Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Jul;52(3):363-371.
doi: 10.1177/00207314221100647. Epub 2022 May 12.

A Proposal to Increase Value and Equity in the Development and Distribution of New Pharmaceuticals

Paul Sorum  1 , Christopher Stein  2 , Danielle Wales  1 , David Pratt  3
Affiliations

A Proposal to Increase Value and Equity in the Development and Distribution of New Pharmaceuticals

Paul Sorum et al. Int J Health Serv. 2022 Jul.

Abstract

The process of developing and marketing new pharmaceuticals in the United States is driven by a need to maximize returns to shareholders. This results all too often in the production of new medications that are expensive and of marginal value to patients and society. In line with our heightened awareness of the importance of social justice and public health-and in light of our government's alliance with private companies in bringing us COVID-19 vaccines-we need to reconsider how new pharmaceuticals are developed and distributed. Accordingly, we propose the creation of a new agency of the Food and Drug Administration (FDA) that would direct the whole process. This agency would fund the research and development of high-value medications, closely monitor the clinical studies of these new drugs, and manage their distribution at prices that are value-based, fair, and equitable.

Keywords: United States food and drug administration; costs and cost analysis; drug development; drug industry; health equity.

PubMed Disclaimer

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr. Wales received salary support from Gilead, Inc., for Project Focus, a hepatitis C screening project.

Similar articles

See all similar articles

References

    1. Baker D. Financing drug research: what are the issues? Center for Economic and Policy Research. Issue brief, September 22, 2004. https://cepr.net/documents/publications/intellectual_property_2004_09.pdf. Accessed January 10, 2022.
    1. Kesselheim A, Avorn J, Sarpatwari A. The high cost of prescription drugs in the United States: origins and prospects for reform. JAMA. 2016;316(8):858–871. doi:10.1001/jama.2016.11237 - DOI - PubMed
    1. Congressional Budget Office. Research and Development in the Pharmaceutical Industry. April 2021. https://www.cbo.gov/system/files/2021-04/57025-Rx-RnD.pdf. Accessed January 10, 2022.
    1. Becerra X. Comprehensive plan for addressing high drug prices. A report in response to the executive order on competition in the American economy. U.S. Department of Health and Human Services. September 9, 2021. https://aspe.hhs.gov/reports/comprehensive-plan-addressing-high-drug-prices. Accessed January 10, 2022.
    1. Blumenthal D, Miller M, Gustafsson L. The U.S. can lower drug prices without sacrificing innovation. Harvard Business Rev. October 1, 2021. https://hbr.org/2021/10/the-u-s-can-lower-drug-prices-without-sacrificin.... Accessed January 10, 2022.

Substances

LinkOut - more resources