Oversight & Investigations

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 "At What Cost: Oversight of How the IRA's Price Setting Scheme Means Fewer Cures for Patients." CRUSHING INNOVATION “In many ways, this hearing feels like déjà vu. “Just last Congress, we repeatedly warned that the Democrats’ drug pricing control scheme was going to do immense harm to patients by crushing drug innovation. “Earlier this month, President Biden named the first ten drugs that will be subjected to CMS’s price controls in a big celebration at the White House. “However, in the months and weeks leading up to President Biden’s announcement, we saw a steady stream of terrible news for patients in need of hope. “One after another, company and after company started to issue announcements that began: ‘we are discontinuing phase 1’ trials for a promising blood cancer drug’ ‘we will not launch a Phase III trial’ for a drug to treat Stargardt disease’ ‘we are now carefully considering’ whether to seek ‘a second rare disease indication’ ‘we will delay our launch’ ‘we will not be seeking a second indication’ ‘we are abandoning further investigation.’ “These announcements go on and on. “We’ve catalogued over 24 such announcements since the IRA’s passage, and, with the list of the first ten drugs finally out, there are certain to be more.” HURTING PATIENT ACCESS “Each one of these doleful announcements represents a window of hope closing: hope for many patients, families, and caregivers. “Americans rightly expect to have the earliest possible access to the most effective and innovative treatments and cures. “We are a country of believers and American biomedical innovation gives people battling a disease or illness a fighting chance at life. “This was the great bipartisan balance achieved by Hatch-Waxman. “A framework that provided incentives to make massive private sector investments in research and development while allowing for competition to drive down prices after a drug had been on the market. “Was it perfect? Of course not. Are there bad actors who abused patent protections and gamed the system? Absolutely. “But it did ensure that Americans got cutting edge treatments and cures—sometimes years before people in other developed countries that have government price controls. “I’m deeply concerned that—because of the so-called Inflation Reduction Act—the American people will not have the same fighting chance for a host of serious diseases. “Instead, they will join people in so many other countries—like the UK and Canada, where unaccountable bureaucrats—not cutting-edge science—backed with entrepreneurial initiative—dictate the value of new cures. “That’s why I’m looking forward to hearing from patient advocates and caregivers, like Mr. Crowley and Mr. John Czwartacki — individuals who are on the front lines. “And from people, like Dr. Potts who have dedicated their lives to not just researching cancer but fighting it.  “If there’s going to be a successful cancer moonshot it’s not going to be done by the National Institutes of Health or ARPA-H alone. “The bulk of the work is going to have to be done by private industry innovators. People like Dr. Potts, who spend years and billions of dollars translating basic research into lifesaving treatments.” CONSEQUENCES OF GOVERNMENT PRICE CONTROLS “This brings me back to why this hearing is so important. “Last Congress—with a bipartisan vote—this Committee stopped Speaker Pelosi’s government price controls in H.R. 3. “Then, the so-called Inflation Reduction Act was passed on a party line vote through budget reconciliation. “It short-circuited the hard bipartisan work of lowering drug prices for all Americans while preserving innovation. “Instead, Democrats passed the buck to the Secretary of HHS and CMS and gave bureaucrats virtually unlimited discretion to dictate the price of a negotiation eligible drug. “Congress’s failure to do the hard work has created a whole host of consequences. “As Chairman Griffith mentioned, the drug price negotiation program is currently being challenged in court on constitutional grounds. We will see what the courts say, but I share Chairman Griffith’s belief that, at least, parts of it will likely be found unconstitutional. “When that happens, this Committee will stand ready to do the hard work of building bipartisan solutions that lower drug prices without sacrificing innovation and America’s biomedical edge. “I thank the witnesses again.” 

Washington D.C. — House Energy and Commerce Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA) delivered the following opening remarks at today’s hearing titled: “At What Cost: Oversight of how the IRA 's Price Setting Scheme Means Fewer Cures for Patients.” PROGRESSIVE ATTACK ON DRUG INNOVATION “Today we take stock of where things stand with the drug provisions implemented in the Inflation Reduction Act . “I want to say at the outset that Congress needs to work to address high drug prices. Thankfully this Committee historically has a track record of working in a bipartisan fashion to address this issue. “But most of the medical drug pricing provisions signed into law by the Inflation Reduction Act raise serious concerns. “That legislation was ostensibly to allow negotiations for the price of Medicare drugs through the Centers for Medicare and Medicaid Services Drug Price ‘Negotiation’ Program. “This would allow government bureaucrats to so-call ‘Negotiate’ Medicare drug prices. However, the scheme as written is unconstitutional. “Recently, President Biden named the first ten prescription drugs that will be subject to this so-called ‘negotiation.’  NO REAL “NEGOTIATIONS” “I call it a so-called ‘negotiation’ because it is not true negotiation. “It is a Godfather mafia-style negotiation where bureaucrats at CMS make companies an offer they ‘can not refuse.’ “A drug manufacturer has two options: “One: voluntarily negotiate and face an excise tax of up to 95 percent of gross sales for that drug, if they do not comply with the government’s demands. “Two: if the drug manufacturer doesn’t wish to voluntarily ‘negotiate,’ they are forced to withdraw all their drugs from Medicare, and also Medicaid. “Reiterating, a drug company is forced to either accept the drug price the government gives them ‘out of the goodness of the government’s heart’ or the government will take up to 95% of gross sales from that drug. “Or, if they refuse to ‘negotiate,’ the manufacturer loses access to Medicare and Medicaid. “The federal government, through Medicare, Medicaid, and CHIP, controls almost 40% of the legal drug sales in the United States. “Last week, Health and Human Services responded to legal action claiming that participation in Medicare Drug Price ‘negotiation’ is voluntary and that the Program does not compel participation. “But you must participate or lose access to almost 40% of the US market on all of your medications. “And, if you participate, you have virtually no bargaining power. “The federal government can take from a private company more money on a medicine than that private company receives, or makes, from that medicine. Unless the private company agrees to the offer, they ‘can not afford to refuse.’ “The private pharmaceutical company is just like the movie producer, Jack Woltz, in the film The Godfather. “Take the government offer or else." UNCONSTITUTIONAL PRICE SETTING “This law clearly violates the takings clause of the Fifth Amendment. “I raised this concern in 2019 when the bill was first presented. “No matter how much elaborate wordplay big government apologist lawyers want to use in calling the plan a form of ‘negotiation’ does not make it true. The fancy words do not change the fact their scheme is a taking. “To paraphrase an old saying: ‘calling a skunk by any other name does not make it smell any better.’ “When a competing Republican measure with similar language was briefly brought forward, I voted against that one too on constitutional grounds. “Moreover, the non-partisan Congressional Research Service warned that the price setting regime in the Inflation Reduction Act was on constitutionally weak legs. “There are now nine legal cases challenging this drug price ‘negotiation’ program. “I am confident that one or more of these lawsuits will be successful and this program will be found to be unconstitutional." DESTROYING INNOVATION “This hearing will help us in Congress to understand the aspects of the price control scheme that are most harmful to patients and innovation so that we can craft Constitutional bipartisan legislation that brings relief on drug prices without crushing drug research and development. “One study says, 24-49 therapies currently on the market would not be available today if the Inflation Reduction Act was in place during their development. “These therapies could range anywhere from cancer, rare diseases, or MS drugs. “As our witnesses can testify to today, small molecule drugs and biologic drugs used to treat rare diseases are among those treatments most impacted by the Inflation Reduction Act . “Patients rely on the incredible innovation we have had in the US and the provisions we are talking about today will make the US second rate in the world, when it comes to the realm of new drug development. “We know the American people want lower prices on the most expensive prescription drugs, but we shouldn’t sacrifice access to life changing treatments in the process. “That’s why it’s so important for Congress to fix the worst impacts of the drug price ‘negotiation’ program and in a manner that is consistent with the United States Constitution.”

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.

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.

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.

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