Collins Leaves Big Shoes to Fill at NIH

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.

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:

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.

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. 

ARPA-H, the Proposed Agency to Transform Biomedical Research

The internet.  GPS.  The computer mouse.  These are some of the technological innovations made possible by the Defense Advanced Research Projects Agency (DARPA), a Defense Department agency tasked with advancing research and development of science and technology programs.  Now, the Biden administration wants to replicate DARPA’s success in biomedical research with a newly proposed entity called Advanced Research Projects Agency for Health (ARPA-H). 

What Is ARPA-H?

The Biden administration’s Fiscal Year (FY) 2022 budget request provided a $6.5 billion investment for APRA-H, which would be directed to drive “transformational innovation” in health research and speed application and implementation of health breakthroughs.  The initial focus of ARPA-H would be cancer, disabilities, and Alzheimer’s disease.  According to a concept paper provided by the White House, examples of projects that could be pursued by ARPA-H include:

  • mRNA vaccines to prevent most cancers.
  • Molecular “zip codes” that target drugs only to specific tissues and cell types, to eliminate serious side effects.
  • Highly accurate, inexpensive, wearable monitors for blood pressure and blood sugar that provide real-time data to patients and providers.
  • Holistic systems that eliminate racial disparities in maternal morbidity and mortality rates and premature births.
  • A process to design, test, and approve a vaccine against any newly emerging human virus in 100 days.

The National Institute of Health (NIH) further explains that ARPA-H will predominantly focus on “time-limited” projects with goals, metrics, and accountability.  It also states that the director of ARPA-H will be selected based on having a “proven innovation and partnership-building track-record,” and ARPA-H program managers will be recruited from industry, academia, or other sectors based on “scientific vision, judgement, and management skills.”

ARPA-H is also included in the Cures 2.0 discussion draft that was released by Reps. Diana DeGette (D-CO) and Fred Upton (R-CO).  However, the discussion draft is still a work in progress, and it contains far fewer details on the proposed agency than those provided by the Biden administration. 

How Would ARPA-H Advance Biomedical Research?

Ideally, ARPA-H would need many of the same authorities used by DARPA to accomplish its mission to delivery breakthroughs in biomedical research.  Key authorities would include:

  • The ability to hire individuals rapidly based on “a unique skill set” outside the typical civil services hiring system and pay those individuals a competitive wage, as well as the ability to recruit experienced program managers from the private sector. 
  • Broad, flexible funding authority that make it possible to mix and match the best ideas with minimal bureaucracy that allow for projects that can be funded for multiple years or don’t necessarily fit into one-year intervals.
  • Exemptions from the traditional review process for biomedical research, which can take up to 18 months or longer, to get from an idea to a scientific review before the actual work begins.

According to a July 26 Federal News Network interview with NIH Director Francis Collins, an ARPA-H with “some new authorities” could make a difference for experimental drugs that show a lot promise during clinical trials but fail to attract investment from pharmaceutical companies due to an experimental products being perceived as too risky or having a limited market share.  In these cases, Collins explained ARPA-H could chose to invest in certain experimental drugs and hand them over to the private sector when necessary.

The Structure of APRA-H

The Biden administration has stipulated that ARPA-H would be a “distinct division” within NIH, with a “unique culture and organization.”  However, some medical experts have argued ARPA-H should be a stand-alone entity within the Department of Health and Human Services (HHS), including a former chair from DARPA’s advisory committee, who suggested NIH’s approach to research and innovation is too time-consuming and bureaucratic.  In response, Collins told The Washington Post in mid-June that putting ARPA-H outside of NIH would be a big mistake because it would lead to “administrative duplications” and preclude the chance for ARPA-H program managers to develop synergy with their colleagues at NIH.  While the Cures 2.0 discussion draft has yet to define ARPA-H’s structure and home, Collins has said that DeGette and Upton are leaning towards having the new agency withing NIH.

Collins also threw cold water on the notion that ARPA-H could create internal jealously within NIH in his Federal News Network interview by countering that many NIH employees are excited about the prospect of a new research agency and that “unfriendly competitiveness” exists in other parts of the government.  It’s worth noting that the administration’s FY 2022 budget request includes a major increase in NIH funding rather than diverting away funds to create a new agency. 

Next Steps

APRA-H only becomes a reality when FY 2022 appropriations bills are signed into law, and the FY 2022 appropriations process has gotten off to a slow start.  The House passed an appropriations minibus for FY 2022 on July 31 that includes $3 billion for ARPA-H, while the Senate only began reviewing its FY 2022 spending proposals on August 2. , Notably, the proposals to create a new biomedical research agency been favorably viewed by members of both parties, meaning ARPA-H is unlikely to be cut from the legislation. However, given lawmakers’ slow progress on appropriations and long list of other items that require their attention in the next 60 days, all FY 2022 spending measures are unlikely to be finalized by the end of the FY 2021 on September 31.  This means NIH may not be able to take the first steps in building up ARPA-H until Congress finalizes the FY 2022 appropriations bills later in the fall or winter.

Once FY 2022 funding is squared away, Collins hopes to hit the ground running.  In his Federal News Network interview, the NIH director said he hopes to recruit 50-100 program managers for the agency’s first year, with results on research projects expected in the following one to two years as ARPA-H continues to “staff up and ramp up.”  Collins also projected to have 50-60 projects going at ARPA-H by the end of FY 2022, assuming all FY 2022 spending bills are enacted by December 2021.