What Is the Mini Act and Why Do We Support It?

Maintaining Investments in New Innovation “MINI” Act (H.R. 1672)

The MINI Act will help expand research, accelerate advancements in medical breakthroughs, and improve access in healthcare.

What is the MINI Act?

Bipartisan legislation that requires genetically targeted technologies (GTTs) to have market approval for 11 years instead of seven before they qualify for the Medicare Drug Price Negotiation Program. Allowing GTTs to come up for Medicare price negotiation after only seven years discourages investment in this technology.

The MINI Act would correct the part of the Inflation Reduction Act (IRA) that treats GTTs as simpler medications, as opposed to grouping them with more sophisticated and complex therapies such as biologics, which require more time and investment for development.

Investing in the future of medicine

Medical breakthroughs such as genetically targeted technologies (GTTs), which target diseases at the genetic level, go beyond just treating symptoms. They have the potential to be life-saving and transformative for patients and caregivers.

GTTs can improve quality of life, ease the burden of disease, and address adherence challenges for patients and their caregivers.

Strong policies must follow to ensure that these lifesaving treatments continue to reach those who need them most. GTTs hold great promise for several disease areas but are at risk without federal support:

Cardiovascular Health

• Cardiovascular disease remains the leading cause of death among Americans, yet it is often underdiagnosed and undertreated. GTTs, which are taken only once or twice per year, can improve adherence, a critical factor in CV disease management and a barrier for rural Americans.

Rare Diseases

• Many rare diseases impact women disproportionately or uniquely, yet research and therapeutic development remain limited. GTTs under development would treat several rare diseases that currently have no available treatments.

Neurological Conditions

• Women are at higher risk for diseases such as Alzheimer’s, Parkinson’s, and multiple sclerosis, yet provider shortages for these conditions make it hard to get treatment. GTT's would reduce the number of healthcare provider visits required to manage these conditions, thereby easing provider burden.

Pediatric Health

• Investing in research that addresses pediatric diseases, such as spinal muscular atrophy, is critical to ensuring healthy outcomes for future generations.

How do GTTs help women?

GTTs can target sex-specific genetic factors, so they have the potential to revolutionize the prevention, diagnosis and treatment of multiple complex, rare and hard-to-treat disorders that disproportionately affect women.

The MINI Act would:

• Protect continued investment in treatments for cardiovascular, rare, neurological, and pediatric diseases.
• Mitigate unintended consequences of the Inflation Reduction Act that threaten medical innovation.
• Support caregivers — primarily women — by reducing medical visits, crises, and costs.

We urge Congress to:

• Prioritize women’s health research and innovation.
• Advance policies like the MINI Act that protect investment in lifesaving therapies.
• Commit to closing research gaps that disproportionately harm women and families.

Together, we can improve health outcomes for women and families nationwide.

Resources

HealthyWomen Policy Statement

Capital Conversation