Summaries of the Alliance webinars with Associate Commissioner for Regulatory Affairs Judy McMeekin and with CFSAN Director Dr. Susan Mayne

Summary of the Remarks of Associate Commissioner for Regulatory Affairs Dr. Judy McMeekin and
Summary of the Remarks of CFSAN Director Dr. Susan Mayne

This week’s Analysis and Commentary summarizes the comments of

• Associate Commissioner for Regulatory Affairs Judy McMeekin on April 6, 2022, [transcript][video]

• CFSAN Director Dr. Susan Mayne on April 12, 2022[video]

during their appearances at Alliance webinars.

Summary of the Remarks of Associate Commissioner for Regulatory Affairs Dr. Judy McMeekin (a more complete summary is at link)

FDA’s Office of Regulatory Affairs (ORA), led by Associate Commissioner Judy McMeekin, reaches across all of FDA. In an information-filled webinar on April 6, Commissioner McMeekin said that ORA has one-third of FDA’s workforce, with a current budget of $1.2 billion. Their activities include inspections around the world, looking at produce, tobacco, data from vaccine trials, testing product samples, analyzing cosmetics, following up on adverse events, and conducting import investigations and inspections at all nine import mail facilities.

ORA routinely works with FDA Center Directors, and this past year created the FDA Inspectional Affairs Council to plan and coordinate inspection activities and look at the use of new technology to optimize agency resources.

For FY 23, ORA is seeing $1.36 billion, with 91% of this amount coming from budget authority appropriations and just 9% from user fees. A key effort in this budget request is the need to optimize inspection approaches with support for the recruitment and training of new inspectors.

Associate Commissioner McMeekin emphasized the importance of further investment in data modernization and enhanced technology. She hoped Congress will support funding for the development of new IT systems which will both gain operational efficiency and meet customer expectations. She did say that ORA’s budget has not kept up with the demands placed on it.

In response to a question about resumption of foreign inspections, Associate Commissioner McMeekin indicated that they have continued foreign mission critical inspections. Certain inspections that were not mission critical have been prioritized. They have been able to resume domestic inspections across all commodities and are starting some foreign inspections. While she could not say when all inspections will be back on track, she did say that ORA will use all available tools.

A more complete summary of her remarks is at link.

Summary of the Remarks of CFSAN Director Dr. Susan Mayne
(a more complete summary is at link)

On April 12, 2022, The Alliance for a Stronger FDA continued its FY 23 budget priorities webinar series with Dr. Susan Mayne, the Director of the Center for Food Safety and Applied Nutrition (CFSAN). During this wide-reaching event, Dr. Mayne spoke about CFSAN’s priorities under the FY 23 budget proposal, reviewed final FY 22 funding levels provided by the Consolidated Appropriations Act, focused on the importance of nutrition issues within CFSAN, and addressed supply chain challenges.

She spoke very directly about the value of providing more resources for CFSAN with 97% of funding coming from budget authority, and the challenges of what she described as a limited CFSAN staff. She also responded to criticisms of CSFAN made in a recent Politico article, saying she takes all criticism seriously.

CFSAN is responsible for overseeing 80% of the nation’s food supply, along with cosmetics and dietary supplements. CFSAN does not receive user fees. She said that two-thirds of CSFAN’s funding is transferred to the Office of Regulatory Affairs (ORA) for field activities.

Dr. Mayne highlighted additional funding provided as part of the final FY 22 appropriation with increases for Maternal and Infant Health and Nutrition; Emerging Chemical and Toxicology Issues; New Era of Smarter Food Safety; and for Standards of Identity. She suggested these increases were a “down payment” and that the funds requested for FY 23 bridges the resource gap.

With respect to FY 23 priorities, she said nutrition is one of CFSAN’s priorities, but only 7% of the CFSAN budget. She highlighted Health Equity through Nutrition, dietary guidance, work with vulnerable populations, and nutrition labeling. She said CFSAN is advancing its partnership with sister agencies regarding the Dietary Guidelines for Americans. She spoke about research on the development of a healthy symbol to help consumers quickly identify healthy foods. She said toxicological and chemical work is important as the public’s attention increases as new issues emerge.

A more complete summary of her remarks is at link.

Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.