Insights^

Francis Collins announced plans to retire from his role as Director of the National Institutes of Health (NIH) on October 5.  This is a big deal for the Biden administration, as this leaves another crucial leadership position vacant, as the administration still has not nominated a Commissioner for the Food and Drug Administration (FDA).

Brief background: The Staunton, Virginia native first came to NIH in 1993 to serve as Director of the National Human Genome Research Institute, a role he held for 15 years.  Under his leadership, the institute made landmark discoveries of disease genes and contributed to the international Human Genome Project, which for the first time fully mapped all genes of the human genome.  Collins was later nominated to lead NIH under then-President Barack Obama and was confirmed by the Senate in 2009. (pongsak-clinic.com)

Why is he retiring?  Even though a public health emergency is still ongoing, Collins told reporters that his “hour-to-hour oversight” is no longer as necessary now that three vaccines are out and case numbers are declining nationwide.  According to reports from Politico, Collins initially wanted to quit last winter, but National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci convinced him to stay on a little while longer.

It wasn’t a spur of the moment decision.  Collins said he had been thinking about retirement for the past 3-4 months.  By making the decision now, Collins hopes to facilitate a smooth transition for the next NIH director.

Who’s taking over?  Principal Deputy Director Lawrence Tabak, number two at NIH, is most likely to serve as acting director in the interim.  But it’s unclear if he’s in the running for the top job – Collins said in an October 5 interview that he wants a woman to succeed him.  The only certainty is that Fauci won’t be the next NIH director – he’s already said no to the role.

Whoever takes over will have big shoes to fill.  During his decade-plus at the helm of NIH, Collins:

• Overhauled NIH Clinical Center in 2016.
• Opened the NIH Translational Science Center (now the National Center for Advancing Translational Sciences) in 2012.
• Oversaw initiatives like Precision Medicine Initiative, the NIH BRAIN Initiative, and the Cancer Moonshot.

And whoever becomes the next NIH director has plenty of challenges to look forward to, including:

• Leading the agency though the next (and hopefully final) phase of the pandemic.
• Shaping the development of the Advanced Research Projects Agency, or ARPA-H.
• Overseeing clinical trials for COVID-19 treatments.
• Defending the administration’s public health policies and handling of the  pandemic on Capitol Hill.

It’s also worth noting that Francis Collins is a bit of a Renaissance man.  Here are some of his other accomplishments outside of leading the world’s largest medical agency.

• Early in his career, Collins served as a physician volunteer in a rural missionary hospital in Nigeria.
• He is an Evangelical Christian who has written several books about spirituality and the intersection between science and religion.
• Collins plays guitar in a band, consisting of current and former NIH senior staff, called the Affordable Rock ‘n’ Roll Act (ARRA).  They perform at NIH events to raise money for the agency.
• He is a motorcycle enthusiast and owns a Harley-Davidson.
• Collins was appointed to the Pontifical Academy of Sciences by Pope Benedict XVI in 2009.

Collins won’t be the NIH director anymore, but he isn’t leaving NIH.  In fact, he’s planning to return to his laboratory at the National Human Genome Research Institute.

Walensky Overrides CDC Advisory Panel, Approves Booster Doses for At-Risk Workers

Late Thursday, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky  took the unusual step of overriding a recommendation from the Advisory Committee on Immunization Practices (ACIP) on whether adults aged 18-64 with frequent exposure to the virus should receive a COVID-19 booster shot.  While ACIP members felt there is not enough data to show that boosters are necessary for at-risk workers like nurses and teachers, Walensky said providing boosters for these individuals would help the US prepare for the “next stage in the pandemic.”  She also pointed out that the decision would align the CDC with an FDA decision made earlier this week on boosters for high-risk workers.  Walensky did however approve other recommendations made by ACIP to allow individuals over age 65 and people with chronic health conditions to receive a third booster dose.

Pfizer Releases Vaccine Data for Kids, J&J Posts Booster Shot Data

Pfizer announced on September 20 that a two-dose regiment of its COVID-19 vaccine administered three weeks apartment generated a strong immune response in children aged 5-11, according to topline results from a phase 2/3 clinical trial.  The trial used a third of the vaccine dose that is currently approved for people 12 and older.  Pfizer plans to file the full results to the FDA soon, teeing up an emergency use authorization for children within the next several weeks.  The following day, Johnson & Johnson announced that a second “booster” dose of its single-dose COVID-19 vaccine generated a strong immune response.

House Advances Doomed Appropriations, Debt Ceiling Bill

On September 21, the House approved legislation to fund the federal government through December 3, 2021 and suspend the debt ceiling through December 22, 2022.  The combined appropriations-debt ceiling bill, which passed on a 220-211 party line vote, could be considered in the Senate as soon as Monday, September 27.  However, the measure is certain to fail in the upper chamber due to a lack of support from Republican Senators.  Instead, Republicans are urging Democrats to pass a debt ceiling suspension by attaching it to the human infrastructure package , which Democrats say is not possible due to “parliamentary obstacles.”  Government funding expires on October 1, while Treasury Secretary Janet Yellen says the government could begin to default on its debt sometime next month.

CMS Final Rule Extends Open Enrollment, Boosts User Fees

In its third part of its 2022 Notice of Benefit and Payment Parameters rule, the Center for Medicare and Medicaid Services (CMS) finalized proposals to extend the open enrollment deadline for Affordable Care Act (ACA) plans through January 15, 2022 and create a new monthly special enrollment period geared toward low-income individuals.  The final rule also increases the user fee for 2022 to 2.75% for insurers in the federally run exchange and 2.25% for state-based exchanges..  According to CMS, the user fees are intended to support consumer outreach activities, including the Navigator program.

ICYMI: Capitol Fence Goes Up, Capitol Fence Goes Down

Metal fencing that was erected in advance of a rally last Saturday went down almost as quickly as it came up.  The rally, which was organized to support the hundreds of people arrested for the January 6 riot, ultimately attracted more law enforcement and news media than actual protestors.  Work crew began to disassemble the fencing on Sunday afternoon, and by Monday afternoon, the fencing was completely gone.