New Governors, New Opportunities
New Governors, New Opportunities
With SCHIP funding secured (15,000 children are hospitalized each year for liver disease complications) and only passing mention of healthcare in President Trump’s State of the Union, liver health advocates would do well to look to states in 2018. Ralph Northam, a Democrat from Virginia, and Phil Murphy, a Democrat from New Jersey, are the newest governors sworn into office. 2018 also marks the end of term for the governors of Alaska, Hawaii, and New York. With all of the changes to office, it is important to use this time to put liver health on the public health agenda.
Ralph Northam’s past in health care as a practicing physician, associate professor, and Medical Director may give him a different take on health policy. His Policy Council on Health and Human Resources includes Karah Gunther of Virginia Commonwealth University and VCU Health System, and Steve McCoy of Patient First.
Phil Murphy addressed a variety of health-related issues in his inaugural address this month. In his campaign, he advocated for “Healthcare That Works for All of Us” and was endorsed by New Jersey’s largest nurses’ union. He urges New Jersey residents to take action, and is leading the state’s fight to save the Affordable Care Act and has asked for legislation “to reaffirm our support for women’s health.”
We ask that if you are a resident of Virginia, New Jersey, Alaska, Hawaii, or New York, you take a moment to review the policies of your newly elected governor or to examine the candidates for governor in your state. This new wave of changes to state governments can open doors to improving state legislation and can provide a platform for all liver patient advocates.
- Donna Cryer, JD, President & CEO, GLI
OPEN ADVOCACY OPPORTUNITIES
Nominations are now open for the 2018 Rare Impact Awards. If you or someone you know has done outstanding work and had a positive impact on the rare disease community in 2017, nominate them for the 2018 Rare Impact Award.
Participate in the HOPE Study, a hepatitis B and C observational, longitudinal, prospective study. Participants will be seen on an annual basis with optional additional visits for up to 10 years and will provide biologic samples for research and evaluation of disease progression.
Are you a liver cancer patient or survivor? The Exercise Oncology Lab at the University of Illinois at Urbana-Champaign is conducting an online study examining exercise programming and counseling preferences of liver cancer patients and survivors
POLICY DEVELOPMENTS AT GLI
GLI and Smart Patients are thrilled to announce a new Smart Patients community for liver patient advocates. The Liver Health Advocates Network allows liver patients and caregivers to come together to improve local, state, and national liver health policy while giving personal, first hand advice on coping with all aspects liver disease. Learn about comorbidities, clinical trials, insurance, state legislation, and how to make your voice heard. Join us today!
GLI has created a new monthly newsletter, NASH News, to report developments in various organizations as well as policy updates, and upcoming conferences. The purpose of NASH News is to help an expanding set of stakeholders, patients, and others stay up to date on NASH-related activities. Subscribe to NASH News before its second publication, coming soon!
Advanced Advocacy Academy
GLI’s Advanced Advocacy Academy (A3) brought together students and faculty from more than a dozen states to learn what it means to be a liver health advocate. Over the course of two days, patients and caregivers learned about clinical research and development, value frameworks, legislation, healthcare delivery, and more. One patient said, “I appreciated the diversity of topics and the incredibly high caliber of presentations. It definitely exceeded my expectations!” Learn more about A3 and apply for next year’s Academy!
FOR YOUR CALENDAR
February 1: GLI NASH Council: Public Education and Screening Workgroup. 12:00pm EST.
February 8: GLI NASH Council: Clinician Education, Diagnosis, and Management Workgroup. 12:00pm EST.
February 15: GLI NASH Council: Patient Education and Support Workgroup. 12:00pm EST.
February 22: GLI NASH Council: Policy Workgroup. 12:00pm EST.
February 26-27: Global NASH Congress. London, United Kingdom.
April 23-25: 2nd Annual NASH Summit. Boston, MA.
June 2-5: Digestive Disease Week. Washington, D.C.
Food and Drug Administration (FDA)
FDA Commissioner Dr. Scott Gottlieb issued a statement detailing steps FDA is taking to increase clinical trial information and new drug approval transparency. Clinical study reports (CSRs) contain information that may better inform scientists, providers, and patients on drugs. In a new pilot program, following the approval of a new drug application (NDA), FDA will include certain information from the CSR to improve public access to drug information. Learn more about current clinical trial transparency and the efforts FDA is taking to improve clinical trial and new drug public information.
FDA announced plans to increase generic drug competition as part of the Drug Competition Action Plan. The Drug Competition Action Plan aims to reduce the ability of branded companies to delay generic drug entry, to resolve scientific and regulatory issues standing in the way of approving generic versions complex drugs, and to improve efficiency and predictability of the FDA’s generic drug review process. FDA has released two documents: Good Abbreviated New Drug Applications (ANDA) Submission Practices and its accompanying Manual of Policies and Procedures (MAPP). FDA hopes these new resources will help streamline the generic drug review and approval processes and increase generic drug competition. Learn more about generic drug competition and FDA’s recent work to improve generic drug review.
FDA Commissioner Dr. Scott Gottlieb published a blog post detailing FDA’s successes in 2017 and their goals for 2018. 2017 was marked by record generic drug approval and new policies that safe and effective product innovation. FDA also took many steps to promote drug competition in 2017 and spent the year empowering and protecting consumers. In December 2017, Dr. Gottlieb published a piece detailing his goals for 2018, which include advancing biosimilar policy, adapting over-the-counter policies, and increasing drug safety. Read Dr. Gottlieb’s blog post to stay up to date on FDA’s 2018 goals.
Mechanisms of Disparities in Chronic Liver Diseases and Cancer. Funds available from NIH: $200,000. Application deadlines: April 4, 2018 or April 4, 2019.
HIV and Hepatitis B Co-Infection: Advancing HBV Functional Cure through Clinical Research (R21). Funds available from NIH: $275,000. Application deadline: May 8, 2020.
Addressing Health Disparities in NIDDK Diseases (R01 Clinical Trial Not Allowed). Funds available from NIH: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications; application budgets are not limited but need to reflect the actual needs of the proposed project. Application deadline: January 7, 2020.
TERMS TO KNOW
Pharmacovigilance: drug safety; “the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products”
Non-Medical Drug Switching: “the switching of a patient’s medicine, often at the behest of a third party, for reasons other than the patient’s health and safety”