Greg Walden

Mr. WALDEN

Mr. WALDEN. Mr. Speaker, I yield 3 minutes to the gentleman from Utah (Mr. Curtis), Utah's Third Congressional District.

Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in strong support of H.R. 2281, the Easy Medication Access and Treatment, or Easy MAT, for Opioid Addiction Act, which was introduced by myself and my Committee on Energy and Commerce colleague, Mr. Ruiz. Emergency room clinicians are well positioned to interact with those struggling with opioid addiction and help transition them into treatment. Currently, an ER clinician who does not have a DATA 2000 waiver can only provide a 1-day supply of narcotic drugs to be used for medication-assisted treatment to an individual at one time for a total of up to 3 days. What does that mean? It means that while the patient waits to get into treatment, they have to go back to that same clinician on each of those 3 days to obtain medication. Now, in a rural district such as mine--which, by the way, is larger than the landmass of any State east of the Mississippi--this is not realistic, especially when there is already a shortage of health practitioners who are willing to treat patients with substance use disorder. One of my constituents, who I met in Hermiston, Oregon, told me she had to travel 5 hours--5 hours--just to find a physician who could oversee her Suboxone treatment because no one in her community was available to do that. H.R. 2281 would allow physicians to dispense up to 3 days of narcotic drugs at one time for purposes of relieving withdrawal symptoms while the individual awaits arrangements for treatment. This is commonsense legislation, another good product of the Committee on Energy and Commerce. Mr. Speaker, I urge a ``yes'' vote, and I reserve the balance of my time.

Mr. WALDEN

Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume. I, too, rise in support of H.R. 4499, the National Institute on Minority and Health Disparities Research Endowment Revitalization Act. Mr. Speaker, I thank my Committee on Energy and Commerce colleagues on both sides of the aisle, especially Congressman Carter and Congresswoman Barragan, for their leadership on this bill, and the chairman for moving it. This bill authorizes the National Institute on Minority Health and Health Disparities to award research grants to current and former Centers of Excellence that conduct research on minority health disparities. Health inequalities and inequities are disproportionately experienced by minority populations, and we all know they can have adverse impacts on health outcomes, on economic opportunities and, frankly, on overall quality of life. The COVID-19 pandemic has exacerbated these disparities, which is why this legislation is so important, Mr. Speaker. Continued support of these Centers of Excellence is critical in advancing minority health, addressing health inequities, and expanding educational and training opportunities for those interested in further advancing research in this space. Mr. Speaker, I urge my colleagues to support this important legislation, and I reserve the balance of my time.

Mr. WALDEN. Mr. Speaker, I yield 2 minutes to the gentleman from Ohio (Mr. Latta).

Mr. WALDEN. Mr. Speaker, I yield 2 minutes to the gentleman from Georgia (Mr. Carter), one of the coauthors of this piece of legislation.

Mr. WALDEN. Mr. Speaker, I don't believe we have any other Members wishing to speak on this legislation, so I will just close and say it is another great work product from our Energy and Commerce Committee, bipartisan legislation that I encourage our colleagues to support, and I yield back the balance of my time.

Mr. WALDEN

Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in support of H.R. 5668. This is the MODERN Labeling Act, and I want to thank our colleagues, Representatives Guthrie and Matsui, for their leadership on this important legislation which will allow the FDA to require modifications be made to outdated labeling for generic drugs. Now, while drug manufacturers are required to update a label when it becomes inaccurate, false, or misleading, there is no such requirement when new scientific information indicates there may be a new use for the product. Generic drugs are generally required to have the same labeling as the brand drug they reference; however, once the brand drug is no longer on the market, the generic manufacturer is actually prohibited from updating their label to reflect the most accurate, up-to-date information, information that is often discovered through postmarket use. So the inability to update labeling can result in information gaps for providers and patients when discussing treatments. For example, it has been estimated that more than half, Mr. Speaker-- half--of all uses of cancer drugs are off-label, meaning the drug is used for a disease or medical condition that it is not approved to treat. Many of these uses are widely accepted in the medical community and based on the most up-to-date scientific evidence; however, they are not reflected in FDA-approved labeling. So H.R. 5668 would help. It would close this existing information gap. It would give doctors and patients the information they need when making decisions about their treatment options. Mr. Speaker, I urge support of this bill, and I reserve the balance of my time.

Mr. WALDEN

Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I too rise in support of H.R. 4712. This is the Fairness in Orphan Drug Exclusivity Act as you have heard. I want to thank Representatives Carter, McKinley, Dean, and Veasey for their work and leadership on this important legislation. The Orphan Drug Act was enacted to incentivize the development of drugs for rare diseases by providing products that receive an orphan drug designation 7 years of market exclusivity. That means a drug produced by another manufacturer that contains the same active ingredient to treat the same condition is barred from entering the market during this time period. One way a drug can receive an orphan designation and subsequent marketing exclusivity is by the manufacturer's demonstration that there is no reasonable expectation that the cost of developing the drug will be recovered. However, we have seen in recent years that some drug manufacturers, in an effort to block competitors from entering the market, have taken advantage of a loophole in this law. Existing law allows an orphan drug designation and marketing exclusivity to carry forward to future versions of the same drug without requiring the manufacturer to demonstrate the drug has not been, and remains unlikely to be, profitable. This legislation closes that loophole. It requires manufacturers to demonstrate there is no reasonable expectation that the costs of research and development will be recovered for each successor drug, while still preserving incentives for orphan drug development. While disagreements do remain, Mr. Speaker, on whether these amendments should apply retroactively, those differences should not prevent us from addressing this important issue today. So I look forward to continuing negotiations on these differences as we work with the Senate and get a bill down to the President's desk for signature. Mr. Speaker, I reserve the balance of my time.

Mr. WALDEN. Mr. Speaker, I yield 2 minutes to the gentleman from Georgia (Mr. Carter), who is one of the coauthors of this very important legislation and who is the only--I think still only-- pharmacist in the United States House of Representatives.

Mr. WALDEN. Mr. Speaker, I do not have any more speakers on my side of the aisle on this matter. Mr. Speaker, I urge colleagues to approve the bill, and I yield back the balance of my time.

Mr. WALDEN

Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I too rise in support of H.R. 2466, the State Opioid Response Grant Authorization Act which, as you heard, was introduced by Representatives Trone, Armstrong, Sherrill, and Riggleman. I would like to thank Representative Trone for leading this work on this bill and for working with us to get the language to a good place. We appreciate that. When I chaired the Energy and Commerce Committee, I think we passed out something like 60 or more pieces of legislation dealing with the opioid crisis. All of them were cosponsored by Democrats and Republicans--bipartisan effort--that became the SUPPORT Act signed by President Trump into law now almost over 2 years ago. I just want to say this epidemic continues, and so does our work. It has been made worse by the pandemic as people have turned to these sorts of medications to help themselves cope, and it is sad. This important bill would authorize appropriations for the Substance Abuse and Mental Health Services Administration's State Opioid Response grant program by placing it under the 21st Century Cures Act, which first established State Response to Opioid Abuse Crisis grants. The United States remains in the midst of this opioid crisis, and it has been exacerbated, as I said, by the COVID-19 pandemic. But Federal grants have provided a substantial level of support for innovative and lifesaving programs in States across the country that are on the front- lines of addressing substance use disorders. By authorizing this grant program and aligning it with the initiatives established in the 21st Century Cures Act, H.R. 2466 would ensure continued, reliable support for substance use disorder prevention, treatment, and recovery efforts. Of course, Mr. Speaker, I strongly lend my support to passage of this legislation, and I join with the chairman of the committee, Mr. Pallone, in urging our colleagues across the building to act swiftly on this. I reserve the balance of my time.

Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I have no additional speakers on this important legislation. I encourage my colleagues to support the bill, and I yield back the balance of my time.

Mr. WALDEN

Mr. WALDEN. Madam Speaker, I yield myself such time as I may consume. I rise today to urge passage of H.R. 6624, the USA Telecommunications Act. This bill will help put the United States at the helm of network security, ensuring that communications providers have a secure, diverse, and competitive marketplace of trusted equipment suppliers for their next-generation networks. Until now, most network providers have relied on a small set of trusted suppliers to build their networks. While these suppliers have done a tremendous job, they face increased pressure from untrusted Chinese suppliers who are handpicked and encouraged by the Chinese Communist Party to significantly undercut the network equipment marketplace by offering nearly free equipment. As a result of this unfair competition, trusted suppliers have increasingly relied upon proprietary soup-to-nuts offerings to survive. But under the soup-to-nuts model, once a network provider selects a vendor, the provider must use the same vendor for all of the hardware and software across its network. Well, this model is simply not sustainable, Madam Speaker. If we want the United States to continue to have access to trusted, affordable communications equipment that can withstand state-sponsored attempts to undermine our security, then we have to act. This model results in an expensive and timely process to upgrade equipment and software for the next-generation 5G networks. Furthermore, competing for a small set of contracts in a limited marketplace, while simultaneously trying to fight off untrusted state- sponsored vendors, has also resulted in significant losses to research, development, and innovation. So Congress needs to act. We need to do all we can to ensure the United States supports capitalism and competition among trusted vendors. Today's bill will help us do just that. The USA Telecommunications Act will promote and accelerate the deployment and use of open radio access technology by infusing the marketplace with a $750 million grant program. This hefty infusion should help create a marketplace filled with a diverse array of vendors, large and small, who are aggressively researching and innovating. Competition among open network solutions will reduce costs for network providers by creating a diverse marketplace of trusted suppliers and ensure that the same suppliers can withstand pressure from those who do not have our best interests in mind. So this strong endorsement of open, interoperable, and standards- based equipment would help ensure the United States maintains its place as a global leader in wireless communications for 5G as well as future network generations. I am very pleased to support this legislation which will help ensure the superiority of our wireless networks for generations to come. I urge a ``yes'' vote on this legislation. Madam Speaker, I yield 5 minutes to the gentleman from Kentucky (Mr. Guthrie), one of the principal authors of this legislation.

Mr. WALDEN. Madam Speaker, I have no other speakers on this legislation, so I urge its passage, and I yield back the balance of my time.

Mr. WALDEN

Mr. WALDEN. Mr. Speaker, I rise in support of H.R. 2117, the Food Allergy Safety, Treatment, Education, and Research Act. This legislation codifies sesame as a major food allergen. This means that, with enactment of the legislation, products containing sesame would have to list this ingredient on the food packaging label. That is really important for consumers. Recent studies indicate that sesame allergies in the United States have a prevalence rate on par with the allergies for soy and fish, which are both listed as major allergens under the Federal Food, Drug, and Cosmetic Act. It is commonsense legislation. It provides consumers with important and, perhaps, even lifesaving information to protect themselves and their families from dangerous allergic reactions. Mr. Speaker, I urge support of the bill, and I yield back the balance of my time.

Mr. WALDEN

Mr. WALDEN. Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I rise today in support of H.R. 5855, the Bipartisan Solution to Cyclical Violence Act of 2020. I want to thank our colleagues, Representatives Ruppersberger and Kinzinger, for putting forward a meaningful solution to address violence in all of our communities. This legislation provides Federal grants to hospitals and trauma centers for intervention services for victims of violent crime. Violence in America disproportionately impacts urban and underserved communities where poor social determinants of health can contribute to structural violence. Hospital-based intervention programs help reduce violence because they reach high-risk individuals recently admitted to a hospital for treatment of a serious violent injury. Hospitalization presents a unique and, frankly, teachable moment when an individual may be open to help, in turn, breaking the cycle of violence by immediate intervention. Currently, many hospitals are left with nothing but simply discharging gunshot injury patients without any strategy in place to reduce the risk of recidivism or retaliation. However, according to the American College of Surgeons, those who received violence intervention at the hospital, Madam Speaker, were significantly less likely to be reinjured and to get involved in crime in the future. So it works. By supporting hospital-based violence intervention programs, this bill would help individuals at risk from becoming entangled in violent crime and connect them with local resources that address the underlying risk factors for violence. Madam Speaker, I urge a ``yes'' vote, and I reserve the balance of my time.

Mr. WALDEN

Mr. WALDEN. Madam Speaker, I rise to support H.R. 3878, the Block, Report, And Suspend Suspicious Shipments Act, which was led by my Energy and Commerce Committee colleagues, Representatives McKinley and Dingell. This legislation addresses an alarming problem that was identified in the committee's 2018 bipartisan investigation in the distribution of prescription opioids by wholesale drug distributors. The committee found that when millions of prescription opioids were dumped into communities, large and small, across the country, the distributors flagged the orders for the DEA, but shipped the orders anyway, even after notifying the authorities that the orders were suspicious. H.R. 3878 would place additional commonsense obligations on drug manufacturers and distributors who discover a controlled substance suspicious order. In addition to reporting the suspicious order to the DEA, this legislation requires the manufacturer or distributor to exercise due diligence, to decline to fill the order, and to provide information to the Drug Enforcement Administration on the indicators that led to the belief that filling the order would violate the Substances Controlled Act. We all have a part to play in the fight against the opioid epidemic, and it is critical that pharmaceutical manufacturers and distributors step up in stopping pill dumping. Madam Speaker, I thank my colleagues, Representatives Dingell and McKinley, for their extra effort on this legislation. It is a fine piece of work moving forward, and I commend them for their work. Madam Speaker, I don't believe I have any speakers on this one, so I yield back the balance of my time.

Mr. WALDEN

Mr. WALDEN. Madam Speaker, I yield myself such time as I may consume. I rise in support of H.R. 4806, the Debarment Enforcement of Bad Actor Registrants, or DEBAR Act, which was introduced by Energy and Commerce Communications and Technology Subcommittee leader Bob Latta. He spoke to this legislation earlier on a different bill and had a commitment now that precludes him from being here as this bill comes up. This legislation would give the Drug Enforcement Administration debarment authority to prohibit a person who has repeatedly violated the Controlled Substances Act from being able to receive a registration to manufacture, distribute, or dispense a controlled substance. A recent Justice Department Office of Inspector General report found that certain bad actor registrants who had their registration revoked were able to simply reapply for registration the day after the enforcement action or registration surrender occurred. As a result, registrants who pose a significant risk of diverting drugs are actually given an opportunity to do it again. Repeat offenders should not be able to get away with a new registration from the DEA just days after the suspension of the old one. Limited debarment authority is a commonsense and effective administrative tool to address diversion, fraud, and misconduct. I strongly support Mr. Latta's legislation and I thank my colleague, the chairman of the committee, for his work on this, as well. Mr. Speaker, I urge our colleagues to support this bill, and I reserve the balance of my time.

Mr. WALDEN. Madam Speaker, I, too, would urge this bill's passage, and I yield back the balance of my time.

Mr. WALDEN

Mr. WALDEN. Madam Speaker, I yield myself such time as I may consume. I rise today in support of H.R. 4812, the Ensuring Compliance Against Drug Diversion Act spearheaded by Energy and Commerce Committee colleague Representative Morgan Griffith. I thank Mr. Griffith for his leadership on this and many other pieces of legislation. This legislation addresses a policy issue that was identified again in our 2018 Energy and Commerce Committee report summarizing the committee's bipartisan investigation into the distribution of prescription opioids by wholesale drug distributors and subsequent enforcement practices by the DEA. The investigative report that we issued found that an opioid distributor and its pharmacy customer did not go through the appropriate process of transferring a registration to a new pharmacy owner. This is disturbing, because failing to appropriately contact the DEA and verify whether the agency approved the transfer of a registration to dispense controlled substances creates a serious risk that could lead to drug diversion. In order to prevent people who have not been vetted by the authorities from dispensing controlled substances, H.R. 4812 makes clear that the transfer of any controlled substance registration without written consent from the DEA will be prohibited. Madam Speaker, I urge support of this legislation, and I reserve the balance of my time.

Mr. WALDEN. Madam Speaker, I yield as much time as he may consume to the gentleman from Virginia (Mr. Griffith), who has been a real workhorse on this and many other pieces of legislation.

Mr. WALDEN. Madam Speaker, I again thank the gentleman from Virginia for his leadership on this and so much other legislation. Madam Speaker, I urge passage of the legislation, and I yield back the balance of my time.

Mr. WALDEN

Mr. WALDEN. Madam Speaker, I yield myself such time as I may consume. I rise in support of H.R. 6096, the READI Act. This legislation will help improve the Federal Communications Commission's oversight over the wireless and broadcast emergency alert systems, something that is much needed in a new age of communication. This year, our Nation was hit by horrific and deadly wildfires that destroyed entire communities. My district and many parts of Oregon witnessed this situation with catastrophic fires that moved very, very rapidly, caused incredible and historic destruction, and will take years for people to recover. Our Emergency Alert System is so important during these times, and we need to make sure it delivers for Americans when they need it most. In some parts of my State, it worked flawlessly. In other parts, they are reviewing what worked and what didn't work. I daresay I am probably the only Member of Congress who actually has wired in Emergency Alert System components because we used to own radio stations. So I have pushed the buttons, and I have done the alerts, all of that. I know how important that coordination is and how important it is to work together ahead of time to really understand the plans and who triggers what and how it works going forward. Because when the emergencies do hit, there isn't time to come up with a plan. You need to have that in place. This bill will help establish State Emergency Communications Committees, develop Emergency Alert System plans, and coordinate those plans with the FCC. This type of coordination allows States the independence to tailor their plans to their specific needs and to alert citizens during emergencies that are specific to their localities. However, the bill also allows the FCC to review the plans to ensure States and other localities have considered any necessary technical issues so that there is consistency across the plans in the case of multistate or national emergencies. Importantly, this bill requires coordination not only with the experts on telecommunications technology but also with the experts on emergency management, FEMA. The FCC will ensure State plans have considered the necessary technical requirements, while FEMA ensures consistency regarding the types of emergency alerts. This type of State and national coordination will make sure that all Americans receive alerts during emergencies and that those alerts make sense, and that will no doubt save lives and property. Madam Speaker, that is why I am happy to support this forward-looking bill to improve the Emergency Alert System management at all levels, and I urge my colleagues to do so as well. I would just close my comments with a brief story about one of these practice emergency sessions in my hometown on a Saturday morning. It was a full-fledged one. All the various resources in the area were to be engaged. The theory was that one of the mainstem Columbia River dams had breached and that there would be massive flooding. So, that was kind of the idea: What do you do in a mass casualty situation like that? Fortunately, the gentleman who worked Saturday mornings at our local radio station had been around the block a few times. He was actually a retiree who just liked working, doing an old radio show on Saturday mornings. When they got the call and told him he needed to trigger the Emergency Alert System because Bonneville Dam had been breached, he said, ``Okay. I understand that is the practice, but I am not going to actually go on air and say the dam has been breached.'' Because he had been around a little bit, he pushed back on the emergency folks who were going by the letter of the plan and decided not to create one of these events like occurred in Hawaii by saying, ``I don't think we really want to say that, even though this is a practice.'' I think we headed off probably a little bit of a problem there. Madam Speaker, this is important, and these plans are important. I thank my colleagues for their work on this legislation, and I reserve the balance of my time.

Mr. WALDEN. Madam Speaker, I don't believe I have any other speakers on our side of the aisle on this legislation, so I would urge its passage. Madam Speaker, I yield back the balance of my time.

Mr. WALDEN

Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume. I rise today in support of H.R. 7310, the Spectrum IT Modernization Act. I would like to thank Chairman Doyle and his team for working with us, along with our colleagues in the Senate who introduced this bill, Senators Wicker, Cantwell, Inhofe, and Reed. Today's bipartisan legislation will help improve NTIA's ability to fulfill its mandate of managing spectrum among Federal agencies. The Energy and Commerce Committee has long conducted oversight of our Nation's spectrum resources, and we work to balance the critical agency mission needs and the demand to make spectrum available for commercial users. Through NTIA and the Federal Communications Commission, we have successfully made Federal spectrum available for commercial use, which is why the United States has led the world in deploying advanced networks such as 3G and 4G, and we are continuing these efforts to maintain U.S. leadership in 5G. Working across all of the Federal agencies has resulted in unprecedented commercial access to our airwave resources--like the recently announced 100 megahertz of spectrum identified for commercial use that the FCC will auction next year--and has garnered billions of dollars in private investment by the private sector. In order to leverage the efficiencies and innovation from our free market system, NTIA must have visibility across Federal agencies as to how agencies are using or not using these critical resources consistent with their statutory mission. As our world continues to demand increased connectivity, it is essential that we harness technological innovations and empower the NTIA to efficiently track Federal spectrum use to identify new opportunities to improve efficiency. Done correctly, this results in benefits for American consumers, taxpayers, and, frankly, the Federal agencies as well. H.R. 7310 would require NTIA to establish a process to upgrade their spectrum management infrastructure for the 21st century. The bill would direct the policy coordination arm of NTIA to submit a plan to Congress as to how they will standardize the data collection across agencies and then directs agencies with Federal spectrum assignments from NTIA to issue an implementation plan to interoperate with NTIA's plan. This is a good-government bill--it really is--and with continued support and oversight from Congress, we can continue the United States' leadership in making Federal spectrum available for flexible use by the private sector. So I encourage my colleagues to support the legislation. Mr. Speaker, I have no further speakers. I urge passage of the legislation, and I yield back the balance of my time.