Legislative Update; Safer Food Supply Basics: Whole Genome Sequencing
Top-Line:
Legislative Update
Safer Food Supply Basics: Whole Genome Sequencing
Upcoming Alliance Webinars – On November 15 (Oncology Center of Excellence),
December 6 (FDA gene therapy programs), and December 14 (FDA nutrition programs) - details below
Upcoming 2022 Dues Invoice from the Alliance for a Stronger FDA
Analysis and Commentary – Taxpayer Funding through Appropriations and User Fees: Both Important but Serve Different Purposes
Legislative Update. Congress was not in session this week. The House and Senate both return on Monday, November 15. Because of the impact or potential impact on FDA, we are tracking annual appropriations, reconciliation, and ARPA-H.
There is no visible progress on the appropriations bills. In the meantime, the end of the Continuing Resolution (CR) on December 3 is looming large, especially with Thanksgiving break coming up. An extension of the CR seems inevitable. The primary roadblock is House and Senate agreement on total discretionary spending and subsequent allotments to each subcommittee. Even if an unlikely agreement is reached soon, it will take at least a couple of weeks to resolve House/Senate differences at the program level, construct an omnibus bill, and pass all the procedural hurdles.
The Ag/FDA Appropriations Bill provides a good example of House and Senate disagreement on Appropriations. The House and Senate positions on Ag/FDA programs are nearly $700 million apart from each other, out of a total House allotment of about $26.5 billion to all Ag/FDA programs. Reportedly, Appropriation Subcommittee staff are trying to preconference House and Senate bills, but it is clear why final bills cannot be constructed until that sizable gap is resolved with a single House/Senate number.
The revised House Reconciliation Bill - H.R. 5376, the Build Back Better Act – continues to provide $300 million for FDA infrastructure that was not in previous versions of the bill. Section 31023 of the modified Build Back Better Act provides $150,000,000 for “improving technological infrastructure, including through developing integrated systems and improving the interoperability of information technology systems,” and $150,000,000 for “modernizing laboratory infrastructure of, or used by, FDA, including modernization of facilities related to, and supporting, laboratory infrastructure, including through planning for, and the construction, repair, improvement, extension, alteration, demolition, and purchase of, fixed equipment or facilities.” The House may take up this bill during the week of November 15, but this is dependent on certain House members being satisfied with the available budget scoring information. The Senate will likely make changes in this bill before taking final action.
The pending Labor-HHS Appropriations bills include funding for ARPA-H. House appropriators have set-aside $3 billion and the Senate appropriators $2.5 billion. These funds cannot be spent until the House Energy and Commerce Committee and the Senate Health Committee authorize the agency and that legislation becomes law. The Alliance has no position on the bill, but remains committed to ensuring that FDA has the necessary resources to be the full partner and ensure ARPA-H’s success.
Safer Food Supply Basics: Whole Genome Sequencing. In 2013, the FDA created the GenomeTrakr Whole Genome Sequencing Network (WGS), which sequences and makes available the isolates of known food pathogens. It is a scientific tool that helps the FDA detect, investigate, and limit the spread of foodborne illness outbreaks. As reported in Food Safety News, an FDA study published this month found the annual health benefit of the WGS Network was nearly $500 million in 2019, a number that should grow as the WGS databases become more robust.
Upcoming Alliance Webinars. The Alliance is pleased to host FDA leadership to address the Alliance members and media in these upcoming webinars.
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 the 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
Director of the Office of Tissues and Advanced Therapies (OTAT) Wilson Bryan, MD is scheduled for December 6 at 10 a.m. OTAT is the division of CBER that regulates cell, tissue, and gene therapies as well as therapeutic vaccines for various disease indications. Dr. Bryan’s office is at the frontline of guiding and evaluating a rapidly growing portfolio of cutting-edge medical products, many of which are first in class. Sign up here.
Director of the Center for Food Safety and Advanced Nutrition, Susan Mayne is scheduled to discuss FDA nutrition initiatives on December 14 at 2 p.m. FDA is responsible for fostering good nutrition and effective food safety practices. It is one of the most important FDA function that is not product-based. Dr. Mayne will be discussing FDA’s nutrition programs and major initiatives. Sign up here.
Why You Should Sign Up to Hear Dr. Kluetz. Our next webinar, on November 15, is with Dr. Paul Kluetz, Deputy Director of the FDA’s Oncology Center of Excellence (OCE). The Center was created in January 2017, with the goal of bringing together oncology scientists and reviewers from all the products centers. Subsequently, several Centers of Excellence (COE) have been created, notably in digital health. Dr. Kluetz will be discussing some of OCE’s accomplishments and initiatives, as well as the strengths and weaknesses of the COE model.
Non-members interested in participating in any of these events should contact Alliance Executive Director Steven Grossman at: sgrossman@strengthenfda.org.
Keep an Eye Out for 2022 Dues Invoices from the Alliance for a Stronger FDA. The Alliance will be sending out its dues invoices for 2022 during the week of November 15. We choose this time of year because many of our members want to pay their dues from 2021 funds, while other prefer to wait for January 1 and pay from their 2022 budgets. If you have not received your invoice by November 19, please let us know.