Patience with Election Results; Congressional Committee Leadership; New Alliance Drug Shortage Webinar
Top-Line
Election Results May Take Time to Resolve.
Changes in Congressional Committees and their Leadership Linked to Final Results.
ICYMI: Stories About FDA That We Read with Interest.
New Alliance Webinar: Valerie Jensen, Associate Director of FDA’s Drug Shortage Staff.
2023 Dues Invoices to be Sent in Mid-November.
The F in FDA: Both Funding and Reforms Needed to Improve Food Programs
This week’s Analysis and Commentary is entitled “The F in FDA: Both Funding and Reforms Needed to Improve Food Programs.” It further develops a theme from the Alliance’s Reagan-Udall Foundation testimony (here) that “the Alliance asking for more resources for food programs is an essential complement to the reforms sought by food stakeholders.” Properly resourcing the food safety and nutrition components of FDA would allow the agency to develop and maintain a system that is intentionally excellent.
Election Results May Take Time to Resolve – A number of Congressional races – especially in the Senate - may be too close to call on election night. The Alliance will provide as much information as possible in the Friday Update, but prudence requires our members to recognize that final outcomes may not be known in every race. We could see challenges, recounts, and perhaps even a runoff that could affect majority status. We will supplement reports as quickly as possible.
Changes in Congressional Committees and their Leadership Linked to Final Results – The Alliance, as part of Friday Update, will provide ongoing information once Congressional majorities and the size of those majorities are determined and organizational activities for the 118th Congress get underway. Committee ratios will be set. Appointments to committees will begin. Committee leadership will be chosen. Most of these activities will begin in December but will not be completed until January. In fact, subcommittee assignments cannot be done until the committees are formally set.
We expect several changes important to the Alliance. We know that there will be a new chair and a new ranking member on the Senate Appropriations Committee regardless of who holds the majority. For the first time, all 4 corners – the chair and ranking of both the House and Senate Appropriations Committees – and the OMB Director will be women. There will be a new Republican leader and possibly a new Democratic leader on the Senate HELP Committee. We expect several new members on the House Appropriations Committee and the House Energy and Commerce Committee. Who chairs and who serves as ranking members on their respective subcommittees will be influenced by the election.
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 FDA’s mission and its growing responsibilities.
We are highlighting a few of this week’s interesting reports on FDA’s activities:
Endpoint News reports that FDA is still not ready to have in-person meetings at White Oak.
Commissioner Califf addressed drug compounding (here and here) at an inter-governmental meeting on drug compounding.
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.
New Alliance Webinar: Valerie Jensen, Associate Director of FDA’s Drug Shortage Staff. The program will be on December 1 at 2 p.m. To register click here. 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, contact Steven. Thanks to all for supporting the Alliance.