MEMORANDUM

To: Interested Parties

From: Crossroads Strategies

Re: Departments of Labor, Health and Human Services, Education, and Related Agencies Subcommittee - National Institutes of Health (NIH)

Date: Tuesday, November 19th

On Tuesday, November 19th, the Departments of Labor, Health and Human Services, Education, and Related Agencies Subcommittee held a hearing regarding the National Institutes of Health (NIH). The link to the full video can be found here. 

Witnesses

The Honorable Monica M. Bertagnolli – Director of the National Institutes of Health 

Opening Statements

Rep. Robert Aderholt (R-AL):

• I appreciate the scientific research and investments made at NIH, particularly in gene immunotherapy, early stages of diabetes prevention, and diagnostic testing.
• I am disappointed that NIH is the only entity within the HHS that has not released an assessment or acknowledgment regarding failures in the COVID-19 pandemic response.
• I would urge NIH to prioritize rebuilding public trust and confidence in its nonpartisan, objective basic science.
• There has been significant funding given to NIH, as it is important that America remains a world leader in research and innovation.
• I am concerned that China's Thousand Talents Program and outsized investments in biomedical research, could be a threat to U.S. national interest.
• NIH needs to protect the security of data and intellectual property and to combat foreign interference at research institutions.
• I do not approve of the distribution of NIH funding, with 10% of institutions receiving 75% of the funding. This is unacceptable.
• I support the efforts to increase funding for lower-resource institutions and expand the base of schools receiving basic research grants.
• I would like to encourage NIH to avoid controversial research agendas and focus on rebuilding public trust.
• The NIH is operating under an expired authorization that calls for a comprehensive evaluation of the institution's structure.
• I am disappointed in the lack of progress in reforming NIH and calls for a departure from the status quo, but I am looking forward to proposals to help the agency move forward in the new Congress.

Ranking Member Rosa DeLauro (D-CT):

• I appreciate the leadership of Dr. Monica Bertagnolli, the first surgeon and second woman to hold the position of director of NIH, and her contributions to the field of clinical oncology.
• Dr. Bertagnolli's has focused on expanding NIH's life-saving research to more places and patients, especially in rural communities.
• There is a bipartisan effort to increase funding for NIH research by nearly 60% from 2015 to 2023, and the passage of another bipartisan bill for 2024 to support research into various diseases.
• I am concerned about the delay in finalizing the LHHS Appropriations bill and the potential negative impact of CRs on government agencies.
• I would urge my Republican colleagues to negotiate on appropriations bills to address issues such as border security, public safety, and extreme weather.
• As an ovarian cancer survivor, I understand the importance of advances in cancer research.
• I am committed to addressing the mental health crisis in our country and the need for research to understand and treat mental illness.
• I am looking forward to hearing about progress in treating various diseases and health conditions.
• The President's Budget for FY25 requests a total of $49.8 billion in discretionary funding for the NIH, an increase of $1.2 billion.
• I am opposed to the House Majority's proposal to overhaul the NIH through the annual appropriations process, advocating for a bipartisan and bicameral approach.

Monica Bertagnolli, M.D.:

• I appreciate the funding provided to NIH in FY24 and the inclusion of NIH funding in the FY25 bill.
• NIH awards nearly 60,000 new grants supporting more than 300,000 researchers at over 2,700 institutions across the nation annually.
• NIH contributes to nationwide innovation in biomedical research, supports the economy, and the next generation of researchers.
• NIH laboratories are delivering answers to questions about gene replacement, immune system function, and tissue and organ replacements.
• A top priority is to regain trust lost during COVID by better communicating information about the research and its benefits to all Americans.
• Several programs are in place to engage people across the country, including the NIH Engage Initiative, the NIH Community Engagement Alliance, and Care for Health.
• A new network involving all NIH institutes and centers was established in less than a year.
• NIH aims to integrate all that is learned from laboratories, clinics, and communities, with data playing a crucial role.
• There is a need to expand the National Library of Medicine to advance data use, data analytics, and data science.
• There are high rates of maternal mortality, Alzheimer's disease, and substance use disorders across the country.
• The 2025 PB represents support to address these critical needs and other important programs.
• There is always a need for continual improvement and an importance of working with the Scientific Management Review Board and Congress to drive operational and administrative advances.
• NIH-supported discoveries have benefited all, and continued support is crucial for the mission to help all people live longer and healthier lives.

Questions

Rep. Robert Aderholt (R-AL): 

• What are your thoughts on the proposed reorganization of the NIH's 27 institutes and centers into 15 institutions, and do you believe that everything at NIH is working as it should?
  • Bertagnolli: Learning how to adapt in a changing world is important. There has been increased collaboration between different institutes and centers at NIH. I am concerned about the potential loss of visibility and trust from specific disease groups and constituencies if the institutes and centers collapsed 

Ranking Member Rosa DeLauro (D-CT): 

• What strategies can be undertaken to increase the inclusion of women in research studies and the inclusion of both sexes in all preclinical studies? Where do we need breakthroughs in women's health? Where should we be targeting our resources to improve women's health?
  • Bertagnolli: The Office of Women's Research on Women's Health has been reassessing women's health and identifying areas where progress is lacking, such as maternal health, menopause, endometriosis, and polycystic ovary disease. Since 2017, all clinical trials and research projects are required to report the sex of the participants, and most programs have more women than men participating. Pre-clinical research also considers sex as a biological variable.
• What kind of progress are we making to help Americans struggling with mental health? What are we discovering about the brain or our genetics or environmental factors? How is the NIH ensuring that research discoveries are being translated into treatment and mental health care that's improving people's lives?
  • Bertagnolli: The National Institute of Mental Health has received increased funding and is coordinating efforts to understand the fundamental biology and genetic basis of disease, the role of society in mental health, and the delivery of quality mental health care. The BRAIN Initiative is driving new research by providing unprecedented imaging of the brain. Public-private partnerships are also being leveraged for the development of new treatments and therapies. The two greatest areas of opportunity are better science for new treatments and better societal support for mental health care.

Rep. Mike Simpson (R-ID): 

• How does the National Institutes of Dental and Craniofacial Research (NIDCR) contribute to advancing oral health research and improving dental care outcomes? What makes its work impactful in the broader field of healthcare? Are there emerging fields that the institute is particularly focused on? How might the proposed consolidation of the NIDCR into a new National Institute on Neuroscience and Brain Research affect the U.S.'s standing in oral health research and the research budgets?
  • Bertagnolli: Oral health is a significant indicator of overall health. The NIDCR's work is impactful because it informs all of health, not just oral health. Many cancers first express themselves in the oral cavity, and the NIDCR is working across NIH on these issues. The proposed consolidation will not create silos but will allow for more collaboration across different fields.
• What plans are in place to restore the credibility of the NIH?
  • Bertagnolli: Trust is earned by solving problems that people need to have solved and by communicating effectively about how the NIH's work is relevant to them. The NIH plans to be in every community, partnering with the public and making them part of what the NIH does. The NIH also plans to have an active speaker bureau across the country to engage with various organizations and communities.

Rep. Mark Pocan (D-WI): 

• Has any drug come to market in the last year that hasn't had support from NIH?
  • Bertagnolli: I cannot think of any such drug.
• Why do we pay 15 times the price for drugs in the U.S. than we do in Canada or Europe?
  • Bertagnolli: I cannot answer that question, but there is a plan where at the time of licensing a technology developed with NIH funding, a discussion is held with the company partner about how the drug will be accessible to the American people.
• What can we do about the high cost of certain drugs, such as a childhood muscular atrophy treatment that costs $2.1 million and isn't covered by many insurance companies?
  • Bertagnolli: Everyone should receive the benefits of what NIH has contributed to and I would be proud to work across all of the government to make that happen.
• What can we do in the next year to solve the issue of high drug costs?
  • Bertagnolli: NIH plans to start delivering more out of their pipeline of gene therapies for rare diseases, manufacture and test them within the clinical center at NIH, and then hand them over to the for-profit sector with strict terms that the people who need them can access them.

Rep. Andy Harris (R-MD): 

• Does NIH have a scientist who specializes in studying diet-related diseases?
  • Bertagnolli: The perception that NIH does not have a scientist who specializes in studying diet-related diseases is incorrect. Nutrition is fundamental to health and every institute or center across NIH has research that touches on nutrition.
• Is it true that NIH does not have a scientist in the Office of Nutrition Research who specializes in studying diet-related diseases?
  • Bertagnolli: I am unsure and will have to get back to you with an answer.
• Did you receive a letter from House Oversight regarding a $9.7 million NIH grant after Dr. Johanna Olson-Kennedy, the medical director of the Center for Trans Youth Health and Development at Children's Hospital Los Angeles, told the New York Times that she plans to delay publication of her study?
  • Bertagnolli: I did recieve the letter.
• Is it true that Dr. Johanna Olson-Kennedy is delaying the publication of an NIH-funded study because the outcome of the study was not liked?
  • Bertagnolli: I only know what was published in the New York Times and have not seen a publication of the study yet
• Is it acceptable for an NIH grant recipient to delay the publication of a study for political purposes?
  • Bertagnolli: The NIH focuses on science, not politics, and has a mandate against political interference in their work. We encourage grantees to publish their work and have safeguards to ensure that the public gets access to data as a result of publicly funded research.

Rep. Lois Frankel (D-FL): 

• What would be the downside if our children were not vaccinated?
  • Bertagnolli: The leading cause of death 100 years ago was infectious disease, which changed due to vaccination. If vaccination stops, we will see more severe illness and death in children. It can also affect mothers who haven't been vaccinated and might get diseases like rubella. The impact of diseases like polio is also significant.
• What is NIH doing about the recommendations in the 21st Century Cures Act, which set up a task force on research on pregnant and lactating women?
  • Bertagnolli: NIH has set up a group of pharmacologists and gynecologists to work on the issue of drug safety during pregnancy. We are gathering data and increasing the clinical trials participation of women. However, there is a concern over litigation if there is some untoward effect during pregnancy and their drug was being tested.
• What do you anticipate the impact of Medicare negotiating to lower the cost of drugs will be on the health of our seniors?
  • Bertagnolli: Anything that increases access to needed medications where we have proof of benefit will be of great benefit. Affordability is one of the issues with access.

Rep. Chuck Fleischmann (R-TN): 

• How is the NIH utilizing the national resource of the U.S. research program, particularly in Tennessee, and how will it be supported in the future?
  • Bertagnolli: The resource has become a worldwide treasure due to its diverse genetic data set that ties people's genes to their health. It is valuable because of its diversity and its nationwide reach, encompassing people from every walk of life, race, ethnicity, and socioeconomic status. The program has built an enduring relationship with 800,000 people who have agreed to partner with NIH for research, which is a significant step towards building trust.

Rep. Barbara Lee (D-CA): 

• Why has NIH not focused more on sickle cell trait research, given its prevalence among black Americans and Hispanics, and why is testing for the trait not part of a standard battery of tests for these populations, especially considering the risk of passing on the disease to offspring?
  • Bertagnolli: The issue is important, and I agree that when a risk assessment like this is known, it should be acted upon in the care delivery and public policy arena
• Why won't NIH make it a requirement or at least suggest labs and physicians to include sickle cell trait testing in a battery of blood tests, given the known risk factors?
  • Bertagnolli: There is always room for improvement in the implementation of your work and I will consider the issue. 
• Why isn't prevention of sickle cell disease, which is cost-effective, prioritized, especially considering the racial and ethnic disparities it highlights?
  • Bertagnolli: The issue is important and the "All of Us" program is proud of being able to return results, including sickle cell trait, to its participants in a research format.

Rep. John Moolenaar (R-MI):

• Why was it important to issue a statement that there was no conclusive evidence preterm infant formula causes necrotizing enterocolitis (NEC), and how can we ensure that preterm infant formula manufacturers remain in the market?
  • Bertagnolli: The statement was important due to concerns that these formulas had a higher risk of NEC, which can be lethal in premature babies. While mother's breast milk is the best, there's debate about what to do if the mother can't produce breast milk. The National Institute of Childhood Health and Development is working with FDA and HHS on solutions to ensure these formulas don't disappear from the market.
• Is there any work being done to improve treatments for those suffering from FSGS, a rare kidney disease that damages kidney filters?
  • Bertagnolli: I can't speak about that specific issue, but I will find out. NIH needs to champion gene therapies that can be curative for these individuals, including in-utero gene therapies.
• What are your thoughts on biomedical research on rare diseases and the desire to develop these therapies, given the risk involved and not a lot of profit for businesses?
  • Bertagnolli: NIH is responsible for everybody and needs to be there for what the private sector can't do. They can't abandon these patients and families.

Rep. Bonnie Watson Coleman (D-NJ): 

• What actions are being taken to increase the diversity of clinical trials, particularly for African Americans who have been under-resourced and under-represented?
  • Bertagnolli: Teams across NIH are working on this issue, but a coordinated, dedicated approach is needed. The Care for Health Program, launched in one year, aims to conduct clinical trials research using primary care doctors, focusing on early detection and screening. The program is currently being implemented in three diverse rural communities.
• How are the grants for research in our communities being diversified, considering they have been under-resourced and misunderstood in terms of their value?
  • Bertagnolli: The approach involves partnering with diverse communities, who become part of the decision-making process and guide the research based on what they find most meaningful.
• What is being done in response to the fact that young people, particularly African Americans, are dying of cancer earlier due to lack of screening?
  • Bertagnolli: The Care for Health Program is focused on early detection and screening in primary care settings. The aim is to intervene before patients reach an oncologist's office, which is often too late. The program is currently being implemented in diverse rural communities.
• Are there measures of improvement in terms of the diversity in the staff that make decisions about research and doctor involvement?
  • Bertagnolli: The approach involves partnering with diverse communities, who become part of the decision-making process. The new program is tailored to every community, with the local population and organizations involved in developing the research.

Rep. Andrew Clyde (R-GA): 

• Are you familiar with the investigation into NIH officials using personal email accounts and the unauthorized disposition of HHS Secretary records?
  • Bertagnolli: I am familiar with the investigation and condemn the inappropriate management of public records.
• Have you responded to the National Archives and Records Administration's (NARA) request for a comprehensive report on these allegations?
  • Bertagnolli: I cannot comment on ongoing personnel matters within the agency.
• This is not a personnel matter but part of a congressional investigation. I would like you to respond to the committee with information about the ongoing NARA investigation.
  • Bertagnolli: I will look into the matter.
• Has NIH implemented protocols to preserve documentation and ensure a seamless transition with the incoming administration?
  • Bertagnolli: Yes, NIH abides by all legal requirements for retention and preservation of public records and will be open with the incoming administration.

Rep. Steny Hoyer (D-MD): 

• Would your directors of at least the 10 institutes that account for about 80% of the spending be willing to testify before this committee regarding the FY 26 budget when it comes up next year?
  • Bertagnolli: The directors would be willing to testify.
• Have you been the only witness that has appeared on behalf of NIH in the last fiscal year?
  • Bertagnolli: Yes, I have been the only one.
• Can you explain where we are on pay lines in the various institutes?
  • Bertagnolli: The institutes and centers range from around 10 to 12 to a high of 20s or low 20s in their pay line.
• What would be the optimal pay line?
  • Bertagnolli: It's hard to say, but we leave brilliant work on the table every year because of lower pay lines.
• Would you agree that pay lines have, at times, been in the 30s, with the scientific community judging that at least 3 out of 10 of the requests and applications are good science?
  • Bertagnolli: Yes, I agree.

Rep. Juan Ciscomani (R-AZ):

• What has been done to increase engagement on women's health matters and include more Hispanic representation in studies, particularly in research dealing with Alzheimer's and cancer?
  • Bertagnolli: Biomedical research must include everyone, considering factors such as genes, society, environment, and culture. The NIH has a plan to bring research inclusively to every community in the nation through the Care for Health Program. This program will provide data on how different communities are affected by health issues and will help improve health and health care in areas with poorer health.
• What is the timeline for getting findings from the efforts you're already working on?
  • Bertagnolli: The new community research enterprise was set up in one year, and the first investigator meeting is in two weeks to launch the studies. The studies will focus on what the communities need, such as pain, nutrition, substance abuse, and maternal health.
• What is the NIH doing to understand the trends of Alzheimer's disease in the Hispanic population, and how can we ensure that Hispanic and Latino populations are included in these clinical trials?
  • Bertagnolli: The NIH is taking a comprehensive approach to Alzheimer's disease, focusing on the fundamental science, genetics, environment, and the development of new treatments. The goal is to detect Alzheimer's disease earlier and intervene with people at risk far before to prevent or at least ameliorate the symptoms. There is a commitment to ensure that the development of these new therapies reaches every single community.

Rep. Chuck Edwards (R-NC): 

• What changes have been made to policies or procedures since the release of the Office of the Inspector General's report on NIH's inability to effectively monitor foreign grant recipients?
  • Bertagnolli: Measures have been taken to strengthen oversight, including penalties for noncompliance such as withdrawal of funding. The NIH expects foreign grantees to comply as rigorously as domestic ones.
• Can you provide more specifics on these measures?
  • Bertagnolli: I am happy to provide more details upon request.
• Are applications for research grant support from foreign organizations treated the same as applications from domestic organizations, or are additional oversight and transparency measures put in place?
  • Bertagnolli: All grantees, domestic or international, must comply with federal laws, rules, and regulations. The same stringent requirements apply to foreign grantees.
• Shouldn't foreign entities be held to a different standard than domestic ones?
  • Bertagnolli: The NIH's approach is to apply equally stringent policies regardless of where the federal money is spent.
• How does the proposed budget ensure that rural populations are incorporated into the research?
  • Bertagnolli: The proposed budget includes funding for the Care for Health Program, which is focused on rural populations and aims to bring research to these communities.

Rep. Robert Aderholt (R-AL):

• How does NIH coordinate with ARPA-H to ensure that agencies are not duplicating research efforts, and what processes are in place to prevent duplicate efforts overall?
  • Bertagnolli: There is a formal process for avoiding duplication of funding, starting from when a study is proposed and carried through when any award is made.
• As the NIH looks forward, could you elaborate on what the agency is thinking regarding initiatives like All of Us Research Program, Advancing Precision Medicine, the Brain Research through Advancing Innovative Neurotechnologies, and the Cancer Moonshot? Has it contemplated which it would find valuable to continue and find space within its broader NIH budget versus using the research and insights gained from those efforts but letting the program end in its current form?
  • Bertagnolli: It would be unfortunate to let any of these three programs end as they have been tremendously beneficial and productive. If budgets are flat or if there is a need to replace disappearing funds, difficult decisions will have to be made. However, these programs are critical and should not be let go.
• So, you commit to both of those?
  • Bertagnolli: Difficult decisions will have to be made, but these programs are high priority.

Ranking Member Rosa DeLauro (D-CT): 

• What actions is NIH taking to disseminate information about the benefits of human breast milk and human milk-derived fortifiers for very low birth weight infants?
  • Bertagnolli: There is a need for more research in this area, particularly regarding the effectiveness of donor milk and better formulations. The issue of human milk fortifier versus bovine is also an area that needs further investigation.
• Is there a federal need to focus more efforts on human milk-derived fortifiers, especially considering recent concerns about bovine fortifiers and the potential exit of the only two manufacturers from the market?
  • Bertagnolli: There is a need for more research in this area, particularly regarding the potential risks and benefits of different types of fortifiers.
• What is the status of the ALS Expanded Access Program?
  • Bertagnolli: There is significant work being done through the Accelerated Medicines Partnership and the Foundation for the NIH, which includes developing new drugs and expanding access for the ALS population.

Rep. Mike Simpson (R-ID): 

• What impact does the increase in treatments for diseases, but not cures, have on the health statistics of our society?
  • Bertagnolli: The increase in treatments has led to more people living longer with diseases, which affects the perception of whether society is healthier or less healthy. The goal is to promote healthy aging and longevity.
• Why is our life expectancy decreasing as a country?
  • Bertagnolli: The decrease in life expectancy is due to younger people dying before they get old, often due to diseases of despair, substance abuse, poor nutrition, diabetes, and untreated hypertension. These issues are particularly prevalent in rural communities. The challenge is to keep older people healthy, active, and thriving, through prevention and affordable, accessible approaches to health.

Rep. Barbara Lee (D-CA): 

• Has there been any progress in the testing for diabetes in individuals with the sickle cell trait, considering the A1C test could give a false positive?
  • Bertagnolli: I am not a hematologist expert in sickle cell trait, but the NIH's role is to conduct thorough research in this population and present the data to regulatory agencies. I will provide specifics on the A1C test and sickle cell trait. 
• Is there a cost-benefit analysis being conducted on the national program "food as medicine" in terms of budget implications?
  • Bertagnolli: The program is important. It has been successful in the Chickasaw Nation. I agree on the need to document the budget implications of the program for future scaling.

Rep. Andy Harris (R-MD): 

• Was the National Institute of Drug Abuse consulted before the decision was made by HHS to recommend that marijuana be rescheduled from Schedule I to Schedule III?
  • Bertagnolli: I do not know the answer to that question.

Rep. Mark Pocan (D-WI): 

• I am concerned about high drug prices in the U.S., stating that Americans pay 15 times more than Europeans and Canadians. There is a need for action as many people, including my mother, struggle to afford their medications. The “All of Us” is very important, and I am concerned about cuts. 

Chuck Edwards (R-NC): 

• What is the value of the NIH workforce and their role in infectious diseases?
  • Bertagnolli: The NIH workforce is invaluable, awarding 60,000 new grants annually to 300,000 researchers across 27 institutions. Their deep knowledge of medicine and relationship with the industry is irreplaceable. In terms of infectious diseases, they are crucial in risk assessment and mitigation, especially with threats like H5N1.
• What steps have been taken to improve NIH's ability to close contracts following the Office of the Inspector General's report on NIH's failure to close contracts in accordance with federal requirements?
  • Bertagnolli: Since the report, NIH has been working diligently to resolve the issues raised, although specific details are not immediately available.
• Can you provide more details on what "working diligently" means in this context?
  • Bertagnolli: I will. 

Rep. Steny Hoyer (D-MD):

• It is important to understand the return on investment from the $50 billion spent on health research and development.
• As Dr. Lowe said, the savings from health improvements in a single year exceeded the total investment in the National Institute of Dental Research (NIDR).
• We need a comprehensive analysis of the economic and health benefits derived from the investment, including early cancer detection, increased life expectancy, and reduced disease risk.
• The return on investment for $1 of NIH funding is estimated at about $2.5 to the economy.
• New grants awarded in the current year have created roughly half a million jobs.
• There are economic and societal savings from preventing illnesses and deaths. 
• I would like a detailed assessment of the economic benefits for people not dying prematurely, including their tax contributions and work output.

Ranking Member Rosa DeLauro (D-CT):

• The pharmaceutical companies should be investigated to deal with pricing issues.
• The NIH's record of supporting life-saving cures, treatments, diagnostics, and vaccines is unparalleled in human history.
• If investigations into infectious diseases stop, people will die.
• The subcommittee has a history of broad bipartisan support for NIH research.
• Congress should focus on finishing appropriations before the end of the year, as going from one continuing resolution to another is irresponsible and a waste of taxpayer dollars.
• A four-year appropriation bill for the NIH should be enacted by December 20.
• The NIH's research brings hope to families and should be above partisan politics.
• The NIH has made a significant difference in human history.