Alliance Endorses President’s $372 Million Increase for FDA

Alliance Supports President’s $372 Million Increase for FDA. The Alliance for a Stronger FDA endorsed the President’s requested increase in FDA’s budget authority (BA) appropriations of $372 million over the FY 2023 appropriated amounts for a proposed total of $3.963 billion. The request is about a 10% increase in BA (taxpayer) funding compared to the FY 23 appropriated level.

The Alliance’s press release on the President’s Request is here. This week’s Analysis and Commentary looks at the details of the FY 24 budget submission

Deadlines for Members of Congress to Submit Their Funding Priorities: Ongoing and Just Announced.  Each year, Members of Congress ask their constituents and interested parties to recommend program funding for the coming fiscal year. In turn, Members formulate lists of their priorities, which they share with subcommittee leadership. Requests can be highly localized (monies to rebuild a bridge) or broadly programmatic (increases for FDA, for example).

The House Appropriations Committee’s Subcommittee on Agriculture and FDA has set its deadline for input from Members as March 24 at 6:00 pm.

The Senate Appropriations Committee’s Subcommittee on Agriculture and FDA has just announced its deadline for receiving input from Member is March 31.

Contact Roger Szemraj for further assistance.  

House Deadline for Submission of Testimony is April 10. There is the opportunity to submit testimony in the House, with a due date of April 10, 2023. Accordingly, the Alliance encourages all members to submit testimony to the House in support of the Alliance “ask” for FY 24 FDA funding. The Alliance’s main message is that a growing agency (FDA) requires a budget that grows. The case for this is stronger if Alliance members tell Congress why more resources are necessary.

The House Subcommittee has provided explicit directions about formatting and other submission details (here). The best testimony intermixes broader points about FDA funding needs with specific examples of how a well-funded FDA advances programs that affect you or your organization. Alliance staff welcomes requests for assistance in preparing testimony in support of FDA funding.

Woodcock Transcript Available on Alliance Website. On March 3, 2023, the Alliance for a Stronger FDA hosted a webinar with Dr. Janet Woodcock to discuss emerging changes in food programs at the FDA. A transcript of that conversation is available here.

FDA Issues Discussion Paper on Artificial Intelligence in Drug Manufacturing.  As FDA considers the application of its risk-based regulatory framework to the use of AI technologies in drug manufacturing, the agency has issued a discussion paper for public feedback.  

The areas in the paper focus on the manufacture of drug products that would be marketed under a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA).

There are some other additional areas of consideration not covered within this document; for example, difficulties that could result from potential ambiguity on how to apply existing Current Good Manufacturing Practice (CGMP) regulations to AI or lack of Agency guidance or experience. Presumably, those will be raised later for public feedback.

Coalition for Trust in Health & Science Formed to Counter Public Misinformation. The Coalition for Trust in Health and Science, announced this week, was formed to unite leading organizations from across the entire health ecosystem to advance trust and factual science-based decision-making.

The partnership aims to achieve a measurable increase in the public’s willingness – and ability – to access evidence-based information necessary to make the best personally appropriate health decisions for themselves, their families and the communities in which they live and work. Enhancing the perception and reality of the trustworthiness of the health and medical system is a key element of this goal.

Combatting scientific information is an important priority for Commissioner Califf, as he expressed in his recent webinar with the Alliance. The transcript of that program is here.

Alliance FY 24 FDA Budget Webinar Series: Essential Information on FDA Priorities.  The President’s FY 24 Budget has now been released.

Starting on March 23, the Alliance is sponsoring six webinars on the President’s Request. All five Center directors and the head of the Office of Regulatory Affairs are set to appear and will discuss their programs and priorities for FY 24, as reflected in the Budget Request.

Registration is open; sign up now.

3/23     Dr. Shuren, CDRH                  11:00   Shuren event registration

3/29     Ms. McMeekin, ORA               2:30   McMeekin event registration

3/31     Dr. Mayne, CFSAN                11:00   Mayne event registration

4/04     Dr. Marks, CBER                     3:30   Marks event registration

4/05     Dr. Cavazzoni, CDER              2:00   Cavazzoni event registration

4/10     Ms. Forfa, CVM                       3:00   Forfa event registration