Nonprice Competition in “Substitute” Drugs: The FTC's Blind Spot

DOI10.1177/0003603X1405900308
Published date01 September 2014
AuthorGregory Dolin
Date01 September 2014
Subject MatterLundbeck: A Prescription Drug Merger—Articles & Commets
THE ANTITRUST BUL L E T I N :Vol. 59, N o. 3/Fall 2 014 :579
Nonprice competition
in “substitute” drugs:
The FTC’s blind spot
BYGREGORY DOL IN, M.D.*
As the recent case of United States v. Lundbeck illustrates, the Federal
Trade Commission’s lack of knowledge in medical and pharmacological
sciences affects its evaluation of transactions between medical and
pharmaceutical companies that involve transfers of rights to
manu fact ure or se ll dru gs, cau sing t he age ncy to o bjec t to suc h
transactions without solid basis for doing so. This article argues that
in order to properly define a pharmaceutical market, one must not
just consider the condition that competing drugs are meant to treat,
but also take into account whether there are “off-label” drugs that are
used to treat a relevant condition, whether drugs actually compete
with each other on price or whether they are selected based on their
side-effects (or lack thereof), mechanism of action, physician
knowledge, and other noneconomic considerations, and finally
whether the drugs in question enjoy any patent or nonpatent-based
exclusivity that prevents generic manufacturers from entering the
market.
KEY WOR DS:FTC, antitrust, pharmaceutical, off-label, FDA, patent,
exclusivity
© 2014by Federal Legal Publications, Inc.
* Associate Professor of Law and Co-Director of the Center for Medi-
cine & Law, University of Baltimore School of Law, Adjunct Associate Profes-
sor of Emergency Medicine, Johns Hopkins University School of Medicine.

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