Generic industry raises issues with FDA’s cover letter checklists

The generic drug industry says it wants reassurances that the cover letter attachments detailed in a recent US Food and Drug Administration (FDA) draft guidance are truly optional and won’t be held against applicants if they are not included or are incomplete.

The industry comments are in response to a draft guidance on cover letter attachments for controlled correspondences and abbreviated new drug application (ANDA) submissions that was issued for comment in December. The guidance provides three attachments, or checklists, that FDA says are meant to help applicants when preparing cover letters that go along with controlled correspondences, ANDAs, ANDA amendments or supplements to approved ANDAs.

While the Association for Accessible Medicines (AAM) “applauds FDA’s efforts” to ensure that such submissions are effectively managed and acted upon by their Generic Drug User Fee Amendments (GDUFA) goal date, the group expresses reservations about some aspects of the guidance.

AAM stresses that while the guidance states that the attachments are optional, it also includes language stating that the cover letter attachments were developed “in an effort to ensure that submissions are effectively managed by FDA and acted upon by their performance review goal dates.”

“With language like this, applicants will likely feel compelled to provide the attachments for fear that otherwise, their submissions will not be properly managed within the user fee goal dates or will be otherwise disadvantaged,” the group writes.

One of the group’s other issues has to do with FDA’s characterization of the lists as optional attachments. “AAM believes that rather than characterizing the documents as ‘optional’ and as ‘attachments’ which implies that they should be included in submissions, FDA should call them 'checklists' and state that they are, in fact, entirely voluntary,” it writes.

AAM also seeks reassurance from FDA that the absence of a checklist, or an incomplete checklist, will not be grounds for FDA to refuse-to-receive (RTR) an ANDA, amendment, or supplement. Similarly, the group says that FDA should not close out a controlled correspondence for those same reasons.

AAM also calls on FDA to clarify that the omission of the checklists would not be considered a minor deficiency that could contribute to an RTR. According to FDA’s RTR guidance, the presence of “ten or more minor deficiencies or one or more major deficiencies” in an ANDA would prompt the agency to consider the application as not being received.

The group also highlights specific concerns with the three checklists contained in the appendices of the guidance. AAM notes that much of the content listed in the controlled correspondence cover letter attachment in Appendix 1 is duplicative and covered in FDA’s controlled correspondence guidance. It also asks for FDA to revise its manual of policies and procedures (MAPP) on the filing review of ANDAs to “explain the difference between the reviewer checklist and the cover letter checklists and to clarify that submission of the applicant’s cover letter checklist is voluntary.”

Additionally, AAM asks for clarification on the checklists contained in Appendix 2 and 3 in the draft guidance, such as whether the “applicable information in the submission” relates to the original submission or only to the amendment or supplement at hand.

Generic drugmaker Perrigo wrote that it feels the guidance is “unnecessary,” and asks for the agency to remove redundant information from the guidance, including all of Appendix 1 and parts of Appendix 2.

Similarly, Viatris says the guidance as written would amount to “extra work” and stresses that FDA could achieve the goals of the guidance “through more targeted means.”

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Generic industry raises issues with FDA’s cover letter checklists

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