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Washington D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) joined POLITICO’s Alice Miranda Ollstein this morning for a discussion on the importance of increasing health care transparency to drive down costs for patients.  As Chair Rodgers said, “This is a 95% positive issue for people when they hear about price transparency for health care. They support it. They believe that it's needed.”   Watch it here and check out key highlights of Chair Rodgers’ remarks below.  ON THE LOWER COSTS, MORE TRANSPARENCY ACT :   “ I'm 100% committed to getting this bill up for consideration on the floor, passed out of the House, and ultimately onto the President's desk.   “I’m really, really proud of the work that has been done around this legislation. It passed out of the Energy and Commerce Committee unanimously.  “I'm proud to Chair this Committee. This Committee has a rich history of plowing the hard ground necessary to legislate, and that's what we've done on this bill.  “This is a very important first step when we talk about price transparency. We've worked hard with the Ways and Means Committee, the Education and the Workforce Committee. We're working with Leadership to get this bill out of the House.  “I also am really grateful to Ranking Member Pallone for his work and partnership in bringing the bill this far and we're committed to getting it done.”   ON PRICE TRANSPARENCY:    “I have a hospital in my district that has embraced this. They’re working with local employers and really looking at how can reimbursements be targeted to make sure that we're driving down costs for seniors for patients.  “Our goal is to really get price transparency within the health care system, whether it's hospitals, health plans, or PBMs. Price transparency is really important to accountability and ultimately to empowering patients and doctors to be making these decisions.”  ON EMPOWERING PATIENTS:   “One of my colleagues said it best when I was talking to him about it recently. He said ‘You know, in America, we know the price for everything that we buy. And as consumers, we're able to go out and make decisions based upon what the prices are. And in health care, we need that too.’  “We need, as individuals, to be empowered with the prices. That is one of the best things that we could do to bring back the decision-making to the patient and the doctor, which is my goal in this huge health care system to really get to the core issues on what's driving the cost of health care.  “We continue to see health care costs increasing, and we need to address what's driving the cost of health care. We've seen a lot of consolidation, and it is not bringing down the cost of health care.   “This is a very important first step to really look at how we address the rising cost of health care and make sure that we're protecting the decision-making between the patient and the doctor.”  ON ENSURING COMPLIANCE:   “Part of the reason this legislation is important is so that we have data that can be used most effectively. And the continued focus on making sure that the hospitals and others in this legislation—the health insurance companies, PBMs—are also in compliance.  “But we also have more stories because of price transparency today, of individuals and employers that are making decisions that are benefiting seniors and are bringing down the actual cost that they're having to pay out-of-pocket and as employers.  “I have employers in my district, but there's others around the country, that are also seeing those savings, because they're able to make a value-based decision, but also based upon on the price.”    CLICK HERE for more on the Lower Costs, More Transparency Act .  CLICK HERE for how the Lower Costs, More Transparency Act helps patients. 

The Lower Costs, More Transparency Act is good news for seniors. That is why the Association of Mature Americans Citizens (AMAC) and AARP support it. It will drive down the costs of health care and strengthen the Medicare program. Here’s what you need to know:  Right now, America’s seniors are being forced to pay more out-of-pocket for the exact same treatment, by the exact same doctor, in the exact same office, if that doctor’s office is owned by a hospital. It's a legal gimmick that is putting seniors into medical debt. The Lower Costs, More Transparency Act bans this practice and makes health care more affordable for seniors. Medicare is running out of money and growing at an unsustainable rate. The bill also saves Medicare money. This is how we preserve benefits for seniors while also making sure the program is strong for future generations.  The “site neutral” policies included in the Lower Costs, More Transparency Act have been praised by conservative experts, like Bob Moffit and Bobby Jindal , for how they strengthen the health care system through less consolidation and lower costs.  Bottom line: the Lower Costs, More Transparency Act will strengthen Medicare for current seniors and generations to come.  CLICK HERE to more from former Speaker Newt Gingrich about the benefits of price transparency in health care.  CLICK HERE to read more about how the Lower Costs, More Transparency Act will help patients.  CLICK HERE to read the section-by-section summary. 

Washington D.C. — House Energy and Commerce Health Subcommittee Chair Brett Guthrie (R-KY) delivered the following opening remarks at today’s legislative hearing titled "Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology." NEXT STEPS TO FIND SOLUTIONS "Today is our second hearing designed to examine solutions to help our seniors gain access to innovative medical drugs and technologies, to help lower drug costs, as well to ensure our regulatory policies are responsive to market innovation that will help seniors live longer, healthier lives. "In July, we heard from a panel of experts about the importance of updating the Medicare program to meet the needs of a growing senior population. "Now we’re taking the next step to examine specific solutions, which seek to turn the principles and ideas from members, previous expert witnesses, and wide-ranging stakeholder input, into legislation to support millions of seniors across the country. "For example, according to the National Cancer Institute, cancer cost the United States about $208 billion in 2020. Further analysis shows that late-stage cancer cost the health care system $105,000 per patient in 2019, representing the highest costs among all cancer patients. "Today, patients and their families bear a significant financial burden despite the growing availability of less invasive and more successful treatments, along with cutting-edge diagnostic tools that can personalize treatment plans and detect aggressive, but treatable, cancers sooner. H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, attempts to address this policy imbalance by increasing access to these diagnostics and potentially lowering downstream costs and helping seniors live longer lives. "Additionally, I am proud to support H.R. 1691, the strongly bipartisan Ensuring Patient Access to Critical Breakthrough Products Act, which would essentially codify the Trump era Medicare Coverage of Innovation Technology or 'MCIT' rule and provide for a predictable Medicare coverage pathway for FDA approved breakthrough therapies for at least four years while companies can collect data to make their case for more permanent coverage." CMS COVERAGE TRANSFORM LIVES "These products—many of which are FDA approved but have yet to receive CMS coverage—could transform lives and make daily activities more manageable for seniors who may currently be bedridden or one device or technology away from being able to finally manage their cardiovascular disease. "On the top point coverage, we have a number of solutions to make regulatory policies work better for innovators, for providers, and most importantly, for patients. My bill, H.R. 5389, the National Coverage Determination Transparency Act, would hold CMS accountable to a more consistent process for making National Coverage Determinations, and specifically their communications with product sponsors, ensuring patients can gain access to these products as quickly as possible. "We will also discuss policies that would help clarify the local coverage determination process so that medical items and services can expeditiously reach seniors. For too long, we’ve heard how broken the coverage process delays or, in the case of the Alzheimer’s NCD, which we will also discuss today, significantly restricts access to life-saving care for seniors. "We’re finally looking at more effective ways to help address chronic disease management as well as other policies to provide seniors access to generic drugs and biosimilars, particularly by allowing for biosimilar products to be added to Medicare drug formularies throughout the plan year if a biosimilar becomes available mid-year. Which would allow seniors to save more on lower cost, clinically effective drugs." GAO REPORT RAISES CONCERNS "The Government Accountability Office recently finalized a report on the impact of rebates in the Medicare Part D program, specifically how rebates effect the prices seniors pay at the pharmacy counter. The report provided a detailed analysis on the impacts of rebates on seniors’ cost-sharing and Medicare liabilities resulting from [rebates]. "GAO indicated that for 79 of Medicare Part D’s top 100 highly-rebated drugs, seniors or others on seniors’ behalf, spent $21 billion on their drugs versus the $5 billion the plan sponsors spent on these drugs after accounting for drug rebates. Seniors and taxpayers shouldn’t be paying more for a drug than the actual value of the drug. "That’s why we are considering ideas today that are designed to help address these issues. Each proposal was drafted to ultimately achieve lower costs without the Federal Government directly negotiating the prices of these medications. "In closing, it is important to note that, while these policies can help drive innovation, we also must consider the budgetary implications of each proposal. I look forward to working with my colleagues to ensuring these ideas are fully offset should as we continue our work. I yield back."

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) delivered the following opening remarks at today’s Health Subcommittee legislative hearing titled "Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology." ENSURING SENIORS HAVE ACCESS TO CARE  "We have all heard from patients who are unable to access the medicines or devices they need to improve their lives.  "Many times it is because of bureaucratic red tape and a Medicare program that is struggling to keep up with innovation.  "Today our goal is to cut the red tape and roll out the red carpet for all. "In our July hearing, we heard from Sue Wronsky, a patient advocate and caregiver, who told her story about her mother, Lynn’s, battle with Alzheimer’s.  "Millions of Alzheimer’s patients today stand to benefit from newly approved treatments—treatments that Lynn never had the chance to receive.  "Today, we’re following up on that conversation with doctors, patients, innovators, and caregivers. "We will hear from Dr. Dora Hughes from CMS who can hopefully shed light on CMS’s unprecedented coverage policies, which are limiting seniors’ access to these FDA-approved drugs.  "We are also interested in learning more from Dr. Hughes about CMS coverage policies, including the recent TCET proposed notice.   "This has come more than two and half years after CMS delayed and ultimately repealed the MCIT policy, which would have created a predictable transitional coverage policy for innovative technologies." BIPARTISAN SOLUTIONS FOR SENIORS "We are all worried about seniors’ access to innovative new technologies.  "We’re going to discuss a lengthy list of bills—I would highlight that 16 are bipartisan or led by my Democrat colleagues.  "And I am hopeful that we can build more bipartisan support for many of the remaining bills in the weeks and months to come.   "For example, we would welcome Democrats joining on legislation that would:  allow seniors to continue to access the same technologies that they had access to on commercial insurance permit seniors to upgrade their wheelchairs to increase their mobility and potentially improve their quality of life improve home infusion care safely in their homes support a number of Medicare Part D and PBM policies that have received bipartisan support in the Senate. "These are policies that can help patients access innovative drugs and technologies and are distinct from major policies—like the price setting scheme in the IRA—which we disagree on. "I am also glad we are including several bills on the Medicare Part D program, especially following the troubling report from GAO that found patients are paying more for their drugs than insurance companies." MORE WORK TO COME  "And while I’m glad that so many members on both sides of the aisle have brought forward ideas that we will discuss today, a lot more work will need to be done.  "A number of the bills before us would increase what seniors pay, as well as Medicare spending, unless we are able to find reductions.  "There are a lot of big ideas, and we may need to think through steps to get us to where these bills want to go. Today is focused on taking a first step.   "It will take stakeholders and members rolling up their sleeves and working together to start making progress.  "Nobody wants to see their family and friends lose access to lifesaving and life-improving care when they age into Medicare." DANGERS OF MEDICARE-FOR-ALL "Today’s hearing, and the number of bills being considered, should also be a warning about Medicare-for-All proposals. "Imagine if it was up to the federal government to decide what treatment was covered for every American?  "Without other options for coverage—and being at the mercy of a health care bureaucracy—you’d have to lobby your congressman to pass legislation if you wanted to change the coverage policy. "Once again, Energy and Commerce is leading the way on health care issues top of mind for Americans.  "From addressing the fentanyl crisis, working together on price transparency and addressing consolidation in health care to making sure seniors have access to innovative medicines and technology. "I am proud of the work this committee has done and look forward to continuing it today."

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.

It’s time to change the status quo and make health care more affordable H.R. 5378, The Lower Costs, More Transparency Act, was written with patients in mind so they can find the right care at a price they can afford. It includes solutions like making hospitals post their prices—something that 95 percent of Americans support.  Don’t miss these stories on how this bill will make a real difference in people’s lives.  RIGHT NOW: Hospital pricing is complicated and hard to navigate. Dani Yuengling, a patient from South Carolina, had a $6,000 deductible and needed a biopsy. She attempted to shop responsibly and was quoted $1,400 by her hospital’s price estimator, but she ended up with a charge of $18,000—more than $5,000 of which she was forced to pay out-of-pocket.   The Lower Costs, More Transparency Act makes hospital pricing clear and understandable to patients. It requires hospitals , insurance companies, labs, imaging providers, and ambulatory surgical centers to publicly list the prices they charge patients , building upon the Trump administration price transparency rules.  __________________________________________________________________________________________ RIGHT NOW: Patients don’t know how much they’ll be charged until AFTER they receive care. Take for example Nikki Pogue, who was overcharged $11,000 by a hospital that attempted to bill her for a service she didn’t receive. According to testimony before the Energy and Commerce Committee, “She had no idea what this charge was and did not get any transparency or explanation from the hospital. She spent the next five months working to decipher the bill on her own, only to discover the hospital had miscoded her Emergency Severity Index and severely over-charged her.”  The Lower Costs, More Transparency Act brings patients accurate and accountable pricing information BEFORE they seek care. It empowers patients to shop for health care and make informed decisions by providing information about the cost of care, treatment, and services. ___________________________________________________________________ ____________________  RIGHT NOW: Patients are charged more for the same medicine provided by the same doctor to the same patient, if the doctor’s office is purchased by a hospital. This happened to Kyunghee Lee, a senior citizen from Ohio, who saw the cost of her annual steroid injection increase from $30 to $354.68. Her bill increased by more than 1,000 percent just because her doctor’s office was purchased by a bigger hospital system, despite the fact that she was receiving the same shot, from the same doctor, in the same building.  The Lower Costs, More Transparency Act ensures that patients pay the same price for the same drugs regardless of where those drugs are administered by preventing out-patient facilities owned by hospitals from charging more for a drug than a non-hospital-owned doctor’s office.  ___________________________________________________________________ ___________________  RIGHT NOW : Consolidation in the health care sector drives up pricing by eliminating competition and limiting choices for patients, in many cases, those battling cancer. Earlier this year, the Energy and Commerce Committee heard testimony from the Leukemia and Lymphoma Society (LLS), who described the Committee’s work on transparency and health care costs as “urgent” for the 180,000 Americans who are diagnosed with blood cancer each year.   According to LLS, “We are encouraged by many of the proposals the Committee is considering today to promote healthcare competition and encourage meaningful transparency. We share these goals because we believe that improved competition and transparency have the potential to realign incentives to achieve improved health outcomes while lowering costs for patients, consumers, employers, and taxpayers.”  The testimony also noted the importance of site neutral drug policies for cancer patients given the proportion of chemotherapy infusions to Medicare beneficiaries in higher-cost hospital-owned outpatient facilities, which were once lower-cost independent physician practices, has increased from 15.8 percent in 2004 to 45.9 percent in 2014. Further, LLS noted, “Equalizing payments between these sites of service would weaken the incentive for provider consolidation, which would also produce long-term cost savings across insurance types and give patients additional options for their care.”  The Lower Costs, More Transparency Act helps cancer patients afford their care by increasing transparency and competition in health care.  ___________________________________________________________________ ___________________ RIGHT NOW: Vague bill practices leave patients on the hook for bills they never saw coming. Last year, Mike Lauze spent one hour in an O.R. undergoing eye surgery. His bill included three separate facility fees totaling $7,800 and professional fees totaling $6,200. In the words of Energy and Commerce Chair Cathy McMorris Rodgers, “Why are three facility fees necessary for one hour of surgery in one O.R.? I do not know. But I do know that the system must be simpler, more affordable and work better for patients.”  The Lower Costs, More Transparency Act extends price accountability to outpatient surgery centers by requiring price transparency for services.   It’s time to change the status quo that is hurting patients and make health care more affordable. That is why the bipartisan Lower Costs, More Transparency Act has a singular goal in mind—lowering costs for patients through increased price transparency and competition.   CLICK HERE to learn more about how the Lower Costs, More Transparency Act helps patients.  

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 

Washington D.C. — House Energy and Commerce Health Subcommittee Chair Brett Guthrie (R-KY) delivered the following opening remarks at today’s legislative hearing titled “Legislative Proposals to Prevent and Respond to Generic Drug Shortages.” ONGOING DRUG SHORTAGES   “Today’s hearing is focused on the critical topic of finding long-term solutions to prevent future shortages of key drugs for patients. For months, cancer patients, including pediatric cancer patients, have had to scramble to find the drugs recommended or use alternatives because of instability in the markets and supply chains.    “In 2022 alone, there were 301 drugs in active shortages according to the University of Utah. For over a decade, professionals in the medical and regulatory community have sounded the alarm on the underlying economic causes of drug shortages.   “Unforeseen circumstances, like a tornado hitting a pharmaceutical warehouse in North Carolina or a manufacturing facility in India shutting down due to quality concerns, can throw a supply chain out of whack and potentially lead to shortages of vital drugs.”  CREATING DRUG SUPPLY CHAIN STABILITY   “ To ensure we’re prepared to respond appropriately to these issues, we must encourage strong investments to ensure that there are multiple means to develop, store, and distribute drugs.   “That’s why the Energy and Commerce Committee is continuing extensive work to identify the drivers of what can cause a supply chain to be unstable and lead to the shortages we’ve seen over the last decade. This Congress alone, we’ve held an oversight hearing, heard testimony on shortages at a PAHPA hearing, the Chair did a request for proposals, all leading to the hearing today on potential solutions that span numerous federal agencies and players.  Through this work a key theme emerged - the fundamental economics of the generic drug market, specifically sterile injectable drugs, must be reformed, if we want a more stable pipeline of drugs, including sustained investments in domestic manufacturing.     “Earlier this year, the New York Times wrote, in an article diving into the complex supply chain for generic drugs, that ‘there is a high cost to low prices.’ From there, the article dives into the frailty of supply chains that operate at low costs, with these low costs oftentimes being driven by artificially deflated prices from government programs like Medicare and Medicaid policies. Even Commissioner Califf agrees economics are the main driver, which he publicly shared before this committee during a previous hearing.” INCREASING ACCESS TO LOW-COST GENERICS   “That’s why today we’ll be considering a discussion draft from Chair Rodgers that aims to improve the systematic market failures of our drug supply chain. This discussion draft includes proposals to reform reimbursement rates for low-cost drugs and includes new ideas to ensure that the FDA is appropriately prioritizing and using regulatory discretion to help get more low-cost generics to the market sooner.”   “It is also important to note that this is only a discussion draft, and I certainly expect there to be a healthy discussion among all members today on this draft and other proposals to address the issue of supply chains and shortages. We are also continuing to actively solicit stakeholder feedback given the complexities of the supply chain.   “ It’s my hope nonetheless that after we’ve had our robust discussion that we’ll be able to find common-sense, bipartisan solutions to shore up our generic drug market. Doing so will keep Americans healthy and protect our national security by making us less dependent on adversarial nations for medical needs in the event of future, unforeseen natural disasters. I look forward to the discussion today and our continued work to advance long-term policies designed to address this critical issue.”