Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable'
A generic drug industry group and several companies have taken issue with recent US Food and Drug Administration (FDA) draft guidance on pre-submission facility correspondence (PFC) that spells out what companies need to do to obtain faster abbreviated new drug application (ANDA) reviews.
In June, FDA released the draft guidance noting that it is "critical" for there to be a two-month lead time to determine whether facility inspections will be needed for the 8-month, rather than the 10-month ANDA reviews, and if necessary, to initiate inspection planning earlier in the review.
Calling the draft "a fundamental departure" from what was agreed in the user fee negotiations, the industry group known as the Association for Accessible Medicines (AAM) said in its comment dated Monday that it "has significant concerns" as it "may unintentionally discourage ANDA sponsors from submitting a priority review request."
The group also said the draft effectively means the agency "would require a mini ANDA to be submitted in advance of the actual ANDA" and is "not in the best interest of the public health and defeats the mission and goal of the new Commissioner to increase access to affordable generic medicines in a timelier manner.
"Collectively, these issues mean that as written, the Draft Guidance is basically inoperable, especially problematic considering the important public health interests—including decreasing drug shortages, facilitating PEPFAR [President's Emergency Plan for AIDS Relief], alleviating public health emergencies, and improving public health by increasing access to affordable drugs – that are intended to be addressed through PFCs and priority review," AAM said.
Generic drugmaker Teva, meanwhile, said the PFC was meant to provide FDA with information on facilities included in a particular ANDA that may qualify for priority status.
"The PFC was not intended to be a pre-assessment of the ANDA 2 months prior to the planned submission," Teva said. "The PFC guidance exceeds the details included in the commitment letter by stating that a ‘thorough’ description of the manufacturing process should be included, whereas the commitment letter only calls for a ‘description of the manufacturing process.’ As captured in the commitment letter, it was agreed that industry would include a description of the manufacturing process only as detailed as would be necessary to facilitate the facility evaluation process."
Other companies including Apotex and Perrigo also sought more specific changes to the draft.