Moore: Reform Needed for Inflation Reduction Act’s Pill Penalty

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TL/DR –

The leader of AIDS Delaware, Christopher Moore, has expressed concern over the barriers preventing patients from accessing lifesaving medications under the Biden Administration’s Inflation Reduction Act (IRA). The IRA penalizes small molecule drugs (pills and tablets) by making them eligible for Medicare drug price negotiation seven years after FDA approval with price controls going into effect at year nine, while biologics (typically injectables) have an 11-year eligibility period and price controls go into effect at year 13. Moore advocates for the passage of the Ensuring Pathways to Innovative Cures Act (EPIC Act), which aims to rectify these disparities by extending the small molecule exemption period to 13 years, aligning it with biologics and ensuring equitable access to medications for all patients.


Combatting Issues in Lifesaving Medications Access with the EPIC Act

Moore: Reform Needed for Inflation Reduction Act’s Pill Penalty

Christopher Moore, the interim executive director of AIDS Delaware, calls for congressional support of the Ensuring Pathways to Innovative Cures Act (EPIC Act). Moore argues that the proposed bill could correct the Inflation Reduction Act’s pill penalty, promoting equal access to vital medications for all Americans irrespective of location or background.

The EPIC Act aims to address the disparities in the existing IR framework, established by the Biden administration. The current model places small molecule drugs, such as pills and tablets, at a disadvantage compared to biologics (typically injectables). Currently, small molecule drugs can be chosen for the Medicare drug price negotiation program seven years post-FDA approval, with price controls implemented at year nine, whereas biologics have an 11-year eligibility period, with price controls starting at year 13.

These regulations, while intending to control costs, have unintentionally created an imbalance in the pharmaceutical sector. This disparity has resulted in the halting of the pursuit of new cures and shifting resources away from small molecule medicines. For instance, significant clinical studies for treatments of cancer and rare diseases have been paused due to the Inflation Reduction Act implementation.

The impact of this regulatory imbalance is significant. A University of Chicago policy brief suggests that the disparity in price control eligibility could result in 188 fewer small molecule medicines in the market, leading to a loss of 116 million life-years.

The EPIC Act plans to rectify this by extending the small molecule exemption to 13 years, aligning with the exemption period for biologics. By ensuring equality in the treatment of all drugs, the legislation aims to ensure patients are not discriminated based on the type of medication they require. The EPIC Act advocates for health care fairness and safeguards the well-being of vulnerable patient groups.

The EPIC Act, as Moore advocates, represents a crucial step towards guaranteeing access to essential medications for everyone. He encourages lawmakers to expedite the passage of this key legislation to uphold justice and compassion for patients reliant on lifesaving drugs across America.

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