How the GOP Tax Plan Grinch is trying to Steal Christmas from Patients
POLICY PERSPECTIVE
How the GOP Tax Plan Grinch is trying to Steal Christmas from Patients
The House and Senate tax bills, as of this writing, drafted by the Republican controlled Congress, have several provisions that would hurt individuals and families living with rare, chronic, and expensive diseases. First, they would eliminate the Medical Expense deduction, which could prove economically catastrophic to patients with high medical expenses, like many liver patients in the year of their transplant or many liver cancer patients navigating treatment. The deduction is already limited by a high threshold before claiming. The elimination of such a deduction could force liver patients to lose homes, retirement accounts, or education funds.
Second, the bills would reduce the Orphan Drug tax credit, which was laid out in the 1983 Orphan Drug Act. Under original rules, companies developing orphan drugs receive a tax credit for 50% of the cost of their clinical trials for that drug. The proposed legislation cuts that credit to 27.5%, decreasing incentives to explore possible treatments and cures for rare diseases. It also undermines the importance and difficulty of performing research and clinical trials for rare diseases. Finally, a provision to eliminate the Affordable Care Act’s individual mandate will raise premiums for everyone still on an exchange plan by causing fewer young and healthy people to enroll or stay enrolled.
There is still time to make your voice heard. Make it known that these tax reform provisions will harm liver patients and families. Pick up the phone and call your senators. Sign on to letters addressed to our policy makers. Find the correct information at www.senate.gov and www.house.gov.
- 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 provide samples for research and evaluation of disease progression.
Attend the FDA’s public workshop, "Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology." The workshop will take place on January 29, 2018 in Silver Spring, MD.
- 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
NASH News
GLI is creating 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 the first publication, coming out next week!
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
November 30-December 2: 8th Annual Ruesch Center Symposium: Fighting a Smarter War Against Cancer. Washington, D.C.
December 13: Hepatitis C Among Pregnant Women. Webinar 12:00 pm ET.
January 4-6: NASH-TAG 2018. Park City, UT.
January 18-20: 2018 Gastrointestinal Cancers Symposium: Multidisciplinary Care: Local Practice, Global Outcomes. San Francisco, CA.
February 26-27: Global NASH Congress. London, United Kingdom.
April 23-25: 2nd Annual NASH Summit. Boston, MA.
May 18: NORD’s 35th Anniversary Celebration and 2018 Rare Impact Awards. Washington, D.C.
June 2-5: Digestive Disease Week. Washington, D.C.
HHS NEWS
Food and Drug Administration (FDA)
FDA has several tools to measure and manage the risks associated with medications and medical technology. One such tool is the Risk Evaluation and Mitigation Strategy (REMS), which includes items such as medication guides and patient information. However, FDA Commissioner Scott Gottlieb voiced his concern that REMS could inhibit or slow generic drug innovation, and explains how generic and brand drug competition is influenced by REMS. Read his statement online to learn how FDA aims to improve generic drug access by making changes to REMS policy.
FDA released a policy framework addressing development, oversight, and management of regenerative medicine products. The framework aims to inspire innovation in regenerative medicine, increase access to novel products and therapies, and ensure patient safety. Learn more about regenerative medicine and how FDA stays up to date with ever-changing medical technology.
FDA has awarded funds to increase pediatric clinical trials research. Nearly 60% of drugs used on children are not approved for use in pediatric patients, and 90% of drugs used on neonatal babies are not approved for use in neonates. Institute for Advanced Clinical Trials for Children (IACT for Children) and Duke University have both been awarded $1 million to optimize the potential for successful pediatric clinical trials. Learn more about the challenges associated with pediatric clinical trials research and what FDA is doing to overcome them.
National Cancer Institute (NCI)
NCI published a blog post titled Liquid Biopsy: Using DNA in Blood to Detect, Track, and Treat Cancer to compare tissue and liquid biopsies and compare the pros and cons of each test. The traditional tissue biopsy carries more risk, pain, and expense than newer liquid biopsies that examine bodily fluids like blood and urine for abnormalities. Learn more about liquid biopsies and the roles they play in cancer screening, diagnosis, and treatment.
National Institutes of Health (NIH)
NIH’s All of Us research program aims to engage more than one million volunteers across the nation to create a diverse and robust dataset for health research. Fourteen organizations, from national community groups to health care provider associations, have partnered with the program and will educate their communities about the importance and benefits associated with participation in the All of Us project. Learn more about the All of Us research project and what you can do in your community to increase volunteers in health research.
GRANT OPPORTUNITIES
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/HCV Co-Infections in Substance Abusers (R01). Funds available from NIH: $3,000,000. Application deadline: January 8, 2018.
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.
NAMES TO KNOW
Lamar Alexander (R-TN). Proponent of the Alexander-Murray agreement.
Patty Murray (R-WA). Proponent of the Alexander-Murray agreement.