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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.

Advocacy at a Glance

November 8, 2020

Top-Line: This week’s Analysis and Commentary tries to sort through some of the knowns and unknowns about the election’s impact on FDA resources. HHS has issued a regulatory sunset rule, for which comments are due quickly with the intent to promulgate the rule by January 20. The impact of who is the majority party in the Senate, the Presidential transition, and progress in food safety are addressed. … READ MORE …

Whether There Is or Whether There Isn’t

October 31, 2020

Q: What rules govern a presidential transition?

A: The statutes governing presidential transitions date to 1963, including the most recent update, the Presidential Transition Enhancement Act of 2019 (signed into law by President Trump on March 3, 2020.) These require a series of progressive steps that begin 6 months before Election Day and end after the inauguration. These include designation of:

  • A White House Transition Coordinating Council,
  • Agency Transition Directors; and
  • Individuals to serve as “points of contact’ within each agency. 

As Election Day draws closer, the work escalates inside the Administration with preparation of briefing books, issue papers, and interactions with the non-incumbent candidate(s) transition groups.

Q: What is happening now?

A: Much of this activity is happening in the shadow of a hard-fought campaign and receives little attention from the general public. According to the statute, the General Services Administration (GSA) plays a coordinating role, providing funding and office space to the non-incumbent candidate(s) transition teams. In the era of Covid-19, however, that work is proceeding remotely.

By the end of September:

  • Agencies must complete succession plans for non-career positions in the agency.
  • The incumbent Administration must complete a Memorandum of Understanding (MOU) with the non-incumbent candidate(s) regarding a host of logistical items.
  • Campaigns must provide detailed ethics plans to govern their teams during the interim between Election Day and Inauguration Day.
  • OPM must provide quarterly reports on current political appointees attempting to “burrow in” (transfer to civil service status).
  • The Comptroller General of the United States (the leader of GAO) must identify “midnight regulations” (regulations created by executive branch agencies in the lame duck period of an outgoing president’s administration).
  • Agencies must identify key priority decisions needing to be made in the opening weeks of a new term and issues demanding immediate attention.

Q: Does any of this matter if the incumbent wins?

A: Yes. History shows that up to 50 percent of an Administration’s key political appointees leave in the period between the election and the first 6 months of a second term (year 5). At a minimum, the transition documents serve as a starting point for new political appointees coming on in year 5. Thoughtful transition plans also provide assessment of first term successes and failures, an update on priorities, and reevaluation of difficult issues that were not addressed during a first term.

Q: What happens if Biden wins?

A: “Landing parties” arrive at each agency before the Inauguration to plan the actual transfer of authority and begin the process for filling political appointments.

Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s law firm, Olsson, Frank, and Weeda.

Advocacy at a Glance

October 31, 2020

Top-Line: After the election, it is expected that Congress will take up both another COVID-19 relief bill and FY 21 Appropriations bills. Prospects are discussed. An Alliance webinar with CDRH Director Dr. Jeffrey Shuren is announced and sign-up is available to Alliance members and media. Erosion in support for scientific expertise is described. This week’s Analysis and Commentary examines Presidential transitions that occur whether the incumbent is re-elected or there is a new incoming President. A reminder to reporters: the entirety of Friday Update is “on the record.”

Pandemic-Related Aid and Delayed Appropriations: to Be Resolved Together in Lame Duck?  Post-election sessions tend to over-promise and under-deliver. Congress often finds that the disagreements that could not be resolved in September are not much easier to resolve in December. Nonetheless, the current expectation is that, during the post-election session, Congress will pass a multi-trillion-dollar omnibus bill that combines massive additional COVID-19 relief with FY 21 appropriations bills.

There is lots of room to wonder how likely that is. The House and the White House continue to be far apart on the relief bill. Further, Senate Republicans seem largely uninterested in any compromise that might emerge from the Pelosi-Mnuchin talks.

The prospects are somewhat better for passing appropriations bills before the CR expires on December 11. However, there is a remarkably large way to go in a short period of time (e.g., Senate bills have not even been released). An extension of a CR into February or March of 2021 must be considered the most likely outcome. However, 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.

Alliance Webinar with CDRH Director Dr. Jeffrey Shuren Announced. The Alliance is pleased that Dr. Shuren, Director of the Center for Devices and Radiological Health has accepted our invitation to a webinar on Thursday, December 3 from 2:00 to 3:00 p.m. ET. He will be addressing CDRH’s priorities and resource needs and we have asked him to specifically address the Center’s digital health initiatives. To sign-up to participate, please contact Reed Diskey. The event is limited to Alliance members and media. If you are not a member and would like to participate, please contact Steven Grossman.

Pandemic Has Increased Public Skepticism About Scientific Expertise. For policymakers and the American public, FDA’s greatest strength is its reliance on science-based decision-making. Yet, a new set of focus groups conducted and reported in Axios (here) finds that the pandemic has increased the skepticism of many Americans about science and scientists. The context of the findings was climate change, but any decrease of public confidence in science should be of concern to both FDA and its stakeholder community.

Proposed Revisions to Civil Service Rules Likely to Undercut Science-Based Decision-making.  Executive Order 13957, “Creating Schedule F in the Excepted Service”, issued by President Trump this week, would increase the ability of the executive branch to fire federal employees who are in “positions of a confidential, policy-determining, policy-making, or policy-advocating character not normally subject to change as a result of a Presidential transition.” There is not a public comment period on the executive order. Agencies are required to conduct a preliminary review to identify such positions by January 19, 2021 and provide a final list by next mid-July.

According to the terms of the Executive Order (EO), FDA’s review of its personnel would need to include those who have substantive participation in the development or drafting of regulations and guidance, and those involved in viewing, circulating, or otherwise working with proposed regulations, guidance, Executive Orders, or other non-public policy proposals or deliberations. The EO will probably go into effect if President Trump is re-elected; withdrawn if Biden is elected. There is also the possibility of Congress acting to block the Executive Order and federal unions have already filed lawsuits. The Alliance’s law firm, Olsson, Frank, and Weeda, has examined the EO in more detail ​(here).