POLICY PERSPECTIVE
Rapid advancements to policy and committees welcomed in the new year. One of the most highlighted actions was the advancement of the nomination of Dr. Robert Califf as the incoming commissioner of the FDA to the full U.S. Senate. GLI and the patient advocacy community depend upon a reliable regulator that understands the importance of patient representation, and inclusion throughout the drug development process. We support the eventual selection of a new FDA commissioner that shares these values. With this in mind, GLI and GLI’s Liver Action Network (LAN) submitted a letter of support to U.S. Senators Patty Murray and Richard Burr, the Chair and Ranking Member on the Committee on Health, Education, Labor and Pensions in support of Dr. Califf’s nomination. His extensive experience collaborating with patients equips him with the knowledge and tools to address the diverse influencing factors that can impact liver disease such as obesity, COVID-19, and substance use disorders.
He was the former FDA commissioner previously in 2016 under the Obama administration. Dr. Califf’s work as a cardiologist and biotechnology consultant gained him extensive research experience on clinical trial design and established partnerships with the pharmaceutical industry. The incoming commissioner faces profound challenges concerning the future of the pandemic given that rapid COVID-19 tests regulated by FDA are expensive and hard to find. However, Dr. Califf is not given sufficient credit for his commitment to patients and the patient advocacy community. His support for the People-Centered Research Foundation strengthened the ability of patients and patient advocates to partner with researchers across the People-Centered Research Institute’s PCORnet. Dr. Califf has demonstrated throughout his career that he would ensure the FDA continues its expansion of these vital initiatives.
In order to advance liver health, partnership with regulatory bodies such as the FDA is vital due to the diverse nature of liver cancers, rare liver diseases, and chronic liver diseases. The absence of leadership in the FDA has left a gap in making significant progress to offer new and innovative treatments for liver health patients most in need. GLI and GLI’s Liver Action Network are encouraged to see the nomination of Dr. Califf to the full Senate. We look forward to the filled Commissioner role that will offer the FDA more stability, and progress forward in placing patient needs at the forefront of medical treatment development and research.
Donna R. Cryer, JD
President & CEO
Global Liver Institute
OPEN ADVOCACY OPPORTUNITIES
Register Today for the DDNC’s 32nd Annual Public Policy Forum
The DDNC Spring Public Policy Forum, held virtually this year from March 6th to March 8th, is an advocacy conference that brings together patient advocates, health care providers, and industry representatives from the major national voluntary and professional societies concerned with digestive diseases. This year’s theme is “Putting Patients First”, and over the course of this event, attendees will hear from multiple panels of leaders in the digestive disease community, learn about the key legislative issues impacting digestive disease patients, and advocate for digestive disease research and improved patient care in virtual meetings with Capitol Hill congressional offices.
To register for the Public Policy Forum today, please fill out the registration form here.
GLI POLICY DEVELOPMENTS
Register for GLI Primary Biliary Cholangitis (PBC) Externally-Led Patient-Focused Drug Development (EL-PFDD) Meeting
An EL-PFDD meeting of this magnitude will allow the U.S. Food and Drug Administration (FDA) and other stakeholders across the medical field to obtain a wide range of patients’ and caregivers’ input on PBC including their perspectives on their condition, its impact on daily life, and the urgency around developing therapies. Global Liver Institute will lead an Externally-Led Patient-Focused Drug Development Meeting (EL-PFDD) on Primary Biliary Cholangitis (PBC).
This online event is scheduled for February 4, 2022 and is open to the public with registration required. Register here.
NIDDK Strategic Plan for Research
This past month, the National Institute of Diabetes and Digestive and Kidney Diseases released their final strategic plan. The strategic plan presents a broad vision for accelerating research over the next 5 years to improve the health of people who have or are at risk for diseases within its mission: diabetes and other endocrine and metabolic diseases; liver, intestinal, and other digestive diseases; nutritional disorders; obesity; and kidney, urologic, and hematologic diseases. The Strategic Plan is based on extensive input from leading researchers and patient advocates, including GLI and GLI’s LAN, across the country.
GLI Advocacy Letters:
Updates from the Liver Action Network
Fatty Liver Foundation
Coming to grips with the risk of dying from liver disease is the key to learning to live with liver disease. If you know someone who might benefit from learning about us or who you think might be supportive please feel free to forward this to them. Here are some links to information that might be of value as an introduction to the foundation:
- Wayne Eskridge of the Fatty Liver Foundation was a recent guest on the Surfing the NASH Tsunami podcast and spoke about the SUNN (Screening for Undiagnosed NAFLD and NASH) Study. Podcast episode linked here.
- The Fatty Liver Foundation SUNN study report is now published and live on PLOS ONE. Read it here.
- The Fatty Liver Foundation launched a public-private partnership fund with the long-term goal of screening a million asymptomatic, undiagnosed individuals a year for nonalcoholic fatty liver disease (NAFLD).
Liver Health Foundation
Webinar: Liver Cancer, Hepatocellular Carcinoma (HCC), and Cholangiocarcinoma
When: February 23, 2022
Time: 5:30-6:30 PT
This webinar will offer crucial facts about liver cancer, its multiple and various causes in adults and children, available treatments including medication and transplantation, guide for prevention of liver cancer, and points on surviving liver cancer. Knowledgeable hepatologists and oncologists will touch upon the risk factors and at-risk individuals and will offer updated guidance on liver health. Pre-registration is required here.
Mid-South Liver Alliance
Mid-South Liver Alliance will be holding a ‘Walk With Me’ campaign in collaboration with a new initiative called Lifestyle Changes in the South. This event will begin March 1, 2022 and the goal is to promote a more physically active lifestyle in the southeastern US. More information will be shared soon on their website: https://midsouthliveralliance.org/.
Register for RDLA Virtual Rare Disease Week on Capitol Hill – February 22-March 2, 2022
Rare Disease Week on Capitol Hill brings together rare disease community members from across the country to be educated on federal legislative issues, meet other advocates, and share their unique stories with legislators.
No prior experience is necessary. Registration for this event and all RDLA events are free for all rare disease advocates. Register here.