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 approval in November 2014 and other manufacturers were then instructed to stop production of their IV vasopressin by January 2015. However, without marketing competition, the wholesale price of IV vasopressin was increased by 3141% by November 2016, to $138.40 per vial. Sales of IV vasopression totalled $4 million in 2013, but total annual sales for Vastostrict in 2016 were almost $400 million, resulting in reports of the removal of vasopression from code charts. Overall, prices of all previously unapproved prescription drugs increased by a median of 37% between 2006 and 2015 after UDI action or approval, and FDA approvals for almost 90% of these drugs were supported by literature reviews rather than new evidence from clinical trials. Entry of generic competitors to the market after FDA approval of an unapproved marketed drug can be delayed by the time to approval of an Abbreviated New Drug Application, prevention of access by competitors to the active pharmaceutical ingredient, new patents for the approved drug products in the FDA Orange Book, statutory marketing exclusivity under the Orphan Drug Act, and closed distribution systems, said the authors. The FDA has announced policy measures to remove obstacles to generic competition including a list of branded drugs without patents or exclusivities from which generic drug applications can be prioritised, and expedition of reviews of generic drug applications until three generics of a product have been approved. Additional reforms were suggested by the authors to mitigate potential harms from price increases by monopolies following drug approvals through the UDI: coordination between the FDA and Federal Trade Commission to publicise anticompetitive practises; a federal government requirement for drug companies to disclose development costs for achieving approval via the UDI; and "the federal government could provide prespecified, fixed monetary payments to reimburse the development of formerly unapproved drugs". "Ultimately, although FDA’s goal of strengthening regulatory oversight related to unapproved drugs is laudable, monopolies carry societal harms, and the current system appears to lead to rewards out of proportion to manufacturer investment," commented the authors. 1173-5503/17/0792-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved PharmacoEconomics & Outcomes News 2 Dec 2017 No. 792 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png PharmacoEconomics & Outcomes News Springer Journals

Costs increase after approval of unapproved marketed drugs

Free
1 page
Loading next page...
1 Page
 
/lp/springer_journal/costs-increase-after-approval-of-unapproved-marketed-drugs-ahPrXCP3DY
Publisher
Springer International Publishing
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
D.O.I.
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 approval in November 2014 and other manufacturers were then instructed to stop production of their IV vasopressin by January 2015. However, without marketing competition, the wholesale price of IV vasopressin was increased by 3141% by November 2016, to $138.40 per vial. Sales of IV vasopression totalled $4 million in 2013, but total annual sales for Vastostrict in 2016 were almost $400 million, resulting in reports of the removal of vasopression from code charts. Overall, prices of all previously unapproved prescription drugs increased by a median of 37% between 2006 and 2015 after UDI action or approval, and FDA approvals for almost 90% of these drugs were supported by literature reviews rather than new evidence from clinical trials. Entry of generic competitors to the market after FDA approval of an unapproved marketed drug can be delayed by the time to approval of an Abbreviated New Drug Application, prevention of access by competitors to the active pharmaceutical ingredient, new patents for the approved drug products in the FDA Orange Book, statutory marketing exclusivity under the Orphan Drug Act, and closed distribution systems, said the authors. The FDA has announced policy measures to remove obstacles to generic competition including a list of branded drugs without patents or exclusivities from which generic drug applications can be prioritised, and expedition of reviews of generic drug applications until three generics of a product have been approved. Additional reforms were suggested by the authors to mitigate potential harms from price increases by monopolies following drug approvals through the UDI: coordination between the FDA and Federal Trade Commission to publicise anticompetitive practises; a federal government requirement for drug companies to disclose development costs for achieving approval via the UDI; and "the federal government could provide prespecified, fixed monetary payments to reimburse the development of formerly unapproved drugs". "Ultimately, although FDA’s goal of strengthening regulatory oversight related to unapproved drugs is laudable, monopolies carry societal harms, and the current system appears to lead to rewards out of proportion to manufacturer investment," commented the authors. 1173-5503/17/0792-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved PharmacoEconomics & Outcomes News 2 Dec 2017 No. 792

Journal

PharmacoEconomics & Outcomes NewsSpringer Journals

Published: Dec 2, 2017

There are no references for this article.

You’re reading a free preview. Subscribe to read the entire article.


DeepDyve is your
personal research library

It’s your single place to instantly
discover and read the research
that matters to you.

Enjoy affordable access to
over 18 million articles from more than
15,000 peer-reviewed journals.

All for just $49/month

Explore the DeepDyve Library

Search

Query the DeepDyve database, plus search all of PubMed and Google Scholar seamlessly

Organize

Save any article or search result from DeepDyve, PubMed, and Google Scholar... all in one place.

Access

Get unlimited, online access to over 18 million full-text articles from more than 15,000 scientific journals.

Your journals are on DeepDyve

Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.

All the latest content is available, no embargo periods.

See the journals in your area

DeepDyve

Freelancer

DeepDyve

Pro

Price

FREE

$49/month
$360/year

Save searches from
Google Scholar,
PubMed

Create lists to
organize your research

Export lists, citations

Read DeepDyve articles

Abstract access only

Unlimited access to over
18 million full-text articles

Print

20 pages / month

PDF Discount

20% off