What is the Latest in FDA Policy, Legislation, and International Affairs?
On January 13, 2023, the Alliance for a Stronger FDA held an informative webinar with Andi Fristedt, FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs. She covered a wide range of issues including: the user fee actions taken by Congress last September; the additional authorities provided to FDA as part of the Consolidated Appropriations Act of 2023; priorities for the coming year; and anticipation of challenges facing the FY 2024 budget request.
FDA’s Office of Policy, Legislation, and International Affairs includes several entities, including:
the Office of Policy, which reviews every regulation and guidance document prior to its issuance;
the Office of Economic Analysis, which provides regulatory impact analysis;
the Office of Global Policy and Strategy, which looks at global regulation and multilateral efforts;
the Office of Intergovernmental Affairs, which coordinates agreements with states and third parties; and
the Office of Legislation and the Office of Congressional Appropriations. Together, they offer proactive outreach to the Hill, respond to requests for briefings, and participate in many requested meetings.
When user fees reauthorizations were completed in September 2022, Congressional leadership committed to continuing work on the program and policies that had been part of the House and Senate passed bills. Many (but clearly not all) were included in the December package attached to the Consolidated Appropriations Act of 2023.
From the December package, Ms. Fristedt noted efforts to improve the approval process, provide FDA with enhanced hiring authority, and important new cosmetics safety authorities. With respect to cosmetics, she said they are in the early stages of implementing cosmetics safety reform and they expect there will be opportunities for public comment. Other issues addressed in December include medical supply chain resiliency and device cyber security.
Items that still need to be addressed in 2023 include the regulatory schemes for diagnostics and for dietary supplements, and issues around orphan drug exclusivity. It is possible those could be addressed as part of this year’s legislation to renew the two animal drug user fee programs.
Responding to questions about food safety, Ms. Fristedt emphasized it as a priority for Commissioner Califf. Among the food issues she mentioned are innovations in the food industry (such as biotechnology and cell cultured food), food traceability, and further work on the agricultural water rule.
The FY 2024 budget request is not likely to be sent to Congress until late February or early March, as opposed to the traditional first Monday in February. The Congressional Justification accompanying the FDA budget request provides an important opportunity to tell FDA’s story, especially with some new leadership across the committees responsible for FDA and its budget.
When asked about suggestions that some in the House want to see funding capped at FY 2022 levels, she said the increases provided in FY 2023 are very meaningful, moving the needle for public health. Even a flat budget is a significant decrease and would have real consequences.
On the international front she suggested priorities include continuing supply chain issues including building the agency’s information assets; leveraging information with global counterparts; partnership agreements with large food exporters to ensure food safety; the African Union’s medical agency, and work with multilateral institutions.
She concluded the webinar by identifying innovation as central to public health issues; food safety; data modernization, and front of package labeling as among FDA’s priorities for 2023.
During the webinar Ms. Fristedt responded to other questions from webinar participants including:
Information sharing with state and local partners, including data modernization;
Cannabis policy, including the need to provide clarity on pathways for dealing with food and dietary supplement issues;
Priorities in Cures 2.0; and
Animal biotechnology issues.
The Alliance plans another series of webinars with the Center Directors and ORA following the release of the FY 2024 budget request. Announcements will be included in Friday Update as this schedule is developed.