Hostname: page-component-cd9895bd7-p9bg8 Total loading time: 0 Render date: 2024-12-26T09:48:21.041Z Has data issue: false hasContentIssue false

INTRODUCTION: Public Sector and Non-Profit Contributions to Drug Development — Historical Scope, Opportunities, and Challenges

Published online by Cambridge University Press:  21 April 2021

Abstract

Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'
Type
Symposium Articles
Copyright
© 2021 The Author(s)

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.)

References

Kleutghen, P., Mitchell, D., Kesselheim, A.S., Najafzadeh, M., and Sarpatwari, A., “Drugs Don’t Work if People Can’t Afford Them: The High Price of Tisagenlecleucel”, Health Affairs Blog, available at <https://www.healthaffairs.org/do/10.1377/hblog20180205.292531/full/> (last visited January 27, 2021).+(last+visited+January+27,+2021).>Google Scholar
Herper, M., “Non-Profit Says $850,000 Gene Therapy is at Least Twice as Expensive as it Should Be”, Forbes, available at <https://www.forbes.com/sites/matthewherper/2018/01/12/non-profit-says-850000-gene-therapy-is-at-least-twice-as-expensive-as-it-should-be/#5ad00d03b979> (last visited January 27, 2021).+(last+visited+January+27,+2021).>Google Scholar
Stein, R., “At $2.1 Million, New Gene Therapy is the Most Expensive Drug Ever”, NPR, available at <https://www.npr.org/sections/health-shots/2019/05/24/725404168/at-2-125-million-new-gene-therapy-is-the-most-expensive-drug-ever> (last visited January 27, 2021).+(last+visited+January+27,+2021).>Google Scholar
Kolata, G., “Two New Drugs Help Relieve Sickle-Cell Disease. But Who Will Pay?” New York Times, available at <https://www.nytimes.com/2019/12/07/health/sickle-cell-adakveo-oxbryta.html> (last visited January 27, 2021).+(last+visited+January+27,+2021).>Google Scholar
Hakim, D., “Humira’s Best-Selling Drug Formula. Start at a High Price. Go Higher”, New York Times, available at <https://www.nytimes.com/2018/01/06/business/humira-drug-prices.html> (last visited January 27, 2021); S.J. Tribble, “Several Probes Target Insulin Drug Pricing”, NBC News, available at <https://www.nbcnews.com/health/health-news/several-probes-target-insulin-drug-pricing-n815141> (last visited January 27, 2021).Google Scholar
BioPharma Dive, “Price Increases on Top Drugs Drove Majority of Recent Growth, Analysis Finds”, available at <https://www.biopharmadive.com/news/price-increases-on-top-drugs-drove-majority-of-recent-growvth-analysis-find/539337/> (last visited January 27, 2021).+(last+visited+January+27,+2021).>Google Scholar
Sarpatwari, A., Avorn, J., and Kesselheim, A.S., “Accounting for US Public Funding in Drug Development: How Can We Better Balance Access, Affordability, and Innovation?The BMJ 371 (2020): m3841.Google ScholarPubMed
Congressional Research Service, “National Institutes of Health (NIH) Funding: FY1995-FY2021”, available at <https://fas.org/sgp/crs/misc/R43341.pdf> (last visited January 27, 2021).+(last+visited+January+27,+2021).>Google Scholar
Cleary, E. Galkina, Beierlein, J.M., Khanuja, N.S., McNa-mee, L.M., and Ledley, F.D., “Contribution of NIH Funding to New Drug Approvals 2010-2016”, Proceedings of the National Academies Sciences of the United States 115, no.10 (2018): 23292334.CrossRefGoogle Scholar
Nayak, R., Avorn, J., and Kesselheim, A.S., “Public Sector Financial Support for Late Stage Discovery of New Drugs in the United States: Cohort Study”, The BMJ 367 (2019): l5766.CrossRefGoogle ScholarPubMed
Wilson, J.M., “Carl June Speaks of His Pioneering Efforts that Led to the First Food and Drug Administration-Approved Gene Therapy Product”, Human Gene Therapy Clinical Development 28, no. 4 (2017): 175177.CrossRefGoogle Scholar
Porter, D.L., Levine, B.L., Kalos, M., Bagg, A., and Jun, C.H., “Chimeric Antigen Receptor-Modified T Cells in Chronic Lymphoid Leukemia”, New England Journal of Medicine 365, no. 8 (2011): 725733.CrossRefGoogle ScholarPubMed
Cancer Discovery, “UPenn, Novartis Team Up on Adoptive T Cells”, available at <http://cancerdiscovery.aacrjournals.org/content/2/10/OF10> (last visited January 27, 2021).CrossRef+(last+visited+January+27,+2021).>Google Scholar
Richtel, M. and Pollack, A., “Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits”, New York Times, available at <https://www.nytimes.com/2016/12/19/health/harnessing-the-us-taxpayer-to-fight-cancer-and-make-profits.html> (last visited January 27, 2021).+(last+visited+January+27,+2021).>Google Scholar
Kochenderfer, J.N., Dudley, M.E., Feldman, S.A., Wilson, W.H., Spaner, D.E., Maric, I., et al., “B-Cell Depletion and Remissions of Malignancy Along with Cytokine-Associated Toxicity in a Clinical Trial of Anti-CD19 Chimeric-Antigen-Receptor-Rransduced T cells”, Blood 119, no. 12 (2012): 27092720.CrossRefGoogle Scholar
GEN, “Kite, NCI Partner on Engineered Autologous T-Cell Therapies”, available at <https://www.genengnews.com/topics/translational-medicine/kite-nci-partner-on-engineered-autologous-t-cell-therapies/> (last visited January 27, 2021).+(last+visited+January+27,+2021).>Google Scholar
Maguire, A.M., High, K.A., Auricchio, A., Wright, J.F., Pierce, E.A., Testa, F., et al., “Age-Dependent Effects of RPE65 Gene Therapy for Leber’s Congenital Amaurosis: A Phase 1 Dose-Escalation Trial”, Lancet 374, no. 9701 (2009): 15971605.CrossRefGoogle ScholarPubMed
Script, “CHOP Spins Off Spark Therapeutics, Launches with $50mm Series A Round”, available at <https://scrip.phar-maintelligence.informa.com/deals/201330607> (last visited January 27, 2021).+(last+visited+January+27,+2021).>Google Scholar
Barone, E., “The Trump Administration’s ‘Operation Warp Speed’ Has Spent $12.4 Billion on Vaccines. How Much Is That, Really?” Time, available at <https://time.com/5921360/operation-warp-speed-vaccine-spending/< (last visited January 27, 2021).Google Scholar
US Department of Health and Human Services, “Fact Sheet: Explaining Operation Warp Speed”, available at <https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html> (last visited January 27, 2021).+(last+visited+January+27,+2021).>Google Scholar
Baden, L.R., Sahly, H.M. El, Essink, B., Kotloff, K., Frey, S., Novak, R., et al., “Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine”, New England Journal of Medicine (2020): E-pub Ahead of Print.CrossRefGoogle Scholar
Birnbaum, M., Rowland, C., and Ariès, Q., “Europe is Paying Less than the US for Many Coronavirus Vaccines”, Washington Post, available at <https://www.washington-post.com/world/eu-coronavirus-vaccines-cheaper-than-united-states/2020/12/18/06677e34-4139-11eb-b58b-1623f6267960_story.html> (last visited January 27, 2021).+(last+visited+January+27,+2021).>Google Scholar
Lau, M., “Good Vaccine News and a Flurry of Stock Sales By Executives. There is a Pattern, Study Finds”, Los Angeles Times, available at <https://www.latimes.com/business/story/2020-12-07/good-vaccine-news-executive-stock-trades> (last visited January 27, 2021).+(last+visited+January+27,+2021).>Google Scholar
Sampat, B., “The Government and Pharmaceutical Innovation: Looking Back and Looking Ahead”, Journal of Law, Medicine & Ethics 49, no. 1 (2021): 1018.CrossRefGoogle ScholarPubMed
Marko, C.K. and Miller, J.W., “Opporuntities and Challenges in Translational Research: The Development of Photodynamic Therapy and Anti-Vascular Endothelial Growth Factor Drugs”, Journal of Law, Medicine & Ethics 49, no. 1 (2021): 1924.CrossRefGoogle ScholarPubMed
Baker, D., “The Future of the Pharmaceutical Industry: Beyond Government-Granted Monopolies”, Journal of Law, Medicine & Ethics 49, no. 1 (2021): 2529.CrossRefGoogle ScholarPubMed
Liljenquist, D. et al., “A Nonprofit Approach to Address Foreign Dependence of Generic Drugs”, Journal of Law, Medicine & Ethics 49, no. 1 (2021): 3033.CrossRefGoogle ScholarPubMed
Kapczynski, A., “Realizing Public Rights Through Government Patent Use”, Journal of Law, Medicine & Ethics 49, no. 1 (2021): 3438.CrossRefGoogle ScholarPubMed
Mazzucato, M. and Li, H.L., “A Market Shaping Approach for the Biopharmaceutical Industry: Governing Innovation Towards the Public Interest”, Journal of Law, Medicine & Ethics 49, no. 1 (2021): 3949.CrossRefGoogle ScholarPubMed