Appropriations bills move in the near term (House); face difficult long-term prospects. Progress on FDA’s New Era of Smarter Food Safety Blueprint.
Top-Line: Appropriations bills move in the near term but face difficult long-term prospects. Plan on attending our upcoming Alliance Webinar with CDRH Director Jeff Shuren (July 22), which follows our informative July 14 Webinar with FDA Associate Commissioner for Regulatory Affairs Judy McMeekin that is summarized in this week’s Analysis and Commentary. Significant progress is reported in FDA’s New Era of Smarter Food Safety Blueprint.
Appropriations Bills: Movement in the Near-Term. The full House Appropriations Committee favorably reported by voice vote the FY 2022 Agriculture/FDA bill on June 30. There were no amendments impacting FDA funding levels considered during the Committee’s markup. The House is expected to take up a 7-bill appropriations minibus (including Ag/FDA) that will be considered on the House floor the week of July 26. The House expects to adjourn for the August recess at close of business on Friday, July 30. The House leadership strategy is to group the non-controversial bills while deferring for later the more uncertain ones, such as Homeland Security, Defense, and State-Foreign Operations.
In the Senate, Appropriations Chairman Leahy has said he wants the Senate Committee to move four bills before the August recess, including Agriculture/FDA. However, no specific date has been announced yet. The Senate is scheduled to be in session through Friday, August 6, before starting its recess. We are unlikely to know what is in the bills before the mark-ups occur.
Appropriations Bills: Difficult Long-Term Prospects. There is almost always an element of “hurry-up and wait” in the appropriations process. Right now, we are in the “hurry-up” phase, as described in the prior story. The pending question is how long the “wait” phase will be. Can any appropriations bills become law if there is not a bicameral agreement on total spending levels? Can a separate 7-bill minibus of less controversial spending bills pass and become law with the rest funded by Continuing Resolution (CR)? If a CR is adopted for some or all spending bills, will it extend to the end of October, after Thanksgiving, or into next year?
Upcoming Alliance Webinar: CDRH Director Jeff Shuren (July 22, 10:00-11:00 AM ET). Wholly apart from the pandemic, CDRH has never been busier as it addresses a surge in innovation in medical devices and the impact of transformative technologies, such as artificial intelligence and digital health. CDRH Director Dr. Jeff Shuren will provide a view of CDRH’s current opportunities and challenges and discuss how the FY 22 budget request will help CDRH meet its responsibilities. To sign up, please register here. These events are limited to Alliance members and media. If you are not a member and would like to participate, please contact Steven Grossman.
Why You Should Sign Up for the Alliance Webinar with CDRH Director Dr. Jeff Shuren. Among its many responsibilities, CDRH assures timely and continued access to safe, effective, and high-quality medical devices and facilitates medical device innovation by advancing regulatory science and providing predictable regulatory pathways. Given the diversity of medical devices, their broad impact, and the pace of change, CDRH’s mandate is large and growing.
When Dr. Shuren last spoke to the Alliance in December 2020, he emphasized that the Center has met its pandemic-related responsibilities while maintaining its existing commitments. He hoped that 2021 would be a “reset” year, where more new initiatives could move forward despite a likely a surge in COVID-related products seeking full marketing approval. At the Alliance webinar, Dr. Shuren will address how the reset year is going, his progress on new initiatives, and the key elements of CDRH’s FY 22 budget request.
Informative Alliance Webinar with FDA Associate Commissioner for Regulatory Affairs Judy McMeekin. FDA field programs—encompassing about $1.2 billion and more than 5000 employees—are spread throughout the agency’s budget but centralized in the Office of Regulatory Affairs (ORA), run by the ACRA. This week about 100 Alliance members, guests and media heard the ACRA talk about the ORA’s global inspection and enforcement activities. An audio version of the program is here. This week’s Analysis and Commentary (below) discusses ORA and Dr. McMeekin’s remarks.
FDA Reports “Significant Progress” In Its New Era of Smarter Food Safety Blueprint. One year after releasing the New Era of Smarter Food Safety Blueprint (here), Acting Commissioner Janet Woodcock and Deputy Commissioner Frank Yiannis penned an FDA Voices article (here) describing progress in implementing the plan. The article covers: enhanced food traceability, predictive analytics, import screening, inspections, and bending the curve of foodborne illness.
