By Paula Eichenbrenner, TMA Executive Director
Myositis advocates are gathered on Capitol Hill in Washington, DC to meet with Members of Congress about issues that are incredibly important to our community. As we observe Rare Disease Day on February 28, 2026, #TheMyositisAgenda led by TMA encompasses support for therapeutic development, care partners, supplemental oxygen usage, and more.
While we applaud our community’s recent wins – particularly the increased FY26 appropriations that support a strong federal research infrastructure – much work remains. TMA’s current policy priorities include:
- Funding for FDA’s Rare Disease Innovation Hub in FY27.
- Regulatory flexibilities that recognize the complexities of rare disease research.
- The Credit for Caring Act (H.R. 2036 / S. 925).
- The Supplemental Oxygen Access Reform (SOAR) Act (H.R. 2902 / S. 1406).
- The Health Equity and Rare Disease (HEARD) Act (H.R. 1750).
TMA supports funding and report language in FY27 for FDA’s Rare Disease Innovation Hub. We ask Representatives to join a sign-on letter led by the Co-Chairs of the Rare Disease Congressional Caucus, Reps. Gus Bilirakis (FL-12) and Doris Matsui (CA-07). We ask Senators to include Hub funding in their office’s FY27 priorities.
Each type of myositis is rare, and TMA is grateful for FDA’s renewed commitment to supporting innovation through the new Rare Disease Innovation Hub, created in 2024. Only 5% of the more than 10,000 rare diseases have FDA-approved treatments, including most types of idiopathic inflammatory myopathies (IIMs).
Specifically, in the next bill to fund Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, TMA advocates for $5 million for the Rare Disease Innovation Hub. These funds are needed to support the Hub’s work and implementation of its current strategic agenda, particularly actions to expand opportunities for patient and clinical community stakeholders to engage earlier and more fully in the therapy development, and to enhance implementation of efforts to support and sustain cross-center consistency on rare disease review standards.
TMA joins the EveryLife Foundation’s Rare Disease Legislative Advocates in advancing this priority for the strategic, efficient Rare Disease Innovation Hub at FDA.
TMA supports regulatory flexibility at FDA because it is essential for the myositis community and our biopharma partners. Congress has powered innovation by explicitly giving the FDA authority to uphold the highest standards of regulatory safety and rigor, while applying tailored approaches.
The recent news about Abcuro’s ongoing effort to bring an inclusion body myositis (IBM) therapy to patients with significant unmet medical need illustrates the need for clinical trial design and agency reviews that adapt to the complexities of rare disease research. Congress must continue its outreach to FDA to maximize the impact of the accelerated approval pathway, orphan drug designations, and similar mechanisms.
TMA supports policies that enable FDA to leverage patient and expert insights even more effectively. We recommend the establishment at FDA of a Rare Disease and Condition Advisory Committee and a Science-Focused Drug Development initiative, as proposed in H.R. 1532 / S. 822, the Scientific EXPERT Act of 2025.
In addition, TMA advocates for FDA to immediately resume Advisory Committee Meetings to receive external expertise on product reviews and key policy issues.
Family care partners are the backbone of our myositis community. They help parents, spouses, and other loved ones live independently in their homes, saving taxpayers billions. TMA supports the bipartisan Credit for Caring Act (H.R. 2036 / S.925), which would create a tax credit available to family carers.
This bill would help working family caregivers offset the cost of some care-giving expenses such as a home care aide, adult day services, home modifications, assistive technology, respite care, transportation, or other supports that help them and their loved ones. Eligible family caregivers could receive the credit if the care recipient meets certain requirements certified by a licensed healthcare practitioner.
The credit amount would be 30% of the qualified expenses paid or incurred by the caregiver above $2,000, up to a maximum credit of $5,000. The bill includes careful provisions to prevent waste, fraud, and abuse and does not duplicate other sources of relief for family caregivers.
TMA joins AARP in supporting this ask. Learn more.
TMA supports the Supplemental Oxygen Access Reform (SOAR) Act (H.R. 2902 / S. 1406). The SOAR Act will improve Medicare patients’ ability to access the necessary and appropriate oxygen equipment, supplies, and services.
Interstitial lung disease (ILD) is a common complication in several forms of myositis, including dermatomyositis, antisynthetase syndrome, and polymyositis. The frequency of ILD in DM/PM has been reported to range between 20 and 78%. Many myositis patients with ILD use supplemental oxygen.
The SOAR Act would implement helpful oxygen reforms, such as creating a statutory service element to provide adequate reimbursement for respiratory therapists to ensure patients have access to their expertise. The bill would also ensure predictable and adequate reimbursement, while protecting against fraud and abuse, by establishing national standardized documentation requirements that rely upon a template to support claims.
On behalf of families affected by myositis and ILD, TMA joins the Pulmonary Fibrosis Foundation and all our partners in urging adoption of the SOAR Act by Congress. Learn more.
TMA supports funding to advance the study and treatment of rare disease and its impact on diverse populations. We urge the House to pass H.R. 1750, the Health Equity and Rare Disease (HEARD) Act.
This critical legislation addresses the diagnostic and care gaps that disproportionately affect historically underrepresented communities living with rare diseases like myositis. Health disparities and poor outcomes are particularly pronounced for women and people of color with all forms of myositis.
The bill amends the Public Health Service Act to provide for greater investments in research on rare diseases. The HEARD Act will develop a comprehensive federal plan to study and improve treatment outcomes in minority populations; establish a scholarship and loan repayment program for healthcare professionals serving rare disease patients; and strengthen inter-agency activities—namely, clinical trials, outreach and data collection, and early detection screening.
TMA joins Rare Disease Diversity Coalition (RDDC) in championing evidence-based solutions like the HEARD Act that prioritize diversity in research, access, and outcomes. Learn more.
Additional Priorities
TMA and our Board of Directors Chair, Rich DeAugustinis, are also advocating of federal legislation called The Right to Try for Individualized Treatments Act. This would expand access to individualized investigational treatments tailored to an individual’s unique genetic makeup, and ensures patients with a life-threatening disease or condition, or severely debilitating illness, are also eligible. Learn more.
Are there additional legislative or policy priorities that you think TMA should add to #TheMyositisAgenda? Email us or comment below.