FDA Tightens ANDA Review and Rejection Timelines
(Thursday, October 1, 2020]​
Soon ANDA applications for generic drugs will not be able to go through multiple review cycles due to the applicants taking too long to respond to the deficiencies identified by FDA. This week FDA released a new guidance that sets strict timeline of 1 year to respond to the deficiencies with a goal to eliminate arbitrary repeated extension requests by applicants and clear the backlog. After the initial review of an ANDA application for a generic drug, when not approved, FDA releases a complete response letter (CRL) to the applicant citing specific deficiencies in the application. Per the regulations, the applicants always had 1 year from the receipt of the CRL to submit a response to the FDA containing answers to all the issues identified in the CRL. However, applicants could request extensions of the CRL response submission date, and FDA has so far liberally granted such requests for extension leading to ANDA applications being stuck in the FDA review process for long times. These delays cause the number of pending ANDA applications to artificially bloat creating a project management overwork at FDA. Going forward, FDA would consider an application withdrawn or formally reject the application if the response is not received within 1 year after issuing the CRL to the sponsor of the ANDA. Extension to the 1 year response time would be granted only when the applicant demonstrates a justifiable reason for delay such as events beyond the applicant’s control, additional work being performed to respond to the CRL that needs longer time, and public health reasons necessitating an extension. The applicant will also need to specify and justify how much additional time is needed to respond. If FDA disagrees with the sponsor’s justifications for extension and denies the request, it would give a 30-day notice to the applicant, when the applicant can either submit the response to CRL, present additional information to further justify an extension, or withdraw the application. In case the applicant does not respond within 30 days, the FDA will consider the application automatically withdrawn. Repeat extensions would be harder to get. The assumption is that most applicants would either respond within the 1-year timeline or withdraw their applications. The guidance is still a draft and an implementation date has not been announced, but ANDA applicants should expect this to get finalized soon and start planning accordingly. This policy would likely apply to future application and not be retrospective although it will likely apply to the next time an applicant requests another extension for the CRL response.