Health

WASHINGTON, D.C.  – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, and Congressman Earl L. “Buddy” Carter (GA-01), Chairman of the Subcommittee on Health, announced a hearing titled  An Examination of  How Reining in PBMs Will Drive Competition and Lower Costs for Patients . “As outlined in recent reports, significant consolidation in the PBM marketplace has led to fewer options for patients and employers and less competition to keep out-of-pocket drug costs in check,”  said Chairmen Guthrie and Carter.   “Over the past few years, this Subcommittee has led on a myriad of legislative solutions which will help guide our continued work toward delivering high quality heath care for the American people.” Subcommittee on Health hearing titled  An Examination of How Reining in PBMs Will Drive Competition and Lower Costs for Patients . WHAT: Subcommittee on Health hearing to examine PBM reform policies.  DATE:  Wednesday, February 26, 2025  TIME: 10:00 AM ET  LOCATION: 2123 Rayburn House Office Building  This notice is at the direction of the Chairmen. The hearing will be open to the public and press and will be live streamed online at  energycommerce.house.gov . If you have any questions concerning the hearing, please contact Emma Schultheis with the Committee staff at  Emma.Schultheis@mail.house.gov . If you have any press-related questions, please contact Christopher Krepich at Christopher.Krepich@mail.house.gov .  ###

WASHINGTON, D.C. —  Congressman Earl L. “Buddy” Carter (GA-01), Chairman of the Subcommittee on Health, led a hearing yesterday titled  Combatting Existing and Emerging Illicit Drug Threats . “One death due to illicit drugs is too many, and this hearing gave members the chance to hear from patient advocates and experts, including law enforcement and medical professionals. Solving the drug crisis will include everything from empowering law enforcement to crack down on drug traffickers to providing support to those struggling with substance use disorder,”  said Chairman Carter.  “This Subcommittee has led on proposing solutions to these problems in the last Congress, and this hearing shows signs that we will continue to do so moving forward.” Watch the full hearing  here . Below are key excerpts from today’s hearing: Rep. John Joyce (PA-13), Vice Chairman of the Committee on Energy and Commerce: “Since the inauguration of President Trump, we have seen President Trump take immediate action to combat the growing threat of illicit fentanyl flowing through our borders. He designated the cartels in Mexico as a foreign terrorist organization and reached an agreement with the Mexican president to deploy her country's National Guard to help stop the transport of this deadly drug into our country. Unfortunately, these positive steps come only a few years after the inaction of the Biden Administration. And because of that delay, fentanyl poisoning has risen dramatically with seven out of 10 illicit fentanyl pills tested by the DEA in 2023 containing a potentially lethal dose of fentanyl. That's seven out of 10, and go back just two years before that, it was only four out of 10. Why would I say only four out of 10 deadly pills? Ray Cullen, thank you for being here. Thank you for sharing the story of your son, Zach. Can you talk about how fentanyl poisoning is distinct from an accidental overdose?”  Ray Cullen:   “Thank you for the question. So, in my opinion, an accidental overdose is when someone takes something—whether prescribed or not—that’s more of what they were supposed to then the body could handle. Poisoning to me means that someone took something that had something in it. that they were not expecting. So, in our case Zach purchased cocaine—bad decision—but the coroner told me that there was more fentanyl and cocaine in his system. He did not die because he took too much cocaine.” Rep. Neal Dunn (FL-02), Vice Chairman of the Subcommittee on Health: “Doctor Westlake, as a medical doctor, I'm interested to hear from you about how this issue presents in the emergency room. Can you speak from your own experience—how the presentations of drug overdoses have evolved over the last few years?”   Dr. Westlake:   “I think when, when we kind of saw the starting, it was with prescription opioid epidemic, and there were overdoses on prescription pills because of the overprescribing issue. That has pretty, pretty much, you know, at least in Wisconsin, and my understanding across the country is pretty much stopped. And now it's moved on to the illicit substances. And then once they became the counterfeit, counterfeit substances, initially it was people that knew they were using and were taking risks, and now moved into people that don't even know that they're that they're using. The majority of overdoses that I see are people that are not aware that they're taking fentanyl. The last 10 overdoses that I've seen in the last couple of months, all thought they were taking heroin, and when we tested it, there was no opioid, it was all pure fentanyl that was they were overdosing from.” ###

WASHINGTON, D.C.  – Congressman Buddy Carter (GA-01), Chairman of the Subcommittee on Health, delivered the following opening statement at today’s hearing titled  Combatting Existing and Emerging Illicit Drug Threats. "As we gavel in the first Energy and Commerce Subcommittee on Health hearing, American families across the country continue to suffer from failures of the Biden-Harris Administration’s disastrous four years and its inability to address one of the greatest public health threats of our lifetimes: the illicit drugs pouring over our borders.  "Under the previous Administration, the United States experienced a historic rise of drug overdoses and poisonings, driven by an increased supply of synthetic opioids, such as illicit fentanyl and its analogs. "Last fiscal year, Customs and Border Protection confiscated over 21,000 pounds of fentanyl at our borders. That is enough fentanyl to kill every American several times over. And that’s just the drugs we know about.  "Under the Biden-Harris Administration, we saw rates of overdose and poisoning deaths skyrocket, peaking at nearly 108,000 in 2023, driven by the surge of fentanyl coming across our borders. Illicit fentanyl overdoses are now the number one cause of death among adults 18 to 45. Each year, more Americans are dying from illicit fentanyl than the number of American lives lost during the Vietnam War. "However, I believe we have a great opportunity to make significant and sustainable progress in combating this crisis. To do so we must continue to expand the availability of overdose reversal treatments like naloxone, removing the stigma associated with carrying it and making it as common as a fire extinguisher. Every school in America should have access to naloxone. "We must secure our borders to stop the scourge of illegal drugs, especially poisons like illicit fentanyl. President Trump has already made progress to address the fentanyl crisis by forcing Mexico and Canada to come to the negotiating table. With President Trump’s leadership, we must continue to crack down on China, Mexico, and anyone who smuggles fentanyl and other synthetic drugs across our borders with the sole intention of preying on Americans.  "Additionally, this Committee is already taking action to help keep illicit fentanyl out of our communities and save lives. Later today the House will vote on a bill developed by this Committee, the Halt All Lethal Trafficking of Fentanyl Act, which will take the critical step of permanently scheduling all fentanyl-related substances as Schedule I drugs under the Controlled Services Act.  "These tools and solutions address today’s problem. But, like the evolution of the opioid crisis from the over prescribing of oxycontin to today’s scourge of synthetic opioids like fentanyl, we must prepare for what’s next. In this hearing we’ll hear from our witnesses not just on the illicit drugs threatening our communities today but potential new threats that if left unaddressed will be driving this crisis tomorrow. "I look forward to hearing that testimony and working alongside my colleagues on addressing these issues." ###

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.