Letter - Health Updates

Feb 16, 2024
Press Release

E&C Republicans Request Former NIH Official Participate in Transcribed Interview Regarding Oversight of Risky Virus Research Experiments

Washington, D.C. — As part of its ongoing investigation into the origins of the COVID-19 pandemic and the adequacy of the National Institutes of Health’s (NIH) oversight of risky virus research, 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 requested former senior NIH official Dr. Teresa Hauguel participate in a transcribed interview before the Committee.  KEY EXCERPT :  “As a former program officer at the National Institute of Allergy and Infectious Diseases (NIAID), documents indicate that you participated in internal institute committee meetings to determine whether certain virus research experiments presented risks that required additional scrutiny and possible actions to mitigate the risks such as redesign of the experiment. You have been identified by a senior official at NIAID as a subject matter expert for reviewing risks in respiratory virus research projects. For these reasons, we believe you could be helpful to the committee’s examination of virus research oversight, and thus, we request that you appear for a transcribed interview to be held on the week of March 4, 2024.”  CLICK HERE to read the letter.

Feb 16, 2024
Press Release

E&C Republicans Raise Concerns with Proposed Rule that Weakens HHS Refugee Resettlement Vetting Process

Washington, D.C. — 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), on behalf of the Health and Oversight Subcommittee Republicans, wrote to Biden administration officials who oversee the Department of Health and Human Services (HHS) Office of Refugee Resettlement. In the letter, the Chairs raise concerns about a recent Notice of Proposed Rulemaking that would weaken the vetting process for children in the program as well as ORR’s poor stewardship of taxpayer dollars and potential conflicts of interested related to the ORR Director.   In addition, the Chairs note that HHS has failed to respond to questions for the record from a hearing in July of 2023, despite several extensions given to the original deadline.  KEY EXCERPTS : “ORR’s inclusion of this provision [Sec. 410.1202 (c)] is particularly surprising considering continual bi-partisan Congressional interest in bolstering the sponsor vetting process. In fact, the Department of Health and Human Services (HHS) Secretary Xavier Becerra was repeatedly questioned on the thoroughness of the sponsor vetting process at a Subcommittee on Oversight and Investigations hearing last summer. The Secretary repeatedly assured the Subcommittee that ORR was conducting a ‘very thorough vetting process for any sponsor to make sure we understand who is asking for the opportunity to care for these children.' Making background checks and fingerprinting optional is inconsistent with the Secretary’s testimony to Congress .”  […]  “Numerous media and government oversight reports have clearly shown that the care provider facilities and sponsors do not always act in the best interest of the unaccompanied children. Many ORR influx care facility’s personnel have shown that they are frequently unqualified to care for vulnerable children. There have even been allegations of neglect and sexual misconduct by influx care facility staff with migrant children. Loosening vetting procedures for sponsors by eliminating background checks, fingerprints, and home visits, will put vulnerable unaccompanied children at a greater risk of being trafficked, exploited, or placed in unsafe settings.   “ Whistleblowers have reported to Congress how HHS endangered the lives of unaccompanied migrant children by not properly vetting sponsors and not tracking children after they left ORR custody. Many children have ended up working in unsafe environments, such as roofing and meatpacking plants, after they were placed with an ORR approved sponsor. Some unaccompanied children have even died from injuries sustained while working at these sites. The Committee has received new allegations that ORR knowingly attempted to place a child with a convicted sex offender who was previously convicted of sexually abusing another child in his custody.”  […]  “ORR’s neglect of the unaccompanied children comes at a time when the agency has received unprecedented levels of funding. The Administration for Children and Families (ACF), ORR’s parent agency, has received $20 billion in the last two years—$8.9 billion in fiscal year (FY) 2022 and $10.9 billion in FY 2023—for refugee and entrant assistance, including more than $10 billion for the care of unaccompanied migrant children . ORR’s continued failure to care adequately for unaccompanied children in its custody, shows not only indifference to child welfare, but poor stewardship of taxpayer dollars.  “ The Committee is also disturbed to learn of potential conflicts of interest stemming from Director Dunn Marcos’ prior role as Senior Director for Resettlement, Asylum, and Integration Programming at the International Rescue Committee (IRC). Recent reports indicate not only that the IRC has been the top beneficiary of refugee and entrant assistance discretionary grants since 2013, but also that the funding amounts allocated to the IRC in 2022 and 2023 have ballooned, with the organization receiving more than $235 million in spending in FY 2023 compared to $22 million in FY 2021—curiously, since Director Dunn Marcos took office.”  BACKGROUND : Section 410.1202 (c) of the Proposed Rule states, "As part of its suitability assessment, ORR may also require such components as an investigation of the living conditions in which the unaccompanied child would be placed and the standard of care the unaccompanied child would receive, [. . .] a home visit or home study […], background and criminal records checks, which may include a fingerprint based background check, on the potential sponsor and on adult residents of the potential sponsor’s household." Section 410.1210 (a)(3) does not require PRS for children with mental health needs, as the UC Program Foundational Rule now states “ORR may conduct PRS in additional cases involving unaccompanied children with mental health or other needs who could benefit from ongoing assistance from a community-based service provider,” based on available appropriations.  Unaccompanied children often undergo extreme physical and mental trauma in their perilous journey to the U.S. and are in need of regular mental health and wellness checks by appropriate providers.   Such services must be available for children manifesting obvious mental health symptoms.  Section 410.1210 (a)(4) states “ORR shall not delay the release of an unaccompanied child if PRS are not immediately available.”   By including this provision, ORR absolves itself of all responsibility that an unaccompanied migrant child will be properly taken care of after release in situations where the unaccompanied child clearly needs PRS.  Section 410.1210 (e) provides that ongoing check-ins and in-home visits will be made “in consultation with the released unaccompanied child and sponsor,” and may be done “either in person or virtually. ”  CLICK HERE to read the full letter. 

Feb 12, 2024
Press Release

E&C Leaders Ask Government Watchdog to Assess Risks of HHS and USDA Selling Excess Laboratory Equipment

Members raise dual-use concerns over lab equipment that could facilitate bioterrorism or warfare Washington, D.C. — 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), on behalf of the Health and Oversight Committee Republicans, wrote to Government Accountability Office (GAO) Comptroller General Gene Dodaro. In the letter, the Chairs request GAO study the oversight by the Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA) of sales of used and excess laboratory equipment and protective clothing that could be used to facilitate bioterrorism or warfare.  KEY EXCERPT :  “In 2023, GAO reported that a number of incidents over the past 10 years have led to questions about the nature and adequacy of U.S. government oversight of pathogens with pandemic potential. Moreover, these lapses have furthered concerns about the potential for a biological weapons attack. In recent years, increases in the accessibility of scientific findings and dual-use biological laboratory equipment—such as used fermenters, centrifuges, and other equipment—could increase the likelihood of such an attack. The availability of both biological laboratory equipment and protective clothing on the commercial market provides access to materials needed to conduct legitimate scientific research, but also increases the chances this equipment could be used for malicious purposes, such as biological terrorism or warfare. Furthermore, the existence of a resale market for this type of equipment and clothing at reduced cost means terrorists have the potential for even greater access to the supplies needed to create biological weapons.” CLICK HERE to read the full letter.

Feb 5, 2024
Press Release

Chair Rodgers Subpoenas NIH for Documents Related to Investigation into Sexual Harassment at NIH and NIH Grantee Institutions

Committee seeks whistleblowers to inform investigation Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) today issued a subpoena to the National Institutes of Health (NIH) for documents and information related to the Committee’s multi-year investigation into the NIH’s handling of sexual harassment complaints within the agency and its grantee institutions. The investigation, led by Chair Rodgers and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA), has uncovered at least 300 cases related to harassment since 2018. Over the course of the Committee’s investigation, the NIH has refused to turn over more information related to its handling of this widespread problem. The subpoena comes after Chair Rodgers notified the NIH of the Committee’s intent to use compulsory measures, including in a formal letter on January 26, 2024, and subsequently last week. The NIH failed to respond adequately to the request by last Friday's deadline.  In the January 26 letter, Chair Rodgers wrote:  “ Sexual harassment is degrading and illegal. Studies show it has a negative effect on the ability of women to engage in research at the same level as men. Title IX prohibits sexual harassment and other forms of sex discrimination in education programs that receive federal funding, and federal agencies are required to enforce the law at the universities they fund. As the largest public funder of biomedical research, the NIH is uniquely positioned to transform the culture of science to prevent sexual harassment and mitigate its detrimental impacts.”  […]  “ Unfortunately, the NIH has failed to comply adequately with requests for information and documents related to its handling of sexual harassment complaints. The NIH’s course of conduct demonstrates a lack of good faith and an unwillingness to engage with the Committee voluntarily. Accordingly, the Committee has no choice but to issue a subpoena compelling production of these documents so that the Committee can carry out its oversight responsibilities. ”  CLICK HERE to read the full letter.  CLICK HERE to read the subpoena cover letter.  TIMELINE LEADING UP TO SUBPOENA :  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 Subpoenas to Obtain Information on NIH’s Handling of Sexual Harassment if Questions Go Unanswered  January 26, 2024 : Chair Rogers notifies NIH of Imminent Subpoena  WHISTLEBLOWERS:   The Committee is seeking whistleblowers with knowledge of sexual harassment at the NIH or NIH grantee institutions, as well as those with knowledge of how the NIH handles such complaints.  The right for public employees to communicate with Congress, in their private capacities, is established in the First Amendment of the U.S. Constitution. In addition, various U.S. laws prohibit retaliation against whistleblowers for providing information to Congress. However, individuals still take serious risks when they engage in whistleblowing activity.  To better protect your communications, do not contact the Committee using work resources, work contact information, or while you are working . Further, consider consulting an attorney experienced in representing whistleblowers before you make a disclosure.  Do not submit classified information or other information barred from release through this form or by email. Unauthorized handling of classified information could result in criminal prosecution.  The Committee respects your need to remain confidential and will use your contact information only to follow up with you regarding your submission. You may submit a disclosure anonymously. However, please be aware that anonymous disclosures may limit the Committee’s ability to respond to the information that you provide.  Individuals with information about harassment at the NIH may contact the Committee via email at:   Individuals with information about harassment at institutions that receive NIH grants may contact the Committee via email at:   Additional resources can be found HERE .

Jan 22, 2024
Press Release

Bipartisan E&C Leaders Request FDA Briefing Regarding Lead and Chromium Contamination of Applesauce Pouches

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Ranking Member Frank Pallone, Jr. (D-NJ), Subcommittee on Health Chair Brett Guthrie (R-KY) and Ranking Member Anna G. Eshoo (D-CA), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) and Ranking Member Kathy Castor (D-FL) wrote to Food and Drug Administration (FDA) Commissioner Robert Califf to request a briefing regarding the possible intentional contamination of applesauce pouches. BACKGROUND :  On November 9, 2023, the FDA announced that WanaBana USA had voluntarily recalled three applesauce brands—Weis, WanaBana, and Schnucks—“due to reports of elevated levels of lead.” Subsequently, on January 5, 2024, the FDA announced that its testing of the applesauce pouches and cinnamon collected from the manufacturing facilitiy had also found chromium.  In a statement , the FDA’s Deputy Commissioner for Human Foods, Jim Jones, indicated that recent lead contamination in applesauce pouches may have been an intentional, economically motivated act by a foreign supplier of cinnamon for the recalled products.  As of January 8, 2024, the FDA had received 87 confirmed complaints/adverse event reports linked to the recalled product.  The Centers for Disease Control and Prevention (CDC) reported a total of 321 cases from 38 different states.  Of those 321 cases, reports suggest more than 60 children under the age of six in the United States have tested positive for lead poisoning.  Children in this age range are more susceptible to lead poisoning, which makes the Committee’s concerns about intentional product adulteration along the global supply chain particularly urgent.  KEY LETTER EXCERPT:   “Though the FDA has in the past elevated concerns about unacceptably high levels of lead in some baby food, recent events raise whether more can be done to prevent and detect illicit food contamination. Therefore, the Committee urgently requests a detailed briefing on the FDA’s suspicion of intentional lead contamination in applesauce pouches, particularly the steps undertaken for its investigation and measures for future prevention. It is crucial to understand the FDA’s strategies for detecting and addressing intentional contamination in the food supply chain given the limited authority your agency has over contaminated cinnamon from abroad, which was identified as the potential source of this issue. ”  The bipartisan Committee leaders requested a briefing no later than February 2, 2024, and requested that the following topics should be covered:  A timeline of events leading to the discovery of lead contamination in the three applesauce brands listed above.  How did the FDA determine that the adulteration of raw cinnamon may have been intentional?  How is the FDA collaborating with international partners, particularly Ecuadorian authorities, to investigate this issue thoroughly?  How is the FDA collaborating with domestic partners, including state departments of health, to investigate this issue thoroughly?   What steps have been taken to determine if other foods have been contaminated as a result of this supply chain vulnerability?  How, if at all, does the FDA’s process for detecting lead contamination in food products differ for foods produced domestically from food produced abroad?   Since 2020, what has the FDA done to identify lead-contaminated foods and prevent them from reaching shelves?   Since 2020, how many recalls has the FDA issued related to lead contaminated foods? Of those, please specify how many were related to contamination products manufactured in America and how many were related to contamination abroad.    What are the FDA’s capabilities within its existing authorities to enhance monitoring and inspection processes to better detect and prevent intentional acts of lead contamination along the supply chain, including internationally, and what plans does the FDA have to use those authorities?  What additional resources or authorities are needed to better detect and prevent intentional acts of lead contamination along the supply chain, including along international supply chains? Will the FDA commit to providing the Committee with rolling updates on the status of the investigation, including findings related to the suspected international contamination?  CLICK HERE to read the full letter. 

Jan 17, 2024
Press Release

E&C Investigation Uncovers Earliest Known SARS-CoV-2 Sequence Released Outside of China

Discovery that shows virus sequence existed two weeks earlier than previously known undercuts China’s timeline of events Washington, D.C. — The House Energy and Commerce Committee’s investigation into the origins of COVID-19, led by 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), uncovered that a SARS-CoV-2 sequence was submitted to GenBank, the National Institutes of Health’s (NIH) genetic sequence database operated by the National Center for Biotechnology Information (NCBI), on December 28, 2019—two weeks before the Chinese Center for Disease Control and Prevention (China CDC) first released the virus’s sequence. The sequence was submitted by Dr. Lili Ren, an accomplished virologist at the Institute of Pathogen Biology of Chinese Academy of Medical Sciences in Beijing, China, which has ties to the Chinese Communist Party (CCP) and People’s Liberation Army. She is also a current subgrantee of non-profit EcoHealth Alliance on the same National Institute of Allergy and Infectious Disease (NIAID) grant as the Wuhan Institute of Virology (WIV), which has been debarred from receiving NIH grants for ten years for failing to provide laboratory records requested by NIH and for conducting research that “did lead or could lead to health issues or other unacceptable outcomes.”  Dr. Ren’s submission was missing some of the technical (not scientific) information required for publication on GenBank. She was notified by NIH staff on December 31, 2019, that her submission would be deleted without the additional information. Dr. Ren’s sequence is not the first instance of Chinese researchers attempting to delete early SARS-CoV-2 sequences posted to GenBank, but it is the earliest known one.  The Department of Health and Human Services (HHS) has confirmed that Dr. Ren’s December 28, 2019, sequence was nearly identical to the sequence later made public by the China CDC on January 10, 2020, which at the time was the first known sequence. China has consistently stated that it published the genetic sequence of SARS-CoV-2 as soon as it was available.  "This significant discovery further underscores why we cannot trust any of the so-called ‘facts’ or data provided by the CCP and calls into serious question the legitimacy of any scientific theories based on such information. The American people deserve to know the truth about the origins of SARS-CoV-2, and our investigation has uncovered numerous causes for concern, including how taxpayers’ dollars are spent, how our government’s public health agencies operate, and the need for more oversight into research grants to foreign scientists. In addition to equipping us to better prepare for the next pandemic, this investigation’s findings will help us as policymakers as we work to strengthen America’s biosafety practices and bolster oversight of research grants,” said Chairs Rodgers, Guthrie, and Griffith.   KEY TAKEAWAYS :  The existence of a SARS-CoV-2 sequence days before the CCP acknowledged an outbreak, and more than two weeks before the China CDC release their sequence, calls into question how early the CCP knew about the virus and how long they withheld this information from the world, resulting in more deaths and wasting critical time to develop vaccines and treatments. The NIH’s system for monitoring GenBank submissions is insufficient as the United States had an early SARS-CoV-2 sequence in our possession and apparently had no idea.  The Biden administration, the NIH, and HHS have obstructed and delayed Congressional investigations into the origins of SARS-CoV-2, refused to produce this sequence for over seven months, and only released it to the Committee after the Committee threatened to subpoena the sequence.  TIMELINE OF THE COMMITTEE’S INVESTIGATION :  May 3, 2023 : E&C Republicans Seek Data and Documents from NIH on Early COVID Cases  CLICK HERE to read the letter.  August 9, 2023 : E&C Presses Unresponsive NIH for Answers about COVID Origins and Risky Research Projects  CLICK HERE to read the letter.  September 28, 2023 : E&C Republicans Signal Intent to Issue Subpoenas as Biden Admin Stonewalls Crucial Investigations into Government Health Agency Actions  CLICK HERE to read the letter.  DOCUMENTS :  HHS’s Cover Letter   Dr. Lili Ren’s December 28, 2019, SARS-CoV-2 submission to GenBank  

Jan 3, 2024
Press Release

E&C Republicans Launch Investigation into Internal Scientific Disagreements at FDA

Washington, D.C. — 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), on behalf of the Health and Oversight subcommittee Republicans, wrote to Food and Drug Administration (FDA) Commissioner Robert Califf regarding how the agency handles internal scientific disagreements. Of particular concern to the Committee is whether FDA scientists face possible retaliation for expressing differing scientific views. In the letter, the Chairs note they are prepared to pursue compulsory measures should the FDA fail to respond in a timely, good-faith manner. KEY LETTER EXCERPTS : “ [I]n August 2021, the FDA announced two top vaccine regulators were leaving the agency. One reason cited for the departures was that they were upset about the Biden administration’s announcement that adults should get a coronavirus booster vaccination eight months after they received their second shot. Neither reportedly believed there was enough data to justify offering booster shots yet, and both viewed the announcement by President Biden as pressure on the FDA to authorize the shots quickly. It is unknown whether the FDA dispute resolution process was used, and if not, why not. We are concerned that the FDA may have retaliated against career FDA regulators who were viewed as insufficiently cooperative with the Biden administration’s agenda. ” […] “Given the renewed interest in updated scientific integrity policy, the Committee seeks information on the adequacy of the FDA’s existing policies for handling scientific disagreements, and whether FDA leadership has taken retaliatory actions against dissenting FDA officials." BACKGROUND : A September 2023 Government Accountability Office (GAO) report highlighted the Department of Health and Human Services’ (HHS) interest in developing processes for differing scientific opinions. The GAO also noted that the FDA has existing dispute resolution policies and may continue to use them when the updated scientific integrity policy is finalized. In addition, the GAO has issued two other recent reports that are pertinent to the FDA’s handling of internal scientific disagreements. In June 2012, the HHS Office of Inspector General (OIG) issued a study, Scientific Disagreements Regarding Medical Device Regulatory Decisions . The OIG found that accountability for the completeness of administrative files related to scientific disagreements was unclear as Not all Center for Devices and Radiological Health (CDRH) managers and reviewers received training on the new procedures CDRH faced broader challenges in identifying and resolving scientific disagreements because of uncertainty about regulatory definitions and processes and staff perceptions about expressing differences of opinion Further, the OIG recommended that the FDA: (1) define more clearly its requirements for documenting and resolving scientific disagreements (2) train all reviewers and managers on the new policies and procedures for resolving scientific disagreements (3) more clearly assign accountability for the contents of the administrative files of all submissions The FDA concurred with all three recommendations. The Chairs requested a response with the following information by January 17, 2024:  Copies of the administrative files related to all internal scientific disagreements at the FDA since January 1, 2018, documenting whether and/or how the resolution was reached and the basis, including any joint memoranda. All documents since January 1, 2018, related to the Office of Chief Scientist handling of appeals of internal scientific disagreements at the FDA. All documents related to the scientific disagreement within the FDA over coronavirus booster vaccination during summer 2021. If the internal process was not used, please provide all documents related to any changes in decision-making authority on the coronavirus booster vaccination during summer 2021 (e.g., authority removed from the director and deputy director of the Center for Biologics Evaluation and Research (CBER) vaccines office and reassigned to the CBER director). All documents since January 1, 2018, related to all instances where decision-making authority was removed from FDA officials involved in regulatory decisions. CLICK HERE to view the full letter.

Dec 14, 2023
Press Release

E&C Republicans Send Follow Up Letter to FDA Regarding Foreign Drug Inspection Program

Chairs signal intent to subpoena if FDA continues stonewalling crucial request Washington, D.C. — 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 Griffth (R-VA), on behalf of the Health and Oversight Republicans, sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf. The letter follows up on a previous request for information related to the agency’s foreign drug inspection program and comes amid the Committee’s work to address drug shortages . To date, the FDA has not provided any response to the Committee.  KEY LETTER EXCERPT :  “The U.S. cannot afford additional disruptions to the drug supply chain that reduce the availability of essential medications and force doctors and patients to make difficult treatment decisions. Members of this Committee have repeatedly expressed concern regarding the effectiveness of the FDA’s foreign drug inspection program, including at two separate hearings this Congress before the Subcommittee on Oversight and Investigations and the Subcommittee on Health. Addressing drug shortages remains a top priority for the Committee.”  BACKGROUND :  Since the Committee’s July letter to the FDA, there have been additional drug recalls from Indian manufacturers and plant closures in the United States.   In August, Indian drug manufacturers, Alembic and Aurobindo Pharma, issued voluntary drug recalls citing quality and manufacturing deficiencies, respectively.   Alembic recalled over 80,000 bottles of tobramycin, used to treat bacterial eye infections, due to “failed impurities/degradation specifications.”  Aurobindo recalled rufinamide tablets used to treat seizure disorders.  Both companies have a history of drug recalls and quality control failures.   Last year, the FDA issued Alembic a Form 483, which cited its manufacturing plant in Panelav, Gujarat with four observations following a 10-day inspection.  It has come to light that the FDA ended its unannounced foreign inspection program out because the agency believed it was an obstacle to deeper collaboration with India.   The reporting also alleges that the FDA undermined a Department of Defense initiative to independently test the quality of imported drugs used by the military out of fear that it would undermine the FDA’s credibility.   In addition, a newly published study has confirmed that FDA foreign inspections in 2022 were down 79 percent compared to 2019 while at the same time the number of “citations rose dramatically, despite all establishments being given advance notice of inspections.”   ADDITIONAL BACKGROUND :  Domestic production of vital medicines continues to be under stress.   In early August, Pfizer announced it would limit the distribution of injectable drugs manufactured at its North Carolina plant after the facility suffered damage in the aftermath of a tornado.   In September, autoinjector maker Aktiv Pharma Group (“AktiVax, Inc.”), which produces autoinjectors to treat life threating conditions, announced the closure of three manufacturing facilities.   Just last year, the company w as awarded over $45 million to supply a nerve agent antidote to the Strategic National Stockpile. While shortages of cancer drugs appear to have eased slightly in recent months, demand continues to outstrip supply .  The Chairs are prepared to issue a subpoena if the FDA does not produce the requested documents January 5, 2024. CLICK HERE to read the letter.

Dec 7, 2023
Press Release

E&C Republicans Press CDC for Lab Safety Documents Amid Agency Stonewalling

Chairs signal intent to subpoena documents if CDC does not comply with request Washington, D.C — 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), on behalf of the Health and Oversight Subcommittee Republicans, today wrote to Centers for Disease Control and Prevention (CDC) Director Mandy Cohen. The letter , which comes after Director Cohen’s testimony before the Oversight Subcommittee, follows up on a previous request made in June for information on the CDC’s lab safety practices. The Chairs note their intent to subpoena the documents should CDC not comply with the request. Dr. Mandy K. Cohen, MD, MPH   Director   Centers for Disease Control and Prevention   1600 Clifton Road   Atlanta, GA 30329   Dr. Cohen,   Pursuant to Rules X and XI of the U.S. House of Representatives, the Committee is investigating the adequacy of the Centers for Disease Control and Prevention’s (CDC’s) efforts to address laboratory science and safety at CDC’s laboratories. The CDC has failed so far to respond adequately to our June 30, 2023, oversight request letter. HHS, not CDC, sent a November 9, 2023, letter that provided information responsive to only one out of 11 oversight request items. In our June 30, 2023, letter, we requested information and documents from the CDC related to laboratory science and safety at CDC. So far, the CDC has not produced any of the requested documents. Therefore, we are reiterating these document requests in this letter to expedite our inquiry. Please provide the following by January 5, 2024: Copies of all internal CDC center reports since January 1, 2019, on reviews of laboratory safety at CDC center research facilities.   Copies of all reports from the CDC centers since January 1, 2019, sent to the Office of Laboratory Science and Safety (OLSS).   Copies of any laboratory safety incident reports since January 1, 2019, related to laboratory-acquired infections or exposure to biological, chemical, radiological or all hazardous agents, or reports related to an animal bite.  Copy of a document listing all CDC buildings that contain a laboratory or animal testing facility, and their locations.   Copies of all the Federal Select Agent Program (FSAP) inspection reports since January 1, 2019, related to any CDC laboratory.   All documents related to the decision at the CDC as part of the Moving Forward initiative in 2022 to elevate the OLSS to report directly to the CDC director.   A copy of a document listing all CDC researchers who maintain an inventory of pathogens that include federal select agents, including the name of the researcher, laboratory and office, identities of the pathogens, and the number of vials of each pathogen.   Copies of all CDC select-agent theft, loss, or release reports since January 1, 2019.   All documents related to instances of discovery of select agents in unregistered locations at the CDC since January 1, 2019.   A copy of a document listing all select agent laboratories designated either biosafety level 3 or 4 located at each CDC campus.   A copy of a document listing all individuals at CDC approved for select agent work at each CDC campus. In order to carry out our Constitutional oversight responsibilities, the Committee is prepared to issue a subpoena if the CDC does not produce the requested documents by January 5, 2024, since the Committee has a right to obtain these materials to aid in its legislative activities and to ensure that the Executive Branch is complying with the law.