Hostname: page-component-669899f699-ggqkh Total loading time: 0 Render date: 2025-05-04T11:35:27.324Z Has data issue: false hasContentIssue false

Use of Public Research and Manufacturing Enterprises to Lower Prescription Drug Prices and Increase Innovation

Published online by Cambridge University Press:  16 December 2024

Alex Moss
Affiliation:
PUBLIC INTEREST PATENT LAW INSTITUTE, LOS ANGELES, CALIFORNIA, USA
Dana Brown
Affiliation:
THE DEMOCRACY COLLABORATIVE, WASHINGTON, D.C., USA
S. Sean Tu
Affiliation:
WEST VIRGINIA UNIVERSITY COLLEGE OF LAW, MORGANTOWN, WEST VIRGINIA, USA

Abstract

This article proposes building on the success of publicly funded drug research and development and expanding the model to include the full cycle development, testing, manufacture and distribution of innovative and affordable new drugs.

Type
Columns: Health Policy Portal
Copyright
© The Author(s), 2024. Published by Cambridge University Press on behalf of American Society of Law, Medicine & Ethics

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Article purchase

Temporarily unavailable

Footnotes

About This Column

Aaron Kesselheim serves as the editor for Health Policy Portal. Dr. Kesselheim is the JLME editor-in-chief and director of the Program On Regulation, Therapeutics, And Law at Brigham and Women’s Hospital/Harvard Medical School. This column features timely analyses and perspectives on issues at the intersection of medicine, law, and health policy that are directly relevant to patient care. If you would like to submit to this section of JLME, please contact Dr. Kesselheim at [email protected].

References

A. Cicchiello and L. Gustafsson, Commonwealth Fund, Brand-Name Drug Prices: The Key Driver of High Pharmaceutical Spending in the U.S.: An International Comparison of Prescription Drug Spending and Costs (November 17, 2021), available at <https://www.commonwealthfund.org/publications/2021/nov/brand-name-drug-prices-key-driver-high-pharmaceutical-spending-in-us> (last visited September 20, 2024).+(last+visited+September+20,+2024).>Google Scholar
S. Parasrampuria and S. Murphy, Office of the Assitant Secretary for Planning and Evaluation, US Department of Health and Human Services, Trends in Prescription Drug Spending, 2016-2021: Issue Brief (September 2022), available at <https://aspe.hhs.gov/sites/default/files/documents/88c547c976e915fc31fe2c6903ac0bc9/sdp-trends-prescription-drug-spending.pdf> (last visited September 20, 2024).+(last+visited+September+20,+2024).>Google Scholar
Ledley, F. D., McCoy, S.S., Vaughan, G., and Cleary, E. G., “Profitability of Large Pharmaceutical Companies Compared with Other Large Public Companies,” JAMA 323, no. 9 (2020): 834843.CrossRefGoogle ScholarPubMed
“Current Trends Rabies Vaccine, Adsorbed: A New Rabies Vaccine for Use in Humans,” CDC MMRW, (1988), available at <https://www.cdc.gov/mmwr/preview/mmwrhtml/00000010.htm> (last visited September 20, 2024); “US Anthrax-Vaccine Producer Saved for Now,” The Lancet 351, no. 9103 (1998): 657657.+(last+visited+September+20,+2024);+“US+Anthrax-Vaccine+Producer+Saved+for+Now,”+The+Lancet+351,+no.+9103+(1998):+657–657.>Google Scholar
Arnon, S.S., “Creation and Development of the Public Service Orphan Drug Human Botulism Immune Globulin,” Pediatrics 119, no. 4 (2007): 785–9.CrossRefGoogle ScholarPubMed
Institute of Medicine, The Children’s Vaccine Initiative: Achieving the Vision (Washington, DC: The National Academies Press, 2003), doi: https://doi.org/10.17226/2224.Google Scholar
UMass Chan Medical School, MassBiologics: Research, available at <https://www.umassmed.edu/massbiologics/research/> (last visited September 20, 2024).+(last+visited+September+20,+2024).>Google Scholar
Lewis, G.F. and Brubaker, P.L., “The Discovery of Insulin Revisited: Lessons for the Modern Era,” Journal of Clinical Investigation 131, no. 1 (2021): e142239.CrossRefGoogle ScholarPubMed
Congress.gov, “H.R.5155 - 108th Congress (2003-2004): Free Market Drug Act,” October 8, 2004, available at <https://www.congress.gov/bill/108th-congress/house-bill/5155> (last visited September 20, 2024).+(last+visited+September+20,+2024).>Google Scholar
Ledley, F. D. and Cleary, E. G., “NIH Funding for Patents that Contribute to Market Exclusivity of Drugs Approved 2010-2019 and the Public Interest of Bayh-Dole,” PLoS ONE 18, no. 7 (2023): e0288447.CrossRefGoogle ScholarPubMed
White House Fact Sheet, “Biden-Harris Administration Announces New Actions to Lower Health Care and Prescription Drug Costs by Promoting Competition,” December 7, 2023, available at <https://www.whitehouse.gov/briefing-room/statements-releases/2023/12/07/fact-sheet-biden-harris-administration-announces-new-actions-to-lower-health-care-and-prescription-drug-costs-by-promoting-competition/> (last visited September 20, 2024).+(last+visited+September+20,+2024).>Google Scholar
Duan, C. and Morten, C., “Who’s Afraid of Section 1498? A Case for Government Patent Use in Pandemics and Other National Crisis in Pandemics and Other National Crisis,” Yale Journal of Law and Technology 23, no. 1 (2020).Google Scholar
D. Brown and T. Latkowski “Public Pharmaceuticals: How States Can Break Big Pharma Monopolies on Essential Medicines with Public Manufacturing and Distribution of Pharmaceuticals,” Democracy Policy Network, December 2022, available at <https://democracypolicy.network/agenda/strong-people/strong-bodies/public-pharmaceuticals> (last visited September 20, 2024); Congress.gov, “S.3398 - 118th Congress (2023-2024): Affordable Drug Manufacturing Act of 2023,” December 5, 2023, available at <https://www.congress.gov/bill/118th-congress/senate-bill/3398> and Congress.gov. “H.R.6607 - 118th Congress (2023-2024): Affordable Drug Manufacturing Act of 2023,” December 8, 2023, available at <https://www.congress.gov/bill/118th-congress/house-bill/6607> (last visited September 20, 2024).+(last+visited+September+20,+2024);+Congress.gov,+“S.3398+-+118th+Congress+(2023-2024):+Affordable+Drug+Manufacturing+Act+of+2023,”+December+5,+2023,+available+at++and+Congress.gov.+“H.R.6607+-+118th+Congress+(2023-2024):+Affordable+Drug+Manufacturing+Act+of+2023,”+December+8,+2023,+available+at++(last+visited+September+20,+2024).>Google Scholar
M. Florio et al., “European Pharmaceutical Research and Development: Could Public Infrastructure Overcome Market Failures?” commissioned by the Panel for the Future of Science and Technology (STOA), Brussels, December 2021, available at <https://www.europarl.europa.eu/RegData/etudes/STUD/2021/697197/EPRS_STU(2021)697197_EN.pdf> (last visited September 20, 2024).+(last+visited+September+20,+2024).>Google Scholar
EU Parliament, Committee on the Environment, Public Health and Food Safety, Draft report October 20, 2023, available at <https://www.europarl.europa.eu/doceo/document/ENVI-PR-753550_EN.pdf> (last visited September 20, 2024).+(last+visited+September+20,+2024).>Google Scholar
Lazonick, W. and Tulum, O., “US Biopharmaceutical Finance and the Sustainability of the Biotech Business Model,” Research Policy 40 (2011): 11701187.CrossRefGoogle Scholar
Silverman, E.House Democrats Say Pharma Stock Buybacks and Dividends Exceed R&D Spending,” STAT News (July 8, 2021), available at < https://www.statnews.com/pharmalot/2021/07/08/pharma-stock-rnd-dividends/> (last visited September 20, 2024).Google Scholar
Feldman, R., “Trade Secrets in Biologic Medicine: The Boundary with Patents,” Columbia Science and Technology Law Review 24, no. 1 (2022).Google Scholar
Nyang’wa, B. T., et al., “A 24-Week, All-Oral Regimen for Rifampin-Resistant Tuberculosis,” New England Journal of Medicine 387 (2022): 23312343.CrossRefGoogle ScholarPubMed
White House, Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth, 100-Day Reviews under Executive Order 14017 (June 2021), available at <https://www.whitehouse.gov/wp-content/uploads/2021/06/100-day-supply-chain-review-report.pdf> (last visited September 20, 2024).+(last+visited+September+20,+2024).>Google Scholar
Mazzucato, M., “The Entrepreneurial State: Debunking Public vs. Private Sector Myths,” Public Affairs (2015): 110113.Google Scholar