FDA Commissioner and CBER Director Provide Insights on Vaccines at Alliance Briefing

Top-Line: Commissioner Hahn and CBER Director Marks briefed the Alliance on COVID-19 vaccines this week, which is discussed more fully in this week's Analysis and Commentary. The House passed legislation to extend the Continuing Resolution until December 18, but timely passage in the Senate is in doubt. FDA fares much better if the Ag/FDA appropriations bill becomes law.FDA Commissioner and CBER Director Provide Insights on Vaccines at Alliance Briefing. The Alliance was privileged to have a briefing by Commissioner Hahn and CBER Director Marks on December 9, just ahead of FDA advisory committee meetings on COVID-19 vaccines that occurred on December 10 and will occur on December 17. They did not comment on specific applications, but rather provided a number of insights into the process. The briefing is described further in this week’s Analysis and Commentary.Appropriations: Compromises Difficult in September May Be No Easier in December. Intentionally, this is the same heading as we used last week. Since then, negotiations have advanced, but only far enough that the “most-difficult-to-compromise” issues are now at the forefront. To provide enough time for those to (possibly) be resolved, the House passed another CR that will continue government funding until December 18.However, as reported by The Hill newspaper (here), the CR extension has been caught up in a scheduling mess in the Senate and may not pass the Senate before the current CR runs out on Friday (December 11) at midnight. We know from past Congressional brinksmanship that most government employees who are working on Saturday and Sunday are in categories exempt from a shutdown. Serious damage from a shutdown wouldn’t start until Monday.However, breaking the logjam would not resolve any of the difficult issues, it just buys time for that process to continue. On the good side: the Appropriations Committees have a track record of being able to resolve and move legislation quickly.Continuing Resolution vs. Omnibus Legislation: How Does FDA Fare? If FDA continues to be funded under a CR, agency spending is kept at the FY 20 level. This might also effect new initiatives and programming and personnel planning. If the Ag/FDA appropriations bill becomes law -- either as stand-alone or more likely as part of an omnibus -- the agency is most likely to get about a $40 million increase. With a few slight differences, this is the number in the Administration request for FY 21 and the House and Senate bills. The likely distribution of those funds is discussed in a recent Analysis and Commentary (here).Do Budget Caps Still Matter? Yes. The threat of automatic sequestration is gone. However, budget limits will continue to be set and, in most years, exert downward pressure on what appropriations committees can spend. Under the Congressional Budget and Impoundment Control Act of 1974, the House and Senate are expected to agree on a Budget Resolution by April 15 for the next fiscal year. However, that approach was broken before the Budget Control Act of 2011 set annual budget caps for a decade and created the threat of automatic sequestration if caps were breached. Thus, there is no prior approach to fall back on. No one knows how budget limits will be set for FY 22 and thereafter. It may devolve to the House and Senate setting different ceilings, and resolving aggregate spending levels in conference.Digital Media RFP Released by Alliance, Bids Are Welcome. The Alliance is seeking assistance in overhauling its website and improving its digital media visibility. Accordingly, the Alliance released an RFP earlier this month. The deadline for responses is December 30; however, proposals will be reviewed on a rolling basis as they come in. If you are interested in receiving the RFP, please contact Reed Diskey.Alliance 2021 Invoices Sent to Members. By now, every current Alliance member should have received an invoice for their 2021 dues, allowing payment with either 2020 or 2021 funds. If you have not received an invoice, please contact Reed. If you have questions about your invoice or would like to join the Alliance, please contact Steven Grossman.