Health

WASHINGTON, D.C. – Congressman Earl L. “Buddy” Carter (GA-01), Chairman of the Subcommittee on Health, led a hearing yesterday titled An Examination of How Reining in PBMs Will Drive Competition and Lower Costs for Patients . “Patients are counting on us to stop the abusive practices that drive up out-of-pocket costs on their prescription drugs,” said Chairman Carter. “This Committee has worked to identify bipartisan solutions that will meaningfully help patients access their medications. Yesterday’s hearing gave us a chance to further hear from medical professionals and policy experts on why reining in PBMs and increasing transparency in the system will improve our health care system for all Americans.” Watch the full hearing here . Below are key excerpts from yesterday’s hearing: Rep. Diana Harshbarger (TN-01) : “I say this in every PBM hearing, and I'm going to say it again today. PBMs don't treat a single patient. They don't cure a single disease, and they don't insure a single American. So, the bottom line is: it's all about the patients, isn't it, gentlemen? It certainly is and how they're losing access to pharmacy choice. It’s those pharmacies who, in most communities, are your independent pharmacies which are the most trusted and the most readily available healthcare provider in that community. So, PBM reform is a bipartisan issue, and you know what that means? That means that both sides agree on this issue. It's not an issue of contention. It's important that we get some PBM reform done.” Rep. Mariannette Miller-Meeks (IA-01) : “It's no secret that PBM middlemen artificially inflate the cost of and limit access to prescription drugs. This occurs at the expense of patients who receive health insurance in public and private markets and impacts patients of all ages. PBMs claim they reduce prices by holding pharmaceutical companies accountable. This is done, they contend, by requiring rebates on drugs, which are then passed on to the beneficiary. While PBMs often do negotiate discounts for manufacturers, patients are not the ones who benefit from them. In Medicare Part D, for example, patient cost sharing is based off the list price of drugs, which are artificially inflated to extract a higher rebate. As a result, of these practices for 79 of the 100 most rebated drugs in Medicare Part D, beneficiaries pay more for their drug than their insurer. Again, demonstrating that beneficiaries, in this case, seniors are not benefiting from the rebates.” Rep. Troy Balderson (OH-12) : “As a result of PBM's indecent practices, independent pharmacies around the country are closing. I know that in my district we are not strangers to this issue. I hear from my friends, family, and constituents alike that their trusted pharmacies have closed after decades of serving their communities. Pharmacy deserts have continued to grow and patients no longer have access to patient pharmacist relationships that has helped them manage complex medication regimes and diseases. It's estimated that between 2018 and 2021 alone, the number of pharmacies has declined in 41 states. So, this is not just an Ohio problem. This is not a rural problem. This is a countrywide issue that needs addressed.” ###

WASHINGTON, D.C.  – Congressman Earl L. “Buddy” Carter (GA-01), Chairman of the Subcommittee on Health, delivered the following opening statement at today’s hearing titled  An Examination of How Reining in PBMs Will Drive Competition and Lower Costs for Patients. Subcommittee Chairman Carter's opening statement as prepared for delivery: “I want to welcome everyone to today’s hearing on how reigning in Pharmacy Benefit Managers, or PBMs, will drive competition and lower costs for patients. “Before I dive into the policy, I want to take a moment to address the true reason why we’re having this hearing today – patients. Patients, like a fellow Georgian, Mattie McCoy. Mattie, a sixteen-year-old Georgia resident, suffers from a rare genetic disorder. “CVS Caremark denied Mattie’s access to a lifesaving drug that he had been on for two years. As a result, Mattie was forced back into the hospital.  “Let me be clear: PBMs’ greed sent a 16-year-old back to the hospital, in critical condition. While tragic, this story is far from unique.  “So, how did we get here?   “PBMs are the pharmaceutical supply chain’s hidden middlemen that are driving up costs for prescription medications, delaying access to necessary treatments, adding hoops for patients to jump through, and robbing hope from patients. They have only created perverse incentives throughout the drug supply chain.  “Their extensive market control has only grown due to consolidation and vertical integration leading to less competition and decreased patient choice.  “After nearly two decades of consolidation, the PBM industry is now dominated by three companies that control over 80% of the market. They own or are owned by insurers and have vertically and horizontally consolidated their businesses to own doctors, pharmacies, group purchasing organizations, and more. “We have heard directly from our constituents that the harmful and anticompetitive tactics of some PBMs have only gotten worse, and that Congressional action is desperately needed.  “We’ve heard a constant stream of reports that some PBMs are reimbursing independent pharmacies less than the pharmacies they own. “For example, a Mississippi audit revealed that Optum pays its own stores up to 22 times what it pays independent pharmacies for the same drug.  “How are you supposed to stay in business when your competitor makes 2,200% more than you for the same exact service?  “The answer is you don’t. In 2023, there were over 300 independent pharmacy net closures – almost one per day. Unfortunately, that trend continued in 2024. Pharmacists are some of the most accessible and highly trusted health care professionals. Yet, PBMs are putting pharmacies out of business and removing patients’ access to care. We now have “pharmacy deserts” in rural and underserved communities. That’s affecting the accessibility, affordability, and quality of health care for all Americans.  “Recently, the Federal Trade Commission released its second interim report which found that “PBMs charge significant markups for cancer, HIV, and other critical specialty generic drugs” by thousands of percent, and many others by hundreds of percent.  “Another egregious example of PBMs’ abuse of taxpayer-funded programs is the United States Postal Service health plan. In an audit released in March 2024, the Inspector General of the U.S. Office of Personnel Management found that Express Scripts overcharged the American Postal Workers Union Health Plan and the federal government nearly $45 million.  “Thankfully, President Trump is committed to holding PBMs accountable. I commend him and look forward to working with this administration to drive solutions that lower costs for patients at the drug counter.  “The House Energy and Commerce Committee has made commonsense PBM reform policies a bipartisan priority.  “Last Congress, this Committee advanced bipartisan legislation that saves significant taxpayer dollars in state Medicaid managed care programs and – for the first time in Medicare Part D – enforces reasonable and relevant contract terms that support pharmacies’ ability to serve patients in addition to delinking PBM compensation from list price. Further, this Committee championed reporting requirements which would increase transparency by shining a light on the opaque drug pricing system that is driving up drug spending for patients and employers, in addition to harming pharmacists.  “Americans deserve and expect protection from inflated prescription drug costs, forced pharmacy closures, and barriers to health care access. I look forward to working with my colleagues on both sides of the aisle to enact these meaningful PBM reforms for patients, like Mattie, who are suffering at the expense of PBM's abusive tactics.” ###

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. — 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.