Dec 11 2014
“I’m pleased Senator Bennet has joined me in this important effort to encourage the development of desperately needed treatments for some of the most troubling diseases and disabilities out there”
Washington, D.C.—Senators Orrin Hatch, R-Utah and Michael Bennet, D-Colorado, introduced the Dormant Therapies Act, a bill that will establish a new class of pharmaceuticals known as "dormant therapies" eligible for 15 years of data protection. This provision will remove the “ticking patent clock” conundrum that forces companies to prioritize research based on which compounds can be brought quickly to market.
“I’m pleased Senator Bennet has joined me in this important effort to encourage the development of desperately needed treatments for some of the most troubling diseases and disabilities out there,” Hatch said. “We hope to create a time-certain protection to encourage innovators to capture lost opportunities and bring new and essential products to market for the patients who need them.”
“We need to find every possible way to encourage innovation that will improve health care and save lives,” Bennet said. “This bipartisan bill will drive investment in the research and development of therapies that patients need the most.”
Millions of patients struggle with conditions such as Alpha-1, ALS, Alzheimer’s, epilepsy, lupus, mesothelioma, and multiple sclerosis. For many individuals with a long-term disease or disability, no treatments are available. Of over 7,000 known diseases or conditions, there are only satisfactory treatments for about 500 of them.
It takes on average 14 years for a compound to make its way through the therapeutic pipeline from discovery, through clinical trials, to formal approval, and eventually to the patient. Because patents last for only 20 years, much of this time is consumed during the lengthy research and development process. The result is companies are investing in research on compounds that can be brought to market quickly, rather than new treatments that could serve people with the most complex medical needs.
The Dormant Therapies Act will help create promising opportunities to bring new drugs to market for the patients who need them most.
Dec 10 2014
The PATH Act is needed to spur the innovation of new antibiotics and give patients with unmet medical needs access to important antibiotics faster”
Washington, D.C. — U.S. Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) today introduced a bill to create a new drug approval pathway to streamline access and encourage innovation and development of potentially lifesaving antibiotic drugs for patients, particularly Veterans who have encountered antibiotic-resistant bacteria while overseas.
“Antibiotic-resistant bacteria pose serious and unique challenges to health care professionals,” Bennet said. “This bill will allow new antibiotics that show promise combating these bacteria to reach patients more quickly and save lives. It will also encourage bioscience companies to invest in innovative research to develop these lifesaving drugs.”
“By addressing antibiotic-resistant bacteria, we can make major strides in preventing a significant number of illnesses and deaths in the United States,” Senator Hatch said. "I am excited to build on the progress we have made. The PATH Act is needed to spur the innovation of new antibiotics and give patients with unmet medical needs access to important antibiotics faster.”
“Superbugs”—or bacteria that are substantially resistant or unresponsive to any existing and available antibiotic—are an increasingly urgent public health threat, both at home and abroad. While antibiotic resistance continues to cost tens of thousands of lives in the United States each year, less than ten new antibiotics have made it to market since 2000. Antibiotic-resistant bacteria is also a significant concern to our troops, affecting more than a third of returning Iraq and Afghanistan veterans, according to the Department of Defense.
In an effort to address some of the significant regulatory obstacles facing antibiotic development and hindering patient and veteran access, the Promise for Antibiotics and Therapeutics for Health (PATH) Act would permit the Food and Drug Administration (FDA) to accelerate an antibacterial drug’s approval for an identifiable, limited patient population upon determining that the drug treats a serious or life-threatening condition and addresses an unmet need. In addition, the bill requires a drug’s label to include special designation from FDA indicating their intended use in limited, high-risk populations approved under this pathway. The bill also calls for further guidance and potential expansion to other appropriate therapeutic areas.
Dec 09 2014
Harkin, Alexander, Hagan, Hatch Praise Senate Passage of Bipartisan Bill to Enhance Life-Saving Newborn Screening Programs
"Reauthorizing this program means that newborns will have a better shot at dealing with these conditions thanks to early diagnosis."
WASHINGTON, D.C., Dec. 9 – Health, Education, Labor, and Pensions (HELP) Committee Chairman Tom Harkin (D-IA), Ranking Member Lamar Alexander (R-TN), and HELP Committee members Sens. Kay Hagan (D-NC) and Orrin Hatch (R-UT) today praised unanimous passage in the Senate of the bipartisan Newborn Screening Saves Lives Reauthorization Act.
“Today I am pleased the Senate moved forward with this critical bill to invest in healthy families. Newborn screening programs play an essential role in the early detection and treatment of conditions that affect newborns. This bipartisan bill will ensure that infants and families get timely, accurate screenings,” Harkin said. “By supporting states, this legislation will help them to improve their newborn screening programs and assist pediatricians and other providers with finding and treating any medical conditions at the earliest possible time. For families around the country, these screening programs save lives and I thank Senators Hagan and Hatch for their tireless efforts to move this important bill forward.”
“The legislation passed by the Senate today will improve life-saving screenings for nearly 80,000 infants born in Tennessee every year—as well as ensure that parents and doctors have the information and resources they need to keep the newborns in their care as safe as possible,” Alexander said.“Senator Hatch and Senator Hagan have done great work with this bill, and I look forward to the House quickly taking up and passing this important legislation.”
“I am so pleased that the Senate came together to reauthorize these critical programs and ensure more infants have the chance to lead a full and healthy life,” said Hagan, Chair of the Senate Subcommittee on Children and Families. “As a mom and a grandmother, I know that parents have no greater concern than their children’s health, and today, no family should suffer because a treatable condition was left undetected at birth. I hope the House will move swiftly to approve this bill that will give states the resources to improve their newborn screening programs, and ensure that babies with serious or even fatal conditions get the care and treatment they need right when they’re diagnosed at birth.”
“When I first sponsored this bill in 2008, we created national newborn screening guidelines and helped improve comprehensive newborn screening in every state,” Hatch said. “Today, I’m proud that 30 more states treat at least 29 of 31 treatable core conditions. Reauthorizing this program means that newborns will have a better shot at dealing with these conditions thanks to early diagnosis. I’m pleased to support it once again."
The Newborn Screening Saves Lives Reauthorization Act, introduced by Sens. Hagan and Hatch, would reauthorize federal programs and grants that assist states with improvements to their newborn screening programs—including ensuring quality laboratory equipment and surveillance for newborn screening. The legislation also supports states in related education programs for parents and health-care providers and continues the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children, which determines which newborn screening tests should be added to the Recommended Uniform Screening Panel. The screening panel serves as a reference for states in determining which conditions to screen for in their respective newborn screening programs.
Approximately one in every 300 newborns in the United States has a condition that can be detected through screening, according to the March of Dimes.
Dec 05 2014
"I'm proud that the abort launch motor and other integral components involved in this launch were built in Utah and I hope Utahns will continue to play a key role as Americans journey to the stars and beyond"
Washington, D.C. — Senator Orrin Hatch, R-Utah, the most senior Republican in the United States Senate, issued the following statement regarding the Orion launch:
Washington, DC - Today, Finance Committee Ranking Member Orrin Hatch (R-Utah) praised Senate passage of a bipartisan, bicameral bill to terminate Social Security benefits for Nazi persecutors. Hatch introduced the Senate version of the bill, the No Social Security for Nazis Act, in November. The legislation closes a loophole in the current law that allows persecutors to receive benefits. The bill passed the Senate by unanimous consent last night.
“I am proud the Senate spoke in unison and passed this bill in a bipartisan fashion,” said Hatch. “It’s outrageous that Nazi war criminals and anyone who participated in Nazi persecution atrocities continue to collect Social Security benefits while living abroad. With the President’s signature, this will stop once and for all.”
Additional Senate cosponsors include Sens. Michael Bennet (D-CO), Richard Burr (R-NC), Dan Coats (R-IN), John Cornyn (R-TX), Mike Enzi (R-WY), Chuck Grassley (R-IA), Johnny Isakson (R-GA), Mark Kirk (R-IL), Mike Lee (R-UT), Marco Rubio (R-FL), Roger Wicker (R-MS), Pat Toomey (R-PA), and Ron Wyden (D-OR).
In early December, Hatch and Sen. Chuck Grassley (R-IA), pressed the Social Security Administration and the Justice Department for statistics in areas including the total number of Nazi suspects who received Social Security benefits after leaving the United States, how many suspected Nazis currently receive Social Security benefits and live outside the country, information on the potential outcome of certain identified cases, and details of interaction between the Social Security Administration and the Justice Department on the issue.
Text of the legislation and bill summary information is available by clicking here.