Regulatory Open Forum

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 

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

I 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 me 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.

how would I strategically write a response to the FDA?  Or would you respond at all?   Why or why not?

Please help

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 

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

I 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 me 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.

how would I strategically write a response to the FDA?  Or would you respond at all?   Why or why not?

Please help