Insights

On September 16, the House Science, Space, and Technology Oversight Subcommittee held a hearing to discuss how to balance biotechnology innovation and biosecurity. Members expressed concern about the administration’s gain-of-function policy, which was recently implemented in line with a 2025 Executive Order on the subject. There was bipartisan agreement that current policy is not striking the right balance between protecting U.S. research and enabling it to grow. Questions were also asked about the policy’s effects on broader issues within the biotech industry including on the domestic research environment the scientific workforce, and competition with China.

OPENING STATEMENTS

• Full Committee Chairman Brian Babin (R-TX-36)
• Full Committee Ranking Member Zoe Lofgren (D-CA-18)
• Oversight Subcommittee Chairman Rich McCormick (R-GA-7)
• Oversight Subcommittee Ranking Member Emilia Sykes (D-OH-13)

WITNESS TESTIMONY

• Dr. Anemone Franz, Visiting Research Fellow, American Enterprise Institute – Testimony
• Mr. Joshua Hodges, Visiting Fellow, Hoover Institution – Testimony
• Dr. Gigi Gronvall, Professor, Bloomberg School of Public Health, Johns Hopkins – Testimony

MEMBER DISCUSSION

Regulatory Uncertainty

Members from both parties had clarifying questions about the overall impacts of the gain-of-function policy and what the administration and Congress can do to reduce uncertainty. Full Committee Chair Brian Babin (R-TX-36) and Rep. Daniel Webster (R-FL-11) asked who oversees the current safety standards for gain-of-function research and what needs to be done to ensure the research is not misused. Mr. Hodges described this as one of his main areas of concern, as oversight is currently spread out across 15 agencies with no singular leader. In terms of improving oversight, he stated there needs to be better intelligence-gathering methods, and there should be someone accountable to Congress and the Executive. Chairman Babin also asked Dr. Franz how Congress should distinguish legitimate beneficial research from dangerous ones. She explained the focus should be on research with potential to cause outsized harm to society based on a risk-benefit analysis framework.

Oversight Subcommittee Ranking Member Emilia Sykes (D-OH-13) and Rep. Suzanne Bonamici (D-OR-1) asked Dr. Gronvall about the direct impacts of the gain-of-function policy and how the administration can better engage with the research community. Dr. Gronvall explained that the policy lacks any exception process for research with clear public health importance, researchers are self-censoring proposals out of concern for scrutiny, and there is no list of what is in- and out-of-scope. She further explained that the administration needs to talk to the researchers who are part of the regulated community to understand what they actually need.

Workforce

Democratic members were interested in understanding how this new policy, and additional policies implemented by the administration, had impacted the scientific workforce. Ranking Member Sykes asked Dr. Gronvall about the policy’s effects on the broader scientific workforce. Dr. Gronvall explained that there has been a lot of self-censorship as researchers try to navigate the changing policies and aim to avoid negative attention on their institution and work. She also stated that early career researchers have been hit the hardest as they are most dependent on consistent funding and most exposed to grant cancellations. Rep. Bill Foster (D-IL-11) focused on the contributions from international STEM scientists and the impact of changing immigration policies on that population. Dr. Gronvall confirmed that universities have not been able to accept as many students due to visa concerns, further harming the early career workforce, and emphasized the long-time importance international researchers have had in the U.S.

Competition

There was bipartisan discussion about maintaining U.S. leadership in biotech production and preventing important research from moving overseas, specifically to China. Full Committee Ranking Member Lofgren (D-CA-18) asked about the near-term consequences of the competitive shift in biotech innovation. Dr. Gronvall shared that U.S. researchers are already unable to be fully present in the international scientific community because of other policies and China is filling those gaps. Mr. Hodges explained that China is rapidly catching up to us, thanks to the U.S. funding Chinese development, and this is not a new phenomenon to blame on the current administration. He further stated that the country leading in biotech gets to set global standards, which is vital for the U.S. to maintain. Reps. Foster and April McClain

Dr. Gronvall and Mr. Hodges agreed this is a serious concern, which they have been watching for a long time, as it is cheaper and faster to get drugs developed in China. Mr. Hodges explained the risk mirrors what happened with rare earth minerals in that China could restrict American access to drugs and everyday products. All three witnesses agreed it is necessary to have a coordinated national strategy to match China’s whole-of-government approach.

Rep. Nicholas Begich (R-AK-At-Large) asked Mr. Hodges what Congress could do to move production back to American soil. He noted that China surpassed the U.S. in total clinical trials in 2020 and said the remaining advantage lies in lab innovation rather than manufacturing. Mr. Hodges urged Congress to include biotechnology in outbound investment legislation to invest more time and resources in the field.

On September 16, 2026, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing to consider the nominations of Chris Klomp, to be Department of Health and Human Services (HHS) Deputy Secretary, Dr. Nicole Saphier, to be US Surgeon General, and Dr. Timothy Westlake, to be Assistant Secretary for Mental Health and Substance Use. The nominees must next be voted out of Committee, Mr. Klomp by the Senate Finance Committee and the others by the HELP Committee, before consideration by the full Senate.

OPENING STATEMENTS

• Chairman Bill Cassidy (R-LA)
• Sen. Tammy Baldwin (D-WI)

WITNESS TESTIMONY

• Chris Klomp, MBA, to be HHS Deputy Secretary – Testimony
• Nicole Saphier, MD, to be US Surgeon General – Testimony
• Timothy Westlake, MD, to be Assistant Secretary for Mental Health and Substance Use – Testimony

MEMBER DISCUSSION WITH MR. KLOMP

Improving HHS

As with Mr. Klomp’s hearing before the Senate Finance Committee, there was bipartisan interest in how Mr. Klomp plans to improve the function and coordination of HHS. Sens. Tim Kaine (D-VA) and Lisa Murkowski (R-AK) both had concerns about the lack of coordination between HHS and Congress and the Indian Health Service, respectively, in providing technical assistance and consultation. Mr. Klomp assured the senators he intends to improve HHS coordination and wants to continue to work with their offices to provide assistance as needed. Sen. Roger Marshall (R-KS) asked about the status of technological advancement at HHS. Mr. Klomp shared that he is actively working with the Centers for Medicare and Medicaid Services (CMS) to update their information technology systems by bringing in qualified professionals and funding projects. Sen. John Hickenlooper (D-CO) asked how HHS intends to preserve scientific integrity. Mr. Klomp said there needs to be a distinction between science and policy, and that policy conversations should be based on science. Mr. Klomp also committed to publishing HHS research.

Other Topics

• Sen. Tammy Baldwin (D-WI) requested that Mr. Klomp work to restore the “press 3” option on the 988-suicide hotline, which was a specific option for LGBTQ+ youth. Mr. Klomp shared that a new contract for the 988 hotline has been awarded and includes the “press 3” option.
• Sen. Andy Kim (D-NJ) wanted to understand the plan to ensure safe staffing requirements for nursing homes, after the agency rescinded the Biden-era staffing rule. Mr. Klomp stated that he strongly believes in safe staffing levels and will work with experts and the senator’s office to develop a plan on this topic.
• Sen. Patty Murray (D-WA) requested that Mr. Klomp work to repeal the Wasteful and Inappropriate Services Reduction (WISeR) model. Mr. Klomp did not commit, but shared that he would evaluate the model after the report is published by the CMS Innovation Center.
• Sen. Jim Banks (R-IN) asked how HHS intends to improve and speed up Food and Drug Administration (FDA) inspections of both domestic and international manufacturing facilities. Mr. Klomp responded that slow inspections harm manufacturers and that international inspections need to be held to a high standard and include surprise inspections.
• Sen. Banks then asked if the FDA should use clinical research data collected in China in their evaluation, especially if the sites have not been inspected and do not comply with good clinical practice. Mr. Klomp shared the senator’s concern and stated that international data should be held to the same standards as domestic data.

MEMBER DISCUSSION WITH DR. SAPHIER

Role Priorities

Members on both sides of the aisle asked questions about Dr. Saphier’s priorities if confirmed as the surgeon general. Sen. Ashley Moody (R-FL) requested that Dr. Saphier explain the skills that she brings to the role, especially regarding improving the health of children. Dr. Saphier explained that as a physician she can only touch a few patients, but she wants to improve children’s mental health and well-being. Sen. Marshall asked how she plans to address chronic disease. Dr. Saphier shared that she is committed to ensuring people have information about small modifications that can improve health, as well as access to cancer detection and screening. Sen. Susan Collins (R-ME) asked her to expand on cancer screening work, especially as it relates to breast cancer. Dr. Saphier stated that she plans to increase messaging on the importance of early detection and work with other leaders within HHS to improve access and coverage for cancer screenings, as well as finding creative ways to mobilize the health care sector. Sen. Hickenlooper questioned how Dr. Saphier intends to preserve scientific integrity in her role. Dr. Saphier shared that integrity is very important to her as a physician, as well as her commitment to academic medicine.

Vaping

Multiple senators raised concerns about recent actions taken by the FDA in approving additional flavors of vape products and the possible effects of marketing flavors to adolescents. Sens. Kaine, Murkowski, and Collins all asked Dr. Saphier to clarify her position on smoking and vaping, as well as the effects of vaping on adolescents. Dr. Saphier shared that she believes all smoking is harmful for adolescents and is not supportive of marketing encouraging smoking behaviors.

Vaccines

Chairman Bill Cassidy (R-LA) pressed Dr. Saphier on her views about the safety of the Measles, Mumps, and Rubella (MMR) vaccine and whether she believes it causes autism. Dr. Saphier stated that she supports MMR vaccination and has not seen evidence that the vaccine causes autism. Chairman Cassidy then asked if Dr. Saphier supports the recommendation of universal Hepatitis B vaccination for newborns. Dr. Saphier expressed support for Hepatitis B vaccination.

MEMBER DISCUSSION WITH DR. WESTLAKE

Youth Mental Health

There was bipartisan questioning of how Dr. Westlake plans to improve youth mental health. Sen. Marshall asked how to empower the community health model of care. Dr. Westlake shared that it is important to look at the work providers are already doing and find ways to support the needs of each individual community. Sen. Moody questioned how to improve mental health issues related to social media. Dr. Westlake emphasized the need for more connection between families and communities outside of social media. Chairman Cassidy requested a plan to improve the identification and treatment of psychosis after the first episode. Dr. Westlake agreed and shared that he wants to understand what strategies are currently successful and how best to replicate them in other settings. Sen. Murkowski requested Dr. Westlake commit Substance Abuse and Mental Health Services Administration (SAMHSA) resources to improving youth suicide rates, especially in remote and underserved areas. Dr. Westlake agreed and shared that SAMHSA will work with states to see what resources are needed.

Other Topics

• Sen. Maggie Hassan (D-NH) requested Dr. Westlake’s commitment to restoring policy that allows grantees to purchase fentanyl test strips with federal funds as well as reinstate the Drug Abuse Warning Network. Dr. Westlake shared that there is no evidence that fentanyl test strips reduce overdoses so he cannot commit restoring that policy. Dr. Westlake also said he is not aware of the warning network but will look into it and put forward the best policy.
• Sen. Baldwin also asked Dr. Westlake to restore the “press 3” option on the 988-suicide hotline for LGBTQ+ youth. Dr. Westlake stated that he was not at the agency when the decision to remove the “press 3” option was made, but he committed to working through the bureaucratic silos to understand what happened.

On September 15, the Senate Finance Committee held a hearing to consider the nominations of Chris Klomp, to be Deputy Secretary of Health and Human Services (HHS), and Dr. Ge Bai, to be Assistant Secretary of Planning and Evaluation. Senators focused on the nominees’ fitness for the roles as well as their views on vaccines. Members also discussed other topics such as hospital competition and pharmacy benefit manager (PBM) transparency. Ranking Member Ron Wyden (D-OR) shared that he would be voting against the nomination of Mr. Klomp. Both nominations must next be voted out of the Finance Committee before advancing to the full Senate for confirmation votes.

OPENING STATEMENTS

• Chairman Mike Crapo (R-ID)
• Ranking Member Ron Wyden (D-OR)

WITNESS TESTIMONY

• Chris Klomp, to be Deputy Secretary of HHS – Testimony
• Ge Bai, PhD to be Assistant Secretary of Planning and Evaluation – Testimony

MEMBER DISCUSSION WITH MR. KLOMP

Leadership and Competency

There was bipartisan interest in Mr. Klomp’s leadership skills and competence for the role of HHS Deputy Secretary. Chairman Mike Crapo (R-ID) asked how Mr. Klomp would describe his leadership style and how he would use it to ensure the department fulfills its intended objectives. Mr. Klomp shared that he has had the chance to lead in many different settings, but what he has seen consistently across all teams is the importance of building trust. Mr. Klomp continued that trust is built on competence, respect, and integrity, which allows for conversations and collaborations which he said he hopes to deliver across HHS.

Sen. Raphael Warnock (D-GA) questioned if Mr. Klomp and HHS Secretary Kennedy had ever disagreed on a decision. Mr. Klomp responded that he has a reputation with the Secretary and President Trump for speaking plainly and sharing his opinion, even when he disagrees, and he was nominated with that knowledge in mind.

Vaccines

Committee Democrats voiced many concerns about vaccine rhetoric in the Trump administration. Ranking Member Wyden asked Mr. Klomp if he believed the Measles, Mumps, and Rubella (MMR) vaccine causes autism. Mr. Klomp stated that the MMR vaccine is the most effective public health tool to prevent measles and that he does not believe the MMR vaccine causes autism. Ranking Member Wyden and Sen. Ben Ray Lujan (D-NM) both pressed Mr. Klomp on statements made by President Trump that called into question the safety of the MMR vaccine. Mr. Klomp responded that he believes in the safety of the MMR vaccine, but that President Trump believes in the power of parental choice for vaccines. Sen. Michael Bennet (D-CO) asked if Mr. Klomp thinks conflicting messaging about vaccines from the president and CMS administrator is an issue. Mr. Klomp shared that HHS needs to communicate guidance clearly and earn the trust of the American people, and he stated that he is concerned about the increase in vaccine hesitancy.

Sen Ron Johnson (R-WI) asked for Mr. Klomp to explain why studies into the COVID-19 vaccine and vaccine injuries were ended by the department without being released. Mr. Klomp expressed his view that any research conducted by HHS should be published.

Pharmacy Benefit Managers (PBMs)

Sens. James Lankford (R-OK) and Marsha Blackburn (R-TN) asked how Mr. Klomp plans to implement new PBM regulations regarding price transparency. Mr. Klomp said he is not an expert in PBM practices, but he is committed to ensuring experts lead implementation strategies and will lend technical expertise to Congress as needed.

Mifepristone

Sen. Catherine Cortez Masto (D-NV) questioned the current safety review being conducted by the FDA on mifepristone, highlighting that it has been approved for over 20 years. Mr. Klomp stated that he has not been closely involved with the review but understood that the FDA is following regulatory guidance to rereview the drug now that it can be prescribed without an in-person visit with a provider. Sen. Steve Daines (R-MT) encouraged the FDA to complete the review and asked if the agency is on track to publish the review by the end of 2026. Mr. Klomp assured the senator that the review was being conducted and is on track to publish any required reports.

Biotechnology and US Competitiveness

Sens. Bill Cassidy (R-LA) and Daines both highlighted increased concerns about the US’s ability to remain competitive with China in the biotechnology sphere. Mr. Klomp agreed and shared that the FDA is working to streamline the research and development process while ensuring that US biotechnology companies are not harmed.

Other Topics

• Sen. Sheldon Whitehouse (D-RI) raised the issue of Rhode Island’s lower Medicare Wage Index compared to other local states and Mr. Klomp committed to working with him.
• Sen. Elizabeth Warren (D-MA) pressed Mr. Klomp to ensure the release of the contract deals made with pharmaceutical companies for TrumpRx. Mr. Klomp answered that information is available on the TrumpRx website.
• Sen. Cortez Masto questioned the change in federal funding for Medicare Fraud Control Units at the same time the administration has publicly called for combating fraud. Mr. Klomp stated that he would look into it to better understand the issue.
• Sen. Cassidy asked how Mr. Klomp would address what he described as a lack of regulatory alignment between the Food and Drug Administration (FDA) and CMS for the approval of and reimbursement for new medical devices. Mr. Klomp acknowledged the issues that the differences between the agencies can cause and said he would work to reduce stakeholder frustration if confirmed.

Member Discussion with Dr. Bai

Member discussion with Dr. Bai was much more limited. Sen. Johnson asked Dr. Bai if she has an estimate of the level of fraud across HHS funding. Dr. Bai responded that addressing fraud is a structural issue, not a surface-level issue.

Sen. Cassidy questioned some states’ proposed policies to cap hospital expenditures and asked for her thoughts on the topic of price controls. Dr. Bai shared that capping prices is addressing the symptom but not the cause of increased prices and that competition is needed to decrease costs.