Advocacy at a Glance

Top-Line: Senator Tammy Baldwin is the new Chairwoman of the Senate Ag/FDA appropriations subcommittee. Reconciliation is advancing and includes $500 million to support FDA’s COVID activities. Confirmation hearings will be held next week for Xavier Becerra, the President’s nominee to run HHS. Here in this week's Advocacy at a Glance we also look at the breadth of FDA responsibilities covered in this week’s media. This week's Analysis and Commentary is devoted to “FDA exceptionalism” based on the continuing growth of FDA’s mission. Supportive words are noted from House E&C Health Subcommittee Chairwoman Anna Eshoo.

Senator Baldwin to Chair Ag/FDA Appropriations Subcommittee. Democrats on the Senate Appropriations Committee announced a series of changes in leadership and committee assignments. For the Alliance, the key change was that Senator Tammy Baldwin (D-WI) has been named Chairwoman of the Ag/FDA Appropriations Subcommittee, replacing Senator Jeff Merkley. The Alliance congratulates Senator Baldwin and looks forward to working with her to assure the FDA has the resources to meet its many and growing responsibilities. Her interest in FDA is well-known and a perfect match for her new role.

Reconciliation Slowed; Mid-March Enactment Still Planned. The House Budget Committee’s consolidation of the reconciliation bills from each House Committee has taken a bit longer than expected. However, House Democrats are still committed to pass the bill late next week and have it over to the Senate in the first week of March. The target is to have the bill signed into law by March 14, when various emergency benefit programs expire. The Alliance’s interest is in the $500 million in no-year money to support FDA’s COVID-19 efforts. It is contained in the provisions from the House Energy and Committee and we are optimistic that it will remain in any final version.

HHS Secretary Nominee to Face Confirmation Hearings February 23 and 24. Next week, former CA Attorney General and Congressman, Xavier Becerra, will face confirmation hearings before the Senate HELP Committee (February 23) and the Senate Finance Committee (February 24). Only Senate Finance is responsible for moving his nomination to the floor, but both days are critical to his confirmation. While there have been rumors of a Senate floor fight over Mr. Becerra, it is unclear whether that will materialize or whether it will have any effect on his taking office sometime in March.

The Incredible Breadth of FDA’s Responsibilities. This week featured several news stories reflecting FDA’s broad jurisdiction, which includes overseeing products that are 20% of all US consumer spending ($2.6 trillion pre-pandemic). For example, FDA named its first head of medical device cybersecurity (here); responded to questions about lead and other toxic elements in baby food (here); participated in federal efforts that seized 10 million phony N95 masks (here); and marked personalized medicine advances that included 3D printed ankle implants for a rare bone disease (here), and a 46% complete remission rate for a CART-T product for a type of blood cancer (here).

Next week’s headlines will be different, but likely to be equally reflective of the wide impact achieved by agency actions. In acknowledgment, this week's Analysis and Commentary looks at the size and breadth of FDA and concludes: FDA is exceptional among federal agencies and its growing responsibilities require a budget that grows.  

Supportive Words from Congresswoman Eshoo. During the House Energy and Commerce Committee mark-up of its reconciliation bill, Health Subcommittee Chairwoman Anna Eshoo made a number of points in support of the $500 million in no-year money to support FDA’s COVID-19 activities. Notably, she described FDA as “chronically under-funded and under-resourced​.” Representative Eshoo’s remarks were during Day 1 of the mark-up and begin at 5:46:00 of the video from that session (here).

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"FDA Exceptionalism," Redux (Again)

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FDA-related Provision of House Reconciliation Bill