前言

        1、最近年美国国会联系多次信件联系FDA，表示FDA对中国或印度的检查次数不多，且与美国国内检查相比，更为宽松。查看FDA警告信（可查看识林：警告信），今年上半年对中国和印度的警告信只有几次，这包括药品、医疗器械以及化妆品等。

        2、 2024年已过去一半，上半年虽然对中国药企进行了检查，但是比往年次数明显减少，下半年FDA何去何从，中国药企要严阵以待，通过自查或他查的方式尽快解决自身企业问题，按照合规方式进行生产。

    正文

                                               CATHY McMORRIS RODGERS, WASHINGTON     FRANK PALLONE, JR., NEW JERSEY

                                                                   CHAIR                                                                   RANKING MEMBER   

ONE HUNDRED EIGHTEENTH CONGRESS

第一百一十八次代表大会

Congress of the United States

美国国会

House of Representatives

众议院

COMMITTEE ON ENERGY AND COMMERCE

能源与商业委员会

2125 RAYBURN HOUSE OFFICE BUILDING

雷伯恩大厦2125号办公楼

WASHINGTON, DC 20515-6115

Majority (202) 225-3641

Minority (202) 225-2927

July 18, 2023

The Honorable Robert M. Califf, M.D., MACC

Commissioner

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20903 

Dear Dr. Califf,

Pursuant to Rules X and XI of the U.S. House of Representatives, the Committee is conducting oversight of the Food and Drug Administration’s (FDA) foreign drug inspection program. As you are aware, members of the Committee have expressed concern regarding the effectiveness of the FDA’s foreign drug inspection program at two separate hearings before the Subcommittee on Oversight and Investigations and the Subcommittee on Health. 1

根据美国众议院第十条和第十一条，国会对美国食品药品监督管理局（FDA）的外国药品检查计划进行调查。如你所知，国会成员在监督和调查小组委员会和卫生小组委员会举行的两次内部听证会上对FDA外国药物检查计划的有效性表示担忧。^1.

The Committee is particularly concerned about foreign drug inspections conducted in India and China. 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.2 Chinese and Indian manufacturers receive the most FDA Warning Letters.3 These violations have included carcinogens in medicines, destroying or falsifying of data, and non-sterile manufacturing processes. Given that approximately 32 percent of generic drugs and 45 percent of active pharmaceutical ingredients (APIs) 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. 4

国会特别关注在印度和中国进行的外国药品检查情况。FDA最近决定允许从印度和中国临时进口未经批准的药物来解决关键药物短缺问题，那么在以上国家实施有效的外国检查计划至关重要。²中国和印度制造商收到的FDA警告信最多。³这些违规行为包括药物中的致癌物质、修改或伪造数据以及非无菌生产过程。鉴于大约32%的仿制药和45%的活性药物成分（API）来自这两个国家，我们担心美国过度依赖两国制造商，因为这些制造商一再违反FDA的安全法规。^4.

The Committee is not alone in voicing concerns. The Department of Defense recently announced that it will begin independently testing the quality and safety of imported generic drugs.5 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.6 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.”7

   并非只有国会表示关注。美国国防部最近宣布，将开始对进口仿制药的质量和安全性进行独立测试。⁵无党派的政府问责局（GAO）在去年发布的一份报告中也批评了FDA的外国检查计划，指出FDA面临“特有的挑战”，不足以追究外国制造商多次违反规定的责任。⁶特别是，美国政府问责办公室担心FDA进行事先通知外国检查的做法无效，并引发了“对国外与国内检查等效性的质疑”。⁷

 From 2014 to 2015, the FDA conducted a pilot program in India that eliminated extended advance notice for inspections. Instead, 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.8 Despite the pilot program’s success, the FDA elected to discontinue it. 9

2014年至2015年，FDA在印度开展了一项试点项目，取消了延长检查的提前通知。相反，FDA进行了简单或未经通知的检查，并为该机构认为存在重大问题的项目选择了目标。该试点项目似乎成功地暴露出大量的不当行为和严重违反FDA规定的行为，包括伪造的记录。⁸尽管试点项目取得了成功，但FDA还是决定终止该项目。⁹

    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. 10

2020年3月至2022年4月，由于新冠肺炎疫情停止了大多数国外设施检查计划。FDA采用了替代方案和变通办法，如自愿对药品生产设施进行远程互动检查，而不是现场检查。一旦FDA恢复检查，其检查水平远低于疫情前。一项分析发现，在大约2800家外国制造厂中，FDA只检查了其中的6%，其中只有3%的印度制造商接受了检查。¹⁰

    In many respects, China presents a more dangerous situation than India. Between fiscal years (FY) 2020 and 2022, the FDA conducted only 40 inspections in China as compared to 131 inspections in FY 2019 alone.11 On January 8, 2023, the Government of China ended its requirement that international arrivals quarantine for two weeks upon entry to the country.12 However, the FDA only began in-person inspections in China in April 2023.

 在许多方面，中国的情况比印度更加危险。在2020至2022财年期间，FDA仅在中国进行了40次检查，而2019财年进行了131次检查。¹¹ 2023年1月8日，中国政府终止了国外人员入境后隔离两周的要求。¹²然而，FDA于2023年4月才开始在中国进行现场检查。

    Moreover, there have been recent, troubling political developments in China that the Committee believes may jeopardize the viability of the FDA’s in-person inspections there. Last month, 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.”13 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. 14 Authorities have already raided the offices of companies that specialize in collecting market information in China and detained employees. 15

此外，国会认为，中国最近出现了令人不安的政治事态发展，可能会影响FDA在那里进行的现场检查。上个月，执政的中国共产党宣布重新解释其已经颁布的《国家安全法》，将该法的范围扩大到国家机密之外，涵盖“与……国家利益有关的数据、材料或物品”。¹³该法的新解释非常广泛，包括官方认为符合国家利益的情况。¹⁴当局已经突击搜查了专门收集中国市场信息的办公室，并扣留了员工。¹⁵

Accordingly, to assist the Committee in our oversight, please respond to the following questions by August 1, 2023:

因此，为了帮助国会会进行监督，请在2023年8月1日之前回答以下问题：

Foreign Inspections Generally

国外检查概述

1. 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.16 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 oncompliant 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.

1.《CARES法案》第3112（e）条赋予FDA额外的权力，要求FDA 2023年5月9日给国会的信中指出，只有44%的机构向FDA报告了所需的数据。¹⁶根据FDA的回复，不符合规定的API和成品配方奶粉机构位于美国境外的比例很高。FDA针对不符合CARES法案报告要求的外国机构采取了多少监管行动？提供因违规而受到处罚的所有外国设施的清单。在您的回复中包括对FDA所采取行动的详细描述。

2. 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.

2.FDA通过制造商遵守现行良好生产规范（CGMP）来确保药品和其他药品的质量。《食品和药物管理局安全与创新法案》（FDASIA，P.L.112-144）包含了一些条款，使FDA能够更深入地了解赋形剂、API和成品的原始来源。具体而言，第703条要求药品制造商确定所有参与药品辅料生产的机构的名称和生产地点，而第711条修订了CGMP法规，要求对药品生产的任何原材料的生产进行监督。FDA在其最近关于供应链信息的额外授权请求中表示，尽管这些规定提供了此类授权，但其目前无法获得API和其他药物赋形剂的最终来源。

a. 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?

a.鉴于其在FDASIA下的权限，为什么FDA认为其不了解API和药物原材料的来源？

b. 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?

b.详细解释FDA如何处理根据第703条和第711条收到的信息。作为您回复的一部分，请解释根据第703节和第711节收到的数据是如何告知FDA的外国检查计划和药品短缺应对工作的？

3. 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.

3.国防部是否就独立测试其购买的仿制药的质量和安全性的决定咨询了FDA？如果是，请提供与咨询相关的通信和文件。

4. Has the FDA considered a plan to end preannounced inspections of foreign manufacturing facilities? If no, explain in detail why not? If yes, provide copies of any such plans.

4.FDA是否考虑过终止对外国生产设施预先通知的检查的计划？如果没有，请详细解释为什么不这样做？如果是，请提供任何此类计划的副本。

5. How many FDA inspectors are currently conducting domestic inspections?

5.目前有多少FDA检查员正在进行国内检查？

6. How many FDA inspectors are currently conducting foreign inspections? Include in your response how many of these inspectors are operating in each country.

6.目前有多少FDA检查员正在进行外国检查？在你的答复中包括每个国家有多少这样的检查员在工作。

7. How many positions are currently open for foreign inspections? Include in your response what country the open position is for and how long the position has been unfilled.

7.目前有多少职员可供外国检查？在你的回复中包括空缺职位所在的国家和职位空缺的时间。

8. The FDA has noted there is a backlog in conducting foreign inspections. How large is the backlog and what progress has the FDA made in closing it? Include in your response a complete list of the foreign facilities in the backlog.

8.FDA注意到，在进行外国检查方面存在积压工作。积压的工作有多少？FDA在解决积压工作方面取得了哪些进展？在您的回复中包括积压的外国设施的完整列表。

9. In the last 10 years, for each year, what percent of FDA inspections of foreign facilities have been preannounced and what was the lead time given for each preannounced inspection?

9.在过去10年中，每年FDA对外国设施的检查中有多少是预先通知的，每次预先通知检查的准备时间是多少？

10. In the last 10 years, for each year, what percent of the FDA’s inspections of U.S. domestic facilities have been preannounced and what was the given lead time was given for each preannounced inspection?

10.在过去的10年里，每年，FDA对美国国内设施的检查中有多少是预先通知的，每次预先通知检查的准备时间是多少？

Inspections in India

印度的检查

11. Explain in detail why the FDA ended the unannounced inspection pilot program conducted in India between 2014 to 2015.

11.详细解释为什么FDA终止了2014年至2015年间在印度进行的突击检查试点项目。

12. Does the FDA plan to reinstate the unannounced inspection program in India? If not, explain in detail why not.

12.FDA是否计划恢复在印度的突击检查计划？如果没有，请详细解释为什么没有。

13. For foreign facilities in India that have received a Warning Letter in the last 10 years, provide a list of which of these facilities have been inspected in-person, inspected remotely, or not inspected at all since the Warning Letter was issued.

13.请提供一份对于在过去10年中收到警告信的印度外国设施的清单，并说明自发出警告信以来，哪些设施已接受过现场检查、远程检查或根本未接受检查。

14. In the last 10 years, how many times has a foreign manufacturer in India been inspected and had their Warning Letter lifted before the FDA investigator filed a report, allowing the company to get approval for a drug shortage product or its abbreviated new drug application (ANDA)? Provide a list of these companies, dates of approval, and the product that was approved.

14.在过去10年中，在FDA调查员提交报告，允许该公司获得药物短缺产品或其缩写新药申请（ANDA）的批准之前，印度制造商接受了多少次检查并解除了警告？请提供这些公司的列表、批准日期和批准的产品。

15. As early as November 2022, the FDA was aware of significant, repeated quality control failures at Intas Pharmaceuticals’ Ahmedabad, India manufacturing facility. At the time, this facility was one of only five finished product manufacturers supplying the U.S. market with chemotherapy drugs carboplatin and cisplatin.17 Intas voluntarily stopped operations at its Ahmedabad plant in response to quality control failures on June 5, 2023.

15. 早在2022年11月，FDA就意识到在Intas Pharmaceuticals’ Ahmedabad的生产设施存在重复的质量管理问题。当时，该工厂是仅有的五家向美国市场供应化疗药物卡铂和顺铂的成品制造商之一。¹⁷  Intas为解决质量管理问题，于2023年6月5日主动暂停该设施的生产。

During a June 9, 2023, briefing with Congressional staff on cancer drug shortages the FDA stated that it was not aware of the company’s plans to halt operations at its Ahmedabad, India, manufacturing facility until after the plant had shut down operations. This lapse in communication is concerning, as the FDA was ostensibly aware of the ongoing quality issues at the plant, as well as Intas’ significant U.S. market share for cisplatin and carboplatin and the disruption a plant closure would cause in the supply of these drugs.

在2023年6月9日与国会工作人员就癌症药物短缺问题举行的简报会上，FDA表示，在该工厂关闭运营之前，它不知道该公司计划停止其印度艾哈迈达巴德制造厂的运营。这种沟通失误令人担忧，因为FDA表面上意识到该工厂持续存在的质量问题，以及Intas在顺铂和卡铂方面在美国的巨大市场份额，以及工厂关闭将导致这些药物供应中断。

It is important for the Committee to understand exactly how and when the FDA was made aware of Intas’ plans to voluntarily halt operations at its Ahmedabad facility. Explain in detail and provide copies of any communications between the FDA and Intas Pharmaceuticals from January 2023 through June 2023 related to the company’s decision to voluntarily halt production at the Ahmedabad plant closure.

国会必须准确了解FDA是如何以及何时得知Intas计划自愿停止其艾哈迈达巴德工厂的运营的。详细解释并提供2023年1月至2023年6月期间FDA和Intas Pharmaceuticals之间与该公司决定自愿停止艾哈迈达巴德工厂关闭生产有关的任何通信的副本。

Inspections in China

中国的检查

16. What is the FDA’s plan to ensure that inspections in China can continue despite the expanded scope of China’s National Security Law? Provide copies of any analysis or relevant documentation related to China’s National Security Law and its implications for FDA’s foreign drug inspection program and drug safety.

    16.尽管中国的《国家安全法》扩大了范围，FDA有什么计划来确保仍能继续在中国进行检查？请提供就中国《国家安全法》对FDA外国药品检验计划和药品安全有影响的任何资料或相关文件的副本。

17. What actions will the FDA take in response to an inspector being detained, arrested, or otherwise prevented from completing an inspection of a drug anufacturing facility in China?

17.对于检查员被扣押、中止或以其他方式阻止完成对中国药品生产设施的检查，FDA将采取什么行动？

18. Has an FDA inspector even been detained, arrested, or otherwise prevented from completing an inspection of a drug manufacturing facility in China?

18.FDA检查员是否被扣押、中止或以其他方式阻止完成对中国药品生产设施的检查？

19. Provide copies of all communications between the FDA and the Government of China regarding in-person inspections of drug manufacturing facilities in China from January 2020 to the present.

19.请提供2020年1月至今FDA与中国政府之间关于现场检查中国药品生产设施的所有通信副本。

20. Does the FDA plan to start an unannounced inspection program in China? If not, explain in detail why not. If yes, provide copies of any such plans.

20.FDA是否计划在中国启动一项突击检查计划？如果没有，请详细解释原因。如果有，请提供任何关于此计划的副本。

21. For facilities in China that have received a Warning Letter in the last 10 years, provide a list of which of these facilities have been inspected in-person, inspected remotely, or not inspected at all since the Warning Letter was issued.

21.请提供一份在过去10年内收到警告信的中国企业的清单，列出自发出警告信以来，哪些企业已接受过现场检查、远程检查或根本未接受检查。

22. In the last 10 years, how many times has a foreign manufacturer in China been inspected and had their Warning Letters lifted before the FDA investigator filed a report, allowing the company to get approval for a drug shortage product or its ANDA? Provide a list of these companies, dates of approval, and the product that was approved.

22.在过去10年中，在FDA调查员提交报告，允许该公司获得药品短缺产品或其ANDA的批准之前，中国制造商接受了多少次检查并解除了警告信？提供这些公司的列表、批准日期和批准的产品。

Please be advised that intentional misstatements or omissions in response to the above questions may constitute federal criminal violations under 18 U.S.C. §1001. In addition, the Committee believes that interviews from FDA officials and employees about this matter may be necessary.

请注意，根据《美国法典》第18卷第1001节，谎报或漏报上述问题可能构成联邦刑事违法行为。此外，国会认为，可能有必要就上述问题与FDA官员和雇员进行面谈。

Finally, this letter serves as a formal request to preserve all existing and future records and materials in the FDA’s possession relating to the topics addressed in this letter. You should construe this preservation notice as an instruction to take all reasonable steps to prevent the destruction or alteration, whether intentionally or negligently, of all documents, communications, and other information, including electronic information and metadata, that are or may be responsive to this congressional inquiry. This instruction includes all electronic messages sent

using official and personal accounts or devices, including records created using text messages, phone-based message applications, or encryption software.

最后，本函要求提供FDA持有的与本函所述内容相关的所有现有和未来的记录以及材料。您应将本函理解为将采取一切合理措施，防止故意或疏忽地破坏或更改所有文件、通信和其他信息，包括电子信息和元数据，这些信息是或可能是对本国会调查的回复。以上说明包括使用官方和个人账户或设备发送的所有电子信息，包括使用短信、基于电话的信息应用程序或加密软件创建的记录。

If you have any questions, please contact John Strom with the Majority Committee staff at (202) 225-3641. Thank you for your attention to this request.

如果您有任何问题，请致电（202）225-3641与国会工作人员John Strom联系。感谢您对这一请求的关注。

Cathy McMorris Rodgers       

主席

能源和商业委员会

Brett Guthrie

主席

健康委员会

H. Morgan Griffith

主席

调查委员会

CC：

Frank Pallone Jr.，能源和商业委员会高级成员

Anna Eshoo，健康小组委员会资深成员

Kathy Castor，监督和调查小组委员会高级成员

文献：

1 Examining the Root Causes of Drug Shortages: Challenges in Pharmaceutical Drug Supply Chains: Hearing Before the Subcomm. on Oversight & Investigation of the H. Comm. on Energy & Commerce, 118th Cong. (May 11, 2023); Preparing for and Responding to Future Public Health Security Threats: Hearing Before the Subcomm. on Health of the H. Comm. on Energy & Commerce, 118th Cong. (May 11, 2023).

2 Joseph Keenan, FDA to Allow Temporary Overseas Production to Shore up Supplies of Chemo Drug, Fierce Pharma (June 6, 2023), https://www.fiercepharma.com/manufacturing/fda-allow-temporary-overseas-production

shore-supplies-chemo-drug.

3 Preparing for and Responding to Future Public Health Security Threats: Hearing Before the Subcomm. on Health of the H. Comm. on Energy & Commerce, 118th Cong. (May 11, 2023).

4 Drug Shortages Task Force, U.S. Food & Drug Admin., Drug Shortages: Root Causes and Potential Solutions (2019), https://www.fda.gov/media/131130/download.

5 Anna Edney & Riley Griffin, US Military Is So Worried About Drug Safety It Wants to Test Widely Used Medicines, Bloomberg (June 7, 2023), https://www.bloomberg.com/news/articles/2023-06-07/drug-safety-fearsspur-pentagon-plan-to-test-widely-used-meds#xj4y7vzkg.

6 U.S. Gov’t Accountability Office, GAO-22-103611, Drug Safety: FDA Should Take Additional Steps to Improve Its Foreign Inspection Program (2022), https://www.gao.gov/products/gao-22-103611.

7 Id.

8 Sidley, Proposed Bill Seeks to Eliminate Preannounced Foreign Drug Inspections, Sidley (Jan. 31, 2022), https://www.sidley.com/en/insights/newsupdates/2022/01/proposed-bill-seeks-to-eliminate-preannounced-foreigndrug-inspections.

9 Securing the U.S. Drug Supply Chain: Oversight of FDA’s Foreign Inspection Program: Hearing Before the Subcomm. on Oversight & Investigation of the H. Comm. on Energy & Commerce, 116th Cong. (Dec. 10, 2019), https://www.govinfo.gov/content/pkg/CHRG-116hhrg44495/html/CHRG-116hhrg44495.htm.

10 Irena Hwang, After Pandemic Delays, FDA Still Struggling to Inspect Foreign Drug Manufacturers, ProPublica (Apr. 19, 2023), https://www.propublica.org/article/fda-drugs-medication-inspections-china-india-manufacturers.

11 Baker McKenzie, United States: With China’s Re-Opening: Staying Ahead of FDA Drug cGMP Enforcement, Lexology (Feb. 3, 2023), https://www.lexology.com/library/detail.aspx?g=f20c187f-db67-4a97-8d96- b9b0a665f33c.

12 U.S. Mission China, COVID-19 Information, U.S. Embassy & Consulates in China (Jan. 27, 2023),

https://china.usembassy-china.org.cn/covid-19- information/#:~:text=Quarantine%20Information,international%20arrivals%20entering%20the%20PRC.

13 Chun Han Wong & Dan Strumpf, China Spy Law Adds to Chilling Effect of Detentions, Wall St. J. (Apr. 27, 2023), https://www.wsj.com/articles/chinas-expanded-spy-law-adds-to-chilling-effect-of-detentionsce8cea1a?mod=article_inline; see also Jeremy Daum, Bad as It Ever Was: Notes on the Espionage Law, China Law Translate (Feb. 05, 2023), https://www.chinalawtranslate.com/en/bad-as-it-ever-was-notes-on-the-espionage-law/.

14 Wenxin Fan, China Detains Japanese Employee from Drugmaker Astellas, Wall St. J. (Mar. 27, 2023),

https://www.wsj.com/articles/china-detains-japanese-employee-from-drugmaker-astellas

abb01d27?mod=article_inline.

15 Nathaniel Taplin, Beijing’s Bain Raid, Espionage Law Are Self-Sabotage, Wall St. J. (Apr. 28, 2023),

https://www.wsj.com/articles/beijings-bain-raid-espionage-law-are-self-sabotage-40f87276?mod=article_inline;

Yoko Kubota & Miho Inada, In China, a Detention and a New Espionage Law Have Businesses Worried, Wall St. J. (Apr. 28, 2023), https://www.wsj.com/articles/in-china-a-detention-and-a-new-espionage-law-have-businesses

worried-78fc88b1?mod=article_inline.

16 Letter from Hon. Robert Califf, FDA Commissioner, to Hon. Cathy McMorris Rodgers, Hon. Morgan Griffith, and Hon. Brett Guthrie (May 9, 2023) (on file with Committee).