Continuing Resolution prevent shutdown, but delays decisions; ARPA-H is a work in progress
Top-Line:
Kicking the FY 22 Can down the road.
ARPA-H is a work in progress.
Alliance webinars with FDA Chief Scientist Denise Hinton and NCTR Director William Slikker are scheduled for October 15, 3:00-4:00 PM ET, and with Oncology Center of Excellence Deputy Director Paul Kluetz is scheduled for November 15, 3:30-4:30 PM ET.
Strong reason to sign up to hear from Rear Admiral Hinton and NCTR Director Slikker.
Analysis and Commentary – Q&As on FDA funding allocations.
Kicking the Can Down the Road — FY 22 Edition. The FY 22 Continuing Resolution passed Congress on September 30, narrowly avoiding a government shutdown that would have started at 12:01 a.m. on October 1. Because of the agency’s multiple funding streams, several different personnel systems, and vital mission to protect public health and safety, a larger part of FDA would have continued to work compared to other public health agencies. However, 70% of the FDA workforce could never cover the entire agency’s responsibilities. Because of missing colleagues and support services and a significant blow to morale, the inefficiencies would be great even for those not furloughed.
Fortunately, Congress voted yesterday on a CR that funds the government through December 3. There are no guarantees that this brinksmanship will not repeat itself again at that time.
While a shutdown is the worst case for FDA, funding under a Continuing Resolution is a good scenario only by comparison. Between now and the expiration of this CR, FDA will: 1/ be limited to spending the same amount as it had available for FY 21; 2/ face limitations on the initiation of new programs; and 3/ have a degree of uncertainty in implementing its year-long plan for programs, personnel, and purchases. While we all believe there will eventually be a final Ag/FDA appropriations bill containing a positive increase in funding for FDA (House + $257 million; Senate + $200 million), for now the agency must proceed as if a year-long CR with flat funding might be the eventual result.
A Work in Progress: ARPA-H. As we have previously reported, the President proposed the creation of an “Advanced Research Projects Agency for Health, but provided few details.” The new agency would be modeled on the much-admired Defense Advanced Research Projects Agency (DARPA), which has greatly benefitted defense efforts and spun-off numerous projects that have benefitted civilian life. When the House marked up the FY 22 Labor-HHS, it set aside $3 billion in no-year money to fund ARPA-H, conditional upon the passage of authorizing legislation. When the House Energy and Commerce (E&C) Committee marked up its FY 22 reconciliation bill (read Friday Update here) it included $3 billion for ARPA-H and provided authorizing language that covered only some of the basic issues of how the new agency would be run. It is our understanding that the E&C Committee is developing and planning to move forward with an authorizing bill that would provide far more detail.
Meantime, the White House Office of Science and Technology Policy and NIH ran a series of fifteen listening sessions during July and August to help the Administration formulate ideas for the core mission and implementation of ARPA-H. The White House just released a report (here) summarizing some of the major finding from those sessions. A further session is now scheduled for October 20, from 2:30 to 4 p.m., to hear further response to the summary and provide opportunities for additional recommendations. Registration information is here.
Upcoming Alliance Webinars. We continue to invite FDA leadership to address the Alliance membership and media.
FDA Chief Scientist Denise Hinton and NCTR Director William Slikker are scheduled for October 15, 3:00-4:00 PM ET. The Office of the Chief Scientist at FDA is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The National Center for Toxicology Research (NCTR) conducts scientific research to generate data for FDA decision making and develops and supports innovative tools and approaches that FDA uses to protect and promote individual and public health. Alliance members and media can register here.
Oncology Center of Excellence Deputy Director Paul Kluetz is scheduled for November 15, 3:30-4:30 PM ET. The FDA Oncology Center of Excellence leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, devices, and diagnostics. The Center helps expedite development of medical products for oncologic and hematologic malignancies and supports an integrated approach to their clinical evaluation. Alliance members and media can register here.
Non-members wishing to participate in either event should contact Alliance Executive Director Steven Grossman at: sgrossman@strengthenfda.org.
Why Sign Up to Hear from Rear Admiral Hinton and NCTR Director Slikker? We hear the most about the Centers and their decisions. Less public attention is paid to the many offices charged with supporting and coordinating the activities of the Centers. The Office of the Chief Scientist is a hub of such activities. Among other responsibilities, the Chief Scientist oversees staff engaged in the agency’s Advancing Regulatory Science Initiative, FDA's Technology Transfer Program, scientific professional development, scientific integrity and the Medical Countermeasures Initiative (MCMi). It is in the latter capacity that Rear Admiral Hinton has become a central figure in the EUA’s that have been issued by the agency in response to the COVID-19 pandemic.
By far the largest organization falling under the Office of Chief Scientist is the National Center for Toxicological Research. NCTR conducts scientific research to generate data for FDA decision making and develops and supports innovative tools and approaches that FDA uses to protect and promote individual and public health. NCTR is a go-to agency for both food and medical product regulators. This is NCTR’s 50th anniversary and its focus and accomplishments are described here.