Health Update (December 13)
Congress Narrowly Avoids Shutdown
On Friday (Dec. 11), the Senate passed a continuing resolution (CR) to fund the government through next Friday (Dec. 18). The stopgap spending bill was passed by the House on Wednesday (Dec. 9), and will prevent a government shutdown at midnight on Friday.
Lawmakers will now have an additional week to reach an agreement on both a $1.4 trillion, 12-bill spending package, and another COVID-19 relief package prior to the expiration of the current spending bill.
Both House Speaker Nancy Pelosi (D-CA) and Senate Majority Mitch McConnell (R-KY) have indicated they will not release their chambers until an appropriations package is signed, however, an additional CR extending funding through early next year may be necessary.
CBC Issues Statement on 117th Congress Executive Committee
Last Thursday (Dec. 3), Congressional Black Caucus (CBC) Chair Rep. Karen Bass (D-CA) issued the following statement on the election of 117th Congress CBC Executive Committee:
“Under the leadership of Chair-elect Joyce Beatty (OH-03), the Caucus will enjoy it’s largest membership in history, with a record 57 Members forming a body as diverse as the nation,” Bass wrote.
“After four years under one of the most racist and repressive regimes in modern history, the CBC has an enormous opportunity under the Biden-Harris Administration to restore faith in our democracy and show Black Americans the power of their vote. We look forward to the work ahead on behalf of Black America,” she continued.
To view the full statement, click here.
FDA Advisory Committee Recommends EUA for Pfizer Vaccine
Thursday (Dec. 11) evening, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-4 to recommend the FDA issue an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for use in individuals 16 and older.
Over the course of the day, the committee heard from FDA, CDC, and Pfizer representatives to discuss the requirements for issuance of an EUA, plans for vaccine safety and efficacy monitoring, operational distribution strategies, and the continuation of placebo-controlled studies. Additionally, the committee heard presentations on both Pfizer’s and the FDA’s analyses of clinical trial data and plans for further study.
To view an executive summary of the VRBPAC meeting, click here.
VRBPAC’s recommendation is non-binding, however, the FDA traditionally decides to follow the will of the advisory committee. FDA will make a decision on the issuance of an EUA in the coming days.
This week, President-elect Biden announced the following key health nominees, appointees, and advisers:
- Xavier Becerra, Secretary of Health and Human Services (HHS)
- Former House Representative from California
- Chair of the House Democratic Caucus from 2013-2017
- Led the defense of the Affordable Care Act in front of the Supreme Court as California Attorney General
- Dr. Vivek Murthy, Surgeon General
- Served as Surgeon General in the Obama-Biden administration
- Co-Chair of President-elect Biden’s COVID-19 Advisory Board
- Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC)
- Currently serves as Chief of the Division of Infectious Diseases at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School
- Dr. Marcella Nunez-Smith, COVID-19 Equity Task Force Chair
- Dr. Anthony Fauci, Chief Medical Adviser to the President on COVID-19
- He will continue in his role as Director of the National Institute of Allergy and Infectious Diseases
- Jeff Zients, Coordinator of the COVID-19 Response and Counselor to the President
- Natalie Quillian, Deputy Coordinator of the COVID-19 Response
For more on Biden’s health nominees and appointees, click here.
The Biden transition team also announced a slate of domestic nominees and appointees, including:
- General Lloyd Austin, Secretary of Defense
- Retired four-star General with more than 40 years of military service
- Tom Vilsack, Secretary of Agriculture
- Confirmed by unanimous consent in the Senate in 2009 to serve as Secretary of Agriculture, served as secretary from 2009-2017
- Marcia Fudge, Secretary of Housing and Urban Development
- Current representative for the 11th Congressional District of Ohio
- Denis McDonough, Secretary of Veterans Affairs
- Served as White House Chief of Staff, Deputy National Security Advisor, and Chief of Staff of the National Security Council during the Obama-Biden administration
- Katherine Tai, United States Trade Representative
- Served as the chief lawyer for the House Ways and Means Committee
- Susan Rice, Director of the Domestic Policy Council
- Served as National Security Advisor from 2013-2017
- Served as U.S. Ambassador to the United Nations from 2009-2013
To view the Biden-Harris transition website, including a full list of announced nominees, appointees, and White House staff, click here.
HHS Issues Final Rule on 340B Drug Pricing Program
On Thursday (Dec. 10), HHS released a final rule calling on the HHS Secretary to create a panel from a range of agencies, including CMS and HRSA, to oversee the 340B drug pricing program. The panel will be responsible for resolving disputes between hospitals and drug companies in the program.
The rule comes amidst a long-standing fighting between pharmaceutical companies and health care providers, and has been in the works since the passage of the Affordable Care Act (ACA). It is unclear how a Biden administration will handle the rule.
To view the final rule, click here.
Trump Issues EO on Vaccine Prioritization
On Tuesday (Dec. 8), President Trump issued an executive order (EO) entitled “Ensuring Access to United States Government COVID-19 Vaccines.” The EO calls for American citizens to have priority access to free, safe, and effective COVID-19 vaccines and states the U.S. will only facilitate international distribution after domestic vaccination needs are met.
Questions remain as to how the order will be enforced, as many vaccine manufacturers have already reached agreements with other countries. When asked how the EO would work during an interview on Good Morning America, Operation Warp Speed (OWS) chief scientist Moncef Slaouni was unable to provide any information.
“I don’t know, and frankly, I’m staying out of this,” Slaouni responded.
To view the EO, click here.
Forgey, Quint, “‘I literally don’t know’: Operation Warp Speed scientist can’t explain Trump’s vaccine order,” Politico, 8 Dec. 2020.