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Advocacy at a Glance

December 11, 2020

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.

CDRH Update and Future Priorities

December 5, 2020

On December 3, 2020, the Alliance was pleased to sponsor a webinar with CDRH Director, Dr. Jeffrey Shuren. … READ MORE …

Advocacy at a Glance

December 5, 2020

Top-Line: CDRH Director, Dr. Jeff Shuren’s remarks at an Alliance webinar are summarized in this week’s Analysis and Commentary. The Alliance joined other advocacy organizations in urging Congress to increase funding for key public health agencies (including FDA). Congress must come to some resolution of FY 21 funding before December 11. Representative Rosa DeLauro is elected chair of the House Appropriations Committee for the 117th Congress. .,, READ MORE …

Time to Give Thanks — Once Again

November 20, 2020

Next week, many of us will be sitting down to a Thanksgiving dinner and talking about the parts of our lives for which we are grateful. Consider adding thanks to FDA and its devoted staff, including the inspectors who never get sufficient credit for the difficulty and potential danger in their jobs. … READ MORE …

Advocacy at a Glance

November 20, 2020

Progress on FY 21 Appropriations. Nothing significant since last week. See our status report and analysis (here and here). … READ MORE …

Where $40 Million Might Go for FY 21

November 13, 2020

The President’s FY 21 budget request, the House-passed bill, and the Senate’s new proposed bill all have a common core of initiatives for FDA to carry out in the new fiscal year. … READ MORE …

Advocacy at a Glance

November 13, 2020

Top-Line: The Alliance announces a post-election webinar on November 23 and a webinar with CDRH Director Shuren on December 3. As described in this week’s Analysis and Commentary, FDA will likely see an increase of about $40 million in FY 21 funding, spread primarily across six program initiatives. The Biden HHS transition team has been named. The Alliance is sending 2021 dues invoices to members this week and next.

Reminder to Media: Friday Update (including the Advocacy at a Glance and Analysis and Commentary sections) is on-the-record. Further, we are always available to both our members and media to answer additional questions. 

Progress on Appropriations; How Much Progress is Unclear. The full Senate Appropriations Committee released all 12 appropriations bills, including Agriculture-FDA on November 10. Even though the committee has not formally approved these bills, they are expected to be used to negotiate a final set of funding bills with the House of Representatives. Going forward, both Speaker Pelosi and Leader McConnell have said they want to complete an omnibus appropriations bill before the end of the year. While the committees remain hopeful of completing action, resolving the many differences between House and Senate bills is a difficult task. 

The current Continuing Resolution runs through December 11, so possible options include: (1) action on funding bills has to be completed by that time, or (2) another short term CR could be passed to allow additional time to finish the FY 21 package, or (3) a longer-term CR will be adopted to take us into a new Congress, and Administration. Possibly running in parallel, Speaker Pelosi and Leader McConnell have recently said they continue to hope to complete another COVID relief bill, but substantial differences remain.  Where the White House is on this issue at this time is an open question. The general prognosis is that the chances of completing action on the COVID-19 relief bill are slim, notwithstanding that the omnibus appropriations bill might be a handy vehicle.

FDA Likely to See $40 Million Increase for FY 2021. The Senate FY 21 Ag/FDA appropriations bill has now been released. It provides a $43 million increase in program initiatives for cross-cutting, medical product, and food safety activities requested by the Administration. Note: the Committee counts this as a $38 million increase because they have accepted an FDA proposal to save $5 million by not extending a supposedly one-time program.
 
The Senate proposed funding levels for FDA are similar to the Administration’s request and the House-passed numbers. Unless there is a full-year Continuing Resolution — which would flat-fund the agency at FY 20 levels — it is reasonable to assume the agency will receive about a $40 million increase for FY 21. Based on the President’s request and the House and Senate bills, there are some specific initiatives that are likely to be funded. Those are discussed in this week’s Analysis and Commentary.

Upcoming Alliance Webinars:

  • November 23 at 2:00 p.m. ET: “FDA Regulation and Healthcare Policy in A Post-Trump World,” a special post-election webinar featuring Kate Rawson, a senior editor at Prevision Policy LLC who has more than 20 years of experience covering the FDA and its regulated industries.
  • December 3 at 2:00 p.m. ET: “CDRH Priorities,” a webinar with Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health. He will be addressing CDRH’s priorities and resource needs. We have asked him to specifically address the Center’s digital health initiatives.

To sign-up to participate in either event, please contact Reed. The events are limited to Alliance members and media. If you are not a member and would like to participate, please contact Steven.

Biden Transition Team for HHS Announced. In an earlier Analysis and Commentary (here), we discussed the stages of Presidential transition that apply whether the President is new or entering a second term. One of the post-election steps is to announce the transition teams for each federal department. Here are the names of the individuals who will serve as President-elect Biden’s HHS transition team.

Invoices for Alliance 2021 Dues Being Mailed This Month. If you are a member and have not received an invoice by November 20, please let us know. While we believe that most of our members have sustained no or little loss in revenue due to the pandemic, we are aware that a few have been severely affected. If this is your case, please contact Steven to discuss how to continue your membership.

What Happens in the Next Few Months?

November 8, 2020

Q: Is FDA funding affected by which party is the majority in the Senate?

A: No. Asked this by media just prior to the election, we responded:

we have no evidence — or reason to believe — that FDA funding levels is a Republican vs. Democratic issue. Our job is to make the case for increased funding. A flip in the Senate majority wouldn’t change that.

To be specific, we would expect Senator Shelby (R) and Senator Leahy (D) to be equally receptive to FDA’s needs, regardless of which is the Chairman and which the Ranking Member of the Senate Appropriations Committee. The same is true of the Ag/FDA subcommittee leaders Senator Hoeven (R) and Senator Merkley (D).

Q: In last week’s Analysis and Commentary, you wrote that “Congress often finds that the disagreements that could not be resolved in September are not much easier to resolve in December.” Has the election changed your view?

A: The situation has gotten more interesting, but probably not much easier. Senate Majority Leader McConnell is now saying he wants to move a COVID-19 deal forward and pass an omnibus appropriations bill. Still, there are a nearly-endless number of barriers to reaching a compromise that the House, Senate, and President Trump can agree upon. Vox has a longer explanation of the permutations here.

The potential for House-Senate-White House alignment on an omnibus appropriations bill is a tad more likely with Senator McConnell on board. The key is that a lot of work has gone on behind the scenes and appropriators have a good track record of reaching agreements and moving legislation along quickly. If Vice President Biden is elected President, then Senate Republicans will probably be more eager to move an omnibus funding bill this year.

Q: A STAT article (here) made the provocative assertion that the cause of science and public health received a significant setback in the election. As evidence for that, the article pointed to the breadth of support for candidates who downplayed the risks of COVID-19 and don’t support public health precautions. Is that a correct interpretation of the election?

A: I don’t think so. As the greatest public health threat in a century and with over 230,000 Americans dead, it would have been reasonable for the election to be focused on combating the pandemic. However, it wasn’t. The article itself points to exit polls that showed just 14% of Republican voters said that the coronavirus pandemic was the deciding factor in who they voted for. In other words, the election was not a referendum on science; voters had other things on their minds.

That said, there is reason for FDA stakeholders to be concerned about rising public mistrust of science and public health, even if that was not the primary message of the election. In the last few weeks, in Friday Update, we have covered some of the polls and surveys that document this trend (e.g., Axios survey, nominally about climate change). Given that the FDA’s primary asset is its scientific expertise, devaluation of that expertise is troubling.

As we face that concern in 2021, the Alliance plans to speak more widely and more persuasively about: (1) the FDA’s central role in our society and (2) the need for policymakers and the public to respect and support the agency’s science-based decision-making process.

Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s Deputy Executive Director, Steven Grossman.