Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the number of review cycles abbreviated new drug applications (ANDAs) undergo before approval.
Multiple review cycles has been an outstanding challenge for the agency in years past, with less than 10% of ANDAs winning approval in the first review cycle. And prior to 1 October 2017, about half of all ANDAs with GDUFA I goal dates required three or more review cycles to reach approval or tentative approval, the agency said.
But as FDA begins prioritizing its review of ANDAs for branded drugs with three or less competitors, the agency will also look to help companies understand why their ANDAs are deficient.
So far this fiscal year, FDA has also been approving and sending complete responses for ANDAs in much higher quantities than years past. So far in FY 2018, 171 ANDAs have been approved and 565 have received a complete response, whereas by this time in the last fiscal year, 113 ANDAs had been approved and 301 received complete responses.
The 34-page draft highlights common, recurring deficiencies that may lead to a delay in an ANDA’s approval, and it offers recommendations to applicants on how to avoid certain deficiencies.
In addition to discussing patent and exclusivity deficiencies, the draft discusses labeling, product quality and bioequivalence deficiencies.
FDA Commissioner Scott Gottlieb said in a statement: "It currently takes on average about four cycles for an ANDA to reach approval – not necessarily because the product will not meet our standards, but sometimes because the application is missing information necessary to demonstrate that it does. These multiple cycles of review are costly and inefficient."
The new MAPP lays out how, when FDA determines that an ANDA cannot be approved in its current form, reviewers should provide more details to generic drug applicants, how FDA assessment teams should use templates and assessment tools provided by the sub-disciplines that focus the primary assessment on quality, bioequivalence or labeling data, among other information, clarifies the roles and responsibilities of primary assessors, secondary assessors, and division directors "who, under this MAPP, will no longer perform the role of a typical tertiary reviewer," and establishes how FDA will clearly communicate to applicants what deficiencies must be corrected for their ANDAs to be approved.
The MAPP also explains how, moving forward, FDA’s Office of Generic Drugs and Office of Pharmaceutical Quality "will use the term assessment in place of review. Assessment means the process of both evaluating and analyzing submitted data and information to determine whether the application meets the requirements for approval and documenting that determination."
However, Gottlieb noted that the MAPP does not alter the Generic Drug User Fee Amendments II review goals or program enhancements, nor does it alter the regulatory requirements for ANDA approval.
"Rather, the goal of the MAPP is to guide FDA staff to help ensure we work more efficiently with the goal of improving review times," he said.
Good ANDA Submission Practices: Draft Guidance for Industry
MAPP: Good Abbreviated New Drug Application Assessment Practices