Temporary Truce in the Budget/Debt Limit Wars; FY 22 Appropriations Bills Still Hostage.
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Temporary Truce in the Budget/Debt Limit Wars; FY 22 Appropriations Bills Still Hostage.
HHS Strategic Plan Released; Comments Due by November 7.
White House Office of Science and Technology Policy Seeks Input on National Strategic Plan for Advanced Manufacturing.
Upcoming Alliance Webinars - FDA Chief Scientist Denise Hinton and NCTR Director William Slikker October 15, 3:00-4:00 PM ET; Oncology Center of Excellence Deputy Director Paul Kluetz November 15, 3:30-4:30 PM ET.
Why Sign Up to Hear from Rear Admiral Hinton and NCTR Director Slikker
Alliance Webinars Scheduled for December - December 6 at 10 a.m., Wilson Bryan, MD, the Director of the Office of Tissues and Advanced Therapies, at CBER; December 14 at 2 p.m., Susan Mayne, Director of the Center for Food Safety and Advanced Nutrition,
Analysis and Commentary - Q&As About the Appointment of a New FDA Commissioner
Temporary Truce in the Budget/Debt Limit Wars; FY 22 Appropriations Bills Still Hostage. With the Continuing Resolution running through December 3 and a stop-gap truce on the debt limit showdown, it is a time of hope for the appropriations process. Despite the many impediments, appropriators want to finish the FY 22 bills. The intervening 8 weeks should be sufficient time for final bills to be negotiated. What is still missing is a final budget agreement, determining total discretionary spending levels and empowering the Appropriations Committees to lock-in their subcommittee allocations. Even if appropriators agree on a substantial percentage of the allocations within a funding bill, it cannot be finalized until negotiators know what total they have to spend.
Since most of this work will be going on behind the scenes, there may be little to report even if progress is being made. We know that the House has passed a $257 million increase in budget authority (BA) funding for FDA and the Senate Appropriations Committee has adopted a $200 million increase. Although we prefer the larger number, any compromise between those two numbers will provide the agency with a needed boost in funds. Meanwhile, under the CR the agency can only spend at the FY 21 funding and new program starts are limited.
HHS Strategic Plan Released; Comments Due by November 7. HHS has published its strategic plan for 2022-2026 (here) and requests comments by November 7. The primary area of interest to FDA stakeholders is likely to be “Strategic Goal 4: Restore Trust and Accelerate Advancements in Science and Research for All.” This goal covers the following objectives: 1/ Improve the design, delivery, and outcomes of HHS programs by prioritizing science, evidence, and inclusion, 2/Invest in the research enterprise and the scientific workforce to maintain leadership in the development of innovations that broaden our understanding of disease, healthcare, public health, and human services resulting in more effective interventions, treatments, and programs, 3/ Strengthen surveillance, epidemiology, and laboratory capacity to understand and equitably address diseases and conditions, and 4/ Improve data collection, use, and evaluation, to increase evidence-based knowledge that leads to better health outcomes, reduced health disparities, and improved social well-being, equity, and economic resilience
White House Office of Science and Technology Policy Seeks Input on National Strategic Plan for Advanced Manufacturing. Several years ago, FDA sought and received funding to become more involved in the adoption of advanced manufacturing of FDA regulated products. The initiative was predicated on the opportunities to bring manufacturing back to the United States for economic reasons, national security reasons, and to help lessen the specific problem of drug shortages. All these concerns have been magnified during the COVID-19 pandemic and FDA remains involved. A larger view, in the form of a National Strategic Plan for Advanced Manufacturing, is being developed by the White House Office of Science and Technology Policy. Public input is being sought (here) with comments due by December 17.
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 FDA Centers. 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.
Hold These Dates: Alliance Webinars Scheduled for December. On December 6 at 10 a.m., the Alliance will be hosting a webinar with Wilson Bryan, MD, the Director of the Office of Tissues and Advanced Therapies, at CBER. His office is the front-line in the development of gene therapies. On December 14 at 2 p.m., the Alliance will host Susan Mayne, Director of the Center for Food Safety and Advanced Nutrition, who will be discussing FDA’s nutrition programs and major initiatives. Sign-up links will appear in next week’s Friday Update.
The Week’s Analysis and Commentary Looks at the Nomination of a New FDA Commissioner (see below).