2022 Election Results and Committee Leadership; CR Expectations

• Election Update—Committees of Interest Will See Changes

• Continuing Resolution Expires on December 16 – What Next?

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

• No Friday Update next week for Thanksgiving.

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

• CY23 Invoices Being Sent to Members.

This week’s Analysis and Commentary-The F in FDA, Part 3 explains why advocates should focus on the value and resource shortfalls in food programs. Comparisons to other parts of the agency tell us nothing relevant about what food programs need.

Election Update - Committees of Interest Will See Changes. At this time the Senate will have a majority with 50 (plus VP Harris) Democrats and 49 Republicans, pending the outcome of the Georgia runoff between Senator Warnock and Herschel Walker. The House will have a Republican majority with 218 Republicans and 211 Democrats. Six races remain to be called.

In the House, we expect current chairs and ranking members to flip those positions. We do not expect any changes beyond that for the top leadership of House Appropriations Committee or the House Energy and Commerce Committee.

The one exception is that we expect Congressman Andy Harris (R-MD) will become Chairman of the Agriculture, Rural Development, Food and Drug Administration and Related Agencies Subcommittee. He was previously the Acting Ranking Member (replacing Congressman Jeff Fortenberry, who had resigned).

The Senate Appropriations Committee will have changes in full committee leadership with Senator Patty Murray (D-WA) expected to become Chair, with Senate Susan Collins (R-ME) as Ranking Member. We expect Senators Tammy Baldwin (D-WI) and John Hoeven (R-ND) to retain their Chair and Ranking Member positions on the Agriculture Subcommittee.

Senator Bernie Sanders (I-VT) is in line to become Chair of the Senate Health, Education, Labor, and Pensions Committee. Senator Rand Paul (R-KY)—the likely Ranking Member on HELP has chosen a different assignment. Senator Bill Cassidy (R-LA) is now expected to seek the Ranking Member position on HELP.

OFW Law has provided this linked memorandum providing more details on the election outcome, House and Senate leadership races, and other committee changes.

Continuing Resolution Expires on December 16 – What is Next? Senate Appropriations Chair Patrick Leahy said he and Ranking Member Shelby are close to an agreement on overall spending levels for FY 23, which are essential to getting a final bill on or before December 16. While no specifics are yet available as to what those levels might be – and what other non-appropriation items might be included in that final package – there are less than three weeks left once Congress returns from the Thanksgiving Break.
ICYMI: Stories About FDA That We Read with Interest. In addition to advocacy, the Alliance educates 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:

• Cybersecurity. … FDA released its Cybersecurity Modernization Action Plan; a new Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook from the FDA and MITRE, with updates specifically to address medical device cybersecurity incidents. (Agency IQ). For more on cybersecurity, read about our recent webinar with Dr. Suzanne Schwartz, CDRH’s lead on this topic: here and here.

• FDA Released its final traceability rule. Food Safety News covered it as a news story and then published a commentary by Frank Yiannas, the FDA’s deputy commissioner for food policy and response.

• FDA announced that it has completed the first pre-market consultation for an animal cell-cultured animal. Here is context from The FDA Law Blog (Hyman, Phelps) and from Food Fix (here).

• Regulatory Focus summarized an FDA update on its Emerging Technology Program.

No Friday Update Next Week for Thanksgiving. We will resume on December 2, 2022, to account for Thanksgiving. Enjoy the holiday with your loved ones!

Alliance Webinar on Drug Supply and Shortages: December 1, 2022, at 2:00 PM. To register click here. The Drug Shortages 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.

CY23 Invoices Being Sent to Members. We encourage members to keep their eyes out for their invoice for Alliance 2023 dues.

We have begun sending out its 2023 invoices and we will continue the process into next week. This allows members to pay from their 2022 budgets if they prefer. Otherwise, dues are expected in the first quarter of next year.

If you or your organization has not received yours yet, you will soon. If you don’t have it and need it quickly, let us know by contacting Elisa. Thanks to all for supporting the Alliance.