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Letter - Health Updates


Sep 18, 2023
Letter

E&C Republicans Probe Biosafety Practices, Request Information from CDC and USDA Regarding Federal Select Agent Program

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 letters to the Centers for Disease Control and Prevention and U.S. Department of Agriculture. The letters come as part of the Committee’s ongoing investigation into federal laboratory biosafety practices, and the handling of dangerous pathogens in bioresearch.  KEY EXCERPT :  “Committee is investigating the safety and security of federal high-containment laboratories. We are writing to obtain further details about the performance and enforcement of the federal select agent program (FSAP), jointly managed by the CDC/Center for Preparedness and Response/Division of Select Agents and Toxins (DSAT), and the U.S. Department of Agriculture (USDA)/Animal Plant Health Inspection Service (APHIS)/Veterinary Services/Agriculture Select Agent Services.”  BACKGROUND :  At an April 27, 2023, oversight hearing titled “Biosafety and Risky Research: Examining if Science is Outpacing Policy and Safety,” Members and witnesses discussed the FSAP and how to strengthen the oversight of safety in life sciences labs.  According to the seven published FSAP Annual Reports from 2015 – 2021:  The FSAP conducted 1,316 inspections: 173 by the Agriculture Select Agent Services, 857 by the Division of Select Agents and Toxins, and 286 joint inspections by CDC’s DSAT and USDA’s APHIS  The FSAP conducted 46 compliance inspections  17 entities participated in the FSAP Corrective Action Plan program  The FSAP made 20 referrals to the HHS OIG and/or the Animal and Plant Health Inspection Service Investigative and Enforcement Services  The Chairs requested documents and answers to questions, including the following, by September 29, 2023:  Please provide copies of all referrals the FSAP has made to the Department of Health and Human Services (HHS) Office of Inspector General and/or APHIS Investigative and Enforcement Services since January 1, 2015. Please provide the outcomes of these referrals.  According to the 2020 Annual Report, FSAP received one report involving a complaint about transportation issues that were unrelated to the SAR. FSAP referred this complaint to the Food and Drug Administration and the Department of Transportation. Please provide a copy of this referral. Please provide the outcome of this referral.  Please provide copies of all FSAP compliance inspections conducted at laboratories at FDA, NIH, and CDC since January 1, 2015.  Since January 1, 2015, please list all entities levied civil money penalties as a result of FSAP enforcement actions, the nature of the violations, the kinds of pathogens involved, amount of the penalties, and the total amount of civil money penalties collected. Did any federal government entity have SAR violations that would have subjected a non-federal entity to civil money penalties? If so, which ones, and why were civil money penalties not levied?  For 2015-2021, the FSAP reported conducting 1,316 inspections. How many of those inspections were unannounced inspections?  Since December 22, 2022, has there been a release, loss, or theft of an agent or toxin listed as a federal select agent from or within a laboratory facility owned or operated by the HHS, or any other Federal laboratory facility?     If so, was there a notification to this committee or the Committee on Health, Education, Labor and Pensions of the Senate no later than 72 hours after such event was reported to the HHS Secretary, including (1) the Federal laboratory facility in which such release, loss, or theft occurred; (2) the circumstances of such release, loss, or theft? If not, why not?  Not later than 14 days after such notification to the committees, was an update provided to the committees on (1) any actions taken or planned by the HHS Secretary to mitigate any potential threat such release, loss, or theft may pose to public health and safety; and (2) any actions taken or planned by the HHS Secretary to review the circumstances of such release, loss, or theft, and prevent similar events. CLICK HERE to read the full letter.



Sep 15, 2023
COVID-19

E&C Republicans Ask Government Watchdog to Assess NIH’s Ability to Detect or Prevent Misuse of Grant Funds in Light of EcoHealth Alliance Failures

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 requested the Government Accountability Office (GAO) conduct a study on the National Institutes of Health’s (NIH) effectiveness in overseeing grant funding. BACKGROUND :  NIH is one of the top research and development funding agencies—particularly for biomedical research.    NIH’s program level funding for Fiscal Year 2023 as enacted is $47.678 billion.   In fiscal year 2020, the agency obligated nearly $43 billion for research in areas such as infectious disease prevention, cancer treatment, and mental health.   NIH obligated as much as 80 percent of these funds towards extramural research, performed by outside organizations including universities, medical centers, and other research institutions.   Organizations receiving extramural research awards from NIH may, in turn, award sub-grants for a portion of the work.   As highlighted in HHS OIG and GAO reports , the use of sub-grants may further complicate the management and oversight of NIH research funds.  KEY EXCERPTS :  “A January 2023 report by the Office of Inspector General within the Department of Health and Human Services (HHS OIG) detailed failures by NIH to monitor effectively its grants with EcoHealth Alliance, a nonprofit research organization. According to that report, the organization had overcharged the government for its services and improperly used federal grant funds. Further, a July 2023 report by the Government Accountability Office (GAO) raised similar concerns about NIH’s oversight of grant recipients and recommended that NIH make improvements to its oversight processes.”  […]  “In light of the recent problems in NIH’s oversight and the scale of NIH’s funding of extramural research awards, more transparency is needed about NIH’s policies and procedures as well as its effectiveness in overseeing financial management of its extramural research awards.” The Chairs requested answers to the following questions:  How much funding did NIH provide—using grants, cooperative agreements, or other award mechanisms—for extramural research since fiscal year 2014? For the same time frame, what resources did NIH and each of its institutes and centers have to conduct financial management oversight?  What are the trends in award funding including, for example, the research areas and types/characteristics of award recipients funded; the number, size, and duration of awards; the types of award mechanisms used?  What policies, procedures, and processes does NIH follow to administer and oversee its extramural research awards using grants, cooperative agreements, or other award mechanisms? How do policies, procedures, and processes differ among the NIH institutes and centers in administering and overseeing extramural research awards?   To what extent is NIH, consistent with its policies and procedures, ensuring effective financial management oversight of extramural research funding throughout the award life cycle?  What are the roles and responsibilities of those involved in such oversight including the award recipient?    How, if at all, does NIH’s oversight of extramural research funding differ for intramural research funding?  What internal assessments, if any, does NIH conduct to provide reasonable assurance that funds are being used as intended—including that proposed rates and costs are reasonable and funds are being used appropriately?  How much money has NIH recovered as a result of such internal assessments?    What changes, if any, has NIH implemented based on the findings and lessons learned from such assessments?  What data does NIH collect on the findings and results of its internal assessments? Are there data gaps, and can these gaps be addressed?   What are the lessons learned or best practices from institutes and centers that could be implemented across NIH? CLICK HERE to read the full letter.



Sep 14, 2023
Press Release

Chairs Rodgers, Griffith, Guthrie, Wenstrup, Comer Threaten to Subpoena HHS and EcoHealth Alliance President for COVID-19 Origins Information

Washington, D.C. — House Energy and Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA), and Subcommittee on Health Chairman Brett Guthrie (R-KY), along with Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-OH) and Committee on Oversight Accountability Chairman James Comer (R-KY), wrote to the Department of Health and Human Services (HHS) in an effort to force officials to comply with previous requests for COVID-19 origins information and cease stonewalling.  In a letter to HHS Secretary Xavier Becerra, the Chairs renewed requests from four previous letters for potentially incriminating documents and communications concerning EcoHealth Alliance, Wuhan Institute of Virology, and the now infamous “Proximal Origin” publication. The Committees have also asked individuals potentially involved with a COVID-19 origins cover-up to appear voluntarily for transcribed interviews—most notably Dr. Francis Collins, Dr. Lawrence Tabak, and Dr. Hugh Auchincloss. If HHS does not meet the stated deadlines, the Chairs will be forced to consider the use of subpoenas to obtain the requested COVID-19 origins information. “This letter consolidates our previous requests regarding the origins of COVID-19 and, as a further accommodation to the Department, tables some requests, adds significant topic specificity, scopes down the time frame of our previous requests, and prioritizes requests most important to the Committees. Considering these significant accommodations, we expect full and timely compliance with each request,”  wrote the Chairs . “If the Department fails to meet any of the prescribed deadlines, the Committees will be forced to consider the use of the compulsory process.” In a second wave of letters, the Chairs reiterated invitations to three individuals with extensive involvement in COVID-19 origins related operations to appear for voluntary transcribed interviews. Notably, the renewed request for the testimony of Dr. Peter Daszak, President of EcoHealth Alliance, is critical to the investigation into the potential use of American taxpayer funds to conduct dangerous gain-of-function research at the Wuhan Institute of Virology.  Further, the Chairs requested voluntary transcribed interviews with Mr. Greg Folkers—who served as Dr. Anthony Fauci’s Chief of Staff—and with Mr. F. Gray Handley—who served as Associate Director for International Affairs at the National Institute of Allergy and Infectious Diseases (NIAID) during the COVID-19 pandemic. Should Dr. Daszak, Mr. Folkers, and Mr. Handley continue to refuse to cooperate with the Committees, the use of subpoenas will be considered. Read the letter to HHS Secretary Xavier Becerra here.  Read the voluntary transcribed interview requests for Dr. Peter Daszak, Mr. Greg Folkers, and Mr. Gary Handley below:  Dr. Peter Daszak , EcoHealth Alliance President   Mr. Greg Folkers , Former Chief of Staff at NIAID  Mr. Gary Handley , Former Associate Director for International Affairs at NIAID 



Aug 10, 2023
COVID-19

E&C Republicans: SAMHSA Needs To Be Fully Forthcoming About How It Spends Taxpayer Dollars

Agency Received Nearly $9 Billion in COVID Supplemental and 9-8-8 Hotline Funds   Washington D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chair Brett Guthrie (R-KY), and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, sent a letter to the Substance Abuse and Mental Health Services Administration (SAMHSA) requesting a full accounting of how the agency spent more than $8 billion that it was allocated in response to the COVID-19 pandemic. The letter is a continuation of the Committee’s investigation into the COVID supplemental funds received by SAMHSA and awarded to states. Previous responses from SAMHSA did not detail how much of these funds have been spent and how these expenditures were used. KEY EXCERPTS: “Unfortunately, even after prompting by the Committee staff, SAMHSA is not providing the full accounting for billions of dollars in expenditures as requested. SAMHSA needs to be fully forthcoming with information about nearly $8 billion in COVID supplemental funds received by SAMHSA and awarded to states. “In addition, SAMHSA reported more than $900 million has been “invested” in the 9-8-8 crisis care system since FY 2022. This is a massive amount of money, and SAMHSA has not produced specific data showing how these funds are being used, or even if they are being used. “SAMHSA’s description of the December 2022 cybersecurity incident impacting the 9-8-8 Suicide and Crisis Lifeline is also troubling. SAMHSA reported that it is still awaiting the final report from its third-party security assessor.” “Further, SAMHSA suggested that the Committee direct detailed questions to the FBI, given the ongoing nature of the investigation. Given that this incident is being investigated by law enforcement, this indicates a much more significant and concerning event.” CLICK HERE to read the full letter. CLICK HERE to read the Committee’s April 2023 letter to SAMHSA.



Aug 9, 2023
Letter

E&C Republicans Ask Secretary Becerra for Documents Showing Lawful Appointment of New NIAID Director

Washington, D.C. —  House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chair Brett Guthrie (R-KY), and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra. The letter requests the documents signed by HHS Secretary Becerra appointing Dr. Jeanne Marrazzo to a five-year term to serve as Director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). Last month, the committee  uncovered  that Secretary Becerra failed to properly appoint 14 Institute and Center (IC) directors at the NIH. The committee is seeking assurances that Dr. Marrazzo has or will be properly appointed in accordance with the Constitution and the 21 st  Century Cures Act. KEY EXCERPTS : “ We write today because we are concerned that you may be continuing on an unconstitutional appointment process  in an effort to avoid accountability for your previous failure to properly reappoint the 14 IC Directors in December 2021. “On August 2, 2023, the NIH issued a press release announcing the appointment of Dr. Jeanne Marrazzo as director of the National Institute of Allergy and Infectious Diseases (NIAID) and that she would oversee NIAID’s $6.3 billion budget. The press release stated that Dr. Lawrence Tabak, the Acting Director for the NIH, named her to this position.   The press release included no statement from you or any indication that you had a role in her appointment . HHS has acknowledged the Secretary must appoint NIH IC directors . The May 5, 2023, response letter from Health and Human Services (HHS) Assistant Secretary Melanie Egorin stated the HHS Secretary is the approving official for NIH IC director appointments and the NIH director is the recommending official.  Her letter unequivocally states: “ NIH IC Directors are recommended for appointment by the NIH Director and approved for appointment by the Secretary of the Department of Health and Human Services (HHS) .”  Further, you signed affidavits of reappointment with prospective effect of certain NIH IC directors in June 2023.  Your affidavits expressly invoked the Appointments Clause, which tacitly acknowledges that the IC Directors are inferior officers of the United States ." […] “Further, even under HHS’s changed position, Dr. Tabak, as the Acting NIH Director, lacks the authority to make Dr. Marrazzo’s appointment, if in fact he made the appointment.” […] “Since the enactment of the 21st Cures Act in 2016, it is our understanding that the  HHS Secretary in the previous administration personally approved the appointments of NIH IC directors.  This precedent, the clear commands of the U.S. Constitution’s Appointments Clause along with your affidavits of prospective reappointments and HHS correspondence indicate you are required to appoint all NIH IC Directors, including Dr. Jeanne Marrazzo to be the Director of NIAID .” CLICK HERE  to read the full letter. CLICK HERE  to read more about the committee’s investigation and findings. CLICK HERE  to read a transcript of Chair Rodgers’ questioning of Secretary Becerra regarding the appointment of IC Directors at a July 26 th  hearing.



Aug 9, 2023
COVID-19

E&C Presses Unresponsive NIH for Answers about COVID Origins and Risky Research Projects

Washington D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chair Brett Guthrie (R-KY), and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA), sent two letters to the National Institutes of Health (NIH) following up on the NIH’s lack of response to requests for information and documents. By failing to respond, the NIH is hindering Congress from exercising its Constitutionally mandated oversight responsibilities and not being accountable to the American people. On May 1, 2023 , Chairs Rodgers, Guthrie, and Griffith  sent a letter  to the Acting Director of the NIH, Dr. Lawrence Tabak, regarding NIH’s oversight of potential risky research activities such as virus mutation or manipulation in experiments involving SARS, MERS, or SARS CoV-2. It has been over three months, and the Committee has no meaningful evidence that the NIH is responding to this request. Today’s letter to Dr. Tabak builds on the Committee’s investigation of the adequacy of the NIH’s oversight of research it funds that may pose significant biosafety or biosecurity risks. As written in the letter, “in the event that NIH does not provide documents by that date, the Committee will be forced to consider compulsory process to secure production of the requested documents.” CLICK HERE  to read the full follow-up letter. ADDITIONAL BACKGROUND: In January 2022, the Chairs  requested  a list of all proposed, approved, or ongoing research work that NIH is funding in the area of coronaviruses (especially SARS CoV-2), or viruses related to SARS, MERS, or SARS CoV-2. In its written response, NIH specifically ignored the question: “Does the research involve virus manipulation, passaging of a virus, genetically modified animals, or making any mutations to a virus?” On April 27, 2023, the Subcommittee on Oversight and Investigations held a  hearing  titled “Biosafety and Risky Research: Examining if Science is Outpacing Policy and Safety.” In June 2023, Committee leaders   sent letters  to the CDC, HHS, and NIH seeking information on laboratory biosafety and biosecurity safety practices at those agencies. The Committee calls on the Biden administration to increase  transparency  both in declassifying information related to the origins of COVID-19 and in the U.S. government’s role in funding risky virus research, including at the Wuhan Institute of Virology.  On May 3, 2023, Chairs Rodgers, Guthrie, and Griffith  sent another letter  to Dr. Tabak requesting information that would bolster the Committee’s ongoing investigation into the origins of COVID-19, specifically regarding any early SARS-CoV-2 sequences, data from early COVID-19 cases, or other pertinent documents related to the early phase of the pandemic. However, as written in today's letter, instead of providing documents that “could help support the Committee’s potential legislative efforts to improve pandemic preparedness, strengthen NIH grant oversight, and enhance the biosafety of laboratory and field research,” the NIH has failed to meaningfully engage. In this follow-up letter, the NIH is once again asked to either comply with this request for information or face a compulsory process.   CLICK HERE to read the full follow-up letter. ADDITIONAL BACKGROUND:  In March of 2023, Congress passed  S. 619 ,  the Covid-19 Origins Act, which requires the Office of the Director of National Intelligence declassify all information relating to potential links between the origins of COVID-19 and the Wuhan Institute of Virology.  In April of 2023, the  New York Times   reported  that the Chinese Communist Party forced a team of scientists from the United States and China to withdraw an early study on COVID-19. In June of 2023, Chair Rodgers  responded  to the Director of National Intelligence’s release of limited information regarding COVID-19 origins by demanding complete declassification of COVID-19 origins information.



Jul 27, 2023
Press Release

Bicameral Health Committee Leaders Announce Bipartisan Request for Information Regarding FDA Regulation of CBD

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy, M.D. (R-LA), today announced a bicameral Request for Information (RFI) to subject matter experts and stakeholders regarding Food and Drug Administration (FDA) regulation of cannabidiol (CBD).  KEY EXCERPTS :  “Since hemp was descheduled five years ago, consumers, manufacturers, and policymakers have sought clarity regarding the legal status of CBD. Farmers, food and beverage groups, and state regulators have shared their policy priorities with Congress. Questions remain about the best way to provide a legal pathway to market for CBD products.”  […]  "In January 2023, FDA announced that it would like to work with Congress to craft a legislative approach to the regulation of CBD products. We are assessing the potential for a regulatory pathway for hemp-derived CBD products that prioritizes consumer safety and provides certainty to the U.S. market.”  The Members request responses to the RFI be submitted to CBD@mail.house.gov and CBD@help.senate.gov by August 18, 2023.  The RFI’s requests and questions include:  Please comment on the concerns FDA has raised with regard to regulating most CBD products through existing pathways (i.e., conventional foods, dietary supplements, and cosmetics), and FDA’s view that there is a need for a new regulatory pathway for CBD products. If existing regulatory pathways are sufficient for regulating CBD products, please explain how these existing pathways can be used to address the concerns raised by FDA, as appropriate.  How has the absence of federal regulation over CBD created a market for intoxicating, synthetically-produced compounds, such as Delta-8 THC, THC-O, THC-B, HHC-P, and others?  How should a new framework for CBD products balance consumer safety with consumer access?  What precedent exists in foods, dietary supplements, tobacco, and cosmetics for requirements of labeling to present risks to special populations in labeling (e.g., children, pregnant and lactating women, consumers taking certain drugs, etc.)? What amount and type of evidence has been required to support such requirements?  CLICK HERE to read the full RFI. 



Jul 21, 2023
Press Release

E&C Republicans Issue Final Warning to Becerra to Cooperate with Investigation of Risky Mpox Experiments

Administration refuses to produce documents related to supercharged pathogen experiments 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 Subcommittees’ Republicans, today wrote to Department of Health and Human Services (HHS) Secretary Xavier Becerra.   As part of an ongoing investigation, their letter requests a voluntary videotaped, transcribed interview with Dr. Bernard Moss, a leading pox virus researcher at the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), regarding reported experiments he has conducted or proposed to supercharge strains of the mpox virus.  BACKGROUND :  In November 2022, Energy & Commerce Republicans, then in the minority, launched an investigation into a proposed NIAID mpox virus enhancement experiment, which has reportedly made the disease 1000 percent more lethal in mice. Dr. Moss discussed the experiment in an interview with Science magazine . According to an article in the October 19, 2022, Science magazine, scientists were alarmed about these mpox experiments, and that an outbreak strain lab escape could spark a substantially more deadly mpox epidemic.   The Chairs, now in the majority, reopened the investigation in March 2023, also providing a notice to preserve all documents and communications related to the topic.  Following an inadequate response from HHS that simply stated that the study “has not been formally proposed, and NIAID has no plans to move forward with this research,” the Chairs requested a videotaped, transcribed interview with Dr. Moss in May 2023. The Chairs noted “Dr. Moss has been with the NIH since 1966, is one of the leading authorities on pox viruses, and one of the NIH’s most accomplished researchers. He has received numerous awards and prizes. […] The admission that he did not formally propose this research, and the NIAID has no plans to pursue it seems extraordinary. It seems unlikely that Dr. Moss changed his mind. On the other hand, it is hard to believe the NIAID has apparently overruled one of its most highly respected scientists.”   HHS sent a response on June 30, 2023, attaching a letter purportedly written by Dr. Moss. However, the explanation in the letter raised more questions and inconsistencies. HHS and NIH have so far not produced any requested documents.  KEY LETTER EXCERPT :  “It is vital for the committee to get a full understanding about how such risky research proposals are developed and overseen to support our legislative efforts in pandemic preparedness and protection of public health.”  […] “In the event one of the above dates is not selected, the Committee will be forced to consider compulsory process to secure Dr. Moss’s attendance.”  CLICK HERE to read the letter.



Jul 18, 2023
Letter

E&C Republicans Press FDA Over Inadequate Inspection of Drug Manufacturing in India and China

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, sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf. The letter raises questions regarding the FDA’s insufficient foreign drug inspections conducted in India and China.  KEY EXCERPT:   “The FDA’s recent decision to address shortages of critical drugs by allowing the temporary import of otherwise unapproved drugs from India and China makes having effective foreign inspection programs in those countries critical. […] Given that approximately 32 percent of generic drugs and 45 percent of active pharmaceutical ingredients are from these two countries, we are worried that the United States is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations .”  KEY BACKGROUND FACTS:   FDA Foreign Inspections:   Chinese and Indian manufacturers receive the most FDA Warning Letters. These violations have included:  carcinogens in medicines,   destroying or falsifying of data,   and non-sterile manufacturing processes.  The COVID-19 pandemic stopped most in-person inspections of foreign drug manufacturers from March 2020 until April 2022.   In lieu of in-person inspections, the FDA resorted to alternatives and workarounds, such as remote interactive inspections of drug manufacturing facilities on a voluntary basis.  Once FDA inspections resumed, they did so at a much lower level than before the pandemic.   One analysis found that out of approximately 2,800 foreign manufacturing facilities, the FDA inspected only 6 percent of them, with just 3 percent of Indian manufacturers being inspected.  Between fiscal years (FY) 2020 and 2022, the FDA conducted only 40 inspections in China as compared to 131 inspections in FY 2019 alone.   On January 8, 2023, the Government of China ended its requirement that international arrivals quarantine for two weeks upon entry to the country.   However, the FDA only began in-person inspections in China in April 2023.  Additional Governmental Concern with FDA Inspection Inadequacy:   The Department of Defense recently announced that it will begin independently testing the quality and safety of imported generic drugs.  The non-partisan Government Accountability Office (GAO) also criticized the FDA’s foreign inspection program in a report published last year, noting that the FDA faced “unique challenges” and that it is inadequate at holding foreign manufacturers accountable for repeatedly violating regulations.  In particular, the GAO was concerned that the FDA’s practice of conducting preannounced foreign inspections is ineffective and raises “questions about the equivalence of foreign to domestic inspections.”  Unannounced Inspection Pilot Program and Discontinuation:   From 2014 to 2015, the FDA conducted a pilot program in India that eliminated extended advance notice for inspections.   During that time, the FDA conducted short notice or unannounced visits and selected sites for the program that the agency believed had significant issues.   The pilot program appears to have been successful at exposing widespread misconduct and significant violations of FDA regulations, including falsified quality records.   Despite the pilot program’s success, the FDA elected to discontinue it.  Challenges Posed by China’s National Security Law:   The ruling Communist Party of China announced a reinterpretation of its already sweeping National Security Law to expand the scope of the law beyond state secrets to cover “data, materials, or items related to … national interests.”   The law’s new interpretation is so broad that it would allow officials to arrest FDA inspectors or block access to manufacturers’ records if officials deem it in the national interest.   Authorities have already raided the offices of companies that specialize in collecting market information in China and detained employees.  The Chairs requested answers related to questions, including the following, by August 1, 2023:  Section 3112(e) of the CARES Act gave the FDA additional authority to require manufacturers to report certain supply chain information to it. The FDA’s May 9, 2023, letter to the Committee stated that only 44 percent of facilities are reporting the required data to the FDA. Based on the FDA’s letter, a disproportionate percentage of noncompliant API and finished dose formula facilities are located outside of the United States. How many regulatory actions has the FDA enforced against noncompliant foreign facilities regarding the CARES Act reporting requirements? Provide a list of all foreign facilities that have been penalized for noncompliance. Include in your response a detailed description of the action taken by the FDA.  The FDA ensures the quality of drugs and other pharmaceutical products through manufacturers’ compliance with facility registration and Current Good Manufacturing Practice (CGMP) regulations. The Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144) contained several provisions providing the FDA greater insight into the original sources of excipients, API, and finished dosage products. Specifically, Section 703 requires that drug manufacturers identify the name and place of business of all establishments involved in the production of drug excipients, while Section 711 revises CGMP regulations to require oversight over the production of any raw materials for the manufacture of a drug. The FDA has indicated in its recent requests for additional authorities over supply chain information that it does not currently have access to original sources for API and other drug excipients, notwithstanding these and other provisions providing such authorities.   Given its authorities under FDASIA, why does the FDA take the position that it does not have visibility into where API and drug excipients are sourced?   Explain in detail, how the FDA processes information received under Sections 703 and 711. As part of your response, explain how has the data received under Sections 703 and 711 informs FDA’s foreign inspections programs and drug shortage response efforts?  Was the FDA consulted by the Department of Defense regarding its decision to independently test the quality and safety of generic drugs it purchases? If yes, provide communications and documents related to the consultation.  How many FDA inspectors are currently conducting foreign inspections? Include in your response how many of these inspectors are operating in each country.  CLICK HERE to read the letter.  BACKGROUND ON THE COMMITTEE’S DRUG SHORTAGE EFFORTS :   July 12, 2023 : Chair Rodgers announces plans to release drug shortage discussion draft following robust response to RFI.  June 12, 2023 : Chair Rodgers and Ranking Member Crapo (R-ID) sent an RFI to stakeholders and experts.   May 11, 2023 : Chair Rodgers and OI Subcommittee Chair Morgan Griffith (R-VA) convened a hearing titled “Examining the Root Causes of Drug Shortages: Challenges in Pharmaceutical Drug Supply Chains.”   March 27, 2023 : Chair Rodgers, Subcommittee Chair Griffith, and Subcommittee on Health Chair Brett Guthrie (R-KY) wrote to the FDA requesting information into how the agency is managing drug shortages. You can read the FDA’s response here, which notes that only 44 percent of companies are complying with existing requirements to report information on the volume of drugs made at each facility to FDA.