Advocacy at a Glance

Top-Line: Acting Commissioner Woodcock testifies on FY 22 Budget. The Alliance applauds the President’s FY 22 Budget Request for a $343 million increase in Budget Authority (BA) Funding. A webinar with FDA’s food and animal health leadership will be held on June 16. A webinar with Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin will be held on July 14 and a webinar with CDRH Director Jeff Shuren will be held on July 22. The annual report from FDA’s Office of Surveillance and Epidemiology shows 2.2 million Adverse Events Reports sent to FDA in 2020.
 

Acting Commissioner Woodcock Testifies on FY 22 Budget. Dr. Woodcock’s testimony, before the Senate Appropriations Committee’s Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies, was the first opportunity for FDA to discuss the President’s FY 22 Budget Request and the $343 million increase in BA (taxpayer) funding he has proposed. Her testimony is here and video of the hearing is available here. While she covered a range of topics, she emphasized data and technology modernization, strengthening core medical product and food safety programs, and addressing public health issues. Between opening statements at the beginning and questions at the end, it was clear that the subcommittee is supportive of FDA and has a good understanding of the agency and its needs. This week’s Analysis and Commentary examines the content of the hearing and where it positions FDA in its quest for additional investments by Congress in FY 22.
 
Alliance Applauds President’s FY 22 Budget Request for $343 million Increase in BA Funding. The Alliance is pleased with the President’s Budget Request and urges Congress to adopt its increase of $343 million in BA appropriations for FDA in FY 22. Accordingly, the Alliance submitted testimony for the record in the House on June 1 (attached). We have followed up with letters to the 65 House and Senate offices that we met with in April and May, providing an updated version of our one-pager (attached).
 
Last Chance: Webinar with FDA’s Food and Animal Health Leadership. For Alliance members and media: Please join us for a virtual presentation on June 16 from 11:30 AM-12:30 PM ET by Deputy Commissioner for Food Policy and Response Frank Yiannas, CFSAN Director Susan Mayne, and CVM Director Steven Solomon. To sign up, please register here. This will be the first opportunity for the Alliance to hear these speakers address their priorities in the context of the President’s FY 22 budget request. For those wanting additional background, see this recent article by Frank Yiannis (here).
 
Other 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 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, the Associate Commissioner 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 address them. 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.
 
2.2 Million Adverse Events Reports Sent to FDA in 2020. The annual report from FDA’s Office of Surveillance and Epidemiology (OSE) highlights that “adverse event reports made to FDA have more than doubled since 2013 and now total more than 2.2 million reports annually.” A wealth of insight can be gleaned from these reports, and more would be possible under FDA’s Data Modernization Action Plan and Technology Modernization Action Plan. More information on these initiatives can be found here and here. More generally, initiatives involving real world evidence and artificial intelligence are dependent on the agency having larger, more accurate databases that talk with each other. This is a central component of the President’s FY 22 Budget Request.
 
Implanted Brain-Computer Interface Devices for Patients with Paralysis or Amputation: Upcoming FDA Webinar. As part of our case for increased FDA funding, the Alliance often points out that no federal agency’s mission is more affected by changes in science, technology, innovation, commerce, and social trends than FDA. This is illustrated by an upcoming (July 29) FDA webinar to help stakeholders learn more about the agency’s final guidance on “Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations.” More information is here. This is just one of many areas of innovation that FDA supports through guidance and stakeholder meetings.