Congressman Chris Collins, R-NY-27, is hailing the passage of the 21st Century Cures Act - medical innovation legislation he said will directly benefit the lives of Western New Yorkers.
The legislation includes $6.3 billion to help accelerate the discovery, development and delivery of new cures and treatments and provides new funding for the National Institutes of Health and Food and Drug Administration.
As a member of the energy and commerce committee and the health subcommittee, Collins was able to play a direct role in the creation of the legislation. He weighed in on key elements of the bill, including the inclusion of measures to fight the opioid crisis, and helped to secure additional funding for the NIH, which will help fund research at places such as Roswell Park Cancer Institute.
"This bipartisan legislation incentivizes innovation to defeat disease, and most importantly gets cures to the patients who need them most," Collins said. "The 21st Century Cures Act provides the health care industry with the ability to help the thousands of Western New Yorkers impacted by deadly diseases by creating the life-saving cures those patients need."
Collins specifically authored the following provisions included in the legislation:
•Section 3021, which encourages the broader application of innovative clinical trial designs, including the use of Bayesian statistics and adaptive trials, to enhance and accelerate effective clinical trials. These changes to the way the FDA approves clinical trial designs are designed to help unleash new, groundbreaking therapies by allowing researchers to efficiently change their trials to meet the individual responses of their participants.
•Section 3071 will expedite and improve the drug approval process by increasing the number of senior biomedical researchers the FDA is allowed to hire and also making the salary of those individuals more competitive with private industry. This will help ensure the best and brightest scientists will remain with the FDA to review and approve drug applications, and get cures to patients more quickly.
•Section 9023, in collaboration with Congressman Joe Courtney, allows child and adolescent psychiatrists to participate in the National Health Service Corps loan repayment program. This will incentivize these subspecialists to begin their practices in underserved areas, like those in rural Western New York.
•Section 5006, in collaboration with Congressman Paul Tonko, includes the House-passed Medicaid DOC Act, which requires states operating a fee-for-service or primary care case-management system of Medicaid to publish an online directory of those physicians who have billed Medicaid in the past year and whether those physicians are accepting new patients.
"I am proud to have had a role in crafting this landmark legislation," Collins said. "Ensuring medical innovators have the funding and ability to do their jobs is crucial to helping the millions of Americans struggling with incurable diseases. This legislation has the ability to change people's lives, and I could not be more excited about its passage."
The 21st Century Cures Act will:
•Provide $1 billion in grants to states to address the opioid crisis, which is critical to Western New York.
•Addresses the country's mental health crisis and help the one out of five adult Americans suffering from mental illness and substance abuse disorders receive the care they need.
•Provide $4.8 billion to National Institutes of Health, including $1.4 billion for President Barack Obama's Precision Medicine Initiative to drive research into the genetic, lifestyle and environmental variations of disease; $1.8 billion for Vice President Joe Biden's "Cancer Moonshot" to speed research; and $1.6 billion for the BRAIN initiative to improve understanding of diseases like Alzheimer's and speed diagnosis and treatment.
•Help bring drugs and devices to market more quickly and at less cost by making needed reforms to the FDA, including: expedited review for breakthrough devices, increased patient involvement in the drug approval process, a streamlined review process for combination products that are both a drug and device, and freedom from red tape for software that charts exercise and counts calories.
•Provide $500 million to the Food and Drug Administration.
The legislation will now move to the Senate, where it will need to pass before heading to Obama's desk to be signed into law. It's expected to be brought to the Senate for a vote before the end of the year.