FDA updates draft guidance on division-level ANDA disputes

The US Food and Drug Administration (FDA) has published an updated draft guidance explaining how generic drug sponsors can ask for reconsideration of a negative decision at the division level, detailing which issues are not fit for reconsideration and how many such disputes the agency will be able to handle.
 
On 10 January, FDA published a draft guidance laying out its plans on how and when sponsors who have been denied an abbreviated new drug application (ANDA) can have that decision reconsidered at the division level. It updates similar guidance from 2017.
 
“As described in the [Generic Drug User Fee Amendments (GDUFA)] III commitment letter applicable to this latest reauthorization, FDA has agreed to performance goals and program enhancements regarding aspects of the generic drug assessment program that build on previous authorizations of GDUFA,” said FDA. “New enhancements to the program are designed to maximize the efficiency and utility of each assessment cycle, with the intent of reducing the number of assessment cycles for ANDAs and facilitating timely access to generic medicines for American patients.”
 
The guidance details what ANDA sponsors should consider before requesting a division-level reconsideration, how to submit a reconsideration request and FDA’s process when responding to them.
 
GDUFA allows ANDA applicants to ask for their application to be reconsidered, but the reconsideration must be addressed within the specific discipline at the division level or original signatory authority. The guidance notes that the associate director at the Office of Regulatory Operations in the Office of Generic Drugs will be responsible for tracking requests for division-level reconsideration during the resolution process.
 
Both guidances list issues that can be reconsidered in an ANDA dispute, but the new guidance adds that sponsors who have received a denial of a reclassification of a facility-based major complete response letter (CRL) amendment can also ask for their case to be reconsidered. FDA restated that advice given during meetings or teleconferences is inappropriate for reconsideration since they are not considered regulatory actions that the agency has taken.
 
“Matters not appropriate for a request for reconsideration by an applicant include, but are not limited to, general advice letters and advice communicated during meetings or in meeting minutes to discuss generic drug development before ANDA submission (pre-ANDA meetings), including meetings for complex generic drug products as noted in the GDUFA III commitment letter,” FDA said in the updated guidance.
 
“Under GDUFA III, an applicant may request a post-CRL clarification teleconference concerning deficiencies identified in a CRL,” the agency added. “Additionally, applicants can request post-CRL scientific meetings for FDA’s scientific advice on possible approaches to identified deficiencies in a CRL related to establishing equivalence.”
 
In their notice about the updated draft guidance, FDA also said that it will be able to devote more resources to addressing such disputes because it has received more funding under the latest GDUFA reauthorization bill.
 
In 2017, FDA said it will be able to handle at most 150 responses a year from a maximum of 75 respondents. Now, the agency says it will be able to handle double that workload with an estimated 310 annual responses from a maximum of 155 respondents.
 
Stakeholders can comment on the draft guidance until 11 March 2024, on www.regulations.gov under docket no. FDA-2017-D-5868.
 
Updated draft guidance