URGENT UPDATE on Refuse-to-Receive Guidance, Revision 1, Issues for Generic Drugs

Since my post yesterday, a number of readers pointed out that the DMF assessment requirement as a basis for Refuse-to-Receive file determination has been removed from the previous guidance.  I concur that is the case, and there are and may be multiple reasons for its removal.  I have forwarded individual responses to questions:

The DMF assessment review is either conducted prior to submission of an ANDA or at time of submission.  If the DMF is already on the acceptable for reference list this review has already been completed.  If the assessment has not be done and as long as the DMF fee has been paid, the DMF assessment will be conducted as time permits during the review of the application and it becomes a review issue.  It is believed that since most DMF assessments have been conducted prior to ANDA submission, there was no need to have an RTR issue for a DMF assessment.  If there is a fatal flaw noticed in the DMF review, then OGD can just stop review and send the applicant a letter.  Remember that the RTR guidance is not all inclusive of all reasons to RTR and ANDA and if a new DMF is referenced that is found to be woefully inadequate on its face during the initial assessment and if prior to making a filing decision, then OGD can RTR the ANDA.

However, as a former FDAer and knowing how decisions are made at the Agency, I also checked with FDA to determine if there was another overarching reason for the removal of this language from the RTR guidance.  And guess what – I was not disappointed in the response I received.  Apparently, the major reason the DMF assessment was removed from the RTR guidance is that, when the statute was reviewed, it became evident that the DMF assessment was not an RTR issue that was identified, and FDA, thus, removed it from the list.  Just to be clear, it is my continued belief that, if the DMF is so deficient on its face, then OGD can take a separate action to refuse the ANDA or issue an immediate fatal flaw Not Approvable Letter.  I would love to hear what you think – please send comment to me at r.pollock@lachmanconsultants.com.