News

Oversight & Investigations Updates


Jul 25, 2024
Press Release

E&C Republicans Press HHS and NIH over Withheld Documents About Risky MPVX Experiment at NIAID, Threaten Subpoena

Washington, D.C. — In a new letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra and National Institutes of Health (NIH) Director Monica Bertagnolli, 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) requested documents and transcribed interviews related to an approved MPVX experiment.  The letter comes after the Committee released an interim staff report on the experiment as well as an NIH reform framework . It notes that a failure to produce the requested documents by August 8, 2024, may lead to issuance of a subpoena to compel compliance. HHS and the NIH continue to withhold critical documents requested by the Committee last year.  KEY EXCERPT :  “For nearly a year and a half, the Department of Health and Human Services (HHS), the NIH, and NIAID misled the Committee. Both HHS and the NIH told us a risky MPXV research proposal at the NIAID had not been “'formally proposed' or 'planned' when in fact this project was submitted and received approval before the NIH’s Institutional Biosafety Committee (IBC) on June 30, 2015, as documented in written meeting minutes. The misleading statements were included in the following communications to the Committee:  Letter from the HHS Assistant Secretary for Legislation dated April 26, 2023.  Letter from Dr. Bernard Moss to Chair Rodgers, dated June 30, 2023.  Written statements presented at the September 21, 2023, meeting between Committee staff and NIH/NIAID officials from Dr. Bernard Moss, Dr. Steven Holland, NIAID Director of the Division of Intramural Research, and Jeffery Potts, Chief of the Biorisk Management Branch within the NIH Division of Occupational Health and Safety.  “This deception is unacceptable and has led the Committee to conclude that NIAID cannot be trusted to oversee its own research of pathogens or determine whether an experiment poses enhanced risks of a potential pandemic or other serious public health outbreak.”  [...] “NIAID’s lack of candor to this point suggests that it cannot be trusted to oversee the research projects that it funds. Therefore, this Committee will explore policy options to address this inherent conflict of interest and lack of transparency.”  ADDITIONAL BACKGROUND :  A new strain of MPXV has recently emerged that increases the risk of this disease causing a major public health outbreak or a potential pandemic. Since January, the Democratic Republic of the Congo has reported more than 4,500 suspected mpox cases and nearly 300 deaths, numbers that have roughly tripled from the same period last year, according to the World Health Organization.  Congo recently declared the outbreak across the country a health emergency. An analysis of hospitalized patients suggests recent genetic mutations are the result of continued transmissions in humans.  CLICK HERE to read the letter.



Jul 25, 2024
Press Release

E&C Republicans Open Inquiry into NTIA’s Online Domain Name Registry Contracts Ahead of Renewal

Washington, D.C. — In a new letter to the National Telecommunications and Information Administration, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Communications and Technology Chair Bob Latta (R-OH), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) requested information about the agency’s internet domain name registry agreement with Verisign, Inc. (Verisign). BACKGROUND :  The NTIA represents the United States government on the Governmental Advisory Committee of the Internet Corporation for Assigned Names and Numbers (ICANN), the multi-stakeholder, not-for-profit entity that was founded in 1998 to coordinate the Internet domain name system, among other Internet management-related activities. Since 2001, Verisign has operated the .com and .net domain name registries.   Verisign manages the .com registry under two agreements—a .com Registry Agreement between ICANN and Verisign and a Cooperative Agreement between the NTIA and Verisign.  Both of these agreements are in place through November 30, 2024.  As the expiration dates of these agreements approach, some have suggested that the NTIA should reassess certain aspects of both agreements.   Under the Cooperative Agreement’s terms, it will automatically renew on November 30, 2024, unless Verisign provides written notice of non-renewal within 120 days of its expiration.   The Department of Justice has previously recommended ICANN hold a competitive bidding process for renewals of registry agreements.   The current agreement, as amended, has allowed Verisign, with ICANN’s agreement, in each of the last four years of every six-year contract period, to increase the maximum price Verisign charges for yearly registration or renewal of a .com name by up to seven percent over the maximum price it charged in the previous year.   Verisign has since instituted a price increase of the maximum amount in every year it was allowed to do so.   KEY LETTER EXCERPT :  “With both a role in advising ICANN and as a party to the Cooperative Agreement, the NTIA bears responsibility for supporting a domain name system that enables the growth of online commerce. Both individual consumers and businesses depend on responsible management of the .com system. Monopolistic elements and excessive domain name price increases stifle the ability of potential .com registrants to conduct business online.  “As such, we seek more information about the NTIA’s process in considering the renewal of both the Registry Agreement and the Cooperative Agreement.”  CLICK HERE to read the letter. 



Jul 25, 2024
Press Release

Bipartisan E&C Leaders Press WADA President for Additional Information About its Failure to Penalize Chinese Swimmers Who Failed Drug Doping Tests

Letter comes on the eve of athletes competing in the Paris Olympics and after WADA’s President refused to attend an Energy and Commerce Committee oversight hearing Washington, D.C. — In a new letter to World Anti-Doping Agency (WADA) President Witold Banka, bipartisan House Energy and Commerce Committee leaders pressed for answers regarding WADA’s handling of positive doping cases within China’s national swimming team ahead of the Tokyo Olympics. The letter contains questions that bipartisan Committee Members would have asked during a recent Subcommittee on Oversight and Investigations hearing , which Mr. Banka was invited to attend but refused to appear. Witnesses that did testify at the hearing included: Michael Phelps, American swimmer and Olympic gold medalist   Allison Schmitt, American swimmer and Olympic gold medalist   Travis Tygart , Chief Executive Officer, United States Anti-Doping Agency (USADA) KEY EXCERPTS:   “We write today to express our sincere disappointment at your refusal to accept our invitation to attend and provide testimony at our recent Subcommittee hearing. Members of Congress have important questions for the World Anti-Doping Agency (WADA) and are especially concerned about recent reports of your handling of dozens of cases of doping within the Chinese swimming team.  “WADA purports to maintain the integrity of sports by creating a fair and competitive sporting environment free from doping. As a U.S. taxpayer supported entity, WADA has a responsibility to the American people to ensure this integrity by enforcing international testing requirements. We believe WADA has fallen short of this important mission. ”  [...]   “ We are particularly concerned with the excessive deference being extended toward CHINADA—a state-funded operation with leadership deeply intertwined with the Chinese Communist Party (CCP), as current [Chinese Anti-Doping Agency] CHINADA director Li Zhiquan also serves as a Committee Secretary for the CCP. At a meeting in 2023, Zhiquan called on CHINADA employees to be 'loyal to the party' and to 'hold high the great banner of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era.' Furthermore, WADA’s reported sponsorship arrangement with ANTA Sports—the Chinese athletic company sponsoring the Chinese Olympic Committee and China’s national swimming federation—could be perceived as a conflict of interest. Since WADA is expected to uphold and maintain international anti-doping standards, WADA’s apparent lack of skepticism and failure to enforce the rules against CHINADA is troubling. While we are aware that WADA has opened an investigation, we are concerned that international scrutiny was necessary to force due diligence that should be routine .”  [...]  “This incident unfortunately reinforces our concern that WADA appears to be reverting to its previous poor management practices.”  [...]  “With the Paris Summer Olympic Games Opening Ceremony just a day away , the Committee seeks to better understand the circumstances surrounding WADA’s decision not to appeal the decision to clear the twenty-three swimmers who tested positive for trimetazidine.”   BACKGROUND :  In January 2021, 23 Chinese swimmers (“23 swimmers”) tested positive for trimetazidine, or TMZ, a banned substance improperly used to increase stamina and hasten recovery times.  Three months after the positive tests, CHINADA initiated an investigation into the source of the TMZ and by June 2021 claimed the athletes ingested the banned substance through food tainted in a hotel kitchen.  According to reporting, Chinese investigators “offered no explanation […] for how a prescription drug available only in pill form had contaminated an entire kitchen.”  In reliance on “external legal advice” and its science department, WADA determined that CHINADA’s claims were “plausible” and chose not to appeal the decision or further investigate the matter.  Three of these Chinese swimmers went on to win gold medals at the Tokyo Olympic Games in July of 2021.  China has selected 11 swimmers that tested positive for TMZ before the Tokyo Games to compete in the upcoming Paris Games.  In a strikingly similar case, Kamila Valieva, a Russian figure skater, also tested positive for the banned substance TMZ during the 2022 Beijing Olympics.  The Russian Anti-Doping Agency (RUSADA) issued a provisional suspension but was quickly cleared by RUSADA’s discipline board, since Valieva claimed she ingested the substance by mistake through a contaminated source.  Rather than simply accept RUSADA’s contamination explanation, WADA appealed the decision and ultimately, Valieva received a four-year ban from competition and was retroactively stripped of her gold medal. The letter was signed by Committee Chair Cathy McMorris Rodgers (R-WA) and Committee Ranking Member Frank Pallone, Jr., (D-NJ), Subcommittee on Innovation, Data, and Commerce Chair Gus Bilirakis (R-FL) and Ranking Member Jan Schakowsky (D-IL), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) and Ranking Member Kathy Castor (D-FL). CLICK HERE to read the full letter.



Rodgers, Comer, House GOP Committee Leaders Demand Federal Agencies Adhere to Recent Chevron Reversal

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Oversight and Acoountability Committee Chair James Comer (R-KY) sent letters to eight federal agencies today following the recent Supreme Court decision on Loper Bright Enterprises v. Raimondo , in which the court overruled Chevron deference. Science, Space, and Technology Committee Chair Frank Lucas (R-OK) and House Agriculture Committee Chair GT Thompson (R-PA) joined Chairs Rodgers and Comer on an additional letter sent to the Environmental Protection Agency. KEY LETTER EXCERPT: “We write to call to your attention Loper Bright Enterprises v. Raimondo, a recent Supreme Court decision that precludes courts from deferring to agency interpretations when the statutes are ambiguous. In its decision, the Court explicitly overruled Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), which required deference to agency interpretations of ambiguous statutes. By allowing such deference, the Court in Chevron enabled the ‘Administrative State’ to usurp the legislative authority that the Constitution grants exclusively to Congress in Article I. The Chevron decision led to broader, more costly and more invasive agency regulation of Americans’ lives, liberty, and property.   “Perhaps no administration has gone as far as President Biden’s in issuing sweeping Executive edicts based on questionable assertions of agency authority. The Biden administration has promulgated far more major rules, imposing vast costs and paperwork burdens, than either its most recent predecessors. Many of these rules...have been based on overreaching interpretations of statutes enacted by Congress years ago, before the issues now regulated were even imagined.   “The expansive Chevron deference has undermined our system of government, creating an unaccountable Administrative State. Thankfully, the Court has now corrected this pattern, reaffirming that ‘[i]t is emphatically the province and duty of the judicial department to say what the law is.’ Given the Biden administration’s record of agency overreach, we are compelled to underscore the implications of Loper Bright and remind you of the limitations it has set on your authority.”   CLICK HERE to read the letter to the Environmental Protection Agency. CLICK HERE to read the letter to the Federal Communications Commission.  CLICK HERE to read the letter to the Consumer Product Safety Commission.  CLICK HERE to read the letter to the Federal Trade Commission.  CLICK HERE to read the letter to Department of Commerce.   CLICK HERE to read the letter to the Department of Energy.  CLICK HERE to read the letter to the Federal Energy Regulatory Commission.  CLICK HERE to read the letter to the Nuclear Regulatory Commission.  CLICK HERE to read the letter to the National Highway Transportation and Safety Administration.



Jul 9, 2024
Press Release

E&C Leaders Open Investigation into NTIA’s IIJA BEAD Funding Deployment, Citing Abnormal Lack of Transparency and Allegations of Rate Regulation

Washington, D.C. — In a new letter to the National Telecommunications and Information Administration (NTIA), House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Communications and Technology Chair Bob Latta (R-OH), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) requested all communications between the agency and state broadband offices related to Broadband Equity, Access, and Deployment (BEAD) Initial Proposals. The letter comes amid concerns that NTIA is unlawfully pressuring states to rate regulate low-cost broadband plans required by the BEAD Program and following a May 15, 2024, hearing at which Assistant Secretary of Commerce for Communications and Information Alan Davidson committed to being more transparent about BEAD funding decision making.  KEY EXCERPT :  “Based on anecdotal evidence from different entities involved in the process, it appears that the NTIA may be evaluating initial proposals counter to Congressional intent and in violation of the law. Several Members of Congress have directly raised to you that the NTIA, through its review of initial proposals, is unlawfully regulating the rate of broadband through BEAD’s low-cost service option in direct conflict with the IIJA, which states: ‘Nothing in this title may be construed to authorize the Assistant Secretary or the National Telecommunications and Information Administration to regulate the rates charged for broadband service.’9 During Senate floor debate on the IIJA, Members of Congress agreed that this language meant that ‘no rate regulation of broadband services would be authorized or permitted by the NTIA or the Assistant Secretary who leads the NTIA as part of the state broadband grant program.’” “States have reported that the NTIA is directing them to set rates and conditioning approval of initial proposals on doing so. This undoubtedly constitutes rate regulation by the NTIA. Indeed, one state publicly posted the NTIA’s feedback that the agency would not approve their initial proposal without ’an exact price or formula’ for the state’s low-cost option. Without visibility into the approval process, Congress in unable to determine how widespread this practice is. When asked about this at oversight hearings, your responses have failed to provide clarity.”  BACKGROUND:  Congress appropriated an unprecedented $42.45 billion through the Infrastructure Investment and Jobs Act (IIJA) for the NTIA to administer the BEAD program.   The program was intended to ensure that all Americans, specifically those in unserved or underserved areas, have access to broadband.   The NTIA is responsible for managing and distributing this money to the states and territories.  The IIJA prohibits the NTIA from rate regulation.  The IIJA established a process for how states receive money from the NTIA for this program.   First, each of the 56 individual states and territories (state entities) were required to submit an Initial Proposal explaining their proposed process for awarding the funds.   The NTIA was then tasked with reviewing and approving each individual states entities’ proposal, after which funds would be allocated to the state to award.   Some states report that the NTIA is conditioning approval of their Initial Proposals on setting a specific price for low-cost broadband plans despite the prohibition on rate regulation.  Despite every state entity having submitted their initial proposals by the December 27, 2023, deadline, the NTIA has only approved 16 initial proposals as of the date of this letter.   Due to the opaque nature of the NTIA’s review and approval process, the Committee lacks the information necessary to assess whether NTIA is pressuring states to rate regulate and to understand why so few state entities initial proposals have been approved to move forward.  CLICK HERE to read the full letter to Assistant Secretary Davidson. 



Jun 28, 2024
Press Release

Chair Rodgers Statement on SCOTUS Ruling to Restore Article I Power

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.” 



Jun 25, 2024
Hearings

Chair Rodgers Opening Remarks at Hearing on Anti-Doping Measures Ahead of the 2024 Olympics

Washington D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) delivered the following opening remarks at today’s Oversight and Investigations Subcommittee hearing titled “Examining Anti-Doping Measures in Advance of the 2024 Olympics.”  “Thank you, Chair Griffith, and thank you to our highly decorated panel of witnesses whose Olympic careers have inspired an entire generation of Americans.  “Tonight’s hearing comes at an important moment as we are just one month away from the start of the 2024 Summer Olympic games in Paris.  “We will be examining how the World Anti-Doping Agency’s polices—and their failure to enforce those policies—on the use of banned performance enhancing drugs and how that is undermining the integrity of the Olympic games.”  WADA REFUSES ACCOUNTABILITY   “It is completely unacceptable that World Anti-Doping Agency President Witold Banka, whose agency received over three million in U.S. taxpayer dollars this past year, declined to join us tonight.  “Doping scandals have real effects on our athletes, including American swimmers, who must abide by the strictest anti-doping standards enforced by USADA, and include requirements like random testing.  “These anti-doping standards should be applied evenly to ensure a level playing field and that the best athlete wins.”  CHINESE DOPING SCANDAL “Recent reporting unveiled that just weeks before the 2021 Olympic games in Tokyo, 23 members of the Chinese swimming team tested positive for a banned substance—Trimetazidine or TMZ.   “The Chinese authorities dismissed the positive tests, telling the World Anti-Doping Agency this was all a mistake because the banned drug—which is found only in pill form—somehow ended up in the kitchen of a hotel that all 23 swimmers were staying at, and they all somehow unknowingly ingested this banned substance.  “The World Anti-Doping Agency’s review somehow concluded this explanation was plausible and no further investigation was necessary.  “It’s important to note that those swimmers won several medals, including three golds.  “WADA has consistently failed to be transparent or accept any responsibility for its actions.  “And it’s not just the US Congress.  “WADA also declined a hearing invitation from the German Bundestag that was scheduled earlier this month.    “How many more Olympic athletes have to lose out on winning medals and proudly singing their country’s national anthem before the World Anti-Doping Agency decides to enforce its rules uniformly?  “Everyone watching the Olympics in Paris and in their homes next month should know that the system is not rigged against athletes who compete the right way.  “I look forward to hearing from all of you on this important topic.” 



Jun 25, 2024
Hearings

Chair Griffith Opening Remarks at Hearing on Anti-Doping Measures Ahead of the 2024 Olympics

Washington D.C. —  House Energy and Commerce Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA) delivered the following opening remarks at today’s subcommittee  hearing  titled “Examining Anti-Doping Measures in Advance of the 2024 Olympics.”  UPHOLDING THE INTEGRITY OF THE OLYMPICS   “As U.S. athletes prepare to compete in the Paris Olympics, a cloud of uncertainty hangs over the reliability of international anti-doping enforcement which is supposed to eliminate the use of certain performance enhancing drugs.  “This Committee has been alarmed to learn from news reports that several swimmers representing the People’s Republic of China tested positive for banned performance enhancing substances and then went on to compete in the 2021 Tokyo Olympics.  “Just last week, eleven of these swimmers were again named to the People’s Republic of China’s 2024 Olympic team. All of this comes after the World Anti-Doping Agency, or WADA, ignored signs of systemic Russian doping for years.  “Seven years ago, this Oversight subcommittee, held a hearing on ways to strengthen the international anti-doping system. It is unfortunate that we are here again.  “Two witnesses from that 2017 hearing are back with us today—premier Olympian, Mr. Michael Phelps and the CEO of the United States Anti-Doping Agency, or USADA, Mr. Travis Tygart.  “We are also pleased to welcome another outstanding Olympic swimmer, Ms. Allison Schmitt, to join us today so we can revisit doping in sports ahead of next month’s Summer Olympics. “I want to start off by reminding everyone of what Mr. Phelps told us seven years ago, because it bears repeating. “He said ‘if we allow our confidence in fair play to erode, we will undermine the power of sport and the goals and dreams of future generations. The time to act is now.’  “I’m glad Mr. Phelps highlighted the damage performance enhancing drugs has on our country’s youth athletes and am disappointed that WADA has not seemed to heed that call.” THE IMPORTANCE OF A LEVEL PLAYING FIELD   “Children join sports teams and clubs believing that the system is mostly fair and that cheaters will be punished.  “The importance of sports for our country’s children cannot be understated.  “Sports empower children by teaching them life lessons, building their confidence, showing them the meaning of hard work, and offering some of them opportunities to represent our country and make a career. “I myself have had the opportunity to see my own children grow and learn from competitive swimming.   “In fact, this last week was very exciting in my household, because one year ago, in high school regionals, my son competed against Olympian Thomas Heilman, who at age 17, is the youngest male swimmer to qualify for Team USA since Michael Phelps.  “The joke at my house was, that, at one point in the race they were tied, that would be the part where the starter says, 'take your mark.’  “Foundational to the Olympics is the trust that clean athletes, both aspiring and current Olympians, have in the system to keep cheaters out.   “Doping leads to cynicism in sports and inevitable disappointment for aspiring athletes. “As I’m sure Ms. Schmitt and Mr. Phelps can attest to, we cannot overemphasize the dedication, sacrifices, and training required of our Olympians, competing at the very highest, and what I believe to be the most prestigious, athletic level. “Youth athletes dedicate themselves by putting in countless hours of training, pushing both physical and mental limits in the hopes of one day being an Olympian.   “Athletes miss birthdays and holidays to train so that they can achieve success the right way, on their merit.  “Mr. Phelps has previously said he didn’t take a single day off for over a five-year period, just so he could be the best at what he does.  “Doping irrevocably undermines the purpose of that sacrifice by allowing competitors who really want all the glory without putting in as much work.  “Is it fair that we encourage our youth to invest so much of their time if on the greatest stage consequences are not expected for certain countries’ athletes?”  WADA MUST IMPROVE TRANSPARENCY   “That is why I am disappointed that Mr. Banka, the President of WADA, refused our invitation to testify before this Subcommittee today to discuss his role in upholding the integrity of anti-doping testing and enforcement in international sports competitions.  “WADA received nearly four million in taxpayer dollars through Congress last fiscal year. Their refusal to appear today calls into question their commitment to accountability and perhaps if they’re not going to do their job, should we even fund them?  “Mr. Banka and WADA have hidden today rather than explain how WADA let over twenty swimmers representing the People’s Republic of China compete in international competitions after they all tested positive for a banned substance.  “Cheating athletes take away spots and medals from clean athletes.  “The integrity and sanctity of sports is critical for the Olympians competing but also for the children who dream one day to be an Olympian.  “We will keep a seat open for Mr. Banka in case he decides to join us.  “I want to thank the three of you who made it here today despite your very busy schedules ahead of the Paris Olympics.” 



Jun 24, 2024
Press Release

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

Washington, D.C. — In a new letter to Food and Drug Administration (FDA) Commissioner Robert Califf, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) are pressing for more information regarding the agency’s foreign drug inspection program. The letter continues the Committee’s investigation into FDA inspection practices, which include a July 18, 2023, letter , a December 13, 2023, letter , and a February 6, 2024, oversight hearing at which the FDA declined to make an official available to testify.  BACKGROUND :  In the letter, the Members discuss the Committee’s analysis of FDA inspection outcomes in India and China from January 2014 to April 2024, limiting its review to inspectors with ten or more inspections in either China or India.   EXCERPT OF THE ANALYSIS :  “The results of this analysis were surprising, revealing tremendous variation in inspection outcomes. Some FDA inspectors found compliance issues during all or almost all of their inspections. Other inspectors rarely reported finding a single compliance issue. Two inspectors never found a single compliance issue over the course of a combined 24 inspections in India. Another inspector found zero compliance issues in 20 out of 23 inspections (85 percent) in China while finding compliance issues with almost half of domestic inspections during the same period. These are unusual inspection outcomes, the opposite of what would be expected given the widely reported failures in quality control and lack of adherence to current good manufacturing techniques by drug manufacturing facilities in China and India.  “By contrast, 16 FDA inspectors, with over 325 inspections collectively in India, found compliance issues during every inspection they conducted. As a measure of what a pattern of rigorous inspections should look like, the Committee reviewed the inspection outcomes for 3 FDA inspectors with professional reputations for thoroughness who also had at least 10 inspections in China or India during the studied time period. These expert inspectors reported finding no compliance issues during inspections in China at a rate of only 6.7 to 11.4 percent and at a rate of zero to 9.5 percent in India.”  KEY LETTER EXCERPT : “Such large variations in inspection outcomes are troubling, and they merit further investigation. At a minimum, the Committee is concerned that these findings suggest vast differences in the skill, thoroughness, and competence of FDA inspectors. The difference in inspection outcomes appears to be just another example of institutional weaknesses and dysfunction in the FDA’s foreign drug inspection program. Prior to the pandemic, media reporting found that some FDA inspectors took an inappropriately lenient approach with foreign drug manufacturers with serious compliance violations. There were also reports o f, and concerns about, foreign manufacturers attempting to bribe or improperly influence inspectors. The Committee is seriously evaluating the disturbing possibility that some of the variation in inspection outcomes could be the result of bribery or fraud.”  CLICK HERE to read the full letter.