Advocacy at a Glance

Top-Line: The Alliance applauds the President’s proposed increase of $343 million in FDA’s BA budget. The Senate Agriculture-FDA Appropriations Subcommittee set its FDA budget hearing for June 10. Macro budget concerns will impact the ultimate level of funding provided to FDA. The Alliance’s webinar with FDA’s Food and Animal Health Leadership set for June 8 has been rescheduled to June 16. Other upcoming webinars include CDRH Director Dr. Jeff Shuren on July 22. Dr. Eric Lander has been confirmed by the Senate as the President’s Chief Science Advisor and Director of the White House Office of Science and Technology Policy.Alliance Applauds President’s Budget Request for $343 million Increase in BA Funding. The Alliance is pleased with the President’s Budget Request and will urge Congress to adopt its increase of $343 million in Budget Authority (BA) appropriations for FDA in FY 22. Consistent with this, the Alliance submitted testimony for the record on June 1 (see here). The basics are:

• $185 million in additional investments in FDA’s Critical Public Health Infrastructure. This includes monies for data modernization, as well as for improvement and expansion of FDA buildings and facilities, notably laboratory capacity.
• $97 million in additional investments in Core FDA Safety Programs. This includes monies to enhance core food and medical product safety programs, such as human and animal food safety, maternal and infant nutrition, medical product supply chain surveillance, and animal drug safety.
• $61 million in additional investments in Public Health Issues Confronting the U.S. This includes monies for increased inspections, promotion of health equity, and addressing the opioid crisis.

More details are examined in this week’s Analysis and Commentary and we have provided the Alliance’s chart showing proposed increases by center and function, with FDA’s description of program increases. For those who want the original without abridgment, the 400-page Congressional Justification (CJ) document is here.First Congressional Hearing on FY 22 FDA Budget Set for June 10. Acting Commissioner Janet Woodcock will testify on June 10 at 10:00 a.m. ET before the Senate Appropriations Committee’s Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies. She will review the President’s FY 22 budget request with the subcommittee. Details and a video feed for the hearing can be found here.Macro Budget Concerns Affect FDA’s Ability to Receive a Large Increase in FY 22. For the first time in a decade, there are no defense and non-defense spending ceilings set out in law. That means no threat of sequestration, but also that there is no starting point for negotiations on total FY 22 spending. The President’s ambitious budget may not fit under whatever spending ceilings Congress ultimately agrees to. If that became the case, then many or most federal agencies would likely receive less than the President requested. However, House Budget Committee Chairman John Yarmuth has indicated that his committee will advance spending levels consistent with the President’s request. This is good news, but just the beginning of what could be a protracted debate about FY 22 spending levels. This is described by Roll Call here.Upcoming Alliance Webinars. We continue to invite FDA leadership to address the Alliance membership and media. Note that the date and time for next week’s webinar with FDA's food safety and animal health leadership team has been rescheduled so that it will be after Dr. Woodcock testifies before Congress.

• FDA’s Food and Animal Health Leadership (will now be on June 16 from 11:30 a.m. to 12:30 p.m. ET). For Alliance members and media: Please join us for a virtual presentation on June 16 from 11:30 a.m. to 12:30 p.m. ET by Deputy Commissioner Frank Yiannas, CFSAN Director Susan Mayne, and CVM Director Steven Solomon. To sign up, please register here.
• CDRH Director Jeff Shuren (July 22). For Alliance members and media: Please join us for a virtual presentation by CDRH Director Dr. Jeff Shuren on July 22 from 10:00 to 11:00 a.m. ET. To sign up, please register here.

Dr. Eric Lander Confirmed as President’s Chief Science Advisor. Dr. Eric Lander has been confirmed by the Senate as the President’s Chief Science Advisor and Director of the White House Office of Science and Technology Policy. As part of President Biden’s commitment to science and innovation, he has designated the post to be part of his cabinet. We have tracked his nomination and confirmation as relevant to FDA because Dr. Lander would be the first life scientist to hold this position.