House-passed Ag/FDA funding: $257M increase for FDA; Senate Appropriations may consider Ag/FDA next week; support for ARPA-H formalizes
Top-Line:
House Passes Ag/FDA funding as part of minibus Bill, including the $257M increase for FDA.
Senate Appropriations may consider Ag/FDA funding next week.
ARPA-H: Still formative with FDA’s role to be determined, and public comment being solicited.
Follow-ups to the McMeekin and Shuren webinars.
House Passes Ag/FDA Funding as Part of Minibus Bill; FDA Remains +$257M. Late this week, the House approved a seven-bill minibus funding bill that includes Ag/FDA appropriations. The vote was 219-208. The House also adopted two other stand-alone funding bills, leaving 3 remaining: Commerce, Justice, Science; Defense; and Homeland Security. Each has disputed provisions that are slowing their consideration.
The House-passed minibus bill would increase FDA’s FY 22 funding by $257 million over its FY 21 appropriated level. The bill also includes separate funding for the programs created by the 21st Century Cures Act.
At the time of committee mark-up, the Alliance had this to say about the House bill: “We are grateful for the House’s support of FDA and appreciate that its proposed increase in BA funding will go a long way towards addressing the agency’s many resource needs. In any year, a $257 million/8% increase for FDA is substantial and meaningful. For that, we thank the Members of the House Appropriations Ag/FDA Subcommittee and the full Committee.”
Senate Committee May Consider Ag/FDA Funding Next Week. There is still uncertainty, but reports circulate that Senate Appropriations Chair Leahy wants the committee to move on Agriculture/FDA and two other bills next week. No formal schedule has been released at the time of this update.
ARPA-H: Still Formative; FDA Role To Be Determined. The Administration’s FY22 budget request included $6 billion in no-year money to fund a new entity intended to tackle some of the most difficult medical challenges our society faces, such as preventing or delaying Alzheimer’s Disease. The entity would be modeled after the Defense Advanced Research Projects Agency (DARPA). The budget request was short on detail—so the White House Office of Science and Technology Policy and NIH are currently holding listening sessions to receive diverse opinions about the structure, goals, focus, priorities, and organizational location of the ARPA-H entity. Meanwhile, the House Labor-HHS appropriations bill included $3 billion to start-up ARPA-H over the next few years, although the monies will only be available if authorizing legislation is adopted. This is a vast and complex topic—including the role for FDA—so this week’s Analysis and Commentary (below) is devoted to describing the situation and issues.
McMeekin and Shuren Webinar Follow-up. FDA Associate Commissioner for Regulatory Affairs Judy McMeekin addressed the Alliance in a webinar on July 14 and CDRH Director Jeff Shuren did the same on July 22. Transcript of McMeekin is here…. and transcript of Shuren is here. We expect to announce additional speakers soon.
