News

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.

Washington, D.C. — In a letter today to Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., a bipartisan group of House Energy and Commerce Committee Leaders requested a briefing about the presence of counterfeit Ozempic and other semaglutide products in the United States’ medical supply chain.  The letter was signed by Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr. (D-NJ); Subcommittee on Health Chair Brett Guthrie (R-KY) and Ranking Member Anna G. Eshoo (D-CA); and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) and Ranking Member Kathy Castor (D-FL).   KEY LETTER QUOTE : “In addition to concerns about integrity gaps in the legitimate supply chain, we are also concerned about counterfeit Ozempic entering through illegal channels. For example, in June of this year, Eli Lilly issued an open letter expressing concern that counterfeit versions of its own drugs, Mounjaro and Zepbound, were being sold online, through social media and at medical spas. On May 1, 2024, a Department of Justice press release reported that work by FDA’s Office of Criminal Investigations resulted in the arrest of an individual for selling misbranded and adulterated weight loss drugs on TikTok. The Committee fully supports these continued investigations of unlawful sales.”   BACKGROUND :   The FDA alerted the public on December 21, 2023, to the presence of counterfeit Ozempic injection products in the legitimate drug supply; an investigati ve article l ater found that thousands of counterfeit Ozempic pens had arrived in a warehouse in Elmira, New York, as early as the fall of 2023. The fact that counterfeit medications made it into the legitimate medical supply chain raises concern about potential gaps in our supply chain security infrastructure.    This threat continues to grow.   CLICK HERE to read the full letter.

Washington, D.C — In a new letter to Advanced Research Projects Agency for Health (ARPA-H) Director Renee Wegrzyn, the House Committee on Energy and Commerce (E&C) and House Committee on Education and the Workforce (E&W) request information on how ARPA-H is ensuring that institutions and individuals involved in the research projects it funds comply with Title VI to ensure a harassment and discrimination-free environment.  This letter comes after a rise in antisemitism on college and university campuses, including Columbia University and the University of California, San Francisco where ARPA-H currently funds research. It 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 EXCERPT :  “Due to ongoing reports of antisemitism across colleges and universities, federal and congressional investigations into potential civil rights violations at these institutions, and an ongoing congressional investigation into HHS’s and NIH’s handling of these concerns at HHS-funded institutions, the Committees are seeking more information about how ARPA-H ensures that those involved in projects it funds comply with Title VI and relevant civil rights laws to ensure a research environment free of harassment and discrimination, especially towards those of Jewish faith and heritage.”  BACKGROUND :  ARPA-H is an independent agency of the U.S. Department of Health and Human Services (HHS) within the National Institutes of Health (NIH).  ARPA-H reports directly to the Secretary of HHS.  In the last year, ARPA-H has funded more than $595 million in research projects through ISOs and BAA with more than $506 million going to universities and research institutions and the rest to companies or organizations. Some of these research projects include:  August 30, 2024: Up to $39.5 million to Columbia University   August 22, 2024: Up to $7 million to the University of Pennsylvania   August 13, 2024: Up to $18.4 million to the University of Illinois Urbana-Champaign  July 10, 2024: Up to $27 million to the Wyss Institute at Harvard University  June 12, 2024: Up to $24 million to Yale University School of Medicine  April 1, 2024: Up to $35 million to the University of California, San Francisco  September 26, 2023: Up to $104 million to Harvard Medical School  September 25, 2023: Up to $26 million to Stanford University  Of the fourteen university-based projects ARPA-H funded in the last year, eleven (including the eight listed above) are at universities that were recently or are currently under federal and/or congressional investigation for potential Title VI violations and/or are being sued in federal court for permitting antisemitic behavior on campus.  Columbia University has been sued in federal court, is currently undergoing several investigations by the U.S. Department of Education Office for Civil Rights, and is undergoing investigation by congressional committees, for complaints of antisemitism.  The Committee on Energy and Commerce is currently investigating the University of California, San Francisco regarding concerns of antisemitism at the university, medical school, and associated medical centers.  The U.S. Department of Education recently closed its investigation into the University of Illinois-Urbana Champaign with a resolution agreement that found the university was not meeting its obligation under Title VI as it relates to complaints of shared ancestry discrimination—including 135 complaints of anti-Jewish discrimination.  CLICK HERE to read the full letter.

Letter comes following allegation student was delayed care due to Israeli heritage Washington, D.C. — In a new letter to Columbia University Interim President Katrina Armstrong, the House Committee on Energy and Commerce (E&C) and House Committee on Education and the Workforce (E&W) are demanding answers regarding ongoing and pervasive acts of antisemitic harassment and intimidation at the University and its associated medical school and centers. The letter, 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) requests that Columbia University respond to the Committees’ questions by no later than October 2, 2024.  It is part of Speaker Mike Johnson’s (R-LA) House-wide  effort  to crack down on antisemitism on college campuses.  KEY EXCERPTS : “A report from the Columbia University Antisemitism Task Force highlighted how the hostility on Columbia University campuses had spilled over into the medical center and medical services as well. For example, an Israeli student reported that when she went to health services in July 2024, no one came into the room to see her, and she overheard a discussion between two health care professionals in another room in which one said they would not treat her because she was Israeli. She sat in the room for another ten minutes until someone finally came to address her health needs.”  [...]  “Failing to comply with basic safety protections for members of the Columbia University community and to respond appropriately to and prevent harassment and discrimination, no matter the cause, may be grounds to withhold federal funds from the university and its associated medical centers. Congress has an obligation to ensure compliance with Title VI. If Congress determines an institution of higher education is in violation, it may consider rescinding research and development funds previously appropriated. Similarly, if Congress determines a medical facility is in violation, it may consider rescinding the right to participate in federal health care programs.”  CLICK HERE to read the full letter.  BACKGROUND :  Beginning on April 17, 2024, an encampment sprung up on Columbia University’s campus with hundreds of protestors and tents.  Banners and signs vandalized the campus—including residence halls—with antisemitic sentiments and even support for the terrorist organization Hamas.  Chants and statements by those within the encampment also supported messages of violence and hate towards Jewish students, with a leader of the encampment filmed stating that, “Zionists don’t deserve to live.”  Professors at Columbia University have also openly made antisemitic and pro-Hamas statements—including more than 100 professors signing a letter in support of the October 7, 2023, terrorist attack by Hamas—adding to the harassment of Jewish students.  An English professor held his classes inside the encampment, despite the fact that it was an uncomfortable and unsafe environment for some of the students in the class, who did not attend.  A prominent rabbi at Columbia University warned Jewish students to remain off-campus during the end of the academic year in Spring 2024 due to fears that the university and New York City police could not keep students safe.  Jewish students on campus also expressed concerns over their safety on campus and the mental and psychological toll the hostile environment was taking on their ability to work and learn. Despite over 100 arrests, the protests progressed to the occupation of a campus building and physical attacks of Jewish students, leading campus officials to move some classes online for the remainder of the academic year.  Columbia University also has a medical school, as well as several affiliated medical centers. Antisemitism has no place in an institution where students go to learn how to be the next generation of medical professionals caring for patients of all religions and ethnic backgrounds.  An interview with students at Irving Medical Center, where Columbia University’s medical school is housed, emphasized the extent to which Jewish students felt excluded and unable to openly identify as Jewish or express their Jewish identity on campus.  A nursing student, for example, stated that the sheer number of antisemitic policy violations that are minimized and go unpunished have made the behavior a norm and that the “Columbia nursing [school] is not a place for Jews.”

Washington, D.C. — In a new letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, the House Committee on Energy and Commerce (E&C) and House Committee on Education and the Workforce (E&W) issued a request for documentation related to the Committees’ ongoing investigation into how the department is preventing and responding to antisemitism at grantee institutions. The letter follows up on a May 23, 2024, letter to which HHS failed to respond to adequately and 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 EXCERPT :  “Responding on your behalf in an August 22, 2024, letter, the HHS Assistant Secretary for Legislation stated that, “The HHS Office for Civil Right (OCR) enforces federal civil rights laws prohibiting various forms of discrimination in HHS-funded programs and activities […]” and that “OCR takes this duty seriously.” Despite this declaration, the lacking response from HHS failed to provide specific information about how HHS OCR or the NIH have taken steps to ensure that institutions and universities receiving funding from HHS are complying with federal civil rights laws amongst these extensively reported acts of antisemitism, and whether HHS OCR or the NIH have received any complaints regarding potential violations of federal law as it pertains to antisemitism.” The Chairs requested the following documents by no later than October 2, 2024: A list of all misconduct allegations at NIH-funded institutions relating to alleged antisemitic incidents from fiscal year 2023 to present received by HHS OCR and/or the NIH, showing:   the date;   which agency received the allegation;   a brief description of the incident;   role of the alleged perpetrator and victim (e.g., student or faculty) with their names redacted;  institution;   entity responsible for reviewing the case (including whether the complaint is an official Title VI case);   case status;   actions taken by the institution; and   actions taken by HHS/NIH.  All documents and communications, including but not limited to, text messages, emails, and electronic messages, to or from HHS OCR/to or from the NIH referring or related to misconduct allegations or concerns over actions at NIH-funded institutions from fiscal year 2023 to present, referring or relating to, alleged antisemitic incidents; targeting of Jews, Israelis, Zionists, or Zionism; university encampments; and/or the Israeli-Palestinian conflict.  All documents and communication between HHS OCR and other agencies regarding assistance with Title VI compliance, particularly related to antisemitism (shared ancestry).  All documents and communication between HHS OCR and NIH-funded institutions related to Title VI compliance reviews related to antisemitism (shared ancestry).    From fiscal year 2023 to present, all documents, communications, and guidance provided from HHS OCR and the NIH to grantee institutions and individuals at grantee institutions regarding Title VI responsibilities and protections, including those specific to protections for those of Jewish faith and heritage, and all documents or communications regarding HHS/NIH’s stance on antisemitism, the events occurring on university campuses, and/or the Israeli-Palestinian conflict generally.  CLICK HERE to read the full letter.

Committee Leaders request GAO review CMS Part D premium stabilization program Lawmakers are calling on the Government Accountability Office (GAO) to review the Medicare Part D Premium Stabilization Demonstration recently announced by the Centers for Medicare & Medicaid Services (CMS), noting its dubious legality and the danger it poses to health care affordability for seniors. The effort comes as part of a letter to GAO from House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Senate Finance Committee Ranking Member Mike Crapo (R-ID), and House Ways and Means Committee Chair Jason Smith (R-MO).  Through new taxpayer-financed policy adjustments, the demonstration seemingly intends to deflate seniors’ premiums that are otherwise slated to increase dramatically following the counterintuitive, haphazardly-written Inflation Reduction Act’s drug price provisions. However, the agency has not produced any budgetary analysis and appears to lack a clear statutory basis or credible research goals for the proposal. Rodgers, Crapo, and Smith request GAO review the demonstration’s legality under section 402 of the Social Security Amendments of 1967; what budgetary analysis CMS undertook in developing the demonstration; and the estimated budgetary impact of the demonstration. From the letter: “We write to request that the Government Accountability Office (GAO) conduct an expedited review of the Part D Premium Stabilization Demonstration, as announced by the Centers for Medicare & Medicaid Services (CMS) on July 29, 2024. In response to the Inflation Reduction Act’s (IRA) problematic design features and rushed legislative process, the proposed demonstration employs arbitrary policy levers to achieve short-term objectives. The initiative lacks any budgetary analysis, clear statutory basis, or credible research goals. The integrity of the Medicare program and the taxpayer dollars that finance its benefits demand more than partisan aspirations to justify extra-statutory, eleventh-hour policy changes." [. . .] “[T]he policies advanced through the recently announced demonstration would simply shift costs from plan sponsors and enrollees to taxpayers, obscuring the law’s impacts without addressing their underlying drivers. Moreover, consideration of these types of programmatic changes should fall within the purview of the legislative branch. Instead, however, this agency action seeks to sidestep Congress, waiving statutory directives under the guise of a ‘demonstration project,’ with no meaningful research aims, budgetary assessments, or empirical rigor.” CLICK HERE to read the full letter.

Washington, D.C. — In a new letter to the University of California, San Francisco (UCSF), House Energy and Commerce 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) press for information regarding antisemitic harassment and intimidation at UCSF and its associated medical centers under UCSF Health. The investigation comes as part of Speaker Mike Johnson’s (R-LA) House-wide  effort  to crack down on antisemitism on college campuses.  KEY EXCERPTS:   “As a recipient of federal funding—both through various U.S. Department of Health and Human Services (HHS) grants and Medicaid and Medicare reimbursements for health care services provided at UCSF Health medical centers—UCSF has an obligation to comply with federal law and to prevent and appropriately respond to discrimination and harassment.”  [...]  “The reports of antisemitic harassment and intimidation at UCSF and its associated medical centers coupled with the inadequate response by UCSF leadership is concerning to the Committee. Failing to act decisively to ensure a safe environment for all students, faculty, staff, and patients is a grave dereliction of your responsibilities as Chancellor of UCSF and UCSF Health." [...]  “Failing to comply with basic safety protections for members of the UCSF and UCSF Health communities 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 and its associated medical centers. Congress has an obligation to ensure compliance with Title VI. If Congress determines an institution of higher education is in violation, we may consider rescinding research and development funds previously appropriated. Similarly, if Congress determines a medical facility is in violation, we may consider rescinding the right to participate in federal health care programs.”  BACKGROUND :  An encampment in front of UCSF’s medical center has caused significant disruption to campus and health care operations, as well as great distress for members of the community, including health care professionals and patients.  Many Jewish health care professionals working at UCSF Health have also expressed concerns regarding their safety—including concerns of their private information being made public.  This fear is well founded, as there have been numerous antisemitic public statements by faculty, staff, and students at UCSF and/or UCSF Health, such as assertions that patients should fear Jewish doctors, false claims that Israel trains U.S. police to brutalize people of color, or statements that Israelis in the U.S., including students at U.S. universities and medical schools, who have served with the Israeli Defense Forces (IDF) should be tried for war crimes.  Hundreds of complaints of antisemitism and/or a hostile work environment have been made by employees and patients of UCSF and UCSF Health to the UCSF Office of Prevention of Harassment and Discrimination (OPHD), with confidential sources reporting that most complainants receive a response that these actions and statements fall under free speech protections.  CLICK HERE to read the full letter. 

Washington, D.C. — In a new letter to Attorney General Merrick Garland and Department of Health and Human Services (HHS) Secretary Xavier Becerra, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee on Health Chair Brett Guthrie (R-KY) requested information related to rescheduling of marijuana.  KEY LETTER EXCERPTS :  “We write to express our concerns with the recent notice of proposed rulemaking titled ‘Schedules of Controlled Substances: Rescheduling of Marijuana,’ to transfer marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). The circumstances surrounding this proposed rule are unusual, and we are concerned by the process that led to this determination.”  [...]  “We support research into innovative therapies to improve patient outcomes, but we are concerned with how the normal process was circumvented to achieve a result for political purposes and we have a number of unanswered questions.”  BACKGROUND :  History:   Marijuana is a psychoactive substance that has been listed in Schedule I since the CSA was enacted in 1970.  All substances in Schedule I are classified as having no accepted medical use and a high potential for abuse.  This means that the manufacturing, possession, and distribution of marijuana is illegal at the federal level, except for certain research approved by the Drug Enforcement Administration (DEA).  During the Obama administration in 2016, the DEA and HHS, acting through the Food and Drug Administration (FDA), conducted a multi-year review of whether to transfer marijuana from Schedule I to a lesser schedule. Both the DEA and HHS agreed that marijuana continued to meet the criteria to be considered a Schedule I substance.  HHS concluded that “[…] marijuana has a high potential for abuse, has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision.”  President Biden made a public statement on October 6, 2022, issuing pardons for all simple possession federal offenses of marijuana, requesting all Governors do the same with state level offenses, and requiring HHS and DOJ to begin the administrative process to quickly review how marijuana is scheduled under federal law.  While the administration has the authority to alter a substance’s scheduling status, it is bound by the CSA to consider factors, including whether a substance has a medical use and to determine its potential for abuse and dependence, prior to changing its scheduling status.  Process:   The DEA typically determines whether a substance has a medical use if it has been approved for marketing under the Food Drug and Cosmetic Act (FDCA) and by conducting a five-part test, which considers the following:  (1) there were adequate safety studies,  (2) the drug’s chemistry is known and reproducible,  (3) there are adequate and controlled studies,  (4) the drug is accepted by qualified experts, and  (5) there is widely available scientific evidence.  However, this proposed rule indicates that HHS notified the DEA that HHS disagreed with the existing process and decided to develop its own test to determine whether a substance has medical use under the CSA.  This test is comprised of two considerations:  (1) if there is widespread medical use of such a substance under the supervision of a licensed health care practitioner operating within a State-authorized program and,  (2) if so, there is credible scientific evidence to support medical use of such substance.  HHS analyzed marijuana by utilizing its own two-part test, determined it has a medical use, and therefore recommended to transfer marijuana from Schedule I to Schedule III of the CSA.  DOJ received HHS’s recommendation and declared that this new two-part test is sufficient to establish medical use, which is an unusual deviation from the typical process.  It is notable that the proposed rule states, “DEA has not yet made a determination as to its views of the appropriate schedule for marijuana,” seeming to indicate that the DEA is not yet convinced of the merits of this review.  Additionally, most of the professional organizations listed in the HHS “Basis for the Recommendation to Reschedule Marijuana into Schedule III of the Controlled Substances Act” have released position statements that either request more evidence or oppose using marijuana as medicine for their specialties.  Further Considerations:   To date, the FDA has not approved a New Drug Application (NDA) necessary to have satisfied the criteria required under the previous five-factor analysis, such as adequate and well-controlled studies proving safety and efficacy, for a drug product containing botanical marijuana to treat any medical condition(s); thus, it has remained a Schedule I drug without a currently accepted medical use.  This is misaligned from typical practice, as the presence of a marketing application approved to treat a certain condition or disease has been central to the FDA's determinations.  The Delta-9-tetrahydrocannabinol (THC) potency in marijuana is also continuing to increase.  According to the proposed rule, THC potency has spiked from about three percent in 1991 to 17 percent in 2017 and it notes, “[…] DEA anticipates that additional data on public safety risks, risks from acute and chronic marijuana use via oral and inhaled administration routes, and the impact of THC potency may be appropriate for consideration.”  The proposed rule also states, “the vast majority of professional organizations did not recommend the use of marijuana in their respective specialties; however, none specifically recommended against it, with the exception of the American Psychiatric Association, which states that marijuana is known to worsen certain psychiatric conditions.”  Further, HHS’s own report to Congress titled “Health Effects of Cannabis and Cannabinoids and Barriers to Research” states that “[m]ore research is needed to evaluate the therapeutic potential of cannabis and cannabinoids as a means of safely and effectively treating various indications […] it is also worth noting that the U.S. jurisdictions that have legalized the use of cannabis products for medicinal purposes have often done so with inadequate scientific research to support all allowable uses.”  CLICK HERE to read the letter.

Washington, D.C. — In a new letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra and National Institutes of Health (NIH) Director Monica Bertagnolli, House Energy and Commerce 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) requested documents and transcribed interviews related to an approved MPVX experiment.  The letter comes after the Committee released an interim staff report on the experiment as well as an NIH reform framework . It notes that a failure to produce the requested documents by August 8, 2024, may lead to issuance of a subpoena to compel compliance. HHS and the NIH continue to withhold critical documents requested by the Committee last year.  KEY EXCERPT :  “For nearly a year and a half, the Department of Health and Human Services (HHS), the NIH, and NIAID misled the Committee. Both HHS and the NIH told us a risky MPXV research proposal at the NIAID had not been “'formally proposed' or 'planned' when in fact this project was submitted and received approval before the NIH’s Institutional Biosafety Committee (IBC) on June 30, 2015, as documented in written meeting minutes. The misleading statements were included in the following communications to the Committee:  Letter from the HHS Assistant Secretary for Legislation dated April 26, 2023.  Letter from Dr. Bernard Moss to Chair Rodgers, dated June 30, 2023.  Written statements presented at the September 21, 2023, meeting between Committee staff and NIH/NIAID officials from Dr. Bernard Moss, Dr. Steven Holland, NIAID Director of the Division of Intramural Research, and Jeffery Potts, Chief of the Biorisk Management Branch within the NIH Division of Occupational Health and Safety.  “This deception is unacceptable and has led the Committee to conclude that NIAID cannot be trusted to oversee its own research of pathogens or determine whether an experiment poses enhanced risks of a potential pandemic or other serious public health outbreak.”  [...] “NIAID’s lack of candor to this point suggests that it cannot be trusted to oversee the research projects that it funds. Therefore, this Committee will explore policy options to address this inherent conflict of interest and lack of transparency.”  ADDITIONAL BACKGROUND :  A new strain of MPXV has recently emerged that increases the risk of this disease causing a major public health outbreak or a potential pandemic. Since January, the Democratic Republic of the Congo has reported more than 4,500 suspected mpox cases and nearly 300 deaths, numbers that have roughly tripled from the same period last year, according to the World Health Organization.  Congo recently declared the outbreak across the country a health emergency. An analysis of hospitalized patients suggests recent genetic mutations are the result of continued transmissions in humans.  CLICK HERE to read the letter.