Frank Pallone

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include extraneous material on H.R. 1570.

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of H.R. 1570, the Removing Barriers to Colorectal Cancer Screening Act of 2020. This bill eliminates out-of- pocket costs for colorectal cancer screening tests under Medicare, even in situations when a polyp is detected and removed. Colorectal cancer is the second leading cause of cancer death among men and women, combined, in the United States. The American Cancer Society predicts that more than 53,000 Americans will die from the disease this year. This is clearly a tragedy, especially because these deaths are so preventable. Approximately 90 percent of all individuals diagnosed with colorectal cancer at an early stage are still alive 5 years later. But research shows that out-of-pocket costs discourage individuals from seeking out preventative screenings that could save their lives. Under current law, Medicare waives coinsurance and deductibles for colonoscopies. However, when a polyp is discovered and removed during the procedure, it is then reclassified as therapeutic for Medicare billing purposes, and patients are required to pay the coinsurance. This simply is not right. Patients should not be saddled with hundreds of dollars in medical bills that they justifiably thought would be covered by Medicare as part of a preventative service. H.R. 1570 provides a commonsense fix to this oversight. The bill would ensure that colonoscopies, whether they are diagnostic or therapeutic, are treated equally at the billing stage so all cost- sharing is waived under Medicare. By removing the financial burden associated with this procedure, Medicare beneficiaries may seek preventative care for colorectal cancer without the added deterrence of surprise bills. In addition, H.R. 1570 incorporates a policy that requires all part B drug manufacturers to report average sales price data to the Medicare program and provides the Secretary with new authority to verify this data. Under current law, only manufacturers with Medicare drug rebate agreements are required to report average sales price data, and in the absence of such data, the Medicare program ends up paying more. This legislation ensures that the government is paying the right price for part B drugs, saving taxpayers billions and allowing greater transparency around drug pricing. Mr. Speaker, I want to thank the bill's sponsors. First of all, I want to thank Representative Donald Payne from my State. He has been working on this bill for so many years, and, of course, it came out of the passing of his dad from colorectal cancer. I remember his dad so fondly. Mr. Speaker, I also want to thank Representatives Davis, McEachin, and McKinley for their hard work on this important piece of legislation. I want to thank Representative Doggett for his work on the important drug pricing policy that is included today. Mr. Speaker, I urge my colleagues to support H.R. 1570, and I reserve the balance of my time. House of Representatives, Committee on Ways and Means, Washington, DC, December 7, 2020. Hon. Frank Pallone, Chairman, Committee on Energy and Commerce, Washington, DC. Dear Chairman Pallone: In recognition of the desire to expedite consideration of H.R. 1570, Removing Barriers to Colorectal Cancer Screening Act of 2019, the Committee on Ways and Means agrees to waive formal consideration of the bill as to provisions that fall within the rule X jurisdiction of the Committee on Ways and Means. The Committee on Ways and Means takes this action with the mutual understanding that we do not waive any jurisdiction over the subject matter contained in this or similar legislation, and the Committee will be appropriately consulted and involved as the resolution or similar legislation moves forward so that we may address any remaining issues within our jurisdiction. The Committee also reserves the right to seek appointment of an appropriate number of conferees to any House-Senate conference involving this or similar legislation. Finally, I would appreciate your response to this letter confirming this understanding and would ask that a copy of our exchange of letter on this matter be included in the Congressional Record during floor consideration of H.R. 1570. Sincerely, Richard E. Neal, Chairman.

Mr. PALLONE. Mr. Speaker, I yield such time as he may consume to the gentleman from New Jersey (Mr. Payne), the sponsor of this bill, who has worked so hard on it.

Mr. PALLONE. Mr. Speaker, I ask that we support this legislation and pass it, and I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 1966) to direct the Comptroller General of the United States to complete a study on barriers to participation in federally funded cancer clinical trials by populations that have been traditionally underrepresented in such trials, as amended.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 4499) to amend the Public Health Service Act to provide that the authority of the Director of the National Institute on Minority Health and Health Disparities to make certain research endowments applies with respect to both current and former centers of excellence, and for other purposes, as amended.

Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include extraneous material on H.R. 4499.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, may I inquire if the gentleman has any additional speakers.

Mr. PALLONE. Mr. Speaker, I ask all of our Members to support this bill, and I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I have no additional speakers. I urge my colleagues to support the bill, and I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 2117) to improve the health and safety of Americans living with food allergies and related disorders, including potentially life- threatening anaphylaxis, food protein-induced enterocolitis syndrome, and eosinophilic gastrointestinal diseases, and for other purposes, as amended.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 5855) to amend the Public Health Service Act to establish a grant program supporting trauma center violence intervention and violence prevention programs, and for other purposes, as amended.

Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include extraneous material on H.R. 5855.

Mr. PALLONE. Madam Speaker, I also urge all of my colleagues to support this legislation, and I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the bill (H.R. 3878) to amend the Controlled Substances Act to clarify the process for registrants to exercise due diligence upon discovering a suspicious order, and for other purposes, as amended.

Mr. PALLONE. Madam Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous material on H.R. 3878.

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I rise today in support of H.R. 3878, the Block, Report, And Suspend Suspicious Shipments Act of 2020. This bill will improve reporting an action on suspicious orders on controlled substances. Between 1999 and 2017, more than 700,000 Americans died from a drug overdose. Many of those Americans were caught in the first wave of what we typically describe as three waves of this epidemic. This first wave began in the 1990s with deaths involving prescription opioids. In 2010, we saw dramatic increases from heroin-involved deaths. And most recently, we are seeing a third wave involving synthetic opioids, like illicitly manufactured fentanyl. During that first wave, Americans across the country became addicted to opioids. Many of those opioids were prescribed to patients to treat pain. However, throughout the years, we have discovered that many of these opioids were diverted through a system meant to prevent diversion. The Drug Enforcement Administration requires entities that manufacture or distribute controlled substances to register and report their activities through ARCOS. This system is meant to track the manufacture, distribution, and dispensing of these substances. In this system, registrants are also expected to disclose suspicious orders of controlled substances, such as orders of unusual size, orders deviating from a normal pattern, or orders of unusual frequency. As an effort to improve reporting and action on suspicious orders, this bill would clarify the responsibilities of drug manufacturers and distributors when discovering a suspicious order, and require communications around that order to DEA. This will help all entities to better identify suspicious activity and root out bad actors. Madam Speaker, this is a commonsense bill that will make clear the responsibilities for all entities in our supply chain and, hopefully, help to deter opioid diversion and trafficking. I commend the lead sponsors of this bipartisan bill, Representatives Dingell and McKinley, and their staff for their work on this legislation. I also thank the Democratic and Republican members of our committee, as well as bipartisan staff for working together to move this bill. Madam Speaker, I urge my colleagues to support H.R. 3878, and I reserve the balance of my time. House of Representatives, Committee on Energy and Commerce, Washington, DC, November 16, 2020. Hon. Jerrold Nadler, Chair, Committee on Judiciary, Washington, DC. Dear Chairman Nadler: Thank you for consulting with the Committee on Energy and Commerce and agreeing to be discharged from further consideration of H.R. 3878, the Block, Report, and Suspend Suspicious Shipments Act of 2020, so that the bill may proceed expeditiously to the House floor. I agree that your forgoing further action on this measure does not in any way diminish or alter the jurisdiction of your committee or prejudice its jurisdictional prerogatives on this measure or similar legislation in the future. I would support your effort to seek appointment of an appropriate number of conferees from your committee to any House-Senate conference on this legislation. I will seek to place our letters on H.R. 3878 into the Congressional Record during floor consideration of the bill. I appreciate your cooperation regarding this legislation and look forward to continuing to work together as this measure moves through the legislative process. Sincerely, Frank Pallone, Jr., Chairman.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the bill (H.R. 4806) to amend the Controlled Substances Act to authorize the debarment of certain registrants, and for other purposes, as amended.

Mr. PALLONE. Madam Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous material on H.R. 4806.

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. I rise today in support of H.R. 4806, the Debarment Enforcement of Bad Actor Registrants Act of 2020, or the DEBAR Act of 2020, which gives the Drug Enforcement Administration, or the DEA, additional tools to go after bad actors. The DEA is charged with enforcing and implementing policies to protect public health and safety through the Controlled Substances Act. One important lever DEA has at its disposal to manage diversion or noncompliance with the law is the ability to revoke or surrender an individual's CSA registration, which is needed to handle controlled substances. While this is an important tool, a recent Department of Justice Office of the Inspector General report found weaknesses in DEA's registration process and instances where the agency did not fully utilize its regulatory authorities to address noncompliance. Specifically, the inspector general found cases where entities have been able to obtain a new license after having one that was revoked. For example, the report outlined a case that included a doctor who was engaged in serious misconduct and had his registration revoked, who then moved to another State under the authority of a different DEA field division. When the doctor reapplied for registration, it was granted. Another example, Madam Speaker, in the report included a dentist who had voluntarily surrendered his medical license and DEA registration on two separate occasions. The dentist also had been convicted of a felony, which is grounds for suspension or revocation of an individual's registration under the CSA. However, according to DEA, the dentist was still able to obtain another DEA registration. Now, these errors by the DEA are simply unacceptable, Madam Speaker. Today, we are considering H.R. 4806, which would address these errors. The legislation would authorize the debarment of any registrant that either meets the criteria for temporary or permanent suspension or revocation or has a history of prior suspension or revocations. Again, I thank my colleague Representative Latta for leading this legislation and Ranking Member Walden and his staff for working with me on this legislation. Madam Speaker, I urge my colleagues to support the bill, and I reserve the balance of my time. House of Representatives, Committee on Energy and Commerce, Washington, DC, November 16, 2020. Hon. Jerrold Nadler, Chair, Committee on Judiciary, Washington, DC. Dear Chairman Nadler: Thank you for consulting with the Committee on Energy and Commerce and agreeing to be discharged from further consideration of H.R. 4806, the DEBAR Act of 2020, so that the bill may proceed expeditiously to the House floor. I agree that your forgoing further action on this measure does not in any way diminish or alter the jurisdiction of your committee or prejudice its jurisdictional prerogatives on this measure or similar legislation in the future. I would support your effort to seek appointment of an appropriate number of conferees from your committee to any House-Senate conference on this legislation. I will seek to place our letters on H.R. 4806 into the Congressional Record during floor consideration of the bill. I appreciate your cooperation regarding this legislation and look forward to continuing to work together as this measure moves through the legislative process. Sincerely, Frank Pallone, Jr., Chairman.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the bill (H.R. 4812) to amend the Controlled Substances Act to provide for the modification, transfer, and termination of a registration to manufacture, distribute, or dispense controlled substances or list I chemicals, and for other purposes, as amended.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 4712) to amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes, as amended.

Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include any extraneous material on H.R. 4712.

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, today I rise in support of H.R. 4712, the Fairness in Orphan Drug Exclusivity Act, a bill that will close a loophole in the orphan drug program to ensure generic drugs are not unfairly being blocked from entering the market. Since it was first passed in 1983, the Orphan Drug Act has been successful in driving research and discovery of new therapies to treat and even cure rare diseases. The law creates two pathways for manufacturers to be designated as an orphan drug and to gain certain incentives, including 7 years of market exclusivity. The first and most commonly used pathway is for developing drugs approved to treat diseases with patient populations of 200,000 or fewer. There is also the rarely used cost-recovery pathway, where the drug research and development costs are not expected to be recouped by sales of the underlying drug. Now, under certain circumstances, a manufacturer may also receive additional rounds of exclusivity for drugs in their portfolio if they treat the same conditions and have the same active ingredient, even if the second drug does not meet the orphan drug qualifications. This provision has allowed some manufacturers to circumvent the original intent of the Orphan Drug Act, which was to incentivize creation of novel drugs for small populations, all the while blocking generic competitors from coming to market. An example of this recently occurred when a formulation of Buprenorphine, a drug to treat opioid use disorder, was approved in 2017. It was allowed to carry the orphan drug designation granted to its manufacturer's original Buprenorphine drug more than 20 years earlier, in 1994. When the original 1994 orphan drug designation was granted, it was expected that Buprenorphine would not be prescribed frequently; however, as the opioid crisis worsened and our response to the crisis evolved, millions were eventually prescribed the drug, generating billions of dollars in sales. Clearly, we knew in 2017 that Buprenorphine was not an orphan drug. Nevertheless, the drug was granted orphan drug status and exclusivity, delaying additional forms of generic competition. So while the Food and Drug Administration eventually recognized this issue with this particular drug and revoked its orphan drug designation, its exclusivity delayed generic competition that otherwise would have been on the market. We need every tool available to us to combat the opioid epidemic, and loopholes like this one should not be allowed to limit access to treatment, Mr. Speaker. H.R. 4712 will stop this from happening again in the future by requiring drug manufacturers to demonstrate in their application to the FDA that each drug application considered under the cost recovery pathway would fail to recoup development costs. This bill is narrowly tailored. It is a fix for a small but very real loophole in the law, and I want to thank Representative Dean for introducing the legislation. Mr. Speaker, I urge all of my colleagues to support it, and I reserve the balance of my time.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 2466) to extend the State Opioid Response Grants program, and for other purposes, as amended.