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CCTS Newsletter | December 5, 2016

Monday, December 5, 2016   (0 Comments)
Posted by: Blake Goodman
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CCTS Newsletter Copy
 Dale Dirks and Dale Christiansen
December 5, 2016

Shortly after introducing a negotiated 21st Cures Act (H.R. 34), the House passed the measure with strong bipartisan support. The current version of Cures represents months of negotiations between the House and Senate as well as Democrats and Republicans. While some lawmakers, including Senator Elizabeth Warren (D-MA), have voiced objections to the measure, it is expected to pass the Senate and to be sent to the president for enactment. 

H.R. 34 includes many of the provisions from the “Cures” bill that previously passed the House along with provisions from stand-alone bills that were advanced by the House Ways & Means Committee and the Senate’s Health, Education, Labor, and Pensions Committee. The bill also includes robust provisions directed towards promoting mental health services and fighting opioid abuse. The bill focuses on five key topics; reducing barriers to collaboration, further incorporating the patient-perspective, modernizing clinical trials, developing new pathways to approve treatments and devices, and making new investments to fund the National Institutes of Health (NIH) and the Food and Drug Administration (FDA).

Over the next ten years, H.R. 34 provides $1.4 billion for NIH’s Precision Medicine Initiative, $1.56 billion for the BRAIN Initiative, $1.8 billion for cancer research, and $30 million for regenerative medicine using adult stem cells, and $500 million for FDA.

The funding for these specific programs is offset annually and designated for these specific purposes. The legislation allows the appropriations committees to provide the funding for these programs on an annual basis without it counting against the budget cap. The authors of the bill believe this mechanism will encourage ongoing support for these specific initiatives while freeing up traditional discretionary resources so those funds can then be used to provide NIH and FDA with more generous general budget increases each year. 

The bill is a mixed-bag for medical research, patient care, and treatment development. There are many positives created through new opportunities and the potential for enhanced funding. There are also some drawbacks related to relaxing of patient protections in research and regulatory review, and the utilization of the Prevention and Public Health Fund as a funding offset. NIH and FDA are given a significant number of new mandates and relatively few resources to facilitate the additional responsibilities.

Please join the next CCTS advocacy call for a full overview of Cures (details below).

Monday, December 19th, 2016
4:00 PM – 4:30 PM (Eastern Time)
Dial-in number: 1 (800) 944-8766
Participant Passcode: 79743#