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
PharmacoEconomics & Outcomes News – Springer Journals
Published: Dec 2, 2017
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
Query the DeepDyve database, plus search all of PubMed and Google Scholar seamlessly
Save any article or search result from DeepDyve, PubMed, and Google Scholar... all in one place.
Get unlimited, online access to over 18 million full-text articles from more than 15,000 scientific journals.
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.
“Hi guys, I cannot tell you how much I love this resource. Incredible. I really believe you've hit the nail on the head with this site in regards to solving the research-purchase issue.”Daniel C.
“Whoa! It’s like Spotify but for academic articles.”@Phil_Robichaud
“I must say, @deepdyve is a fabulous solution to the independent researcher's problem of #access to #information.”@deepthiw
“My last article couldn't be possible without the platform @deepdyve that makes journal papers cheaper.”@JoseServera