FDA’s regulatory affairs head previews Inspectional Affairs Council

Regulatory NewsRegulatory News | 15 July 2021 |  By 

Judith McMeekin

The top regulatory affairs official at the US Food and Drug Administration (FDA) gave a preview of a soon-to-be-launched council within the agency that will focus solely on inspection-related matters.
“We will soon stand up an agency-wide decision-making body; it’s called the FDA Inspectional Affairs Council,” said Judith McMeekin, FDA’s associate commissioner for regulatory affairs within the Office of Regulatory Affairs (ORA), speaking at a virtual webinar hosted Wednesday by the Alliance for a Stronger FDA.
She kicked off her presentation by reviewing ORA’s purview. “So we are the eyes in the ears of the FDA,” said McMeekin, who has responsibility for over 5,000 staff working across 230 offices in 49 states. “We are the boots on the ground, interacting with all of our regulated industries and stakeholders to provide access to quality food and medical products.” Her staff covers ports of entry and international mail facilities, and “works with federal, state, local, territorial, and foreign regulatory and public health counterparts,” she explained.
Noting that her position gives her the unique vantage point of interacting with all of FDA’s regulated commodities, McMeekin said that her position “really allows me to see the need for an enterprise or FDA-wide approach. investigators are the sharp end of the spear that directly interacts with regulated industry where they operate. “In this work, ORA represents the agency, and I want to be clear that I fully understand regulated industry sees us as FDA – not as CBER, not as CDER, not as ORA. We are one FDA.”
In terms of how to revamp inspection processes and bring forward lessons learned during the pandemic, McMeekin said, “We touch each center; we work with each center. We are always thinking of ways to optimize our inspection process, and what better way to do that than to bring leaders to the table?”
The realignment within ORA that aligned inspectors with specific commodities has been “a huge asset,” said McMeekin. In addition to helping with oversight of increasingly complex industries, the realignment has allowed ORA staff to interface more directly with FDA colleagues in the various centers.
The ORA approach is to be consistent, but “it doesn’t mean that everything has to be exact across the commodities,” McMeekin said. “We just need to have the flexibility within the program, but we should really be working with our regulated industry in a consistent manner.”
This consistency is a key goal of the Inspectional Affairs Council (IAC), she added. “This is focused on optimizing inspections as part of the agencies.” The council will draw from top leadership from ORA and each center within FDA, and take a big-picture approach to strategy and initiatives; it was first previewed in May 2021 as a component of the agency’s resiliency roadmap for inspectional oversight. (RELATED: FDA tallies pandemic inspection toll, issues new 'resiliency roadmap,' Regulatory Focus 05 May 2021)
Although acting FDA commissioner Janet Woodcock does not hold a seat on the IAC, she has nonetheless been “extremely supportive” of the cross-cutting approach, said McMeekin.
“Because inspections cross all the commodities, it's really important that we have these discussions on policy issues surrounding inspections across agencies, as an enterprise, so that we can ensure optimal agency resources,” said McMeekin, adding that the approach will help all of FDA “navigate the regulatory landscape for many years ahead.”
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