December 14, 2021

Secretary of Health and Human Services Xavier Becerra recently announced that Francis Collins, M.D., Ph.D., will step down as NIH Director on December 20 and that NIH Principal Deputy Director Lawrence Tabak, D.D.S., Ph.D., will assume the role of Acting NIH Director. Dr. Collins announced in October that he would vacate the role at the end of the year but did not specify a date.

AAI President Gary Koretzky, M.D., Ph.D., issued a statement on behalf of AAI in October expressing appreciation to Collins “for his dedicated leadership at NIH” and “wish[ing] him the very best as he begins the next chapter of his career.” More recently, Dr. Koretzky sent a letter expressing similar sentiments directly to Collins.

Koretzky also sent a congratulatory letter to Dr. Tabak that offered AAI assistance on issues of mutual concern. Tabak has served as the NIH Principal Deputy Director and Deputy Ethics Counselor since 2010 and was previously Director of the National Institute of Dental and Craniofacial Research (2000-2010). Over the years, he has generously participated in several AAI activities, most recently speaking at a policy session sponsored by the AAI Committee on Public Affairs (CPA) at IMMUNOLOGY 2018™ entitled “Town Hall Meeting on NIH Efforts to Fund the Next Generation: Progress, Challenges, and Future Directions.”

Tabak’s current position of NIH Principal Deputy Director will be filled by Tara Schwetz, Ph.D., who will assume the role in an acting capacity. Dr. Schwetz is the Associate Deputy Director at NIH and spent much of this year on detail to the White House Office of Science and Technology Policy, where she has played a leading role in advancing the development of President Joe Biden’s proposed new entity, the Advanced Research Projects Agency for Health (ARPA-H).

President Biden is expected to nominate a permanent replacement for Collins in the coming months. That nomination will require confirmation by the Senate.

December 14, 2021

In early December, President Joe Biden signed into law a continuing resolution (CR) that funds the federal government through February 18, 2022. The CR, which was approved by both the House and Senate the previous day, funds federal departments, agencies, and programs at roughly last year’s levels. The new law averts a potential government shutdown.

Under the CR, the fiscal year (FY) 2022 NIH budget remains at its FY 2021 level of ~$42.9 billion. In an October Notice outlining its operating plan under a CR, NIH announced that, per its usual practice, it would fund non-competing research grant awards at “generally up to 90% of the previously committed level.” In addition, NIH Institutes and Centers often set conservative interim paylines until a final funding bill has been approved.

Enacting a full-year appropriations bill is particularly important for NIH this year as the agency stands to receive a large funding increase. President Biden’s proposed $52 billion budget for NIH for FY 2022, the House’s approved $49 billion budget for NIH, and a Senate Appropriations Committee draft bill with a $47.9 billion budget for NIH all represent a generous increase over the FY 2021 budget. In each of these bills/proposals, funds would be allocated to support both the regular operations of NIH and to establish ARPA-H.

FASEB has created an e-action alert that allows individuals to easily contact their Members of Congress and urge them to finish the annual appropriations bills and provide robust funding increases for NIH and other federal sciences agencies. We encourage AAI members to participate in this important call to action.

December 14, 2021

President Biden recently announced a plan outlining nine actions that his Administration is taking to continue fighting COVID-19 amid a recent spike in cases and deaths in the U.S., the emergence of the omicron variant, and with the winter months ahead.

The plan focuses on actions to encourage booster shots for all who are eligible. Efforts include expanding pharmacy availability, a public education campaign with a special focus on seniors, and targeting Medicare beneficiaries. In order to protect children and keep schools open, the plan includes the establishment of hundreds of family vaccination clinics and the review of school COVID-19 prevention policies.

Biden also announced steps to increase availability of rapid, at-home, over-the-counter COVID-19 tests. Those with private insurance will be able to receive reimbursement for at-home tests, while those without insurance can access tests through key community sites like health centers.

The plan also includes enhancing public health protocols for safe international travel by requiring inbound international travelers to test within one day of their departure and extending mask requirements on all international and domestic flights. Biden has also called on businesses to require COVID-19 vaccinations or weekly testing.

To help control infection rates and outbreaks this winter, the federal government will create more than 60 winter COVID-19 emergency response teams that can be deployed to states in need, provide $20 million in funding from the American Rescue Plan to strengthen the Medical Reserves Corps, and lead an effort to mobilize volunteers. Federal agencies will also secure and supply antiviral treatments as they become available and distribute them equitably

December 14, 2021

In early November, AAI issued a statement endorsing S.2888, the U.S. Air Travel Public Safety Act. This legislation, which was introduced by Senator Dianne Feinstein (D-CA), requires passengers on domestic flights to either, 1) be fully vaccinated against COVID-19, 2) provide proof a negative pre-departure COVID-19 test (within three days of the flight’s departure, or 3) provide documentation of recent recovery from COVID-19 (within the last 90 days). In addition, the legislation requires the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices to “review data on the transmission of COVID-19 in health care settings and among health care personnel in other settings, and to develop and make recommendations for COVID-19 vaccine use” based on its findings.

A press release issued by Senator Feinstein includes more details about the bill, including background information that led to its development. Other organizations supporting the bill include the American Public Health Association, the American Society for Microbiology, and the Infectious Diseases Society of America.

On November 11, Senator Feinstein co-authored a letter to President Biden with Representatives Don Beyer (D-VA, 8th) and Ritchie Torres (D-NY, 15th), urging him “to put in place requirements for airline passengers to provide proof of full vaccination against COVID-19 or a negative test to board a domestic flight.” The letter was also signed by 33 Democratic members of the House of Representatives.

AAI will closely monitor this legislation as it moves forward.

December 14, 2021

AAI was pleased to participate once again in the annual Rally for Medical Research Capitol Hill Day (Rally Hill Day), which was held this year on September 23, 2021. Rally Hill Day brings together a wide range of stakeholders, from academia to patient advocates to the pharmaceutical and biotechnology industries, for the common goal of advocating for increased funding for NIH. AAI has supported Rally Hill Day, both financially and through the participation of members and staff, since its inception in 2013.

For the second year in a row, all meetings with Members of Congress and their staffs were conducted virtually, some by video and some by phone. This enabled broad participation from across the country, with more than 400 participants from 46 states and the District of Columbia, who altogether met with more than 280 congressional offices. AAI was officially represented by seven individuals: AAI Committee on Public Affairs (CPA) Chair Peter E. Jensen, M.D. (AAI ’87); CPA members Tullia C. Bruno, Ph.D. (AAI ’17); Lauren I. Ehrlich, Ph.D. (AAI ’02); and Joshua J. Obar, Ph.D. (AAI ’05); former AAI CPA member Ling Cao, M.D., Ph.D. (AAI ’08); AAI Director of Public Policy and Government Affairs Lauren G. Gross, J.D.; and AAI Manager of Science Policy and Legislative Affairs Jake Schumacher.

Participants this year delivered three primary messages to Capitol Hill, the first being a well-deserved “thank you” to Members of Congress for their support for NIH, which has led to robust funding increases for six consecutive years. Attendees also stressed the importance of continuing that momentum by asking Congress to provide NIH with a budget increase of at least $3.5 billion for its regular operations for fiscal year (FY) 2022 (excluding any funding that might be provided to launch ARPA-H). Finally, participants asked for congressional support of an AAI-endorsed bill, the Research Investment to Spark the Economy Act, which would authorize $10 billion in supplemental funding for NIH specifically to help trainees and scientists whose research was interrupted by the pandemic.

December 14, 2021

The White House recently released its plan for transforming the nation’s pandemic preparedness infrastructure to better prepare for, and respond to, future pandemics and other biological threats. The 10 year, $65.3 billion plan, entitled “American Pandemic Preparedness: Transforming our Capabilities,” lays out goals under 5 pillars:

“I. Transforming our Medical Defenses, including dramatically improving and expanding our arsenal of vaccines, therapeutics, and diagnostics.

II. Ensuring Situational Awareness about infectious-disease threats, for both early warning and real-time monitoring.

III. Strengthening Public Health Systems, both in the U.S. and internationally to be able to respond to emergencies, with a particular focus on reducing inequities and protecting the most vulnerable communities.

IV. Building Core Capabilities, including personal protective equipment, stockpiles and supply chains, biosafety and biosecurity, and regulatory improvement.

V. Managing the Mission, with seriousness of purpose, commitment, and accountability akin to the Apollo mission, which brought our astronauts to the moon decades ago.”

This plan is the result of President Joe Biden’s request, at the very start of his term, for an in-depth review of U.S. pandemic response capabilities, taking into account lessons learned from the COVID-19 pandemic and the reasonable likelihood that another pandemic, potentially more serious and deadly, could occur in the U.S. in the near future. The plan lays out optimistic yet reasonable goals that would allow the U.S. to respond rapidly and efficiently to any pandemic or biological threat, even if vastly different from COVID-19. The administration is hopeful that some initial funding for the plan will be included in the Build Back Better Act (the budget reconciliation bill).

December 14, 2021

President Joe Biden announced the members of the President’s Council of Advisors on Science and Technology (PCAST) in September. Comprised of experts and leaders in science and technology ranging from agriculture to neuroscience to cybersecurity, PCAST serves as a body of external advisors who make policy recommendations to the President and the White House on matters of science, technology, and innovation. This year’s roster is described as the “most diverse PCAST in U.S. history”: women comprise half, and people of color and immigrants comprise more than one-third, of PCAST. In addition, for the first time since its inception, not just one but two of the three co-chair positions are filled by women.

PCAST held its first meeting on September 28-29, 2021, on “Strengthening U.S. Science and Technology Global Leadership for the 21st Century” and “The State of U.S. Preparedness & Public Health as Revealed by the Pandemic.” The agenda, speaker biographies, presentations, and recording can be viewed here.

December 14, 2021

NIH and the White House Office of Science and Technology Policy (OSTP) held a series of “Listening Sessions” over the summer to solicit feedback from stakeholders on the proposed Advanced Research Projects Agency for Health (ARPA-H). There were 15 sessions in total, with some via invitation only and others open to the public. Each session was organized around particular biomedical science topics in order to collectively hear from interested stakeholder and community groups.

ARPA-H would support high-risk, high reward research that aims to advance human health through bold innovation and acceleration of research breakthroughs. The listening sessions sought to garner input regarding current areas of opportunity as well as some of the barriers to accelerating biomedical research breakthroughs. More than 5100 stakeholders, including almost 250 organizations across academia, industry, patient advocacy, philanthropy, and other sectors, provided feedback and comments through the listening sessions. This press release summarizes common themes around the two following main areas that came out of the listening sessions:

“Scientific Portfolio
* Ensure the programs ARPA-H develops complement NIH’s existing research portfolio, as well as other biomedical research funders, and does not duplicate it.
* Elevate the importance and criticality of addressing health inequities and promoting health equity across all aspects of ARPA-H – from the people it hires to the programs it develops.
* Advance technologies and platforms that are broadly applicable across the spectrum of biomedical and health research and avoid focusing on disease-specific programs.
* Accelerate data accessibility, integration, interoperability, sharing, standards, and tools, and leverage artificial intelligence (AI) in creative ways.
* Focus on de-risking commercialization and translation to push products closer to market in areas with high unmet need and that are not well-supported by industry to bring new therapeutic and diagnostic options to patients rapidly.

Process
* Integrate the community, patients, and their providers early in the program development process to ensure the end-users’ perspectives are considered in program design and implementation.
* Promote and prioritize multi-disciplinary collaboration and partnerships – from drawing in scientists from other disciplines (e.g., physics, economics, sociology) to working with industry, academia, non-profits, and others.”

NIH and OSTP held a follow-up listening session on October 20, 2021, from 2:30 p.m. – 4:00 p.m. Eastern Daylight Time, to give stakeholders another opportunity to learn more about the ARPA-H proposal and provide feedback.