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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.

Washington, D.C. — In new letters to the Department of Health and Human Services (HHS) Inspector General and Government Accountability Office (GAO) Comptroller General, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), House Ways and Means Committee Chair Jason Smith (R-MO), and House Judiciary Committee Chair Jim Jordan (R-OH) ask for systemic reviews of Obamacare enrollment to determine the breadth of improper enrollment and its underlying causes.  The letters come following the release of a paper from Paragon Health Institute, which estimates that four to five million people are improperly enrolled in fully-subsidized Obamacare plans at a cost of $15 to $26 billion per year to taxpayers.  KEY EXCERPT FROM THE LETTERS:   The Democrat-passed tax-and-spend laws resulted in tens of billions of additional taxpayer dollars being spent to prop up Obamacare plans by increasing subsidies given to insurance companies far above those originally authorized by Congress. Recently, the Congressional Budget Office (CBO) estimated that making those subsidy levels permanent would add nearly $400 billion to the deficit on top of the hundreds of billions in existing Obamacare spending.  A key feature of this expansion increases subsidies for insurance companies such that the full cost of premiums for individuals with incomes between 100 and 150 percent of the Federal Poverty Level (FPL) is paid for by American taxpayers, often referred to as “zero-premium” plans. This policy, coupled with the Biden administration's regulatory actions to eliminate program integrity controls in the federal exchanges, such as prohibiting key eligibility verification procedures, appears to have created both the incentive and opportunity for individuals and brokers to misstate enrollees’ income to place them in benchmark plans receiving the maximum subsidy.  Individuals enrolled in this income cohort nationwide exceed the total number of potentially eligible individuals. This problem appears to be particularly acute in certain states, with some reporting hundreds of thousands, and, in one case, millions more individuals enrolled in these plans than are reasonably likely to be eligible. More than half of all enrollees in the federal exchange now report incomes between 100 and 150 percent of FPL—notably higher than the historical average of roughly 40 percent—further demonstrating the breadth of the enrollment incongruity.  While individuals may reasonably misestimate their income at any given point, the scale of the problem suggests malicious intent from certain actors involved. There have been documented issues with broker behavior surrounding these “zero-premium” plans, with reports and litigation detailing practices of consumers having their plan switched by such brokers without their consent.  Estimates show the cost of improperly enrolled individuals in “zero-premium” plans are $15 billion to $20 billion per year and potentially as high as $26 billion per year. If these estimates are accurate, it implies that these improper payments represent more than half the cost of making the expanded subsidies permanent.  Runaway deficits and debt are threatening to breach historic levels in the next decade, and, by 2054, the cost of simply servicing our national debt will more than double relative to Gross Domestic Product (GDP), crowding out other important national priorities. Given this grave situation, it is critical that the federal government safeguard increasingly scarce resources to ensure that every dollar spent goes as far as possible to improve Americans’ wellbeing.  CLICK HERE to read the letter to HHS Inspector General Christi Grimm. CLICK HERE to read the letter to GAO Comptroller General Gene Dodaro.

Washington, D.C. — In a new letter to Food and Drug Administration (FDA) Commissioner Robert Califf, 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) are pressing for more information regarding the agency’s foreign drug inspection program. The letter continues the Committee’s investigation into FDA inspection practices, which include a July 18, 2023, letter , a December 13, 2023, letter , and a February 6, 2024, oversight hearing at which the FDA declined to make an official available to testify.  BACKGROUND :  In the letter, the Members discuss the Committee’s analysis of FDA inspection outcomes in India and China from January 2014 to April 2024, limiting its review to inspectors with ten or more inspections in either China or India.   EXCERPT OF THE ANALYSIS :  “The results of this analysis were surprising, revealing tremendous variation in inspection outcomes. Some FDA inspectors found compliance issues during all or almost all of their inspections. Other inspectors rarely reported finding a single compliance issue. Two inspectors never found a single compliance issue over the course of a combined 24 inspections in India. Another inspector found zero compliance issues in 20 out of 23 inspections (85 percent) in China while finding compliance issues with almost half of domestic inspections during the same period. These are unusual inspection outcomes, the opposite of what would be expected given the widely reported failures in quality control and lack of adherence to current good manufacturing techniques by drug manufacturing facilities in China and India.  “By contrast, 16 FDA inspectors, with over 325 inspections collectively in India, found compliance issues during every inspection they conducted. As a measure of what a pattern of rigorous inspections should look like, the Committee reviewed the inspection outcomes for 3 FDA inspectors with professional reputations for thoroughness who also had at least 10 inspections in China or India during the studied time period. These expert inspectors reported finding no compliance issues during inspections in China at a rate of only 6.7 to 11.4 percent and at a rate of zero to 9.5 percent in India.”  KEY LETTER EXCERPT : “Such large variations in inspection outcomes are troubling, and they merit further investigation. At a minimum, the Committee is concerned that these findings suggest vast differences in the skill, thoroughness, and competence of FDA inspectors. The difference in inspection outcomes appears to be just another example of institutional weaknesses and dysfunction in the FDA’s foreign drug inspection program. Prior to the pandemic, media reporting found that some FDA inspectors took an inappropriately lenient approach with foreign drug manufacturers with serious compliance violations. There were also reports o f, and concerns about, foreign manufacturers attempting to bribe or improperly influence inspectors. The Committee is seriously evaluating the disturbing possibility that some of the variation in inspection outcomes could be the result of bribery or fraud.”  CLICK HERE to read the full letter. 

Washington, D.C. —  In a new letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, 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) request information regarding HHS’s suspension and debarment process.  The letter also provides direct evidence refuting Secretary Becerra’s testimony to the Health Subcommittee asserting that HHS “will take immediate action” to stop sexual abusers from receiving taxpayer funding. It comes amid the Committee’s ongoing investigation into sexual harassment at the National Institutes of Health (NIH) and at NIH grantee institutions.  KEY LETTER EXCERPT :  “At the April 17, 2024, hearing before the Subcommittee on Health, in response to a question about the redactions of names of confirmed abusers or harassers, you said: ‘If there is an abuser that is receiving taxpayer dollars from the Department of Health and Human Services, . . . in this particular case the National Institutes of Health [NIH], we will take action immediately.’    “ However, your claim is belied by the facts. Based on subpoenaed NIH documents reviewed in camera, Committee staff discovered that an individual who served as principal investigator on at least 24 NIH-grants was not suspended or debarred from receiving federal funding despite his conviction in 2021 of sexual abuse and his medical license being stripped . Based on documentation reviewed during the Committee’s in camera review of sexual misconduct allegations on NIH-funded research, staff found that in September 2020, the NIH recommended to HHS an immediate federal-wide suspension and debarment of this abuser for 10 years based on the abuser’s indictment in 2019 on three counts of sexual abuse, and the grantee institution’s determination that the individual was responsible for sexual harassment in January of 2020. Despite this recommendation from the NIH, followed by the individual’s conviction in December 2021, HHS has taken no action. Three and a half years later, this abuser remains eligible for federal funding. On April 15, 2024, Committee staff sent an email to HHS staff requesting information about the status and handling of this matter. HHS has not yet responded.”  [...]  “ We are troubled by the limited use of suspensions and debarments from awarding agencies within HHS along with the timeliness issues and lack of use of suspensions pre-debarment raised by the HHS OIG. Harassers and abusers with public reporting of their actions, and even some with criminal convictions, are not present on SAM.gov as suspended or debarred .”  BACKGROUND : HHS is the largest grantmaking agency in the federal government—awarding over $778 billion in grants in fiscal year 2023.  Federal suspension and debarment programs help to protect the integrity of federal grant programs by ensuring the federal government does business only with responsible persons.  Individuals or parties receiving grants can be suspended or debarred from continuing to receive federal grants if they lack honesty, integrity, or business performance.  Within HHS, a suspension or debarment action may be initiated from an awarding agency—such as the NIH—or another entity—such as the Office of Inspector General (OIG).     Referrals for suspension or debarment are sent to the HHS Office of Recipient Integrity Coordination (ORIC) for review and final decision by the Suspension and Debarment Official (SDO).  Referrals can be conviction-based—originating from a criminal conviction or civil judgement—or fact-based—in which the referring office builds a case based on facts (e.g., audit findings or failures to disclose).  Suspensions and debarments are not retrospective, meaning respondents can maintain their current award(s), but it does prevent them from receiving new federal awards.   Not only are these suspensions and debarments valid within the referring agency, but they also generally make a respondent ineligible for awards from other federal departments.   Suspended or debarred parties or individuals are listed on SAM.gov and awarding departments can check this list before awarding grants to prevent awarding grants to these parties or individuals.   While federal departments have discretion as to when to refer a respondent for suspension or debarment, HHS—and particularly awarding agencies such as the NIH—can prevent known harassers or abusers from receiving additional federal awards across the federal government through these processes.   However, a 2022 HHS OIG report found several concerns during its audit of HHS’s suspension and debarment processes.  HHS OIG found that 84 percent of referrals came from non-awarding agencies—such as the OIG or Office of Research Integrity—rather than those offices charged with supervising ongoing grants.  This statistic raised concerns for the OIG about the extent to which awarding agencies were doing enough to identify and take action against bad actors and if agencies are missing opportunities for additional suspension and debarment referrals.  Another concern is the timeliness of the HHS suspension and debarment process and the limited use of suspensions during pending debarment proceedings.   The HHS OIG found that nearly half of suspensions implemented by ORIC did not meet its 60-day goal, with several suspensions taking longer than 300 days to implement.  Of the 134 debarments that ORIC implemented, nearly all involved grants, yet less than one-third of these debarments included a preceding suspension.  That means more than two-thirds of respondents may have maintained access to additional federal funding during the debarment process, with the longest case taking 1251 days or nearly three and a half years.  Moreover, for conviction-based debarments—in which the evidentiary threshold has generally already been met by the conviction or judgment—75 percent of conviction-based debarments implemented by ORIC did not meet its 100-day goal.  Rather, implementation took an average of 325 days and nearly a quarter of these debarments took over 500 days to be implemented.  The HHS OIG found numerous areas in which the timeliness, efficiency and effectiveness of HHS’s suspension and debarment program were negatively affected by internal factors.   Specifically, there is a very high turnover rate at both the staff and senior leadership levels of the suspension and debarment program, with ORIC’s full staffing levels being four personnel.  Moreover, seven different people served as HHS’s SDO—the official determining if suspension or debarment is to be implemented—in just four years.  With this kind of turnover, cases may fall through the cracks or be heavily delayed.   Moreover, HHS OIG found that a lack of policies and procedures regarding entering and tracking important case information and milestones plus a lack of guidance on what information is needed in fact-based referrals has limited the ability to suspend or debar individuals.  Specifically, ORIC was not able to suspend or debar several individuals due to a lack of documentation in the referral that showed a referring entity followed its own corrective-action escalation process prior to the suspension or debarment.  CLICK HERE to read the full letter.  TIMELINE OF INVESTIGATION:   August 10, 2021 : E&C Republican Leaders Question NIH’s Handling of Sexual Harassment Complaints    August 11, 2022 : E&C Republican Leaders follow up with NIH on Insufficient Response to its Letter on the NIH’s handling of Sexual Harassment    November 30, 2022 : E&C Republicans to NIH: Turn Over Previously Requested Information Ahead of New Congress    March 14, 2023 : E&C Republicans Press NIH for Information on Handling of Sexual Harassment Complaints    October 6, 2023 : E&C Republicans Signal Intent to Issue Subpoena to Obtain Information on NIH’s Handling of Sexual Harassment if Questions Go Unanswered    January 26, 2024 : Chair Rogers notifies NIH of Imminent Subpoena    February 5, 2024 : Chair Rodgers Subpoenas NIH for Documents Related to Investigation into Sexual Harassment at NIH and NIH Grantee Institutions   February 20, 2024 : HHS Responds on behalf of NIH to offer a rolling in camera document review to the Committee. Documents produced in the review have been highly redacted, including the redaction of the names of individuals convicted of criminal offenses, public news articles about individuals who have been found guilty of harassment, and redaction of the names of the institutions where the abuse occurred—effectively preventing the Committee from understanding if NIH continues to fund work performed by substantiated abusers at other institutions—a practice known as “pass the harasser.”   April 16, 2024 : E&C Republicans Expand Investigation into Sexual Harassment at NIH to now Include Review of HHS Office of Civil Rights Compliance Role  May 9, 2024 : E&C Republicans ask Department of Health and Human Services (HHS) Secretary Xavier Becerra to provide the Committee with the legal basis requiring HHS to redact or hide the names of researchers determined to have committed sexual misconduct. 

Washington, D.C. — In a new letter to Director of National Intelligence Avril Haines, 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) have asked for a briefing regarding a Canadian Security Intelligence Service (CSIS) report that a high security lab in Canada was infiltrated by Chinese scientists connected to the Chinese Communist Party (CCP). BACKGROUND : Recently disclosed information from Canada provides additional insight into the Wuhan Institute of Virology's (WIV) interests and activities in the months leading up to the pandemic. In Canada, it was revealed that Canada's highest security lab (where Ebola and coronaviruses are studied) was infiltrated by Chinese scientists receiving secret payments from China’s military. This information was revealed in a report from the Canadian Security Intelligence Service (CSIS) in February 2024, following a two-year investigation. Two scientists at Canada’s high-security infectious disease laboratory—Xiangguo Qiu and Keding Cheng—provided confidential scientific information to China and were fired in 2021 after a probe concluded Dr. Qiu posed “a realistic and credible threat to Canada’s economic security” and it was discovered they engaged in clandestine meetings with Chinese officials. CSIS discovered Dr. Qiu had applied for, and likely received, a position under China’s Thousand Talents Program and that her position came through the WIV. According to CSIS, Dr. Qiu, who worked at the National Microbiology Laboratory in Winnipeg, lied when confronted about her actions, making “blanket denials” and “half-truths, and personally benefited from the arrangement,” noting that she repeatedly lied to the CSIS and “refused to admit to any involvement in various PRC [People’s Republic of China] programs.” In a January 2021 letter recommending that Dr. Qiu’s security clearance be revoked, CSIS stated: “The Service assess that Ms. Qiu developed deep, cooperative relationships with a variety of People’s Republic of China institutions and has intentionally transferred scientific knowledge and materials to China in order to benefit the PRC government.” The two infectious-disease scientists were escorted out of the National Microbiology Laboratory in Winnipeg in July 2019, and later had their security clearances revoked. They were fired in January 2021. Their whereabouts are not known. Of particular concern is that Dr. Qiu covertly and without authorization provided the Ebola genetic sequence, intellectual property related to research of Ebola, and possibly other pathogens to China. Others informed CSIS that Dr. Qiu and her husband used Gmail accounts extensively, rather than her government of Canada emails. This would appear to be a good source of communications between these spy-scientists in Canada and Wuhan and/or the Chinese military. CSIS found an application from her to one of China’s talent programs that said she would work for the WIV for at least two months every year. As part of her enrollment, CSIS said, Dr. Qiu committed to “building the People’s Republic of China’s biosecurity platform for new and potent infectious disease research.” The CSIS investigation found Dr. Qiu led a project at the WIV that would assess cross-species infection and pathogenic risks of filoviruses, work that CSIS said suggests “gain-of-function studies were possibly to take place.” CSIS also noted Dr. Qiu, who headed the vaccine development and antiviral therapies section at the Winnipeg lab, collaborated on scientific papers with Chinese military researchers, including Major-General Chen Wei, a high-ranking officer in the People’s Liberation Army. In a report, the Public Health Agency of Canada (PHAC) found Dr. Qiu lied about an October 2018 trip to China that she had said was a personal vacation, but later acknowledged after being presented with contradictory evidence that the trip was paid for by the WIV and she met the WIV’s director during the visit. CLICK HERE to read the full letter.

Washington, D.C. — In a letter to 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) write regarding their investigation into how NIH recovers misused funds from recipient institutions.  KEY LETTER EXCERPT :  “While NIH funding has resulted in significant advances in science and aided in medical breakthroughs, it is also susceptible to fraud and other misconduct. With more than $35 billion in extramural grants awarded in fiscal year 2023 alone, it is essential that the NIH ensures grant funds are used appropriately and identifies and recovers any misused or abused funds.”  BACKGROUND :  The NIH and its institutes and centers may also become aware of financial misuse or fraud through allegations and complaints made by colleagues at the recipient institution, whistleblowers, or even anonymous complaints. Between fiscal years 2013 and 2022, the NIH received an increasing number of allegations of grant fraud—such as embezzlement and theft of funds—totaling more than 200 allegations.  Several public reports have uncovered substantiated cases of misuse of funding provided by the NIH—including findings that researchers at both Harvard University and Scripps Research Institute improperly charged or overcharged the NIH for time researchers spent on grant activities, leading to over $1.3 million and $10 million being refunded to the NIH respectively.  During the same period, the NIH also received more than 1,000 allegations of research misconduct.   The ORI’s website summarizes nearly 30 cases of substantiated research misconduct—including falsification, fabrication, or plagiarism of data or findings supported by NIH-funded research—since 2018.   These cases involve hundreds of millions of dollars, and it is unknown how much of that funding was used specifically by the person(s) found to have participated in the misconduct.   There are only a handful of public cases in which the NIH has managed to recover some funds from institutions found to have failed to protect the integrity of NIH funding.   For example, in 2019, Duke University agreed to repay $112.5 million to resolve allegations that applications and progress reports submitted to the federal government—including the NIH—contained falsified research.  CLICK HERE to read the full letter. 

Washington, D.C. — In a new letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, 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) are seeking answers as to whether the agency adequately safeguards Clinical Laboratory Improvements Amendments (CLIA) lab accreditation from national security concerns.  The Members are particularly concerned with national security concerns related to the Chinese military and the unethical use of human beings in research studies by entities of concern in China.  BACKGROUND :  Beijing Genomics Institute (BGI) is a firm based in Shenzhen used by the Chinese government to build and operate the China National GeneBank, “a vast and growing government-owned repository that includes genetic data drawn from millions of people around the world.”  The Department of Defense in 2022 officially listed BGI as one of several “Chinese military companies” operating in the United States, and a 2021 U.S. intelligence assessment linked the company to the Beijing-directed global effort to obtain even more human DNA, including from the United States.  On March 6, 2023, the Department of Commerce Bureau of Industry and Security added BGI Tech Solutions (Hongkong) Co. Ltd., to the “Entity List,” which identifies entities for which there is reasonable cause to believe, based on specific and articulable facts, that the entities have been involved, are involved, or pose a significant risk of being or becoming involved in activities contrary to the national security or foreign policy interests of the United States.  It was added to the entity list “based upon information that indicates their collection and analysis of genetic data poses a significant risk of contributing to monitoring and surveillance by the government of China, which has been utilized in the repression of ethnic minorities in China. Information also indicates that the actions of these entities concerning the collection and analysis of genetic data present a significant risk of diversion to China’s military programs.”  CMS accredited a laboratory owned by BGI in 2017-2019. It then provided a CLIA accreditation to an entity called BGI Tech Solutions (Hongkong) Co. Ltd., effective September 8, 2023, with an expiration date of September 7, 2025, and with the same address and the same point of contact listed in the previous BGI CLIA lab accreditation.  CLICK HERE to read the letter. 

Inquiry Part of House-Wide Effort to Combat Rise of Antisemitism on College Campuses Washington, D.C. — In a new letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, House Energy and Commerce Committee (E&C) Chair Cathy McMorris Rodgers (R-WA), E&C Subcommittee on Health Chair Brett Guthrie (R-KY), and E&C Subcommittee on Oversight and Investigations Chair Morgan Griffth (R-VA), along with House Education and the Workforce Committee (E&W) Chairwoman Virginia Foxx (R-NC) and E&W Subcommittee on Higher Education & Workforce Development Chair Burgess Owens (R-UT), raised concerns over how HHS is ensuring that research universities are preventing harassment and discrimination—particularly against individuals of Jewish faith and heritage. The Chairs note in their letter that colleges or universities that violate Title VI of the Civil Rights Act of 1964 can ultimately lose Federal funding.   The investigation comes as part of Speaker Mike Johnson’s (R-LA) House-wide effort to crack down on antisemitism on college campuses.  KEY LETTER EXCERPT :  “We are troubled by the fact that colleges and universities that are recipients of massive amounts of Federal research grants from NIH are actively fostering antisemitism on campus and failing to protect Jewish students, faculty, and support staff. Failing to comply with basic safety protections for members of their communities, no matter the cause, may be grounds for disqualification of universities and colleges from receiving Federal funds. 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.”  BACKGROUND :  Starting in April 2024, antisemitic, and at times violent, protests broke out across campuses at several prominent universities—including Columbia University, the University of Southern California (USC), the University of California Los Angeles (UCLA), George Washington University (GWU), Harvard University, and Yale University—resulting in unsafe learning and research environments for students, faculty, and staff, especially for those of Jewish faith and heritage.     Beginning on April 17, 2024, an encampment sprung up on Columbia University’s campus with hundreds of protestors and tents.   Protestors vandalized the campus—including residence halls—with banners and signs containing antisemitic sentiments and even support for the terrorist organization Hamas.  Despite over 100 arrests by police, the protests progressed to the occupation of a campus building and physical attacks on Jewish students—leading campus officials to move some classes online.  Professors at Columbia University have openly made antisemitic and even pro-Hamas statements, adding to the harassment of Jewish students.   A prominent rabbi at Columbia University also warned Jewish students to remain off-campus due to fears that the university and New York City police could not keep students safe.   Jewish students on campus have expressed concerns over their safety on campus and the mental and psychological toll the hostile environment is taking on their ability to work and learn.  Columbia University—which across its campuses received more than $682 million in grants from NIH in fiscal year 2023—is just the tip of the iceberg as similar events are spreading to other colleges and universities.   USC—which received more than $358 million in NIH funding in fiscal year 2023—is also overrun with students, faculty, and other anti-Israel protests that led the university to cancel its graduation ceremony out of safety concerns.   A protestor at USC was charged with assault with a deadly weapon—showing the threatening and intimidating nature of these protests. UCLA—which received more than $580 million in NIH grants in fiscal year 2023—is yet another example of the impact these actions have on the ability of students—particularly Jewish students—to learn. Protesters at UCLA have blocked off sections of the campus, refusing access to Jewish students seeking to attend their classes.  According to a phone call with UCLA police, the directive from UCLA was to not interfere with the protestors.  Just a few blocks from the White House at GWU—which received more than $73 million in grants from NIH in fiscal year 2023—encampments spread beyond the campus onto public streets, and for weeks no action was taken to clear the encampments.  At both Yale University—which received more than $621 million in grants from NIH in fiscal year 2023—and Harvard University—which received more than $400 million across its campuses in grants from NIH in fiscal year 2023—concerns about antisemitism circulated even before the protests erupted. Dozens of protestors were arrested after setting up an encampment at Yale University and parts of Harvard University have been closed, with classes held remotely in response to hundreds of protestors gathering on campus.  Several lawsuits have been filed against these universities alleging violations of civil rights protections and failure to provide a safe environment, and the U.S. Department of Education has opened investigations into several colleges and universities—including Columbia University—for potential civil rights violations.  According to the U.S. Department of Education’s Office for Civil Rights (OCR), colleges and universities are prohibited from discriminating based on a variety of categories—including national origin. These laws also protect students who are, or are perceived to be, members of a religious group—including those of Jewish faith. A college or university is in violation of Title VI of the Civil Rights Act of 1964 if: 1) there is harassing conduct on the basis of race, color, or national origin that is sufficiently serious as to limit or deny a student’s ability to participate in or benefit from the educational program (i.e., creates a hostile environment); 2) a responsible employee of the school knew, or should have known, about the harassment; and 3) the school failed to take prompt and effective steps reasonably calculated to end the harassment, eliminate the hostile environment, prevent the harassment from reoccurring, and as appropriate, remedy its effects.  According to 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.  HHS’s OCR is responsible for ensuring that institutions that receive Federal financial assistance comply with Title VI as well as other civil rights laws.   Colleges or universities that violate Title VI can ultimately lose Federal funding.   CLICK HERE to read the full letter.