Election Status Update; Alliance Webinar on Drug Supply Shortages

• Election Status Update – No Majorities… Yet.

• ICYMI: Stories About FDA That We Read with Interest.

• Alliance Webinar on Drug Supply and Shortages: December 1, 2022, at 2:00 PM.

• 2023 Dues Invoices to be Sent in Mid-November.

• The F in FDA: Part 2.

This week’sAnalysis and Commentaryis a continuation of last week’s “The F in FDA: Both FundingandReforms Needed to Improve Food Programs” (availablehere). It builds on the Alliance’s Reagan-Udall Foundation testimony (here). This week’s installment explores CFSAN and CVM resource needs, an area we expect to be of concern to Congress in 2023 and prominent in the Alliance’s FY 24 “ask.”

As a special note,today’s Friday Update arrives on Veterans Day and the Alliance takes this opportunity to thank all veterans, including our members, their staff, and their families who have helped preserve our democracy. To all our veterans, we wish you a happy Veterans Day.

Election Status Update – No Majorities… Yet.As we prepare this report, neither the House nor the Senate have formally achieved a majority for the 118thCongress.

It is expected that the House will have a Republican majority. Although ABC News has confirmed this, Politico has suggested there is still a narrow and unlikely path by which a Democratic majority is still possible. It is unclear when that will be resolved, presumably within the next few days. Further action regarding House leadership, committee ratios, committee assignments, and committee leadership has not been scheduled.

The Senate stands at 48 Democrats and 49 Republicans with Arizona, Georgia, and Nevada still unresolved. The Georgia race will go to a runoff on December 6, meaning we may not know the Senate majority until that race is settled. The ultimate winner in Alaska has not been determined, but the top two candidates are both Republican. However, we are not indifferent to the Alaska race, since Senator Murkowski is on the Appropriations Committee.

ICYMI: Stories About FDA That We Read with Interest.In addition to our advocacy for increased resources for FDA, the Alliance continuously pursues its other objective: educating policymakers and media about the breadth of FDA’s mission and its growing responsibilities. As part of that, we are highlighting a few of this week’s interesting reports on FDA’s activities:

• On November 7, 2022, the FDA met its obligation to send the FSMA Final Rule: Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal Register (OFR) by the November 7, 2022, deadline. Publication is managed by the OFR, and the FDA anticipates publication within one or two weeks after submission. Meantime, Food Safety News published an extensive review of the proposed rule, which may differ from the final rule to be published.

• The FDA laid out its recommendations for sponsors planning to study multiple versions of a cellular or gene therapy in a clinical trial for a single disease. RAPS Regulatory Focus

• The Interagency Food Safety Analytics Collaboration’s (IFSAC) newest annual report , “Foodborne illness source attribution estimates for 2020 for Salmonella, Escherichia coli O157, and Listeria monocytogenes using multi-year outbreak surveillance data, United States,” is now available.

• Remarks at an Association of Accessible Medicines conference by FDA officials, discussing biosimilars and interchangeability (Endpoint News)

• Renewed efforts by NIH to contact institutions about unreported clinical trial results. (STAT)

• FDA announced a two-day virtual hearing (December 7-8) to provide pharmaceutical distribution supply chain stakeholders an opportunity to share perspectives on DSCSA implementation.

• FDA has scheduled a Grand Rounds lecture on November 17 to deliver an overview of augmented and virtual reality technology and of the landscape of potential medical applications.

Alliance Webinar on Drug Supply and Shortages: December 1, 2022, at 2:00 PM. Clickhereto register. The FDA’s Drug Shortage Staff (DSS) is a program within the Center for Drug Evaluation and Research (CDER). It was established to address potential or actual shortages of drugs that have a significant impact on public health. Through communication, facilitation, and negotiation, DSS works with pharmaceutical manufacturers, review divisions, compliance, and other components of FDA to manage product shortages.

2023 Dues Invoices to be Sent in Mid-November. The Alliance will be sending out its 2023 invoices during the weeks of November 7 and 14. This allows members to pay from their 2022 budget if they prefer. Otherwise, dues are expected in the first quarter of next year. If you prefer to start sooner, contact Elisa and she will send you an invoice. If you have questions about the Alliance and dues, contactSteven. Thanks to all for supporting the Alliance.