The Alliance offers its perspective on the unique FY 22 budget. Hill Day Part One with House staff yields encouraging reactions.

Hill Day Part Two is coming, and Alliance members are needed for that effort. The Alliance webinar with CDER Director Dr. Patrizia Cavazzoni is coming on May 25, and will be followed by a virtual presentation with Deputy Commissioner Frank Yiannas, CFSAN Director Susan Mayne, and CVM Director Steven Solomon on June 8.

Notes on the FY 22 Appropriations Cycle: The Alliance Perspective. In most years, the President’s Budget Request is released in early February. Because the FDA’s budget is complex and its mission so broad, in the past we have taken three to four weeks to analyze what the President proposed and formulate an Alliance “ask” that reflects the views of the FDA stakeholder community. This year is different because the President’s Budget Request is delayed. We are told that it is likely to be “after Memorial Day,” which means it will be June before we have the details on FDA.To use the time productively, we have created a statement of FDA needs and opportunities (here) and have been using it in meetings with House staff this week and will with Senate staff in May. The priorities expressed in that one-pager focus are: shortening supply lines and advanced manufacturing; product safety and tracking; regulatory science; building expertise to match new science; modernization of FDA’s data infrastructure and technology capacity; and public health priorities, including nutrition. These choices were reinforced by remarks made by Acting Commissioner Janet Woodcock when she addressed the Alliance on April 14 (video here) (transcript here), particularly the importance of technology and data modernization. By the way, Dr. Woodcock’s remarks to the Alliance were widely covered by the medical products and food safety trade media.

Hill Day Part One: Conversations With the House. During this week, the Alliance held more than 30 meetings with House staffers. We thank the nearly 20 Alliance members who joined our efforts and provided valuable perspective on why a strong, well-funded FDA benefits their constituency. Through presentations and our one-page statement, we delivered the message:

the FDA’s mission continues to grow, and its vital activities have become more complex and require greater sophistication and expertise to complete. Rapid acceleration of science and technology creates both new challenges and new opportunities. Completing the job of making FDA into a modern 21st century regulatory agency will require substantial new investments.

This week’s Analysis and Commentary looks at some of the questions we were asked in House meetings and how we answered.

Hill Day Part Two is Coming. We are planning Alliance meetings with Senate staff later in May. More details will be forthcoming in next week’s Friday Update. In the meantime, if you are interested in participating, please e-mail Reed Diskey and he will make sure you are among the first to know about the dates for the Senate meetings.

Upcoming Alliance Webinar: CDER Director Cavazzoni. For Alliance members and media: please join us for a virtual presentation by newly-permanent CDER Director, Dr. Patrizia Cavazzoni on May 25 from 3:00 to 4:00 p.m. Dr. Cavazzoni will discuss CDER’s priorities and resource needs, as well as data modernization, regulatory science, and safety. To sign up, please register here. If you are not an Alliance member and want to participate, please e-mail Steven Grossman to be our guest at this special event.

Upcoming Alliance Webinar: FDA’s Food and Animal Health Leadership. For Alliance members and media: please join us for a virtual presentation by Deputy Commissioner Frank Yiannas, CFSAN Director Susan Mayne, and CVM Director Steven Solomon on June 8 from 2:00 to 3:00 p.m. They will discuss FDA’s food safety and animal health priorities and resource needs, including the New Era of Smarter Food Safety, the Food Safety Modernization Act, and One Health initiatives. To sign up, please register here. If you are not an Alliance member and want to participate, please e-mail Steven Grossman to be our guest at this special event.