FDA outlines process for communicating record requests findings
The US Food and Drug Administration (FDA) says it has put in place an interim process to communicate issues identified during record reviews done in lieu of or in advance of preapproval inspections with drugmakers and consider their responses before taking action on an application.The agency says the interim process will continue throughout the COVID-19 public health emergency and may be extended to other drug inspection programs, including routine surveillance inspections.
Typically, FDA conducts a preapproval or prelicensure inspection before approving new drugs and biologics to ensure the facilities are operating in compliance with current good manufacturing practice (cGMP). However, due to the COVID-19 pandemic, FDA postponed most domestic and foreign surveillance inspections and has been relying on alternative tools such as records requests, where possible, to conduct facility assessments. (RELATED: FDA issues pandemic inspections FAQ guidance, Regulatory Focus 19 August 2020; Inspections: GAO calls on FDA to plan for backlog, review alternatives, Regulatory Focus 1 February 2021).
While records requests and other alternative tools have allowed FDA to advance its work reviewing and approving new drugs during the pandemic, some drugmakers have been caught off guard by complete response letters they received after submitting records to the agency. (FDA details review timelines as facility assessment-related CRLs pile up, Regulatory Focus 22 December 2020).
In one instance, Alkermes said it received a CRL for its investigational schizophrenia and bipolar disorder treatment ALKS 3831 (olanzapine/samidorphan) after a remote records review turned up issues related to the tablet coating process at the company’s Wilmington, Ohio facility.
Now, FDA says it is “implementing an interim process to communicate issues identified following a review of records or other information requested under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in lieu, or in advance, of a pre-approval or pre-licensure inspection for CDER regulated products.”
Under the new process, FDA says it will communicate issues to facility representatives and will consider their responses “prior to taking action on a pending application impacted by these issues, as feasible given user fee agreement and internal review program milestones.” FDA has also updated its guidance on inspections during the pandemic to reflect the interim process and encourages applicants to remain in communication with their facilities and sites “to ensure timely responses to any inquiries to support application assessment.”
FDA