House Appropriations Committee approves FY 22 Ag/FDA Appropriations bill; the Alliance reacts positively to the House bill.

Top-Line. House Appropriations Committee approves FY 22 Ag/FDA Appropriations bill, with full House consideration expected in July. The Alliance reacts positively to the House bill. Upcoming Webinars - Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin (July 14) and CDRH Director Jeff Shuren (July 22). FDA is working on extra ways to hire additional personnel.

House FY 22 Ag/FDA Appropriations Bill Passed by Committee; Due On the House Floor in July. Completing the work started by the Ag/FDA Appropriations Subcommittee on June 25, the full House Appropriations Committee approved the Subcommittee bill with minor and technical amendments and a handful of amendments that do not affect FDA. House Majority Leader Steny Hoyer anticipates floor action in July. So far, the Senate has not scheduled subcommittee mark-ups, but Appropriations Chair Patrick Leahy wants to get started before the August recess. This week’s Analysis and Commentary (below) is devoted to FAQ about the current budget and appropriations situation.

Summary of the House Ag/FDA Appropriations Bill. Here is the committee summary:

“Food and Drug Administration (FDA) – FDA receives a total of $3.471 billion in discretionary funding in the bill, an increase of $257 million above the FY 2021 enacted level. Total funding for FDA, including revenue from user fees, is $6.288 billion. Within this total, the Committee provides a targeted increase of $72 million to address the opioid crisis, medical supply chain surveillance, rare cancers, and increasing and strengthening inspections. It also includes a $65 million increase to better avoid or more quickly respond to food outbreaks, improve the animal food inspection system, and addresses heavy metals in baby food. The bill also appropriates $50 million to accelerate medical product development as authorized in the 21st Century Cures Act.”

The Alliance’s Positive Reaction to the House Appropriations Committee FY 22 Mark for FDA. “We are grateful for the House’s support of FDA and appreciate that its proposed increase in BA funding will go a long way toward 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 Committee. We will work with the Senate to achieve a similarly large commitment to FDA’s FY 22 funding needs. The drive to strengthen the FDA is a multi-year marathon, not a sprint, and the Alliance will continue to advocate for critical funding to strengthen the agency.”

Upcoming Alliance Webinars. We continue inviting FDA leadership to address Alliance members and media:

• Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin (July 14, 1:30-2:30 PM ET). Resources for field programs—about $1.2 billion in FY 21—are spread throughout the agency’s budget, but the responsibility for inspections, compliance, and enforcement is centralized in the Office of Regulatory Affairs (ORA), run by the ACRA. More than 5,000 FDA employees are part of ORA. During this webinar, Associate Commissioner McMeekin will describe how ORA works and challenges in managing a global workforce. This is her first appearance addressing the Alliance. To sign-up, please register here.

• 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 FDA’s Regulatory Affairs Chief, Judy McMeekin. In the many years that the Alliance has run programs, we have never had the Associate Commissioner for Regulatory Affairs (ACRA) as a speaker. Commissioners and Center Directors have always gotten the spotlight. Yet, the Office of Regulatory Affairs (ORA)--overseen by the ACRA and responsible for inspections, compliance, and enforcement—is 20% of FDA’s entire budget (BA + user fees) and more than a quarter of all employees. Despite the scope of ORA, few of us really understand how ORA works, how its priorities are set, and the challenges it faces. Even for those with decades of FDA experience, there will be important things to learn at this webinar. To sign-up, please register here.

FDA Wants You! Seen Around Town. FDA is determined to fill its vacancies. As can be seen in this photograph, they are recruiting every chance and every place they can. Adding to the challenge is that FDA needs specialized talent: chemists, epidemiologists, and statisticians, to name a few.

No Friday Update on July 9. Back on July 16. We wish everyone a restful Fourth of July holiday!