Rep. Brett Guthrie

R

Kentucky – District 2
representative

Leadership

Republican Leader Health

117th Congress

Chairman Health

118th Congress

News & Announcements

Jun 24, 2024
Press Release

E&C Republicans Press FDA Again for Information Regarding Foreign Inspection Program

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. 

Jun 13, 2024
Press Release

Subcommittee Chair Guthrie Opening Remarks at Hearing on CMS Innovation

Washington D.C. —  House Energy and Commerce Subcommittee on Health Chair Brett Guthrie (R-KY) delivered the following opening remarks at today’s subcommittee  hearing  titled “Checking-In on CMMI: Assessing the Transition to Value-Based Care.”  “Thank you to our witness, Dr. Liz Fowler, for being here with us today as we ‘check-in’ on the Centers for Medicare and Medicaid Innovation’s progress in lowering costs and improving quality of care paid for by Medicare and Medicaid. “Our health care system has underdone significant changes over the last decade and Americans continue to cite health care costs as a top concern. “More Americans are stuck paying more for health care, more than they ever have in the past.” HEALTH CARE EXPENDITURES RAPIDLY INCREASING ON THE BACKS OF TAXPAYERS AND PATIENTS “Taxpayers are also on the hook for higher health care expenditures. “In 2022, health care spending grew by 4% year-over-year, reaching $4.5 trillion, nearly 17% of U.S. gross domestic product. “During this same time, spending on hospital care reached 30% of total health care spending while physician and clinical services reached 20% of all health care spending.   “Physicians are now being forced to spend more man hours on back-office administrative tasks in efforts by taxpayers to keep costs low.” CMMI FAILED TO ACHIEVE PROJECTED COST SAVINGS “Policy makers and stakeholders from across the health care system have hoped that by embracing value-based care, high costs and physician burnout would be addressed, and patients would receive a higher quality of care.   “The Centers for Medicare and Medicaid Innovation was supposed to be a key driver of this movement toward value-based care.   “However, Medicare and Medicaid’s transition to value care has clearly stagnated.   “CMMI was established as a part of the Affordable Care Act with the dual goal of driving better patient outcomes and slowing the growth rate of the Medicare and Medicaid program costs.   “The Congressional Budget Office originally projected that CMMI would not just offset the costs of running pilot programs but drive significant long-term savings across our health care system.   “That unfortunately has not come close to materializing. A September 2023 CBO report found that CMMI’s activities increased spending by almost $5.5 billion.    “Under the Biden administration the Center has undertaken an internal reevaluation.   “While I would hope this strategic refresh would generate a renewed commitment to better fulfilling CMMI’s mission of reducing costs and improving quality in its second decade.   “However, I must admit I am concerned the Center has instead further shifted focus from its Congressionally anointed purpose.   “I would be remised if I didn’t mention a few specific actions CMMI has taken recently that could significantly harm the transition to value-based care.   “The first, is the so-called Accelerating Clinical Evidence model in which CMMI has proposed to slash payments to Part B providers who are prescribing therapies fully approved by the FDA through the Accelerated Approval Pathway.   “This not only undermines the FDA gold standard but penalizes those attempting to drive transformative change for patients that otherwise lack treatment options.”  CMMI IS IMPEDING INNOVATION “I am furthermore concerned about CMMI’s Cell and Gene Therapy Access Model, which may inhibit the states’ ability to use value-based agreements to pay for curative cell-and-gene therapies approved by FDA. “We have 50 incubators across the country in the form of our state Medicaid programs and waiver authorities that give states the ability to shape policies that make the most sense for their budgetary needs and the needs of their beneficiaries. “By CMS directly negotiating drug rates for these therapies, it weakens the ability for states to negotiate directly with manufacturers or to form states compacts that give states greater bargaining power in these situations. “I would instead urge CMMI and CMS to work with Congress to pass my MVP Act, which I’ve worked with Ranking Member Eshoo on, which would codify CMS’ multiple best price rule and truly allow states to use value-based agreements to get life-changing treatments to patients as quickly and as affordably as possible, should be the goal of all of us. “In closing, I hope today’s discussion helps us chart a path forward for CMMI that can ensure the center is better delivering on its mission to facilitate innovation payment models that deliver for patients and taxpayers and reenergize the transition to value-based care.” 

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 :

Letters

Jun 24, 2024
Press Release

E&C Republicans Press FDA Again for Information Regarding Foreign Inspection Program

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. 

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 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.