Liver Health Policy Update December 2021 - A Year of Advocacy in Review

POLICY PERSPECTIVE

In the past, efforts in liver advocacy were siloed by individual liver disease lessening their impact and limiting their effectiveness at shaping national health policy. In 2021 thanks to the efforts of Global Liver Institute (GLI), GLI’s newly created Liver Action Network (LAN), and collaboration throughout the liver advocacy community, we finally saw the value of synchronized engagement in liver health policy. The theme for 2021 really was collaboration, and how collaboration can lead to a shifting of the conversation on liver health. As the year comes to a close, we thought it would be worthwhile to highlight the variety of collaborative liver advocacy actions that occurred throughout the year.

January
Global Liver Institute (GLI) released the U.S. NASH Action Plan and applauded the introduction of the COVID-19 Prevention and Awareness Act (CPAA). GLI also applauded the leadership of Congresswoman Nydia Velázquez (D-NY) in the introduction of the COVID-19 Prevention and Awareness Act (CPAA).

The U.S. Food and Drug Administration (FDA) had their NASH Drug Development briefing titled: “Regulatory Perspectives for Development of Drugs for Treatment of NASH.” GLI expressed appreciation that the FDA had followed through on the 2020 line of dialogue and provided a response to many of their previously communicated concerns around acceptable endpoints, biomarkers, non-invasive diagnostics, and accelerated approval.

February 
The new Biden Administration began taking action on a few liver health policy issues this month; President Biden restored ties with the World Health Organization (WHO) on his first day in office, and also proposed an emergency relief package for the COVID-19 pandemic. 

Additionally, the Improving Social Determinants of Health Act (H.R. 379) was introduced by Rep. Nanette Barragán (D-CA) and allowed for the creation of a Social Determinants of Health (SDOH) Program at the U.S. Centers for Disease Control and Prevention (CDC). Find out more about these highlights in this month's LHPU.  

March 
GLI participated in the Digestive Diseases: Digestive Disease National Coalition 31st Annual Public Policy Forum (March 4-10), as well as several Obesity Care Week advocacy days to build support for the Treat and Reduce Obesity Act (TROA). GLI and many others within the liver advocacy community also advocated for these initiatives, and other critical liver policy issues, during the virtual Liver Capitol Hill Day that took place on March 24, 2021.

Furthermore, the Research Investment to Spark the Economy (RISE) Act  was reintroduced into Congress with backing from Senators Edward J. Markey (D-Mass.), Thom Tillis (R-N.C.), Gary Peters (D-Mich.), and Susan Collins (R-Maine) on February 5, 2021. This act provides nearly $25 billion in funding for research outside the realm of COVID-19. Find out more about these highlights in this month’s LHPU.  

April 
GLI participated in and advocated on behalf of patients with Hepatocellular Carcinoma (HCC) at the April Oncologic Drugs Advisory Committee (ODAC). As part of this participation, GLI sent a formal letter highlighting that HCC patients need a variety of therapeutic options at their disposal. GLI also participated in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Stakeholder Meeting, where we  stressed the importance of innovative products within the liver space, particularly in the treatment of NASH.

GLI also worked with the Liver Advocacy Community on submitting a letter to USPSTF asking for the inclusion of NAFLD/NASH within the recommendation statement on screening for prediabetes and type 2 diabetes, and urging the task force to utilize people-first language (attached). USPSTF published the final recommendation statement in August, and thankfully took the community’s recommendations by adjusting the statement to include people-first-language, including a highlighting of the risks of NAFLD, NASH, and diabetes. 

On April 14, 2021, the John Lewis NIMHD Research Endowment Revitalization Act (H.R. 189) was passed in the House and sent to the Senate — this bill expands eligibility for research endowments available through the National Institute on Minority Health and Health Disparities (NIMHD). Find out more about these highlights in this month’s LHPU. 

May 
On May 4, 2021, GLI witnesses (Donna Cryer and LaQuayia Goldring) testified at the U.S. House of Representatives Subcommittee Hearing on Reforming the Organ Transplantation System. On  May 27, 2021, GLI formally announced its Liver Action Network (LAN). GLI’s LAN provides the opportunity for individual advocates, and community roundtable member organizations, to use their voices and insights from lived experiences to advance liver health advocacy at a local, state, national, and global level. Read more here. 

June 
On June 10, 2021, GLI’s  fourth International NASH Day took place and was a remarkable  global success: 120 partners from over 35 countries and more than 25 international organizations participated.Additionally, the International Liver Congress Event took place from June 23-26, 2021. 

The Draft 21st Century Cures 2.0 Act was released in the U.S. House of Representatives along with the Medical Nutrition Equity Act which was reintroduced June 7, 2021. Also, the VALID Act  was also reintroduced in the month of June. 

July 
Virtual Rare Disease Week on Capitol Hill took place from July 14 - July 22 and met with significant success. On July 29, 2021, the U.S. House of Representatives voted on and passed the first iteration of the Fiscal Year 2022 Labor, Health and Human Services, Education, and Related Agencies Funding Bill.

July also sawGLI announcing  the expansion of its LAN to include collaborations with the Liver Coalition of San Diego, the Liver Wellness Foundation, the Midsouth Liver Alliance, and the Texas Liver Foundation. GLI’s LAN now represents more than 40 U.S. states, 2 countries, and 12 community liver advocacy organizations. Find out more about these highlights in this month’s LHPU.

August
GLI responded to the Updated Organ Transplant Societies’ Statement on Vaccine Efficacy in Transplant Recipients. GLI and its LAN  also responded to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Request for Information on the agency’s strategic plan, and urged the agency to consider liver health as an integral part of public health, from nutrition, physical activity, prevention, control and management of risk factors, to education, support, optimal clinical pathways, and policy for children, adults, and seniors. The August issue of The American Journal of Gastroenterology was released and included clinical discussions of diet-associated NAFLD risk and increased risk of mortality from COVID-19 among Proton pump inhibitors (PPI) users. Read more about these highlights in this month’s LHPU. 

September
GLI’s Advanced Advocacy Academy (A3) took place virtually on Capitol Hill September 21-23, 2021 and was a great success! More than 80 A3 advocates participated in and met with more than 40 Congressional offices as part of the virtual day on the Hill. Advocates were able to virtually share stories, and engage policymakers in a discussion about liver health, and the liver advocacy community's policy priorities including the Liver Illness, Visibility, Education and Research Act (LIVER Act), the NASH Care Act, and many other vital pieces of legislation.

GLI and the American Association for the Study of Liver Diseases (AASLD) also led a joint educational Congressional briefing on NASH. 

Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) announced that the committee had held a full Committee markup on the Build Back Better Act Monday, September 13, at 11 a.m. Read More about these highlights in this month’s LHPU .

October 
The LIVER Act was reintroduced, and the Liver Cancer Awareness Month Resolution was introduced on October 21, 2021. GLI thanked Representative Velázquez  and Senator Duckworth for their leadership on the reintroduction of the LIVER Act, and the introduction of the Liver Cancer Awareness month resolution. GLI President and CEO Donna Cryer highlighted that their leadership would be crucial to moving “the field forward and shifting the conversation to shine a spotlight on liver cancer, and liver cancer health disparities,” allowing us to finally elevate liver health to its rightful place on the national public health agenda. Read more in our press release here. 

Liver Cancer Awareness month took place during the month of October and allowed for a major swell in liver health/policy awareness including the launch of the inaugural State of Liver Cancer Report, and a highlight of Liver Cancer Awareness month by the CDC. GLI also collaborated with the Hepatitis B Foundation, NASH kNOWledge, and the Taiwan Hepatitis Information and Care Association (THICA) on a virtual Congressional briefing that explored the challenges and opportunities surrounding liver cancer around the globe, with the goal of improving health equity for all patients going through their own liver cancer journey.

November 
The NASH Externally-Led Patient Focused Drug Development (EL-PFDD) Meeting was held on November 4th (more information below). Representative DeGette and Representative Upton announced the official Cures 2.0 bill on November 16, 2021 and the House officially passed the Build Back Better Act November 19, 2021. Read more about these highlights in this month’s LHPU. 

It has been a great year of impactful advocacy and change and we are so excited about the multitude of y possibilities in  2022. We will continue our efforts to move the needle on liver health policy around the world.  

 

Donna R. Cryer, JD
President & CEO
Global Liver Institute

OPEN ADVOCACY OPPORTUNITIES

Ask Congress to Support the Liver Illness Visibility, Education, and Research (LIVER) Act
The LIVER Act is a public health initiative that will help people of all ages, lifestyles, and ethnic backgrounds reduce their risk for liver cancer and related risk factors like viral hepatitis and NASH. Don’t miss this opportunity to show the groundswell of support for the LIVER Act across the country, and urge your legislators to take action. Take action here.

Ask Congress to Support the Treat and Reduce Obesity Act (H.R. 1577 and S. 596)
TROA would expand Medicare coverage to include screening and treatment of obesity from a diverse range of healthcare providers who specialize in obesity care. Take action here.

GLI POLICY DEVELOPMENTS

GLI led NASH EL-PFDD Meeting on November 4th, 2021
GLI was excited to work with the liver advocacy community, including the member organizations within GLI’s LAN , to lead the first nonalcoholic steatohepatitis (NASH) ExternallyLed Patient Focused Drug Development Meeting (EL-PFDD) on November 4, 2021. 
A PFDD meeting of this magnitude allowed the FDA and other stakeholders across the medical field to obtain a wide range of patients' and caregivers' input on NASH, including their perspectives on their condition, its impact on daily life, and the urgency around developing therapies. It also highlights the FDA’s willingness to form meaningful partnerships that will contribute to the quality of the agency's regulatory decision-making and lend credibility to future therapy review processes. The NASH EL-PFDD meeting marked the continuation of a series of productive conversations that the liver community has had about hepatology with the FDA throughout 2020, and 2021. 
View the NASH EL-PFDD Recording.
A full NASH EL-PFDD outcome report will be released in the near future. It will explore  in detail the data gathered from responses to GLI's patient with NASH and caregiver survey, along with testimonies from the diverse group of patients and caregivers impacted by NASH that participated in the EL-PFDD meeting. 

Launch of GLI’s Liver Central
On December 8th, GLI launched Liver Central as a comprehensive online guide for all things related to liver cancer. With Liver Central, GLI looks forward to reinventing how liver cancer information is accessed. Liver Central will act as a hub that allows all stakeholders across the medical field, whether they are providers or patients and caregivers, to access vital information. This website will act as a critical resource that will give interested stakeholders the necessary tools, and most current information, to shift the conversation on liver cancer. Resources and tools on this site will continue to be built upon and expanded , and will be updated on a regular basis. 


GLI Advocacy Letters: 
GLI joined more than 156 organizations in support of the DIVERSE Trials Act (H.R. 5030/S. 2706)
GLI signed onto a Joint Letter to Congressional Leadership urging them to Protect the Orphan Drug Tax Credit for Individuals Living with Autoimmune Disease

Updates from the Liver Action Network

See more about these updates in the GLI Liver Action Network on the bottom of our Take Action Page! 

The Texas Liver Foundation’s Website is now Live
Click this link to learn more about the work of the Texas Liver Foundation and their initiatives to advance liver health. 

Texas Liver Foundation Virtual Pediatric Liver Transplant Survivors-a Celebration
The event will take place virtually on December 16th from 5:00PM to 6:00PM CST. Join a panel of Texas patients and families, moderated by leading Texas transplant surgeons. Register here.

The Fatty Liver Foundation has its SUNN Report Published in PLOS ONE 
On November 30, 2021 the Fatty Liver Foundation Foundation had its report published in PLOS One Journal. The report, which focused on screening for undiagnosed non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), was a population-based screening study that aimed to provide proof of concept to encourage community-level screening and detection for this non-communicable disease. Read the full article here.  

HepCURE Holds Hepatitis C Informational Events ​​
The first event held by HepCURE was a community outreach day in Toronto as part of the theme “Take 15”. This theme emphasized taking a 15-min break and learning about Hepatitis C in order to get tested. The event was supported by Gilead Canada. HepCURE held a similar second event Dec 3, 2021 in Niagara Falls.

NASH Knowledge Holds Virtual Conference and Updates their Patient & Provider Program in partnership with the Community Liver Alliance. 
On November 18, 2021, NASH Knowledge held a free virtual conference surrounding its Patient & Provider Program.. The conference focused on updating patients and caregivers on new developments surrounding NASH in the healthcare world. Several esteemed speakers with knowledge on liver health spoke .These two organizations partnered with each other  to update their Patient & Provider Program, which aims to provide patients with NASH and caregivers with information to expand their knowledge of support and resources for NASH. Read more in their newsletter here.  

Liver Coalition of San Diego Holds virtual webinars for Hepatitis B patients
On November 16, 2021, the Liver Coalition of San Diego held a virtual Q&A Webinar for Hepatitis B patients. The Q&A answered questions and provided support and resources for newly diagnosed patients. See the full video here. 

The Northeast Ohio Liver Alliance will hold an Upcoming Webinar on Viral Hepatitis 
On December 14, 2021 from 5:30-6:30pm the Northeast Ohio Liver Alliance hosted a webinar on the elimination of Viral Hepatitis in the U.S. The webinar included a variety of expert speakers. Read more here. 

GLOBAL NEWS

National University Cancer Institute, Singapore and MiNA Therapeutics announce Clinical Study about Liver Cancer 
The Phase 1 Clinical Study will aim to examine MTL-CEBPA in combination with the current standard of care for advanced liver cancer. MTL-CEBA has been reported to improve anti-tumor activity in drugs used for cancer treatment. On December 1, 2021 the first patient was dosed at the study location: NCIS clinical trial facility at the National University Hospital in Singapore. The doctors aim to study response rate and examine how new treatment combinations can improve patient outcomes. Read more about the clinical trial here.

U.S. FEDERAL NEWS

The House passed the Build Back Better Act on November 19, 2021
The Build Back Better Act has been passed by a vote of 220-213. The Act  provides funding for four major areas: Health Care Infrastructure and Workforce, Pandemic Preparedness, Maternal Mortality, and Other Public Health Investments. Read a full section by section summary here and the bill text here. 

Representative DeGette and Representative Upton announce the official Cures 2.0 bill on November 16, 2021
The bipartisan duo announced on November 16, 2021, their long-awaited Cures 2.0 bill to speed up medical innovations and create a new federal research agency. The bill hopes to allow for a new biomedical research agency and bring new treatments and technologies through Medicare to seniors faster. Read more about the bill and Degette and Upton’s statements here.

U.S. NGO NEWS

The Digestive Disease National Coalition Held its virtual Fall Forum November 15-19, 2021
The Forum’s theme was "Digestive Disease Patient Priorities" and included  an in-depth look at key digestive disease policy initiatives, including the Safe Step Act. The Forum included a Webinar where policymakers, caregivers, and patients received an overview of the coalition's funding priorities, and information on the Safe Step Act. 

UC Davis Health Team developed first PET imaging based tool to detect liver inflammation in NAFLD patients
The health team developed the positron emission tomography (PET) scan imagining machine to help detect inflammation in patients with non-alcoholic fatty liver disease. Read More Here. 

Obesity Care Advocacy Network (OCAN) hosted a briefing on November 19, 2021
OCAN leaders, along with Dr. Fatima Cody-Stanford, obesity medicine specialist at Harvard Medical School, talked through public opinion on how the federal government should address obesity, and whether people believe federal health programs like Medicare are updated regularly enough to address obesity and racial disparities in health care in the U.S. 

NAME TO KNOW

Dr. Chee Cheng Ean

Dr. Chee is a senior Consultant at the Department of Haematology-Oncology at the National University Cancer Institute, Singapore. She designed a groundbreaking clinical trial and study focusing on bettering treatment for patients with advanced hepatocellular carcinoma (HCC) or liver cancer. She emphasized in her research that “with only 30% of patients benefiting from objective responses to first line standard of care, new treatment combinations are needed in order to improve patient outcomes.” Read more about her research here.

GRANT OPPORTUNITIES

Policy UpdatesDonna Cryer