News

Oversight & Investigations Updates


Jun 11, 2024
Press Release

E&C Republicans Release Interim Staff Report on NIH Misconduct and Inadequate Oversight Involving Taxpayer-Funded Risky MPXV Research that Jeopardizes Public Health Security

Washington, D.C. — The House Energy and Commerce Committee today released a report titled “Interim Staff Report into Risky MPXV Experiment at the National Institute of Allergy and Infectious Diseases.”  The report details the Committee’s investigation, which was launched following a 2022 Science magazine interview in which Dr. Bernard Moss of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) revealed that he was planning to insert segments of a lethal strain of MPXV (formerly known as “monkeypox”) into a more a transmissible strain of the virus. This proposed experiment alarmed some scientists concerned about the risks of creating an enhanced version of the MPXV virus.  For nearly a year and a half, the Department of Health and Human Services (HHS), the NIH, and NIAID misrepresented and deceived the Committee by repeatedly denying that the potentially dangerous experiment was proposed and approved. However, after being pressed repeatedly by Committee Leaders, HHS ultimately admitted Dr. Moss’s research team had been granted approval to conduct a bidirectional MPVX gene-transfer experiment (i.e., inserting the more lethal strain into the more transmissible strain and vice versa). Documents made available for review to Committee staff confirmed the 2015 approval of the experiment and raised additional concerns.   HHS, the NIH, and NIAID still maintain the riskier research project was never conducted. However, no documentation or any other evidence has been produced to substantiate the claim. NIAID has also failed to offer any explanation of the circumstances and rationale that supposedly led the Moss research team to drop the bidirectional mpox gene-transfer experiment after receiving approval for the project.  The report concludes with a series of recommendations related to biosecurity to ensure future transparency and accountability related to risky research like this. 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) released the following statement regarding the report:  “In order to start rebuilding trust in our government health agency guidance, agencies like the NIH must be honest and transparent with Congress and the American people. This report demonstrates a disturbing lack of judgment and accountability from HHS, the NIH, and particularly, NIAID. It is unacceptable and demonstrates the clear need for reform.”  CLICK HERE to read the full report.  TIMELINE OF THE INVESTIGATION :



Jun 4, 2024
Hearings

Chair Rodgers Opening Remarks at Oversight Hearing on the 340B Program

Washington D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) delivered the following opening remarks at today’s Oversight and Investigations Subcommittee hearing titled “Oversight of 340B Drug Pricing Program.”   “This hearing is an opportunity for us to evaluate recent trends and developments in the health care system that impact the 340B Drug Discount Program. “The 340B Program was created by Congress to ‘enable covered entities to stretch scarce federal resources to reach more eligible patients and provide more comprehensive services.’ “It's a worthy goal and a seemingly straightforward one. “For community health centers, high disproportionate share hospitals, and rural providers, savings from the 340B Program are critical. “In some cases, savings from the 340B Program are helping keep the lights on at what may be the only hospital in a rural community, and those cases reflect the spirit and intent of the law to ensure essential services for our most vulnerable communities.”  UNCLEAR BENEFITS FOR VULNERABLE PATIENTS   “With that said, I worry that the program is being co-opted by larger, more profitable health care systems that are using it solely for financial gain at the expense of the patients that who it most. “We have talked a lot in this Committee about addressing the impacts that high health care costs have on patients, employers, and taxpayers, and how we need to work to create a simpler and more transparent health care system. “Every single one of us pays for the high cost of health care, whether that’s at the doctor’s office, through our insurance premiums, or in taxes that cover the ever-increasing costs of Medicare and Medicaid. “Something that’s become increasingly clear is that the 340B Program is distorting markets and behaviors in our health care systems that are increasing costs for all of us. “In multiple studies, researchers found that the 340B Program was associated with a nearly 25 percent reduction in the prescribing biosimilars and other lower-cost drugs in favor of more expensive brand name alternatives, so that hospitals could pursue larger savings from the program, even though patients’ out-of-pocket costs are not tied to any of the savings that the hospital may receive. “Additionally, the New England Journal of Medicine found that the program further incentivizes hospital systems to acquire independent oncology practices, so that they can expand their 340B footprint. “Some will argue that hospitals reinvest these savings in ways consistent with the intent of the program, but there’s little evidence to prove this.” INCREASING ACCESS TO CARE “This Committee has focused so much effort over the past two years on increasing transparency in health care, tackling incentives in the prescription drug market that push up health care costs for Americans, and addressing site neutrality and other reforms that are driving consolidation. “It should be a bipartisan goal for every member on this Committee to apply the same principles to the 340B Program as well. “Let me reaffirm once more that I support this program in its original intent and mission. “Last year, we heard from Pullman Regional Hospital in my district about the value that the 340B Program provides to them and other hospitals across the country. “We’ve also heard testimony in support of increased transparency for the program so that we can, at the very least, understand how covered entities are using this program. “If we are serious about lowering health care costs for Americans, then we must also take a critical look at the 340B Program and make sure it is achieving its intended mission.” 



Jun 4, 2024
Hearings

Subcommittee Chair Griffith Opening Remarks at Oversight Hearing on the 340B Program

Washington D.C. — House Energy and Commerce Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) delivered the following opening remarks at today’s subcommittee hearing titled “Oversight of 340B Drug Pricing Program.”  “Today’s hearing is an opportunity to examine the 340B drug pricing program. “I will start by saying this is a personal hearing for me because this topic is something I made a promise to my dear friend and fellow Virginia member, Don McEachin, that I would do before he passed away. “He called me regarding a 340B report relating to his district before the election and a couple of weeks before his unexpected death and said, 'If you are chairman of Oversight and Investigations on Energy and Commerce, I need your help on 340B.’ I promised him I would help. “So, I am glad we are doing this hearing and fulfilling that promise.” 340B’S ORIGINAL MISSION “The 340B program was established by Congress to allow certain covered entities that provide care to a large number of underserved patients to purchase drugs at significant discounts from manufacturers.  “In theory, the savings these covered entities yield from receiving the discounted drug is meant to be passed along to patients and to be reinvested into that community to help provide additional care or resources.   “But, it is not mandated to disclose where these dollars go and how much they made from this program. It is mostly a black box as to what happens with these dollars.   “When the Affordable Care Act was signed into law in 2010, the program rapidly expanded by allowing more entities to receive the discounted 340B price for drugs.    “The number of covered entities participating in the 340B program has increased from 8,000 in 2000 to more than 50,000 in 2020.   “Today, the 340B program accounts for almost $54 billion in annual discounted sales. Making it the second largest federal prescription drug program.   “I am a supporter of the overall 340B program.   “There are many hospitals, including in my district, who are appropriately using the 340B dollars to keep their doors open and heavily rely on this program.  “Yet, we see reports about entities taking advantage of the system. And that is what caused my friend, Don McEachin, to reach out.”  ABUSE OF THE 340B SYSTEM   “The New York Times reported on how Bon Secours hospital system apparently used the Richmond Community Hospital, in Virginia, which serves predominately poor patients, to expand its use of 340B at the expense of Richmond Community Hospital and patients in that community.  “The New York Times asserted that over the years, services at this Richmond Community Hospital were slashed and departments closed, while Bon Secours used the hospital as a piggy bank and transferred millions out of Richmond to other hospitals within the system, possibly as far away as Ohio.   “This is the reverse Robin Hood. Steal from the poor to pay the rich.   “One specific example in this report was Bon Secours using the Richmond Community Hospital to purchase a cancer drug for more than $3,000 and then turning around and selling that same drug they bought under the 340B discount for more than $25,000 to a private insurer.   “That could be an almost $22,000 in profit alone from one single vial for one patient.  “When reports like the Bon Secours situation occur, it is Congress’s job to step in and provide oversight into this program.”  ENSURING 340B IS EXPANDING ACCESS TO CARE   “The 340B program is a lifeline for many hospitals, health clinics, community health centers, and many other health care facilities.   “My district has more than 50 community health centers and 340B serves as a critical tool to help keep their doors open and to provide additional services for my constituents.   “When I visit these centers and hospitals in my district, they are very open about where their 340B dollars go.   “That is because my district is economically stressed, and health care providers rely on these dollars to serve their patients.   “I believe creating more transparency in the program so we can see where the dollars are flowing and ensuring the program is not being taken advantage of is the first step.   “This will allow Congress to understand the full picture and ensure that the patients are the ones reaping the benefits of this program.  “The patient is the one who must come first in this, and they should not be caught in the crosshairs of any of the issues we will hear about today.” 



Jun 3, 2024
Health

Oversight Subcommittee Chair Griffith Opening Remarks at Covid Select Subcommittee Hearing with Dr. Fauci

Washington, D.C. — Energy and Commerce Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) delivered the following opening statement at the Select Subcommittee on the Coronavirus Pandemic hearing titled "A Hearing with Dr. Anthony Fauci." Given ongoing coordinated efforts, Committee Leaders from the House Energy and Commerce Committee were permitted to participate in the hearing. "Good morning, I want to again thank the leadership of this committee for including Energy and Commerce Committee in this hearing. "Dr. Fauci, the recent revelations that Dr. Morens, a Senior Advisor, and your Chief of Staff, Gregg Folkers, routinely evaded federal records laws, including the Freedom of Information Act, were a shock. "I’ve been doing oversight for 14 years and the scale of the effort to evade FOIA by some at the National Institute of Allergy and Infectious Diseases, or NIAID, has surprised even me. "These men were among your most senior and trusted staff at an agency you led for almost forty years. They worked for you for decades. Your calendars show that you met with them multiple times a week during the pandemic.  "You co-authored dozens of papers with Dr. Morens. He directly implicates you. Even the head of NIAID FOIA office was apparently in on some of this conspiracy. "When the facts lead to the fact that your agency was involved in some form of a conspiracy related to COVID origins, we have to follow those facts. "It is hard time believing that all of this occurred without your knowledge and approval.   "In civil law, when one party has destroyed or refuses to produce evidence in its possession, a jury is allowed to draw an adverse inference that the information destroyed or not produced was unfavorable. "Until we get a full accounting of the communications among NIAID’s leadership, it’s reasonable for us to assume that missing information would mirror the private doubts expressed by so many virologists and other scientists.  "While telling the public, the media and Congress that COVID-19 almost certainly emerged from nature, experts you convened as a team privately worried that a research related incident was a possible if not the probable origin of the virus. Dr. Kristian Andersen even said in February of 2020, 'I think the main thing still in my mind is that the lab escape version of this is so friggin’ likely to have happened because they were already doing this type of work and molecular data is fully consistent with that scenario.' "Further, while you and other NIAID officials were assuring us that the virus could not have come from the Wuhan Institute of Virology, NIAID had no actual idea what the full scope of the WIV’s coronavirus research was or even the trajectory of its gain-of-function research. "That may be because EcoHealth wouldn't give you the reports. I grant that. "But this joint investigation has shown just how little oversight NIAID does of risky experiments involving potential pandemic pathogens. "NIAID set up a system designed to green-light potentially risky experiments while avoiding HHS Departmental level review. "The same program officers who act as 'advocates' for their scientific area are responsible for assessing whether an experiment is too dangerous. "That system creates a clear conflict of interest. "I think that means taking final approval and oversight away from the agencies, like NIAID, that fund it."



May 30, 2024
Press Release

Evidence Uncovered by E&C Republicans Refutes Secretary Becerra’s Assertion that HHS Takes Action to Prevent Sexual Abusers from Receiving Taxpayer Funding

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. 



May 28, 2024
Press Release

Chairs Rodgers and Griffith Announce Oversight Hearing on the 340B Program

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) today announced a subcommittee hearing titled “Oversight of 340B Drug Pricing Program.”  “It’s important that we preserve patients’ access to important and live-saving drugs. We must explore how the 340B program is working to ensure it aligns with how the program was intended to function,” said Chairs Rodgers and Griffith. “This hearing will give Members an opportunity to hear from industry experts about how the 340B program is working and, if necessary, how it could be improved.”  Subcommittee on Oversight and Investigations hearing titled “Oversight of 340B Drug Pricing Program.” WHAT: A subcommittee oversight hearing to learn about recent trends and developments in the 340B drug pricing program. DATE: Tuesday, June 4, 2024 TIME: 10:30AM ET LOCATION: 2322 Rayburn House Office Building WITNESSES: Witnesses will be announced and are by invitation only. This notice is at the direction of the Chair. The hearing will be open to the public and press and will be live streamed online at https://energycommerce.house.gov/ . If you have any questions concerning the hearing, please contact Lauren Kennedy with the Committee staff at Lauren.Kennedy@mail.house.gov . If you have any press-related questions, please contact Christopher Krepich at Christopher.Krepich@mail.house.gov .  



May 24, 2024
Press Release

E&C Leaders to ODNI: What Does the U.S. Intel Community Know About CCP-Linked Security Breach at Canadian High-Containment Lab

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.



May 23, 2024
Press Release

E&C Republicans to NIH: Is Agency Recovering All Misused Taxpayer Dollars?

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. 



May 23, 2024
Press Release

E&C Republicans Investigate Whether CMS CLIA Accreditation Contains Adequate National Security Safeguards

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.