Advocacy at a Glance

Top-Line: The Senate has taken up the COVID relief reconciliation bill and is expected to be done before March 8, assuming the Senate will work this weekend if necessary. At stake is $500 million in no-year money to support FDA’s COVID-19 related work. These monies will not cover the costs of non-COVID programs at FDA that continue to grow. HHS Secretary-designate Becerra’s nomination advanced out of committee and a floor vote is expected either the week of March 8 or 15. The President announced a new government-wide initiative to strengthen critical supply chains, including a number of areas under FDA’s jurisdictions. Details and impact on FDA are discussed in this week’s Analysis and Commentary.Senate Takes Up COVID Reconciliation Bill; Should Finish This Weekend. As of Friday morning (March 5), the Senate has taken up consideration of the $1.9 trillion COVID relief bill. A final vote is expected this weekend. The target is still to have the bill on the President’s desk before March 14, the day upon which many existing relief provisions would otherwise lapse.The Alliance’s interest is in the $500 million in no-year money to support FDA’s COVID-19 efforts. The monies were in the House-passed bill and are in the 500+ page Senate bill. We expect it will remain in the Senate bill and therefore not be subject to revision as part of the Conference Committee. If enacted, it would be by far the largest Congressional acknowledgement of the pressures and costs that the pandemic has imposed on FDA. We thank FDA’s Congressional champions for their continuing support of the agency’s pivotal role in this unprecedented health crisis.Reconciliation Monies for COVID Work “Necessary But Not Sufficient” to Meet FDA’s Funding Needs. Having the agency’s COVID-related resource needs covered by reconciliation -- which is extremely important -- does not lessen the budget and personnel needed to fulfill the agency’s mission and carry out its responsibilities. COVID apart, FDA’s mandate in FY 22 will be larger than it was in FY 20 or FY 21. This is covered in more depth in the last two weeks' Analysis and Commentary pieces(here and here).Becerra's Nomination for HHS Secretary Advances; Senate Vote Likely Next Week. HHS Secretary-Designate Xavier Becerra’s nomination moved out of the Senate Finance Committee this week on a tie-vote. In the case of a tie, the Majority Leader is permitted to schedule a floor vote. That vote is expected sometime during the week of March 8.Issues raised at Becerra’s confirmation hearing (here) were repeated at the mark-up and resulted in the committee voting along party lines. Some portion of the objections to Mr. Becerra focus on his lack of a health or scientific background, an issue addressed in last week’s Analysis and Commentary (here), which showed that most HHS Secretaries have had government or academic leadership roles and only three also had medical degrees.Refresher on FDA Terminology. A hat tip to Politico’s Agency IQ Newsletter for its reminder that FDA is very precise in the language it uses. Specifically, they point out that

510(k) applications are cleared, not approved. Biologics are licensed, not approved. EUAs are authorized, not approved. INDs are allowed to proceed, not approved.

Shortening Supply Chains Now a Presidential Priority. The pandemic has highlighted how key parts of the US economy are dependent on foreign supplies -- whether finished products or raw ingredients. In response, President Biden issued an Executive Order (here) on February 21, 2020. There was an accompanying fact sheet (here). This week’s Analysis and Commentary looks at the Executive Order and considers its implications for current and future FDA activities.