FDA Limits Extensions on CRL Responses for ANDA
(Thursday, July 28, 2022)
Applicants must respond to a Complete Response Letter (CRL) within 1 year unless an extension is requested prior to the expiration of the 1-year period. So far, FDA liberally granted extensions for the CRL responses, but not for long. In a new guidance document describing a previously unenforced policy, FDA announced that it would limit the number and duration of extensions granted to CRL responses for ANDA applications. CRLs are formal rejection letters where FDA lists the deficiencies in market approval applications giving applicants up to 1 year to either address the deficiencies or withdraw an application. In most cases, applicants chose to respond to the CRL rather than withdraw the application to avoid restarting the review clock from Day 1. There could be genuine circumstances that might make it hard for an applicant to address all deficiencies within the 1-year period, and hence the provision for requesting extension of time to respond. But according to the FDA, the extension process has been abused by applicants leading to some applications being on repeated extension for years. This has created a logistical challenge for the FDA. While it is possible that certain deficiencies identified by the FDA might take longer than 1 year to address, such as situations where additional clinical or nonclinical studies are required to respond, many times applicants deliberately delay responding due to business reasons such pending patent litigations or trying to delay competitions. FDA wants to control the abuse of the extension time for response to CRLs. Going forward, an extension request must specify the reasons for the additional time, a progress report for the work completed since the previous deadline, and specific length of extension time with justification for the request. FDA promises to still grant reasonable requests for extension but reserves the option to deny an extension and notify the applicant of a forced withdraw of the application, if FDA deems the extension request not justified. The guidance is specifically applicable to ANDA applications as those applications are not expected to have issues that cannot be addressed within a year. For other applications, the process remains unaltered, for now.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC