Advocacy at a Glance

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).