Health

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) issued the following statement after the United States Supreme Court struck down the “Chevron Deference” in Loper Bright Enterprises, et al. v. Raimondo : “Article I of the Constitution established Congress’s role to write the laws of the land—not the Executive Branch. The Supreme Court’s ruling today will help restore the proper balance of power as the Founders envisioned it. Moving forward, major decision-making authority will no longer automatically be deferred to unelected, unaccountable bureaucrats. Power has been placed back in the hands of the American people and their elected representatives, as the Constitution prescribes.” 

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) today announced a Full Committee markup of 11 bills this Thursday, June 27.  “The Energy and Commerce Committee is continuing to deliver solutions for the American people. At this week’s markup, we will consider nearly a dozen bills, including legislation to establish a national data privacy and security standard for Americans, protect kids online, extend telehealth services for seniors, continue to incentivize important innovation for pediatric rare diseases, and repeal harmful regulations that are jeopardizing America’s economic and energy security, ” said Chair Rodgers. WHAT: A Full Committee markup of 11 bills. DATE: Thursday, June 27, 2024 TIME: 10:00 AM ET LOCATION: 2123 Rayburn House Office Building LEGISLATION TO BE CONSIDERED: H.R. 7188 , Shandra Eisenga Human Cell and Tissue Product Safety Act (Reps. Moolenaar and Dingell)  H.R. 3433 , Give Kids a Chance Act of 2024 (Reps. McCaul and Eshoo)  H.R. 670 , Think Differently Database Act (Reps. Molinaro and Sherrill)  H.R. 7623 , Telehealth Modernization Act of 2024 (Reps. Carter and Blunt Rochester)  H.J.Res. 163 , Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Environmental Protection Agency relating to “New Source Performance Standards for Greenhouse Gas Emissions From New, Modified, and Reconstructed Fossil Fuel-Fired Electric Generating Units; Emission Guidelines for Greenhouse Gas Emissions From Existing Fossil Fuel-Fired Electric Generating Units; and Repeal of the Affordable Clean Energy Rule” (Rep. Balderson)  H.J.Res. 136 , Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Environmental Protection Agency relating to “Multi-Pollutant Emissions Standards for Model Years 2027 and Later Light-Duty and Medium-Duty Vehicles” (Rep. James)  H.J.Res. 133 , Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Environmental Protection Agency relating to “Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles-Phase 3” (Rep. Fulcher)  H.J.Res. 117 , Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Environmental Protection Agency relating to “Reconsideration of the National Ambient Air Quality Standards for Particulate Matter” (Rep. Allen)  H.R. 8818 , American Privacy Rights Act of 2024 (Reps. Rodgers, Pallone, Bilirakis, and Schakowsky)  H.R. 7891 , Kids Online Safety Act (Reps. Bilirakis, Bucshon, Castor, Houchin, and Schrier)  H.R. 8449 , AM Radio for Every Vehicle Act (Reps. Bilirakis and Pallone) 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 Alex Khlopin with the Committee staff at Alex.Khlopin@mail.house.gov . If you have any press-related questions, please contact Sean Kelly at Sean.Kelly@mail.house.gov and Christopher Krepich at Christopher.Krepich@mail.house.gov . 

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 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.