Ensuring Pathways to Innovative Cures (EPIC) Act

Leveling the Playing Field for Small Molecule Medicines by Eliminating the Pill Penalty

The Ensuring Pathways to Innovative Cures (EPIC) Act is critical bipartisan legislation aimed at correcting the unintended negative impacts of the Inflation Reduction Act (IRA), specifically the so-called “pill penalty” that threatens investment in essential small molecule medicines. The EPIC Act aligns the government pricing timelines for small and large molecule medicines to 13 years, restoring crucial incentives for research and innovation.

The pill penalty is already impacting investment into R&D investment, threatening long-term progress in developing innovative treatments for mental illness. This poses a serious threat to mental health clinical research by narrowing the pipeline of innovative therapies available for study and advancement.

The EPIC Act would eliminate the pill penalty by aligning the IRA’s price-setting timeline for small molecule medicines with that of other therapies—setting prices 13 years after FDA approval rather than 9. This change is critical for the future of brain-focused treatments.

Importance of Small Molecule Medicines

Small molecule medicines play an indispensable role in healthcare due to their unique properties:

    • Intracellular Reach: Their smaller size allows them to easily penetrate cell membranes, effectively targeting intracellular mechanisms vital for treating challenging conditions like cancer.
    • Blood-Brain Barrier Penetration: Crucially effective in treating central nervous system diseases such as mental illnesses, epilepsy, stroke, and neurodegenerative disorders due to their ability to cross the blood-brain barrier.
    • Enhanced Patient Adherence: Available in patient-friendly formats like tablets, pills, and capsules, enhancing adherence and ensuring better disease management outcomes.
    • Reduction of Health Disparities: Easier administration can reduce transportation and healthcare access barriers, significantly benefiting underserved populations.

Negative Impacts of IRA’s Pill Penalty

The IRA’s pill penalty undermines the viability of investing in small molecule medicines, so that:

    • Pharmaceutical companies will shift R&D away from critical small molecule medicine development.
    • There will be a projected $232 billion decrease in small molecule R&D investments over the next 20 years.
    • Which means nearly 80 fewer innovative small molecule medicines reaching patients.

Benefits of the EPIC Act

By aligning the pricing timeline for small and large molecule medicines to 13 years, the EPIC Act:

    • Preserves and encourages critical R&D investments.
    • Facilitates continued innovation in treating chronic diseases and conditions with significant unmet medical needs.
    • Protects patient access to advanced therapeutic options.

Real-World Examples of the Pill Penalty’s Impact on Mental Health R&D

✓ Decline in post-approval clinical trials: Industry-sponsored, small molecule post-approval clinical trials dropped by nearly 47.3% following IRA’s implementation — evidence that further therapeutic exploration, including mental health indications, is being deprioritized. source: NPC, , WeWork

✓ R&D funding slashed by 70%: Since September 2021, early-stage investment in small molecule drug development—including those targeting mental illness—has plunged by 70%. source: ITIF

✓ 82% of companies expect substantial pipeline impact: A PhRMA survey found that 82% of companies with mental health projects predict “substantial effects” on their pipelines, with many cancelling or deferring important mental health drug candidates  source: DC Journal, Pfizer, PhRMA, ITIF

✓ Projected loss of dozens of mental health small molecule drugs: University of Chicago economists predict up to 79 fewer small molecule drugs reaching the market over 20 years—including novel treatments for mental illnesses—due to insufficient guaranteed exclusivity time. source: University of Chicago, JAMA, T.Tillis, ITIF

Further Information & Resources

IRA Impact on Mental Illness
PFCD EPIC Act Impact Infographic
EPIC Act Overview
H.R.7174: EPIC Act
PhRMA White Paper on the EPIC Act

How You Can Support the EPIC Act

Take immediate action to support the EPIC Act:

Contact Your Legislators:

Reach out directly to your representatives to express support.

Join Advocacy Efforts:

Participate in campaigns led by patient advocacy groups and industry coalitions.

Spread Awareness:

Utilize social media platforms, community meetings, and professional networks to highlight the EPIC Act’s importance.

 

Progress in mental health research doesn’t just happen—it’s driven by people like you. If you believe in protecting access, accelerating innovation, and breaking down barriers for those living with serious mental illness, now is the time to act.

 

Contact your representatives, amplify these efforts in your networks, and make your voice heard. Policymakers need to know that the mental health research community is paying attention—and ready to lead.