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The 21st Century Cures Act and Parkinson's Disease

The 21st Century Cures Act and Parkinson's Disease

President Obama signs the 21st Century Cures Act into law.

On December 13, President Obama signed the 21st Century Cures Act into law. A number of key provisions in the bill, which will directly impact the Parkinson's community, are highlighted here.

Develop infrastructure to collect data on neurological diseases to better understand who is living with these conditions, facilitate research and plan for health care needs.

Summary: The Cures bill creates the National Neurological Conditions Surveillance System at the Centers for Disease Control and Prevention (CDC) to collect demographic information on people living with neurological diseases.

We do not currently have accurate information about how many people are living with Parkinson's disease, where they are located or who they are (their gender, ethnicity, etc.). Lack of this core data slows research and makes it difficult to ensure health care services are properly allocated. The database will provide a foundation for understanding many factors, such as clusters of diagnoses in certain geographic regions, variances in the number of men and women diagnosed with neurological diseases, and differences in health care practices among patients.

PD community work on this issue: For nearly a decade, the community advocated to make this data collection system a reality. Efforts first began under the Parkinson's Action Network (PAN), which merged with MJFF in mid-2016. PAN, in collaboration with the National MS Society and other groups, crafted the legislation, secured champions in Congress and drove the overall strategy for this effort. PAN constituents sent thousands of emails and phoned hundreds of lawmakers to voice support for the database. They also conducted hundreds of meetings on Capitol Hill. In the last seven months, the PD community continued this momentum with MJFF -- advocates sent an additional 20,000 emails to members of Congress and MJFF staff met with the provision's key advocates in the Senate.

Next steps: In the coming months, we will continue working to implement the data collection system. The Foundation will advocate to ensure the database is fully funded and monies are appropriately allocated by Congress. As the Cures bill does not specify which diseases the system will track, we will collaborate with other Parkinson's organizations and the CDC to push for the inclusion of Parkinson's disease.

Support research initiatives to further our knowledge of the brain and develop individualized treatments, which can lead to better treatments and health outcomes.

Summary: Cures allocates $1.5 billion over ten years to the National Institutes of Health (NIH) for the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative, which supports the development and application of unique technologies to help researchers better understand the brain and treat conditions such as Parkinson's, Alzheimer's and depression.

The bill also provides the NIH with $1.5 billion over ten years for the Precision Medicine Initiative (PMI). Most medical treatments are designed for the average patient, but this one-size-fits-all approach might not be ideal. This Initiative aims to develop ways to tailor prevention strategies and treatments to an individual's unique genes, environment and lifestyle. Advances in precision medicine could be particularly beneficial for people with Parkinson's, each of whom has a unique set of symptoms and experience with the disease.

PD community work on this issue: PAN worked independently and in coalitions to voice support for the BRAIN and Precision Medicine initiatives through meetings with and letters to policymakers. PAN and MJFF leadership also attended the launch of each initiative at the White House.

Next steps: MJFF will continue to support future funding for these initiatives and will engage with BRAIN and PMI researchers in order to further our understanding of Parkinson's disease and the development of new treatments.

Expedite Food and Drug Administration (FDA) approval of regenerative medicines (cell therapies), without lessening the FDA's existing strict regulatory standards or authority.

Summary: The bill provides the FDA with flexibility to consider the unique attributes of regenerative medicine products (as compared to standard drug and device therapies) throughout the review process. This could potentially accelerate approval but would not compromise the agency's high standards for ensuring a therapy's safety and efficacy.

Cures allocates $30 million for clinical research to further the field of regenerative medicine using adult stem cells. Stem cell research in the field of Parkinson's could lead not only to symptomatic therapies but also a deeper understanding of the disease. Read more about PD stem cell projects. Watch a webinar on Parkinson's and stem cell research.

PD community work on this issue: A previous version of this provision included language that would have allowed the use of stem cell therapies that have been shown to be safe but not yet proven effective. (Essentially, it would have removed key FDA regulatory safeguards.) In response, MJFF joined with the Alliance for Regenerative Medicine (ARM), a coalition of patient groups, research organizations and industry partners, to send letters to and conducted meetings with the bill's sponsor and Administration officials to ensure the final version protected patient safety and upheld the FDA's regulatory standards.

Next steps: The FDA will draft guidelines to carry out this provision. As they do, MJFF will continue conversations with and serve as a resource and patient voice for the agency.

Institutes reforms at and provides additional funding for the Food and Drug Administration to improve access to care.

Summary: Cures requires the FDA to take patient perspectives into account in the drug approval process and tasks the agency with creating a framework for collecting patient experience data. This data includes information collected by various sources (patients, family members and caregivers, patient advocacy organizations, disease research foundations, researchers and drug manufacturers) that details a patient's experience with a disease or therapy and the impact it has on their lives. Patient preferences regarding the treatment of their disease will also be assessed. Involving patients in this manner will put government regulators in touch with the community's experiences and priorities as new drugs and devices enter late-stage clinical testing and move toward FDA approval.

The bill also creates an accelerated review process for breakthrough medical devices that offer significant advantages over the currently available products and those that could benefit patients with life-threatening or debilitating conditions. Combination therapies (those that are both a drug and device) will be eligible for a streamlined review process. Both reforms will speed patient access to certain device therapies.

The Cures bill allocates $500 million to the FDA to execute these and other programs.

PD community work on this issue: PAN coordinated the September 2015 FDA Patient-Focused Drug Development meeting on Parkinson's disease, in which patient panelists discussed their experiences living with PD and areas of unmet need. At the same time, PAN facilitated a large-scale survey to collect feedback on patient priorities to help the FDA learn more about Parkinson's.

Next steps: As the FDA budget often falls below what is needed to carry out its many programs, the Foundation will continue to push for adequate funding so the agency can fully and effectively fulfill its mission. MJFF also will offer expertise to ensure reforms are successfully instituted.

As these and other provisions in the bill are implemented the Foundation will continue working with and for the PD community. As evidenced by the 21st Century Cures Act's passage, your voice is critical in influencing legislation and creating policy change. Stay tuned to our blog and social media channels for updates as the process unfolds.

If you'd like to learn more about MJFF's public policy work, visit our policy webpage.

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