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Innovation doesn’t end with a medicine’s first approval by the U.S Food and Drug Administration (FDA). Most oncology medicines approved a decade ago have received additional indications for other types of cancers.

However, price setting provisions in the recently passed Inflation Reduction Act established what’s known as the “pill penalty,” which threatens the continued success of these achievements. With small molecule medicines, meaning medicines that typically come in pill or capsule form, selected for so-called “negotiation” just nine years after initial FDA approval, the law now disincentivizes continued investment in these groundbreaking discoveries. That’s an issue when most cancer medicines approved by the FDA are small molecule medicines, which patients may prefer because they are often easier to take than an infusion or a shot and can be taken at home.

At The Atlantic’s annual People v. Cancer event, I sat down with Catherine Owens, Senior Vice President and General Manager of US Commercialization at Bristol Myers Squibb, to unpack the potentially devastating impacts that the pill penalty could have on small molecule medicine development.

For decades, the biopharmaceutical industry has developed lifesaving treatments that have advanced the field of oncology and improved patient outcomes. In fact, since 1991, the cancer death rate has fallen 33%. It’s crucial that we establish policies that allow the biopharmaceutical industry to continue to innovate and develop treatments that provide better outcomes for patients.

Learn more here: PhRMA.org/Inflation-Reduction-Act

Lori M. Reilly, Esq.

Lori M. Reilly is chief operating officer at PhRMA, providing executive level management, leadership and strategic direction for the organization. In this role, Reilly oversees PhRMA’s advocacy activities, including its federal, state and international government affairs and alliance development work. Reilly provides strategic leadership and works across PhRMA to develop and advocate for practical policy solutions that will lower costs for patients.

Reilly, named by the Washingtonian as one of the 250 most influential people in D.C., has a long record of working with members of Congress on a bipartisan basis and collaborating with stakeholders across the health care industry. Reilly is a frequent presenter on industry-related issues, including testifying before Congress on multiple occasions.

Reilly has over two decades of experience at PhRMA; prior to her current role, Reilly was the executive vice president of policy, research and membership at PhRMA, leading the development and implementation of legislative, regulatory and political strategies to advance policies that encourage patient access and medical innovation. She has also served as counsel at the U.S. House of Representatives Committee on Commerce and was Counsel to a member of the House Ways and Means Committee.

Reilly received a B.A. in political science from the University of Nebraska-Lincoln where she graduated with honors, and a J.D. from the University of Nebraska College of Law. She currently resides in Alexandria, Virginia with her husband and their four children.

Lori Reilly

https://x.com/lreilly71

https://www.linkedin.com/in/lorireillyphrma/

Chief Operating Officer

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Policy Solutions

Research and Development

The IRA’s pill penalty threatens the future of oncology R&D

November 16, 2023

The IRA’s pill penalty threatens the future of oncology R&D

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