Lipinski Helps Pass Life-Saving 21st Century Cures Act
Congressman Dan Lipinski (IL-3) joined with colleagues from both sides of the aisle last night to pass the 21st Century Cures Act. The bill will boost funding for biomedical research, and streamline and update the approval process for medical innovations, improving the quality of life for many Americans.
“This legislation will help speed the development and delivery of life-saving cures,” said Rep. Lipinski. “It provides a critical infusion of resources for medical research, as I have long advocated for. While not compromising patient safety, it will speed up the process by which medications and medical devices are approved in order to get new treatments to patients faster. While this bill is not perfect, I am glad the House could come together to get legislation passed that will improve the lives of so many people.”
Highlights from the bill include:
· Special National Institutes of Health (NIH) and Food and Drug Administration (FDA) innovation accounts to support special biomedical research projects and streamlined approval for new drugs and medical devices. NIH would receive $4.8 billion over 10 years, while the FDA would receive $500 million. These funds would support important priorities set out by the current administration, including research on personalized medicine and Vice President Biden’s “Cancer Moonshot” initiative.
· The formal reauthorization of the NIH through FY2020. The reauthorization requires the NIH to support prize competitions to promote biomedical research for serious health conditions, improve transparency by allowing the NIH Director to require grant recipients to share data generated from NIH-funded research, and focus on supporting young emerging scientists. In addition, a new pediatric research network will help pool resources and improve coordination for efforts related to pediatric rare diseases and birth defects.
· New efforts to streamline FDA reviews. Breakthrough medical devices will now receive priority review. The rare pediatric disease priority review voucher program which incentivized the development of new drugs for kids with rare diseases will be renewed until October 1, 2020. The bill also gives the FDA the flexibility to approve antibiotics for life-threatening infections based on smaller clinical trials and allows them to use accelerated approval pathways for regenerative therapeutic products such as cell therapy and gene therapy. The FDA will also have more flexibility to hire staff at rates competitive with the private sector and academia. Currently, the FDA has trouble recruiting enough scientists as employment in the private sector is much more financially lucrative for them.
· The creation of a fund for states to respond to the opioid abuse crisis. This funding provides resources for the opioid abuse initiatives Congress passed and the President signed into law in July.
· Important provisions to reorganize and expand federal mental health efforts. Mental health research grants will now be subject to closer evaluations and oversight, and federal agencies will be able to better disseminate information about research findings and best practices to providers and consult with stakeholders to improve community-based mental health services. The bill also directs Health and Human Services to clarify situations when medical providers can disclose the private health information of patients with mental illness with their responsible caregivers. Congressman Lipinski supported related mental health legislation when it was first considered as a standalone bill in the House this past summer.
· An Affordable Care Act (ACA) fix that Lipinski cosponsored to aid small employers who want to help pay for their workers’ health insurance plans. Under the ACA, small employers were not allowed to reimburse their workers for any insurance they purchased on their own, even if the employer did not have the resources to sponsor its own job-based health plan. This provision once again allows small employers to help workers with their health costs in this way.
· Legislation Lipinski cosponsored to better track the epidemiology of neurological diseases.
· Healthcare price transparency for Medicare. Because Medicare pays for some services both in hospital outpatient departments and in ambulatory surgical centers, Medicare patients may have different out-of-pocket costs depending on where they go for the service. The bill includes a provision to create a website that would make it easy for Medicare beneficiaries to compare providers’ costs and the resulting out-of-pocket expenses for these procedures.
· Provisions based on Lipinski’s University Regulation Streamlining and Harmonization Act. The bill reduces the time and resources spent by researchers and universities in complying with excessive, duplicative, and inefficient federal regulations.
“While there are many positive aspects to this legislation, passing this bill is only the first step,” stated Rep. Lipinski. “I am disappointed that we could not vote to increase NIH and FDA funding even more, as we did in July of 2015 when the initial version of the 21st Century Cures Act was passed in the House. Furthermore, unlike the bill I supported last year, the legislation we passed last night does not provide a funding guarantee. Continued vigilance from patient advocates and researchers will be needed to ensure that the funding promises in this bill are kept. Congress must also exercise its oversight duties to ensure that the new streamlined FDA approval processes in this bill work as intended and do not facilitate the entry of unduly risky drugs and devices into the market.”
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