Advocacy at a Glance
Top-Line: House mark-up continues good prospects for FDA in FY 22. The Alliance reacts positively to the House Subcommittee mark for FDA. Upcoming Webinars - Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin, July 14; CDRH Director Jeff Shuren, July 22.
House Mark-Up Continues Good Prospects for FDA in FY 22. Today (June 25), the House Appropriations Ag/FDA Subcommittee marked-up their bill for funding FDA and agriculture programs. Full committee mark-up is slated for next Wednesday, June 30. A number of details will not be clear until the draft committee report is released next week at the full committee mark-up. However, here is the subcommittee’s summary of its actions on 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."
This week’s Analysis and Commentary is a chart the Alliance created that shows the BA allotments by line item based on the House subcommittee bill. Because these are derived numbers rather than those given to us by the subcommittee, they are believed to be accurate but cannot be assured.
The Alliance’s Positive Reaction to the House Subcommittee 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 subcommittee. 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 to invite FDA leadership to address the Alliance membership and media:
Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin (July 14, 1:30-2:30 PM ET). The monies for field programs—about $1.2 billion in FY 21-- are spread throughout the agency 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 the 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 always get the spotlight. Yet the Office of Regulatory Affairs, overseen by the ACRA, is quietly responsible for 20% of FDA’s entire budget (BA + user fees) and more than a quarter of all employees. The Alliance talks about FDA’s central role in medicine’s “bench to bedside” and food’s “farm to table.” At different points, many parts of FDA are involved. However, the part of FDA that is always involved is ORA, through inspections, compliance, and enforcement activities. Yet 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.
Alliance Holds Webinar with FDA’s Food Safety and Animal Health Leadership. On June 16 the Alliance hosted a webinar to spotlight FDA’s responsibilities and plans as they relate to food and animal health. During the sixty-minute presentation, members heard from Deputy Commissioner for Food Policy and Response Frank Yiannas, CFSAN Director Susan Mayne, and CVM Director Steven Solomon who fielded questions from members. In case you missed it, please take a look at the transcript and watch the video from the webinar. You can also check out FoodDive’s coverage of it here.
