Summary of: Alliance webinar with Judy McMeekin, Association Commissioner for Regulatory Affairs

FDA’s Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin provided the Alliance with a far-reaching and informative webinar regarding the Office of Regulatory Affairs’ (ORA) critical role in assuring safe food and medical products to the American people. ORA, with more than 5,000 staff in 230 offices in 49 states and other posts overseas is the lead office for FDA’s regulatory field activities.

In her presentation Dr. McMeekin reviewed the history of their operations, including recent developments, as well as the long-term impact of earlier legislation (Food Safety Modernization Act, 2010; FDA Safety and Innovation Act, 2012). She highlighted the just-announced, agency-wide Inspectional Affairs Council (IAC) and the development of Mutual Recognition Agreements with regulatory authorities in 28 countries. In both cases, they will help ORA focus its resources on products presenting the highest risks.

Her long-term priorities include providing greater resources for medical products and medical product safety. The amount available for medical product field services has grown only marginally despite rapid deployment of new technologies and new science, which result in more sophisticated products that need more sophisticated inspectors. She said that science and enforcement tools need to keep pace with such industry development. The FDA workforce needs to be skilled and well-trained—in the centers and in the field.

Data modernization is a key priority in ORA’s FY 2022 budget request. ORA is working to expand partnerships with non-traditional partners and increase regulatory collaboration with international partners. A risk-based approach will be used for both domestic and foreign inspections that may have been postponed during the pandemic.

She responded to a large number of questions including a discussion of how much “boots on the ground” work was done over the past year and how virtual training of new personnel was done; what was learned from this past year and what innovations might be carried forward; expected growth areas for ORA; the challenges presented with foreign inspections; ORA’s role in the international harmonization of regulations; how to deal with higher risk countries not open to collaboration; the expected work of the Inspectional Affairs Council; an assessment of program alignment with inspectors; maintaining and improving morale among FDA field staff; and how ORA will share information with the public in the future.

To listen to her comments on these last areas, as well as to hear the entire program, an audio version of the program can be found here.

We encourage you to participate in other Alliance webinars. Next week (July 22 at 10 a.m.), we will be hearing from CDRH Director Dr. Jeffrey Shuren. To sign up, please register here. We will be announcing future programs soon.