Senate logjam is easing, fate of pending legislation uncertain; Califf confirmation hearing
Top-Line:
Senate logjam is easing, but fate of pending legislation uncertain
Califf confirmation hearing before Senate HELP set for December 14 at 10 a.m
Alliance Webinar- Director of the Center for Food Safety and Advanced Nutrition, Susan Mayne to discuss FDA’s nutrition initiatives on December 14 at 2 p.m
Why you should sign up to hear CFSAN Director Susan Mayne
Must read on regulation of cell and gene therapies: Dr. Wilson Bryan’s remarks
Analysis and Commentary – Excerpts from Dr. Bryan’s OTAT Webinar
Senate Logjam Is Easing, But Fate of Pending Legislation Uncertain. The potential debt limit crisis was averted this week with an agreement to vote next week on this critical legislation. This opens a path for the Senate to consider other legislation.
As a result, the Senate may yet this year take up the Build Back Better (BBB) reconciliation legislation proposed by President Biden. The Alliance’s interest is in Section 31023 of the House-passed BBB bill, which includes $300 million in no-year money for infrastructure improvements for FDA. Half would go to technology and data modernization and the other half to facilities and physical improvements. The fate of the bill, as well as this specific provision, have not yet been determined.
The Alliance’s most important legislative item is the fate of agency’s FY 22 appropriations, in which the agency is slated to receive at least a $200 million increase in budget authority (BA) funding. Because the current Continuing Resolution (CR) extends through February 18, we do not expect any movement on appropriations bills until at least mid-to-late January.
Califf Confirmation Hearing Before Senate HELP Set for December 14 at 10 a.m. The Senate HELP Committee will hold its confirmation hearing for FDA Commissioner Nominee Dr. Robert Califf on Dec. 14. The hearing is being video-cast here.
The goal of the hearing, as with all confirmation hearings, is to assess the nominee’s suitability for the position and ask a broad-ranging set of questions about the nominee’s intended agenda once in office. Large numbers of questions from Senators are likely to focus on tobacco policy, combatting opioid abuse, and FDA’s role in COVID-19. Dr. Califf is also likely to be asked about his prior tenure at the agency and about the work he has done in the intervening 5 years. Beyond those topics, there are likely to be a range of questions across the breadth of FDA’s jurisdiction and responsibilities. The Alliance hopes that the confirmation hearing reflects the importance of FDA, its resource needs (budget and staff), and the urgency of data and technology modernization.
FDA Has Allies in Preferring Appropriations Bills to CR’s. Politico Pro reported this week on a gathering of top Pentagon officials, lawmakers, and defense experts. One of “the most popular topics of the conference” was that funding under a Continuing Resolution was a threat to our nation’s military readiness and future defense needs. While DOD is vastly different from FDA, they share a common concern that a CR has the effect of reducing available funds from intended appropriations levels, undercuts planning for program and staffing needs, and slows critical programming that need additional resources.
Director of the Center for Food Safety and Advanced Nutrition, Susan Mayne is scheduled to discuss FDA’s nutrition initiatives on December 14 at 2 p.m. The Center for Food Safety and Applied Nutrition (CFSAN) has a budget that exceeds $1 billion per year and has responsibility for the safety of human food, cosmetics, and dietary supplements. The Center is also responsible for fostering good nutrition and healthy eating practices. Dr. Mayne, a respected and widely published former academic from the Yale School of Public Health and the Yale Cancer Center who has led CFSAN since January 2015, will discuss FDA’s nutrition programs and initiatives. Sign up here.
This event is limited to Alliance members and media. However, we encourage guests for this important webinar. If you would like to participate, please contact Alliance Executive Director Steven Grossman
Why You Should Sign Up to Hear CFSAN Director Susan Mayne. Improved nutrition and improved nutritional information constitute broad and important responsibilities of FDA. Nutrition policy is central to our health and well-being and CFSAN’s role in promoting sound nutrition policy isn’t as broadly understood as its work to advance food safety. The Alliance convened a food safety webinar program in June and discussed a variety of food topics in subsequent webinars with Judy McMeekin, the Associate Commissioner for Regulatory Affairs and with Dr. William Slikker, Director of the National Center for Toxicological Research. We’re excited that the next installment of our webinar series on food policy issues and leaders at FDA will feature Dr. Mayne and the Center’s work to promote good nutrition and labeling in the evolving food and beverage marketplace. We believe that anyone who follows the agency will benefit from CFSAN Director Susan Mayne’s discussion of FDA’s nutrition programs and initiatives.
Must Read on Regulation of Cell and Gene Therapies: Transcript of Dr. Wilson Bryan’s Presentation to the Alliance. Our Alliance webinar this week with Dr. Bryan covered current programs, progress in cell and gene therapy, and OTAT’s plans to address its mounting workload. The transcript can be found here. Anybody interested in cell and gene therapy—patients, sponsors, researchers, providers, and payers—will learn something new and useful from reading the transcript. In addition, this week’s Analysis and Commentary (below) contains some excerpts from Dr. Bryan’s remarks and his answers to questions.
More Alliance Webinars Planned for 2022. We Are Open to Suggestions. With Dr. Bryan’s presentation this week and CFSAN Director Susan Mayne’s presentation next week, the Alliance will have offered nine webinars this year, starting with Acting Commissioner Janet Woodcock in April. We plan to do more in 2022, featuring Center Directors and other senior leaders of the agency. We are also open to topical programs, such as this week’s webinar on cell and gene therapies and next week’s on nutrition. If you have suggestions for 2022, please send them to Elisa Bayoumi, who will compile them for review by Alliance leadership.