Make America Healthy: Reducing High Pharmaceutical Prices Without Reducing Innovation

Authors

Srividhya Ragavan, Texas A&M University School of LawFollow

Document Type

Article

Publication Date

12-2024

Journal Title

SMU Law Review

ISSN

1066-1271

DOI

10.25172/smulr.77.4.5

Abstract

Cost of medication in the United States has historically remained one of the highest in the world. The conundrum that the United States has faced in balancing innovation with affordability of life-saving medications is palpable, especially when faced with the reality of patent monopolies conflicting with healthcare obligations. The result is an overflow of issues, which emphasize the need to delineate limits on innovation to balance pharmaceutical novelty with robust public health within the United States. This has increasingly shifted the focus of patent law into the realm of healthcare issues. Naturally, it leads to an inquiry about how best to engage in an exercise of prioritizing affordability to enable access to life-saving medications to all people as opposed to a select few. The casualty of the conundrums and conflicts that prevail between patent law and its interludes into healthcare access and trade law is unfortunate and leaves the American consumer literally unhealthy. Meanwhile, a lack of health equity has forced legislators to engage with the public health issues of their constituents to explore solutions that improve affordability and access to high-priced pharmaceuticals. One such legislative solution, the Inflation Reduction Act (IRA) of 2022, forms the backdrop for this paper.

With that background, this paper engages with simple questions. How did prices get so high in the first place? What can be done to dismantle barriers to make America healthy, literally? To answer this, the paper addresses the root causes of high drug prices. It explores how established policies and practices, which Americans fund in the first place, limit affordability and access to life-saving medications. In tracing high drug prices to their source, this paper identifies burdensome legal barriers that prevent both generic and biosimilar medications from entering the market in a timely manner. It also identifies solutions. Specifically, the paper explores whether, and if so, how, agency action between the United States Patent and Trademark Office (USPTO) and the United States Food and Drug Administration (FDA) can intervene to alleviate the burdens. To do this effectively, this paper uses the insulin story and the Humira story to discuss market-entry barriers and to provide suggestions for market entry of generic and biosimilar medications.

First Page

787

Last Page

838

Num Pages

52

Volume Number

77

Issue Number

4

Publisher

Southern Methodist University Dedman School of Law

Recommended Citation

Srividhya Ragavan, Make America Healthy: Reducing High Pharmaceutical Prices Without Reducing Innovation, 77 SMU L. Rev. 787 (2024).
Available at: https://scholarship.law.tamu.edu/facscholar/2161

File Type

PDF