Moore: Inflation Reduction Act’s pill penalty should be reformed


Christopher Moore is the interim executive director of AIDS Delaware. He previously worked for ChristianaCare, most recently as the director of community health education and engagement.

As the leader of AIDS Delaware, an organization dedicated to supporting individuals living with HIV, I am deeply troubled by the barriers that stand between patients and the lifesaving medications they need. Today, I urge our congressional lawmakers to support the Ensuring Pathways to Innovative Cures Act. This bill addresses the injustices perpetuated by the Inflation Reduction Act’s pill penalty and ensures equitable access to essential medications for all Americans, regardless of ZIP code and background.

The EPIC Act seeks to rectify the disparities embedded within the current IRA framework that the Biden administration put in place. Under its price-setting model, small molecule drugs — commonly, pills and tablets — face a significant disadvantage compared to biologics — typically, injectables. Small molecule drugs become eligible for selection in the Medicare drug price negotiation program seven years after Food and Drug Administration approval, with price controls going into effect at year nine. In contrast, biologics have an 11-year eligibility period, and price controls go into effect at year 13.

While the intent of these regulations may have been to control costs, the reality is that they have created a profound imbalance in the pharmaceutical landscape, to the detriment of patients everywhere. The cost to bring a new drug to market can range from hundreds of millions to several billion dollars. By reducing the ability of pharmaceutical companies to recoup these substantial investments, many have halted the pursuit of new cures altogether. Research and development investments have already begun shifting away from small molecule medicines, and clinical studies for crucial treatments for cancer and rare diseases have paused because of the implementation of the Inflation Reduction Act. For organizations like mine, seeking to advocate on behalf of patients living with HIV, it is concerning that new advanced drugs and therapies built on current therapies won’t be prioritized because of this disparity.

The consequences of this regulatory imbalance are significant. According to a University of Chicago policy brief, the nine-13 disparity in price control eligibility will result in 188 fewer small molecule medicines coming to market, leading to the loss of 116 million life-years. These are not just statistics; they represent real patients who are denied access to potentially lifesaving treatments due to arbitrary and unnecessary regulations.

The EPIC Act would address this inequity by extending the small molecule exemption to 13 years, aligning it with the exemption period for biologics. By bringing parity to the treatment of small molecule and biologic drugs, this legislation ensures that patients are not penalized based on the type of medication they require for their treatment. By promoting fairness and equity in health care, the Ensuring Pathways to Innovative Cures Act safeguards the health and well-being of vulnerable patient populations.

As advocates for the health and dignity of individuals living with HIV and other chronic conditions, we cannot afford to ignore the urgency of this issue. The EPIC Act represents a critical step toward ensuring that every individual has access to the medications they need to lead healthy and fulfilling lives. I urge our lawmakers to prioritize the passage of this vital legislation and stand on the side of justice and compassion for all patients reliant on lifesaving drugs and therapies across America.

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