closing the sites, should author a closure report.  I really don't see a way out of having some sort of closure to the study.  Your legal counsel may be correct in that there is no law that requires you to report, but that is a pathway that I would not to fall on my sword for.  With and IND, you can't just say you stopped and refuse to report, there must be a reason why you stopped (economics is acceptable).

    Further, I question the legal department's opinion that you can stop the clinical study, but allow the remaining product to be used under the IND until it expires.  This is highly suspect, and is not favorable if this issue sees litigation.

    James

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    James Bonds J.D.
    Director Regulatory Affairs
    Atlanta GA
    United States
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  • 3.  RE: ND closure and NDA discontinuation challenge question

    Posted 30-May-2019 21:25
    Thank you so much for your advice

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    Charlotte, NC
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