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
PharmacoEconomics & Outcomes News 2 Dec 2017 No. 7921173-5503/17/0792-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved