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Costs increase after approval of unapproved marketed drugs

Costs increase after approval of unapproved marketed drugs PharmacoEconomics & Outcomes News 792, p2 - 2 Dec 2017 Hakim A, et al. High Costs of FDA Approval for Formerly Unapproved Marketed Costs increase after approval of Drugs. JAMA: the Journal of the American Medical Association : 13 Nov 2017. Available from: URL: http://doi.org/10.1001/jama.2017.16481 unapproved marketed drugs Drug costs appear to increase after FDA approval of previously unapproved drugs that have been marketed in the US, say authors of a Viewpoint published in JAMA. The authors assessed the impact of the FDA’s 2006 Unapproved Drugs Initiative (UDI) on access to generic drugs and costs of prescription drugs. The FDA has estimated that several thousands of prescription drugs have been marketed in the US without FDA approval; many of these were marketed prior to the 1938 Federal Food, Drug and Cosmetic Act. The UDI aimed to remove unapproved drugs from the US market. Under FDA guidance, the first previously unapproved drug to gain approval would gain a period of market exclusivity prior to approval of similar products, providing an incentive to seek the first approval. As an example, a New Drug Application was submitted to the FDA by Par Pharmaceuticals for intravenous vasopressin (Vasostrict) in September 2012. Vasotrict gained http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png PharmacoEconomics & Outcomes News Springer Journals

Costs increase after approval of unapproved marketed drugs

PharmacoEconomics & Outcomes News , Volume 792 (1) – Dec 2, 2017

Costs increase after approval of unapproved marketed drugs

Abstract

PharmacoEconomics & Outcomes News 792, p2 - 2 Dec 2017 Hakim A, et al. High Costs of FDA Approval for Formerly Unapproved Marketed Costs increase after approval of Drugs. JAMA: the Journal of the American Medical Association : 13 Nov 2017. Available from: URL: http://doi.org/10.1001/jama.2017.16481 unapproved marketed drugs Drug costs appear to increase after FDA approval of previously unapproved drugs that have been marketed in the US, say authors of a Viewpoint published in JAMA. The...
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Publisher
Springer Journals
Copyright
Copyright © 2017 by Springer International Publishing AG, part of Springer Nature
Subject
Medicine & Public Health; Pharmacoeconomics and Health Outcomes; Quality of Life Research; Health Economics; Public Health
ISSN
1173-5503
eISSN
1179-2043
DOI
10.1007/s40274-017-4525-3
Publisher site
See Article on Publisher Site

Abstract

PharmacoEconomics & Outcomes News 792, p2 - 2 Dec 2017 Hakim A, et al. High Costs of FDA Approval for Formerly Unapproved Marketed Costs increase after approval of Drugs. JAMA: the Journal of the American Medical Association : 13 Nov 2017. Available from: URL: http://doi.org/10.1001/jama.2017.16481 unapproved marketed drugs Drug costs appear to increase after FDA approval of previously unapproved drugs that have been marketed in the US, say authors of a Viewpoint published in JAMA. The authors assessed the impact of the FDA’s 2006 Unapproved Drugs Initiative (UDI) on access to generic drugs and costs of prescription drugs. The FDA has estimated that several thousands of prescription drugs have been marketed in the US without FDA approval; many of these were marketed prior to the 1938 Federal Food, Drug and Cosmetic Act. The UDI aimed to remove unapproved drugs from the US market. Under FDA guidance, the first previously unapproved drug to gain approval would gain a period of market exclusivity prior to approval of similar products, providing an incentive to seek the first approval. As an example, a New Drug Application was submitted to the FDA by Par Pharmaceuticals for intravenous vasopressin (Vasostrict) in September 2012. Vasotrict gained

Journal

PharmacoEconomics & Outcomes NewsSpringer Journals

Published: Dec 2, 2017

There are no references for this article.