Health

WASHINGTON, D.C.  – Congressman Buddy Carter (GA-01), Chairman of the Subcommittee on Health, delivered the following opening statement at today’s hearing titled  Made In America: Strengthening Domestic Manufacturing And The Health Care Supply Chain. Subcommittee Chairman Carter's opening statement as prepared for delivery: “Today’s hearing is critical in addressing our nation’s reliance on adversarial countries for essential medications and health care products. This dependence not only jeopardizes our national security and patient safety, but also highlights the urgent need to increase domestic and friend-shored manufacturing. “Let me be clear: the United States should never be dependent on the Chinese Communist Party for the antibiotics and essential medicines. But that’s exactly the dangerous position we are in today. “In 2002, the United States manufactured 72 percent of the pharmaceuticals it consumed. By 2023, that number had dropped to just 37.5 percent. We didn’t just outsource manufacturing—we outsourced the sovereignty and safety of our health care system. “We saw the impacts of this reliance firsthand during the COVID-19 pandemic. According to a conversation I had with the Administration for Strategic Preparedness and Response, or ASPR, under the Trump Administration, the United States saw a downtick in the amount of PPE and pharmaceuticals coming to our country from China in the fall of 2019. We didn’t learn about COVID-19 until January 2020. “China knew there was an unidentified sickness in its own country, concealed it, and then withheld medical supplies so the United States was less prepared when COVID-19 hit our shores. “As both a pharmacist and a member of Congress, I know how critical these medicines and supplies are — especially for our national security. Under the Biden-Harris Administration, over 323 drugs were in shortage during the first quarter of 2024 – an all-time high – and cancer patients were often forced to switch treatments, adjust dosage regimens, or, in extreme cases, unable to receive their lifesaving medications. There was no comprehensive effort to support American manufacturers or reduce our reliance on foreign supply chains. “That is unacceptable. “Thankfully, President Trump is taking meaningful action by demanding real investment in our domestic production base and putting an end to decades of failed “America Last” policies that left our supply chains hollowed out and put our patients, constituents, and families at risk. “Under the leadership of President Trump, we are bringing manufacturing back to America. Since the start of this year – the start of President Trump’s second term – Johnson & Johnson broke ground on a new $2 billion facility in North Carolina, Amgen announced a $900 million manufacturing expansion in Ohio, AbbVie committed $10 billion to invest in the United States, and Sanofi announced plans to invest at least $20 billion.  “And these are just a few examples. This is just the start.  “I look forward to hearing from my other colleagues about the recent investments in their Districts and States during this hearing today, and I am thrilled to see what additional investments continue to flow and thrive under an Administration focused on unleashing innovation and bringing capacities back home.  “Along those lines, I commend recent efforts by this Administration to bolster domestic production, but we must do our part in Congress as well. This hearing will make it clear that more can be done to eliminate burdensome regulatory barriers, streamline processes that impede our competitiveness on the global stage, and establish the proper incentives to ensure we are creating the environment to allow innovation to flourish.  “It is no coincidence that Georgia – the No. 1 state in the nation to do business – is home to Manus Bio, who has invested nearly $60 million and created over 100 jobs with the acquisition of a new manufacturing facility in Augusta. We need more policies at the federal level that mirror the pro-growth examples we have in the state of Georgia.  “That is why House Republicans passed the One Big Beautiful Bill Act, which incentivizes domestic medical supply production by rewarding companies that build their products in America, like USAntibiotics, who is the last remaining end-to-end domestic U.S. manufacturer of amoxicillin, the most prescribed antibiotic in the country.  This is about protecting American lives, empowering American workers, restoring American sovereignty, and reinforcing U.S. leadership in medical innovation. “China is not our friend. Every product component that then turns into a vial of medicine or a piece of medical equipment that is made in China is a missed opportunity to strengthen our economy and protect our people. “It is time to act. We need to view pharmaceutical and health care supply chain independence just as we are viewing energy independence. I am proud to stand with President Trump and all those committed to putting America First in our health care system—starting with the medicines we rely on every day.” ###

WASHINGTON, D.C. – Today, Congressman Earl L. "Buddy Carter" (GA-01), Chairman of the Subcommittee on Health, led a hearing titled Made in America: Strengthening Domestic Manufacturing and Our Health Care Supply Chain. “Under the leadership of President Trump, we are bringing manufacturing back to America,” said Chairman Carter. “ Since the start of this year – the start of President Trump’s second term – Johnson & Johnson broke ground on a new $2 billion facility in North Carolina, Amgen announced a $900 million manufacturing expansion in Ohio, AbbVie committed $10 billion to invest in the United States, and Sanofi announced plans to invest at least $20 billion. And these are just a few examples; this is just the start.” Watch the full hearing here . Below are key excerpts from today’s hearing: Congressman Buddy Carter (GA-01): “If Congress were to act on the recommendations today, how quickly could our domestic capacity expand? If we were to act on this, how quickly can we get this up and running?” Mr. Cashman: “With the right policy framework, we could significantly expand production with 18 to 24 months. We're currently running three active production lines; we have two crews on first shift and another crew on second shift. By simply adding new crews, to adding shifts so we can have three shifts per day on each line, we could dramatically increase our production.” Congressman Troy Balderson (OH-12): “ We know that a recent analysis showed that around half of the active pharmaceutical ingredients (APIs) for prescription medications in the U.S come from India and the EU. With around 12 percent being manufactured domestically here in the U.S. from your perspective and with your great experience, how do you believe we can increase the share in a sustainable way?” Dr. Piervincenzi: “I think the first layer is to increase the production of API, [which] will require new facilities and substantial new investments and time. There are shorter term ways to bridge the gap and to create a more secure supply chain, including through friend shoring and other purchasing opportunities. And finally, also considering the potentially even higher vulnerability to the starting materials upstream of the APIs, which may be even more highly concentrated in adversary countries and coming to the U.S. through India and Europe.” Congressman Jay Obernolte: (CA-23): “One of the things [Mr. Cashman] suggested was long-term supply contracts, but if you are someone that has consistent demand for a drug like amoxicillin, and you've experienced a situation where supply is constrained and therefore the market reacts by raising prices up to astronomical levels, you would think that would incentivize you, just from a financial perspective, to diversify your supply chains.”

WASHINGTON, D.C.  – The following op-ed by Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, appeared in Fox News last week. In Case You Missed It: “It’s been almost two weeks since the House of Representatives passed the ‘One, Big, Beautiful Bill’ Act (OBBBA). Yet, we continue to hear constant fearmongering by my Democrat colleagues.  “I’ll remind you that the OBBBA makes tremendous strides in providing further tax cuts for middle-class, working families, promoting American manufacturing and energy dominance, and importantly, protecting the integrity of our healthcare programs to support our most vulnerable Americans.  “It is a top priority of House Republicans to eliminate the waste, fraud and abuse in the programs and safeguard expectant mothers, their children, low-income seniors and especially individuals living with disabilities who are receiving Medicaid coverage. Regrettably, Democrats continue to fuel the falsehood that 13 million individuals will lose healthcare coverage under OBBBA.  “According to the Congressional Budget Office, millions of ineligible individuals are receiving benefits through Medicaid, with 1.6 million people enrolled in two state Medicaid programs at the same time (and getting care paid for in both states), 1.4 million illegal immigrants, and 1.2 million enrollees who no longer qualify for eligibility. CBO also assumes there are 4.8 million able-bodied adults without dependents who would rather lose Medicaid coverage than choose to work or give back to their communities. Continuing to direct scarce resources to these ineligible recipients ultimately takes away from Americans truly in need.  “Through the OBBBA, Republicans are strengthening the Medicaid program by removing ineligible beneficiaries and sustaining the program for our most vulnerable Americans. When states are no longer paying for those who shouldn’t be enrolled in the first place, that frees up money they can invest for those who actually need the care most.  “As chairman of the House Committee on Energy and Commerce, please allow me to tell you the truth: pregnant women, children, seniors, and individuals living with a disability are protected under this legislation.  “During our 26-and-a-half-hour marathon markup, Democrats shared stories using scare-tactics, not facts. The Democrats cited story after story about vulnerable individuals who rely on Medicaid for their daily care – like children and people with disabilities and their families – and the fact is, this bill does not impact them. If anything, we are protecting Medicaid for them.  “Every vulnerable American who needs Medicaid should be protected and have access to care. That’s why House Republicans have thoughtfully curated a bill that realigns incentives in Medicaid for states to care for the most vulnerable over individuals who aren’t eligible for the program, including illegal immigrants.  “While Medicaid is predominantly funded by the federal government, states are in the driver’s seat and contribute at least a third of all Medicaid costs, ultimately determining which individuals are covered, what services they receive, and how much taxpayers pay for their care. Our bill reverses a Biden-Harris policy that prohibited states from removing ineligible individuals from their rolls.  “When top-down mandates from Washington crowd out state decision-making, states lose their ability to focus their efforts on core services for vulnerable populations. Our bill changes this. For example, the commonsense community-engagement requirements, also known as work requirements, require that states ensure that able-bodied adults without dependents are either working a part-time job, participating in educational programs, or volunteering in their community for 80 hours per month in order to receive Medicaid benefits.  “Additionally, the bill repeals oppressive Biden-Harris era mandates that forced states to impose unrealistic staffing requirements for nursing homes that were set to close facilities and severely restrict access to care. The Biden-Harris regulators also prohibited states from following standard procedures to disenroll people who are ineligible for coverage, or even fraudulently enrolled, in Medicaid.  “The rational policies in the House bill that stops coverage for illegal immigrants and allows states to remove deceased and duplicative enrollees, and otherwise ineligible beneficiaries from state Medicaid programs further ensures our federal dollars are serving the population that Medicaid was created to protect.  “We must remember that even with the Energy and Commerce Committee’s title creating savings of over $1 trillion, we still don’t halt the rapid pace at which the Medicaid program is growing.  “While the Committee’s savings help to slow the growth of the program, Medicaid is projected to grow by an estimated 25% by 2034. Over the next decade, spending in the program is expected to increase by over $1 trillion above inflation. Only Washington Democrats would say that increased funding is a cut.  “Every dollar misspent on illegal immigrants and ineligible individuals in the Medicaid program means less money going to our children, our pregnant women and mothers, individuals who are disabled, and seniors.  “It is disappointing that Democrats are prioritizing politics through lies and fearmongering instead of actually helping the most vulnerable Americans. House Republicans make no apologies for our continued fight to strengthen government programs that have since been riddled with waste, fraud, and abuse.”

Washington, D.C. — In a new letter to Department of Health and Human Services (HHS) Inspector General Christi Grimm, House Energy and Commerce Committee Republicans requested an investigation into the strength, quality, and types of evidence-based scientific and pediatric medical literature relied on by the department to promote gender transition procedures for children.  KEY LETTER EXCERPT:  “As the agency responsible for safeguarding the health and well-being of Americans, all of HHS’s medical treatment recommendations, especially medical treatment recommendations for children, should be based on rigorous and well-established research, such as randomized controlled trials, that have definitively illustrated the long-term benefits of gender affirming care treatments.”  BACKGROUND:  Under the Biden administration, HHS has advocated for sex reassignment procedures on minors, including the use of serum puberty blockers, which have historically been used to treat children with precocious puberty (i.e., early onset puberty affecting about one percent of U.S. children) and sex offenders.   Puberty blockers, however, are known to stunt normal childhood development in children unaffected by precocious puberty.  HHS officials contend that sex reassignment procedures on minors are an unanimously accepted medical practice.  HHS Secretary Becerra testified before Congress that “every major medical association,” “medical journals,” and “scientific and medical evidence” has demonstrated the benefits of transitioning children’s biological sex.  When asked, via a Freedom of Information Act request, for the underlying scientific or medical basis for its position, HHS was only able to produce a two-page brochure that was already publicly available.  In contrast to HHS, a growing body of literature from medical experts and authorities around the world, including those in Europe, caution against performing such procedures on minors.   Courts and government health agencies responsible for determining child welfare have sought to limit child sex reassignment procedures.   Other countries have banned these interventions and surgeries on minors altogether.  An article published in the British Journal of Medicine found “there is great uncertainty about the effects of puberty blockers, cross-sex hormones, and surgeries in young people.”   A court in the United Kingdom noted the obvious about administering puberty blocking chemicals onto children: “[i]t is highly unlikely that a child aged 13 or under would be competent to give consent to the administration of puberty blockers. It is doubtful that a child aged 14 or 15 could understand and weigh the long-term risks and consequences of the administration of puberty blockers.”  In April 2024, the Cass Review , an independent review of gender identity services for children and young people, commissioned by the National Health Service England, found “[w]hile a considerable amount of research has been published in this field, systematic evidence reviews demonstrated the poor quality of the published studies, meaning there is not a reliable evidence base upon which to make clinical decisions, or for children and their families to make informed choices.”   The Cass Review also found that “[t]he rationale for early puberty suppression remains unclear, with weak evidence regarding the impact on gender dysphoria, mental or psychosocial health,” as well as unknown effects on cognitive and psychosexual development.  In August 2024, the American Society of Plastic Surgeons (ASPS) became the first major U.S. medical association to express caution on the use of gender surgery for gender dysphoria in adolescents. In its formal statement, the association stated: “ASPS currently understands that there is considerable uncertainty as to the long-term efficacy for the use of chest and genital surgical interventions for the treatment of adolescents with gender dysphoria, and the existing evidence base is viewed as low quality/low certainty. This patient population requires specific considerations.”   The letter was signed by Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), Rep. Dan Crenshaw (R-TX), Rep. Gus Bilirakis (R-FL), Rep. Buddy Carter (R-GA), Rep. Gary Palmer (R-AL), Rep. Neal Dunn (R-FL), Rep. Randy Weber (R-TX), Rep. Troy Balderson (R-OH), Rep. August Pfluger (R-TX), Rep. Diana Harshbarger (R-TN), and Rep. Kat Cammack (R-FL).  CLICK HERE to read the letter.

House Republicans scrutinize government grant funding recipients that fail to protect individuals from antisemitism Washington, D.C. — In a new letter to J. David Gladstone Institutes President Dr. Deepak Srivastava, the House Committee on Energy and Commerce (E&C) and House Committee on Education and the Workforce (E&W) have requested information about ongoing and pervasive acts of antisemitic harassment and intimidation at Gladstone and its leadership’s insufficient response to these acts. The letter is signed by E&C Chair Cathy McMorris Rodgers (R-WA), E&C Subcommittee on Health Chair Brett Guthrie (R-KY), E&C Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA), E&W Chair Virginia Foxx (R-NC), and E&W Subcommittee on Higher Education and Workforce Development Chair Burgess Owens (R-UT).  KEY LETTER EXCERPTS: “The Gladstone Institutes, an independent biomedical research organization, claims that it takes an active stance against serious issues like discrimination and harassment and aims to ‘ensure all community members at Gladstone feel included’ and that the Institutes will aim to ‘implement accountability measures and reinforce Gladstone’s commitment to having an environment free of harassment.’ However, these values do not seem to be reflected in the actions of leadership in response to recent concerns of antisemitic harassment and discrimination within the Institutes.” [...] “The reports of antisemitic harassment at Gladstone coupled with the inadequate response by leadership is concerning to the Committees. Failing to act decisively to ensure a safe environment for all trainees, faculty, and staff is a grave dereliction of your responsibilities as President of Gladstone.” “Failing to comply with basic safety protections for members of Gladstone or failure to respond appropriately to and prevent harassment and discrimination, no matter the cause, may be grounds to withhold federal funds from the university. Congress has an obligation to exercise oversight of recipients of federal funds when blatant and ongoing Title VI violations appear to be happening. If Congress determines an institution of higher education/research is blatantly ignoring its legal responsibilities, we may consider rescinding research and development funds previously appropriated.” BACKGROUND ON TAXPAYER FUNDING: Gladstone received more than $41 million in funding from the NIH in Fiscal Year 2023, not including potential taxpayer funding that individual faculty may have received through their affiliation with the University of California, San Francisco (UCSF) or any other affiliated universities.   According to the NIH’s Grant Policy Statement, any institution receiving federal funds must assure work environments are free of discriminatory harassment and are safe and conducive to high-quality work.  Institutions receiving federal taxpayer financial assistance—such as NIH grants—are prohibited from discriminating based on a variety of categories, including national origin.   These laws also protect members of the institution who are or are perceived to be members of a group with shared ancestry, such as students/trainees of Jewish heritage. BACKGROUND ON INSTANCES OF ANTISEMITISM : Two days after the October 7, 2023, Hamas terrorist attack, a graduate student working in a lab within Gladstone sent an antisemitic email to all Gladstone faculty, trainees, and staff falsely stating that the attack on innocent Israeli civilians was “the resistance in Gaza launch[ing] a surprise attack against Israel, taking occupation soldiers hostage, taking over Israeli military vehicles, and gain[ing] control over illegal Israeli settlements.”  The email goes on to claim that all casualties resulting from Palestinian actions are the responsibility of Israel.  Immediately following this mass email, members of the Gladstone faculty began contacting the Gladstone Institutes’ President and other leadership, appalled by the language of the email, concerned for their safety and worried that the email could be seen as an incitement to violence.  Jewish members of the Institutes also expressed their deep, personal pain following the Hamas attack, as some members had family or friends reported killed or missing directly after the attack.  These fears—including fears of being attacked in the lab by the author of this cruel and antagonistic email—were shared directly with President Srivastava.  Despite this, Gladstone leadership did not issue a public statement or position against antisemitism to quell fears of Jewish faculty and trainees.  In May 2024, the Center for Combatting Antisemitism sent President Srivastava a letter requesting administrative action to address the hostile environment and disparate treatment of Jewish members at Gladstone.  This letter noted that Gladstone refused to acknowledge Jewish American Heritage Month, Passover, or Holocaust Remembrance Day, despite sending official celebratory emails and holding events for other religious, ethnic, or national holidays, including Black History Month, International Women’s Day, and Ramadan.  The Center followed up with Gladstone several times, but never received a response.  Jewish faculty and trainees have conveyed to leadership within Gladstone instances of antisemitic harassment and discrimination, which faculty and trainees believe were not taken seriously, making some feel uneasy about speaking out.  For example, per a publicly available Fair Employment and Housing Act complaint to the California Civil Rights Division, a Jewish faculty member openly discussed fellow faculty using racial stereotypes, including comments about a “Jewish nose.”  When these comments were brought to human resources, no investigation occurred.  Instead, the complainant was subsequently targeted with an investigation ultimately deemed to be unwarranted.  Then, following the complainant’s post-October 7th advocacy on behalf of Jewish faculty and trainees, the complainant was threatened repeatedly with career-ending termination, allegedly in an attempt to extort a resignation.  When the threats did not have their desired effect, Gladstone placed the complainant on administrative leave and removed the complainant’s electronic access to email and files but also physical access to the complainant’s lab, removing all ability to conduct work on an NIH-funded grant.  Gladstone ultimately paid an undisclosed sum to settle the matter and avoid litigation.  To elevate concerns regarding widespread, ongoing discrimination, Jewish faculty and trainees requested permission to bring in a speaker related to antisemitism.  Other minority groups had previously been given permission to bring in similar anti-racism speakers.  However, while leadership stated it would look into the idea, ultimately no speaker was brought, and no program was launched regarding antisemitism. BACKGROUND ON AFFILIATIONS WITH OTHER INSTITUTIONS UNDER INVESTIGATION : Gladstone Institutes is affiliated with other institutions under congressional investigation.  For example, Gladstone is an affiliate of the UCSF, which is undergoing congressional investigation for reports of antisemitism within the university, medical school, and medical centers.  Most of Gladstone’s principal investigators are also faculty at UCSF, and the Institutes provide research positions and opportunities for graduate students from UCSF.  Moreover, there is a joint institute—the Gladstone-UCSF Institute of Genomic Immunology—further linking the two institutions.  Gladstone is also affiliated with the University of California, Berkeley and Stanford University, both of which are also under investigation for concerns related to antisemitism. CLICK HERE to read the full letter.

Washington, D.C. — In a new letter to Government Accountability Office Comptroller General Gene Dodaro, House Energy and Commerce Committee Republicans have requested an examination of the structure of laboratory safety programs at the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH).  The letter was signed by Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA).  KEY LETTER EXCERPT :  This committee remains concerned about the effectiveness of the oversight HHS and its agencies provide to the laboratories they own and operate. In addition to numerous GAO recommendations that remain unimplemented by the FDA, both the CDC and the FDA recently announced organizational reforms to their laboratory safety and security functions, and it is not clear whether these changes will strengthen oversight or create new undue risk. The FDA has, for example, reorganized several of its laboratories such that they now fall within the Office of the Chief Scientist. This raises potential independence concerns, as the FDA’s laboratory safety and security functions report to the same office.  BACKGROUND :  The mission of the U.S. Department of Health and Human Services (HHS) is to enhance the health and well-being of all Americans.   As such, HHS is most directly involved in leading public health preparedness and response efforts, as well as associated research.   However, past safety lapses involving the CDC, the FDA, and the NIH have been the result of multiple breakdowns in compliance with established policies coupled with inadequate oversight.   For example, in July 2014, boxes containing decades-old vials of smallpox and other hazardous biological agents were found in a storage space of an FDA laboratory on the NIH’s campus. GAO and other reviews resulted in numerous findings and recommendations to strengthen laboratory safety and security, which led to changes to the way HHS and its agencies oversee their laboratories.   Likewise, GAO and other reviews have highlighted the importance of laboratory science and security in the handling of federal select agents and other dangerous pathogens in research.  CLICK HERE to read the full letter.