FDA gives generics updates at DIA town hall

Regulatory NewsRegulatory News | 29 June 2021 |  By 

FDA officials discuss priorities at DIA town hall

Officials at the US Food and Drug Administration (FDA) addressed plans to prioritize on-site inspections and gave updates regarding certain new drug applications during a generics-focused virtual town hall convened by the Drug Information Association (DIA) as part of its virtual annual meeting.

During the session, regulators also shared post-pandemic learnings, including the importance of international collaborations for generic drug development.
The session included officials from the Office of Generic Drugs (OGD) and the Office of Pharmaceutical Quality (OPQ) who spoke about key priorities and topics of interest for generic drug development going forward. 
Resumption of inspections
Moderator Rachel Turow, associate general counsel of regulatory law and policy at Teva Pharmaceuticals, first asked the panelists to comment on plans for prioritizing on-site inspections following FDA Acting Commissioner Janet Woodcock’s recent announcement that inspections are “resuming as normal” and plans to address the backlog of inspections.
Stelios Tsinontides, director of OPQ’s Office of Manufacturing Assessment, said that FDA’s recently published “resiliency roadmap” lays out the agency’s plans for prioritizing onsite inspections. The roadmap sets out a risk-based approach for resuming inspections, and states that the higher the drug’s criticality, the higher the chances the site will be subjected to an on-site inspection. (RELATED: FDA tallies pandemic inspection toll, issues new ‘resiliency roadmap’ Regulatory Focus 5 May 2021).
High-priority drugs include medicines and tests essential to treating or diagnosing COVID-19, drugs listed as being in shortage, and those with breakthrough status.

Tsinontides said that during the pandemic the agency was able to avoid conducting 50% of needed pre-approval inspections/pre-license inspections via the use of alternative tools such as 704(a)(4) records requests, as well as reliance on mutual recognition agreements and other confidentialty agreements.
Will agency accept established conditions?
The agency also received a question on whether it would accept applications that contain established conditions (ECs) under the International Council of Harmonization’s ICH Q12 guideline. ECs, “legally binding information considered necessary to assure product quality,” are a core concept of the guideline. Any change to ECs necessities a submission to the regulatory authority.
 “Yes, we are now implementing ICH Q12, so we look forward to receiving applications that make the most of these tools and enablers,” responded Ashley Boam, the director of OPQ’s Office of Policy.
Boam said that FDA published a draft guidance in May that explains the US implementation of ICH Q12’s guideline on postapproval changes and explains how manufacturers can submit established conditions (ECs) for new drug applications (NDAs) and prior approval supplements (PASs). The guideline also reconciles ICH post-approval changes classification categories with FDA supplement categories. (RELATED:  ICH Q12: FDA guidance explains US implementation, Regulatory Focus 21 May 2021)
Boam said the agency is “looking forward” to receiving public comments on the draft guideline.
Global efforts to increase engagement and harmonization
FDA officials also stressed the importance of increasing its engagement and collaboration with other regulators in the wake of the pandemic, in responding to a question about FDA’s recently formed generic drug cluster.
In mid-June, FDA announced the establishment of a Generic Drug Cluster to boost alignment of scientific and regulatory approaches to generic drug development among global regulators. (RELATED: FDA launches global Generic Drug Cluster, Regulatory Focus 14 June 2021).
William Chong, OGD’s associate director for clinical affairs, said that through the establishment of the Generic Drug Cluster, “Our hope is that that we can harmonize across regulatory agencies so we can have an aligned approach; we also want to share information. We heard that harmonization and globalization are challenges for generic manufacturers, and we want to use this as forum to share information with other regulators on our scientific decisions.”
Tsinontides also stressed the importance of global collaboration, a necessity for quick technology transfers during the pandemic.
He said that on 7 July, the International Coalition of Medicines Regulatory Authorities (ICMRA) will be hosting a virtual workshop with the biopharmaceutical industry called “Enabling Manufacturing Capacity in the COVID-19 Pandemic.” The workshop will provide a venue for ICMRA members to engage directly with the biopharma’s industry.
At the workshop, “industry and regulators will share case studies and share approaches so we can prepare and fine tune our approvals so to handle this type of pandemic situation,” said Tsinontides.
Plans for KASA
In other areas, the agency was asked to provide an update on its Knowledge-aided Assessment and Structured Application (KASA) for generic drug reviews.
KASA is a system designed for reviewers to manage information in a structured format about the inherent risk and controls approaches for product design, manufacturing and facilities. (RELATED: FDA explains plan for new pharmaceutical quality assessment system, Regulatory Focus 29 June 2021)
Susan Rosencrance, the director of OPQ’s Office of Lifecycle Drug Products, said that the program, which started out as an internal program meant to expedite the review of generic applications, has since expanded externally to solid oral dosage manufacturers to help them submit applications in a structured format.
 She added that plans are in the works to expand KASA to drug master files (DMFs) and biologics applications as well. “We started KASA in the generic space because of the volume of applications we get,” explained Rosencrance “We now have rolled out KASA to generic solid oral dosage forms and it will take us many years to get us to where we need to be….We want to move it to DMFs and then we are looking to other areas of new drug such as biologics.”

Editor's note: Characterization of a comment from FDA's Stelios Tsinontides regarding inspections during the pandemic was updated to clarify that Tsinontides was referring to pre-approval and pre-licence inspections.


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Tags: FDA, ICH, inspections, OGD, OPQ, Q12

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