News

All Updates


May 23, 2024
Press Release

Subcommittee Chair Bilirakis Opening Remarks at IDC Markup

Washington, D.C. — House Energy and Commerce Subcommittee on Innovation, Data, and Commerce Chair Gus Bilirakis (R-FL) delivered the following opening remarks at today’s subcommittee markup of three bills:  As prepared for delivery: “Good morning, and welcome to today’s Subcommittee markup where we will consider three significant Subcommittee priority pieces of legislation to protect Americans’ data privacy rights, protect kids online, and preserve access to AM radio. “I want to thank all the Subcommittee members for their input and feedback on these topics, and I am looking forward to continuing productive conversations in a bipartisan manner to refine these bills as we move through the legislative process.  “We have a historic opportunity to advance legislation that will end the patchwork and finally provide a federal standard to govern how Americans’ personal information is collected, stored, retained, and transferred.  “The American Privacy Rights Act is the strongest consumer data privacy and security framework to date—it provides businesses with certainty through a national preemptive standard, secures individual liberties through strong data minimization provisions, and cements America’s global leadership through data security provisions that warn consumers when their information is being collected and shared with our foreign adversaries, like China and Russia.“  YEARS OF CONGRESSIONAL EFFORT  “For years, Congress has long tried to thread the needle when it comes to getting a national data privacy bill enacted into law, given the many differences in approach from both sides of the political spectrum.  “I want to applaud Chair Rodgers and Chair Cantwell for their tireless efforts to move forward with a framework that strikes this critical balance, as well as all the members on both sides of the aisle that have provisions included in the draft before us today.  “I understand many stakeholders have continued to engage with every office on their requests, and I look forward to hearing from my colleagues about how we can continue to incorporate that feedback.  “I’m thankful for all the constructive comments we’ve received up to this point.  “This is certainly not the last opportunity to deliberate and refine this draft further. “But time is of the essence, so let’s continue to move this process forward to protect Americans privacy rights, promote individual freedoms and civil liberties, and secure data from abuse by bad actors.”  KOSA  “In addition to APRA, I’m proud that we are also considering my bill, H.R. 7891, the Kids Online Safety Act.  “I’m thankful to Rep. Castor for her partnership on this effort, as well as the many colleagues on this Subcommittee who’ve cosponsored our legislation.  Sadly, in the face of an unprecedented youth mental health crisis in this nation, Big Tech has continued to turn a blind eye to harms perpetuated on their online platforms.   “Congress has been forced to step in to ensure children and parents have the safeguards, tools, and transparency measures they need to stay safe.   “KOSA requires the prevention and mitigation of harms to minors, such as the promotion of suicide, depression, substance abuse, sexual exploitation, and illegal drug sales such as fentanyl.  “Too often we’ve seen the design features of social media fuel these problems, rather than prevent them.  “This legislation is not perfect, and I’m hopeful conversations today can illuminate how we can better establish needed protections for children.”  PRESERVING AM RADIO  “Lastly, the Subcommittee will be taking a bipartisan bill I’m leading with Ranking Member Pallone, the AM Radio for Every Vehicle Act .  “At our legislative hearing, we heard from our witnesses about the importance of having a robust emergency alert and public safety communications infrastructure.  “Further, rural and underserved Americans still enjoy listening to AM radio broadcasts for their diverse viewpoints.   “Given AM radio’s significant reach as a medium, much of it taking place in vehicles, we must ensure it remains a readily available option for all Americans, particularly as we approach hurricane season.   “I’m proud to partner with Ranking Member Pallone on this initiative and look forward to advancing it through Subcommittee today.  “In closing, I look forward to working with all my colleagues on both sides of the aisle today to get these critical bills across the finish line."



May 23, 2024
Blog

Innovation, Data, and Commerce Subcommittee Markup Recap: Monumental Step Forward for Data Privacy and Kids Online Safety

Washington D.C. — The House Energy and Commerce Committee advanced proposals today that will establish one national standard for data privacy, protect kids online, and preserve Americans’ access to A.M. radio. In a Subcommittee markup , the Innovation, Data, and Commerce Subcommittee forwarded three pieces of legislation to the Full Committee for consideration. As Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) said , “The American Privacy Rights Act is an opportunity for a reset, one that can help return us to the American Dream our Founders envisioned.  “It gives people the right to control their personal information online, something the American people overwhelmingly want. They’re tired of having their personal information abused for profit.”  Innovation, Data, and Commerce Subcommittee Chair Gus Bilirakis (R-FL) added , “We have a historic opportunity to advance legislation that will end the patchwork and finally provide a federal standard to govern how Americans’ personal information is collected, stored, retained, and transferred.   “The American Privacy Rights Act is the strongest consumer data privacy and security framework to date—it provides businesses with certainty through a national preemptive standard, secures individual liberties through strong data minimization provisions, and cements America’s global leadership through data security provisions that warn consumers when their information is being collected and shared with our foreign adversaries, like China and Russia.”  Legislative Vote Summary: H.R. ____ , the American Privacy Rights Act  discussion draft, was forwarded, without amendment, to the Full Committee by a voice vote.  H.R. 7891 , the Kids Online Safety Act, was forwarded, without amendment, to the Full Committee by a voice vote.  H.R. 8449 , the AM Radio for Every Vehicle Act , was forwarded, without amendment, to the Full Committee by a voice vote. 



May 23, 2024
Press Release

E&C, E&W Republicans Press HHS Secretary Becerra on Preventing Civil Rights Violations at Universities Receiving NIH Grants

Inquiry Part of House-Wide Effort to Combat Rise of Antisemitism on College Campuses Washington, D.C. — In a new letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, House Energy and Commerce Committee (E&C) Chair Cathy McMorris Rodgers (R-WA), E&C Subcommittee on Health Chair Brett Guthrie (R-KY), and E&C Subcommittee on Oversight and Investigations Chair Morgan Griffth (R-VA), along with House Education and the Workforce Committee (E&W) Chairwoman Virginia Foxx (R-NC) and E&W Subcommittee on Higher Education & Workforce Development Chair Burgess Owens (R-UT), raised concerns over how HHS is ensuring that research universities are preventing harassment and discrimination—particularly against individuals of Jewish faith and heritage. The Chairs note in their letter that colleges or universities that violate Title VI of the Civil Rights Act of 1964 can ultimately lose Federal funding.   The investigation comes as part of Speaker Mike Johnson’s (R-LA) House-wide effort to crack down on antisemitism on college campuses.  KEY LETTER EXCERPT :  “We are troubled by the fact that colleges and universities that are recipients of massive amounts of Federal research grants from NIH are actively fostering antisemitism on campus and failing to protect Jewish students, faculty, and support staff. Failing to comply with basic safety protections for members of their communities, no matter the cause, may be grounds for disqualification of universities and colleges from receiving Federal funds. Congress has an obligation to ensure compliance with Title VI. If Congress determines an institution of higher education is in violation, we may consider rescinding research and development funds previously appropriated.”  BACKGROUND :  Starting in April 2024, antisemitic, and at times violent, protests broke out across campuses at several prominent universities—including Columbia University, the University of Southern California (USC), the University of California Los Angeles (UCLA), George Washington University (GWU), Harvard University, and Yale University—resulting in unsafe learning and research environments for students, faculty, and staff, especially for those of Jewish faith and heritage.     Beginning on April 17, 2024, an encampment sprung up on Columbia University’s campus with hundreds of protestors and tents.   Protestors vandalized the campus—including residence halls—with banners and signs containing antisemitic sentiments and even support for the terrorist organization Hamas.  Despite over 100 arrests by police, the protests progressed to the occupation of a campus building and physical attacks on Jewish students—leading campus officials to move some classes online.  Professors at Columbia University have openly made antisemitic and even pro-Hamas statements, adding to the harassment of Jewish students.   A prominent rabbi at Columbia University also warned Jewish students to remain off-campus due to fears that the university and New York City police could not keep students safe.   Jewish students on campus have expressed concerns over their safety on campus and the mental and psychological toll the hostile environment is taking on their ability to work and learn.  Columbia University—which across its campuses received more than $682 million in grants from NIH in fiscal year 2023—is just the tip of the iceberg as similar events are spreading to other colleges and universities.   USC—which received more than $358 million in NIH funding in fiscal year 2023—is also overrun with students, faculty, and other anti-Israel protests that led the university to cancel its graduation ceremony out of safety concerns.   A protestor at USC was charged with assault with a deadly weapon—showing the threatening and intimidating nature of these protests. UCLA—which received more than $580 million in NIH grants in fiscal year 2023—is yet another example of the impact these actions have on the ability of students—particularly Jewish students—to learn. Protesters at UCLA have blocked off sections of the campus, refusing access to Jewish students seeking to attend their classes.  According to a phone call with UCLA police, the directive from UCLA was to not interfere with the protestors.  Just a few blocks from the White House at GWU—which received more than $73 million in grants from NIH in fiscal year 2023—encampments spread beyond the campus onto public streets, and for weeks no action was taken to clear the encampments.  At both Yale University—which received more than $621 million in grants from NIH in fiscal year 2023—and Harvard University—which received more than $400 million across its campuses in grants from NIH in fiscal year 2023—concerns about antisemitism circulated even before the protests erupted. Dozens of protestors were arrested after setting up an encampment at Yale University and parts of Harvard University have been closed, with classes held remotely in response to hundreds of protestors gathering on campus.  Several lawsuits have been filed against these universities alleging violations of civil rights protections and failure to provide a safe environment, and the U.S. Department of Education has opened investigations into several colleges and universities—including Columbia University—for potential civil rights violations.  According to the U.S. Department of Education’s Office for Civil Rights (OCR), colleges and universities are prohibited from discriminating based on a variety of categories—including national origin. These laws also protect students who are, or are perceived to be, members of a religious group—including those of Jewish faith. A college or university is in violation of Title VI of the Civil Rights Act of 1964 if: 1) there is harassing conduct on the basis of race, color, or national origin that is sufficiently serious as to limit or deny a student’s ability to participate in or benefit from the educational program (i.e., creates a hostile environment); 2) a responsible employee of the school knew, or should have known, about the harassment; and 3) the school failed to take prompt and effective steps reasonably calculated to end the harassment, eliminate the hostile environment, prevent the harassment from reoccurring, and as appropriate, remedy its effects.  According to NIH’s Grant Policy Statement, any institution receiving Federal funds must assure work environments are free of discriminatory harassment and are safe and conducive to high-quality work.  HHS’s OCR is responsible for ensuring that institutions that receive Federal financial assistance comply with Title VI as well as other civil rights laws.   Colleges or universities that violate Title VI can ultimately lose Federal funding.   CLICK HERE to read the full letter.



May 23, 2024
Press Release

E&C Republicans to NIH: Is Agency Recovering All Misused Taxpayer Dollars?

Washington, D.C. — In a letter to 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) write regarding their investigation into how NIH recovers misused funds from recipient institutions.  KEY LETTER EXCERPT :  “While NIH funding has resulted in significant advances in science and aided in medical breakthroughs, it is also susceptible to fraud and other misconduct. With more than $35 billion in extramural grants awarded in fiscal year 2023 alone, it is essential that the NIH ensures grant funds are used appropriately and identifies and recovers any misused or abused funds.”  BACKGROUND :  The NIH and its institutes and centers may also become aware of financial misuse or fraud through allegations and complaints made by colleagues at the recipient institution, whistleblowers, or even anonymous complaints. Between fiscal years 2013 and 2022, the NIH received an increasing number of allegations of grant fraud—such as embezzlement and theft of funds—totaling more than 200 allegations.  Several public reports have uncovered substantiated cases of misuse of funding provided by the NIH—including findings that researchers at both Harvard University and Scripps Research Institute improperly charged or overcharged the NIH for time researchers spent on grant activities, leading to over $1.3 million and $10 million being refunded to the NIH respectively.  During the same period, the NIH also received more than 1,000 allegations of research misconduct.   The ORI’s website summarizes nearly 30 cases of substantiated research misconduct—including falsification, fabrication, or plagiarism of data or findings supported by NIH-funded research—since 2018.   These cases involve hundreds of millions of dollars, and it is unknown how much of that funding was used specifically by the person(s) found to have participated in the misconduct.   There are only a handful of public cases in which the NIH has managed to recover some funds from institutions found to have failed to protect the integrity of NIH funding.   For example, in 2019, Duke University agreed to repay $112.5 million to resolve allegations that applications and progress reports submitted to the federal government—including the NIH—contained falsified research.  CLICK HERE to read the full letter. 



May 23, 2024
In the News

NBC News: Republicans and Democrats in Congress See Critical Window to Shield Online Data

Today, the Innovation, Data, and Commerce Subcommittee is holding a markup of the American Privacy Rights Act to establish one national standard for data privacy and security for people of all ages— including kids —in all 50 states. The bipartisan, bicameral draft legislation gives Americans control over where their information goes and who can sell it, empowers individuals to enforce their data privacy rights, and reins in Big Tech. Don’t miss key excerpts from NBC’s article highlighting the bill below: “The presidential election is a little more than five months away, but key Republicans and Democrats in Congress see a critical window to pass sweeping legislation to shield the online data of both children and adults from Big Tech companies. “‘I believe that there’s a moment here where, on behalf of the American people, Congress needs to act,’ House Energy and Commerce Committee Chair Cathy McMorris Rodgers, R-Wash., said in an interview on the steps of the Capitol. “‘There’s a recognition, on behalf of protecting our kids online, in protecting all Americans, that we need to ensure that there are privacy rights in place … and that our identity is being protected online and that we’re in control of our data,’ she said. “The Energy and Commerce subcommittee that oversees online data will take the first step in trying to advance the privacy legislation, holding a markup Thursday on the American Privacy Rights Act, broad legislation that includes privacy protections for kids and adults, as well as the Kids Online Safety Act.” [...] “A revised draft bill was announced this week to address critics’ concerns. “The American Privacy Rights Act would create national consumer data privacy rights and set federal standards for securing people’s data rather than have a patchwork of state laws. Among other things, the legislation would require companies to be clear about how they use people’s data and ‘give consumers the right to access, correct, delete, and export their data,’ according to a bill summary. The bill would also limit how companies collect and use data and ban transferring certain data to third parties without consent. “The measure includes the bipartisan bill to protect kids' and teens' online data, known as COPPA 2.0. “‘I see the American Privacy Rights Act as foundational to protecting kids online, foundational to protecting our individual identity online,’ McMorris Rodgers said. “The bipartisan privacy bill is gathering momentum just weeks after McMorris Rodgers and Cantwell reached a compromise on legislation that forces TikTok’s Chinese owner, ByteDance, to sell the popular video-sharing app or face a ban in the U.S. President Joe Biden signed the TikTok bill into law as part of a larger national security package.” CLICK HERE to read the full article. CLICK HERE to learn more about how APRA is foundational to protecting kids online. CLICK HERE for how APRA will help small businesses grow and thrive.



May 23, 2024
Markups

Chair Rodgers Opening Remarks at Innovation, Data, and Commerce Subcommittee Markup of 3 Legislative Proposals

Washington D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) delivered the following opening remarks at today’s Innovation, Data, and Commerce Subcommittee markup of three legislative proposals:  “Our personal identity is at the very core of what makes us human.   “It drives us to achieve the impossible and inspires us to pursue our goals and dreams. The ability to express our individual identity helps define who we are and deepen ties to our families and our communities.  “Encouraging individualism and identity is something that’s uniquely American, something the founders envisioned and fought for—a society that’s fiercely individual, where people are free to think, speak, and live their lives the way they want.   “Many believed that the internet could empower the individual even more by creating new ways for people and businesses to connect, innovate, and share information. “Unfortunately, trust has been broken.  “Instead, over time our identity has been slowly eroded our identity, freedom to think for ourselves manipulated, and Big Tech is capturing more and more data to surveil and control over our lives.   “Americans should be in control of how that information is disclosed, and it should be voluntary, not coerced.   “If the founders were here today, they would know, as we know, that this digital tyranny is not the American Dream.”  AMERICAN PRIVACY RIGHTS ACT   “The American Privacy Rights Act is an opportunity for a reset, one that can help return us to the American Dream our Founders envisioned.   “It gives people the right to control their personal information online, something the American people overwhelmingly want. They’re tired of having their personal information abused for profit.   “Right now, a person’s location, for instance, can be shared without their knowledge or permission by apps on their phone.  “This bill stops those apps from sharing or selling this data without permission.  “If a person searches the internet about something personal or something they want kept private that information could be tracked with hidden pixels and shared without them knowing about it.  “This bill keeps people's search history private.  “If someone buys a pair of shoes online, they almost instantly are bombarded with ads across the platforms they use.  “The American Privacy Rights Act gives the power back to the people by equipping them with the knowledge of how their data is being used to monetize, manipulate, and exploit them.” PROTECTING KIDS ONLINE   “This legislation is so important, and it is especially foundational for protecting kids online.  “The average American teenager spends 4.8 hours a day scrolling social media platforms. “I’m a mom. I have three young kids. I’ve said it before, and I’ll say it again. It’s my biggest fear: what’s going to happen online with my kids, because I don’t trust what’s happening at all. “As our kids scroll, companies collect nearly every data point imaginable to build profiles on them and keep them addicted.   “They intentionally target children with dangerous and life-threatening content.   “At our hearing last month, we heard from a young woman, Ava, who shared how Big Tech weaponized her data, collecting this arsenal of data and exploited her vulnerabilities.  “Ava’s story is just one of countless we’ve heard from kids, young adults, and families across the country.  “This legislation gets to the root cause of these problems by minimizing the collection and exploitation of our data.   “It serves as a strong foundation from which to layer on other important policies to protect kids online, like the Kids Online Safety Act, which I’m excited we’re also considering today.  “This draft includes key provisions from the Children Online Privacy Protection Act.  “I’d like to thank Reps. Walberg, Castor, and Senators Markey and Cassidy, for working with us.”  HELPING SMALL BUSINESSES AND ENTREPRENEURS THRIVE   “We can achieve stronger protections for people while also continuing to encourage innovation and entrepreneurship.   “18 states now have comprehensive data privacy laws, which means 18 different sets of rules that growing small businesses and startups are forced to navigate.   “Ensuring compliance is costly.  “Just last week, I had a company tell me they may be forced to pull out of certain states because they simply cannot comply with these conflicting standards.  “Our bill would end this patchwork.  “Today, we’ll also be marking up H.R. 8449, the A.M. Radio for Every Vehicle Act, led by Reps. Bilirakis and Pallone.  “Millions across the country rely on AM radio for critical information, especially during public emergencies. “It’s vital we preserve this resource for Americans. “In the nearly 230-year history of this Committee, we have established a rich tradition of taking on the hard problems and delivering solutions for the people. “We have a moment to change the status quo and reset what our online ecosystem looks like.   “The American Privacy Rights Act is a common sense, bipartisan, bicameral proposal. “I’m grateful for Senator Cantwell for working with me on this landmark legislation, as well as Ranking Member Pallone, who has been a trusted partner over the years as we have worked together on privacy and worked to improve this current draft.  “As John Dingell has been known to say, there hasn’t been a perfect law since Moses came down from the mountain.  “I urge my colleagues to advance the legislation today and I look forward to continuing working with all members and stakeholders to further perfect it before the full committee markup.” 



May 22, 2024
Markups

Chairs Rodgers and Bilirakis Announce IDC Subcommittee Markup

Washington D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Innovation, Data, and Commerce Subcommittee Chair Gus Bilirakis (R-FL) today announced a subcommittee markup of three bills.  "The days of Big Tech collecting unlimited data points on individuals and manipulating Americans online are numbered. It’s time for a reset of the internet ecosystem. The American Privacy Rights Act will usher in a new era by giving people the right to control their own data by reclaiming their identities and restoring America’s founding principles of freedom and self-determination,”  said Chairs Rodgers and Bilirakis.  “We also look forward to advancing critical policies to protect kids online and to ensure people continue to have access to A.M. radio. The Energy and Commerce Committee has a rich history of advancing important legislation in a bipartisan way, and we look forward to building on that legacy this week." WHAT: A Subcommittee on Innovation, Data, and Commerce markup of three legislative solutions.  DATE: Thursday, May 23, 2024  TIME: 10:00 AM ET  LOCATION: 2123 Rayburn House Office Building Legislation to be discussed: H.R. ____ , American Privacy Rights Act discussion draft (Rep. Rodgers)   H.R. 7891 , Kids Online Safety Act (Reps. Bilirakis, Bucshon, Castor, Houchin, Schrier)   H.R. 8449 , AM Radio for Every Vehicle Act (Reps. Bilirakis and Pallone)  This notice is at the direction of the Chair. The hearing will be open to the public and press and will be live streamed online at https://energycommerce.house.gov/ . If you have any questions concerning the hearing, please contact Jessica Herron at Jessica.Herron@mail.house.gov . If you have any press-related questions, please contact Sean Kelly at Sean.Kelly@mail.house.gov .



May 22, 2024
Hearings

Chair Rodgers Opening Remarks at C&T Legislative Hearing on Sunsetting Section 230

Washington D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) delivered the following opening remarks at today’s Communications and Technology Subcommittee hearing titled “Legislative Proposal to Sunset Section 230 of the Communications Decency Act.”  “Ranking Member Pallone and I recently unveiled bipartisan draft legislation to sunset Section 230 of the Communications Decency Act. “As written, Section 230 was originally intended to protect Internet Service Providers from being held liable for content posted by a third-party user or for removing truly horrific or illegal content. “The intent was to make the Internet a safe space and allow companies to remove harmful content in good faith without being held liable for doing so.  “However, the Internet has changed dramatically since then.  “Over five billion people around the world use social media, with the average person spending more than two hours a day on social media.  “The Internet has become vital for people to connect, work, find information, and make a living. “Big Tech is exploiting this to profit off us and use the information we share to develop addictive algorithms that push content on to our feeds.  “At the same time, they refuse to strengthen their platforms’ protections against predators, drug dealers, sex traffickers, extortioners, and cyberbullies.  “Our children are the ones paying the greatest price.  “They are developing addictive and dangerous habits, often at the expense of their mental health. “Big Tech has failed to uphold American values and be good stewards of the content they host. “It has been nearly three decades since Section 230 was enacted. “The reality is that many of these companies didn’t even exist when the law was written, and we could not comprehend the full effect of the internet’s capabilities. “It is past time for Congress to reevaluate Section 230.” IMMUNITY “In recent years, U.S. courts have expanded the meaning of what Congress originally intended for this law, interpreting Section 230 in a way that gives Big Tech companies nearly unlimited immunity from legal consequences. “These blanket protections have resulted in tech firms operating without transparency or accountability for how they manage their platforms and harm users. “This means that a social media company, for example, can’t easily be held responsible if it promotes, amplifies, or makes money from posts selling drugs, illegal weapons, or other illicit content. “As more and more companies integrate generative artificial intelligence technologies into their platforms, these harms will only get worse, and AI will redefine what it means to be a publisher, potentially creating new legal challenges for companies.  “As long as the status quo prevails, Big Tech has no incentive to change the way they operate, and they will continue putting profits ahead of the mental health of our society and youth.”  SOLUTION “Reforming Section 230 and holding Big Tech accountable has long been a priority of mine and Ranking Member Pallone. “Last Congress, we both introduced our own legislation to reform the decades old law. “Unfortunately, tech companies did not engage with us in a meaningful way and no solutions or reforms were made. “Big Tech is satisfied with the status quo. “So much so that they have become masters at deception, distraction, and hiding behind others in order to keep Section 230 unchanged. “That’s why we’re taking bipartisan action now. “Our discussion draft will bring Congress and stakeholders to the table to work in good faith to create a solution that ensures accountability, protects innovation and free speech, and requires companies to be good stewards of their platforms. “Let me be clear. “Our goal is not for Section 230 to disappear. “But the reality is that nearly 25 bills to amend Section 230 have been introduced over the last two Congresses. “Many of these were good faith attempts to reform the law and Big Tech lobbied to kill them every time. “These companies have left us with no other option. “By enacting this legislation, we will force Congress to act. “It is long past time to hold these companies accountable. “The shield of Section 230 should be there to protect the American people, not Big Tech. “I am hopeful that this legislation is the start of an opportunity to work in a bipartisan way to achieve that goal. “It’s vital that we develop solutions to restore people’s free speech, identity, and safety online, while also continuing to encourage innovation.” 



May 22, 2024
Hearings

Chair Rodgers Opening Remarks at Hearing with FDA Center Directors

Washington D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) delivered the following opening remarks at today’s Health Subcommittee hearing titled “Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices.”  “The FDA plays a critical role in the health and wellbeing of the American people. If it is successful in its mission, it has the potential to save—and extend—people’s lives. If it fails in its mission, the costs could be astronomical and devastating. “The FDA is responsible for regulating more than $3.6 trillion worth of food, tobacco, and medical products—about twenty cents of every dollar spent in the United States. “Americans must have confidence that the Agency is doing its job. They have to be able to trust that the medical products they are relying on are safe and effective, and it is Congress's duty to ensure that the FDA is using the resources and authorities it has been given to protect and advance public health.” MEDICAL INNOVATION “I am proud that America has been a leader in developing innovative treatments such as non-addictive medicines for chronic pain, so called ‘n of 1' drugs, where hospitals are making drugs designed for one patient, and implantable upper airway devices for pediatric patients with Down Syndrome and severe sleep apnea. “All these things—which will make a meaningful difference in people's lives—were recently approved by the FDA or will be seeking review in the near future. “There are also advances that could reduce the amount of time it takes for new technology to reach patients in need. “New biomarkers have been developed from advances in genetic sequencing, manufacturing techniques, and methods to generate clinical data that, if used properly, could decrease cost and time to demonstrate these new technologies meet FDA’s standards. “This committee worked in a bipartisan manner to give FDA new tools in the last user fee reauthorization, and we expect the agency to use those tools to pave the way for groundbreaking innovation. “I firmly believe that the accelerated approval pathway should be leveraged now more than ever, as more and more diseases can treated—or even cured—because of a better understanding of their mechanisms of action and genetic signatures. “FDA approval, unfortunately, is not the final hurdle for patients, as significant problems with CMS and private coverage still persist. “But it is an important first step.” CONCERNS WITH FDA “FDA cannot move backwards, and I am worried we are starting to see warning signs that may be occurring. “For example, I am disappointed to see that, according to the Fiscal Year 2023 PDUFA and MDUFA Performance Reports, all three Centers here before us today have failed to meet critical performance, process, and hiring goals, despite all-time highs in funding. “In addition, the Agency has been failing to adequately accommodate in-person meetings and respond to outreach related to major clinical and scientific development decisions in a timely manner. “This is particularly concerning as the FDA has unilaterally decided it can regulate, by its own estimate, 80,000 tests under the Laboratory Developed Tests Final Rule. “FDA leadership often says all the right things regarding speeding up innovation to patients when the benefits outweigh the risks, such as not asking for 'nice to know' questions if the statutory standard for approval has been met and not moving the goal posts after a company has invested millions of dollars and years of time on a clinical trial FDA once said was the best path forward. “The challenge is making sure the sentiments expressed by the Agency’s leadership are reflected by the application reviewers. “Unfortunately, I am hearing the opposite from stakeholders who are finding FDA review staff more disconnected and difficult to work with than before. “Everyone on this dais wants the FDA to succeed, because if FDA succeeds, American innovation flourishes, leading to better outcomes for patients. “I am hopeful that we can have a productive conversation about what challenges the Agency is facing and why, and how Congress can help the FDA streamline operations and provide clear, consistent scientific and regulatory information to innovators and drug manufacturers that are looking to improve the daily lives of Americans.”