For Release: October 20, 2004
Statement of the Federal Trade Commission Regarding the Decision to Close Its
Investigation into the Conduct of Akzo Nobel, NV and Its Organon Subsidiary
The attorneys general of several states (the States) today announced their submission, for
approval by the U.S. District Court for the District of New Jersey, of a settlement agreement with
Akzo Nobel, N.V., and its subsidiary, Organon USA Inc. (collectively, Organon), resolving the
States' allegations that Organon violated the antitrust laws by engaging in various anticompetitive
acts relating to its anti-depressant drug, Remeron. The States' complaint alleges, among other
things, that Organon made a "fraudulent misrepresentation" to the FDA about the claims of a
patent listed on the FDA's Orange Book, so as to delay by approximately eight months the
introduction of generic competition to Remeron. Under the settlement, Organon would pay tens
of millions of dollars in damages and become subject to strong injunctive terms barring future
anticompetitive conduct.
Federal Trade Commission staff conducted a parallel, nonpublic investigation regarding
Organon's conduct. The FTC staff's investigatory record contains significant evidence indicating
that Organon may have violated Section 5 of the Federal Trade Commission Act by knowingly
making misleading statements to the FDA in order to delay introduction of generic competition to
Remeron.
FTC staff closely coordinated their investigation with the States. Working with the States,
FTC staff took the lead in developing and negotiating the injunctive terms that are encompassed
in the States' proposed settlement. In consideration of the comprehensive, effective, and
appropriate injunctive terms contained in the States' proposed settlement, the FTC's investigation
into Organon's activities relating to Remeron has been closed.
MEDIA CONTACT:
Office of Public Affairs
202-326-2180
(http://www.ftc.gov/opa/2004/10/organon.htm)
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Related Documents:
Akzo Nobel, N.V. & Organon USA Inc., File No. 031 0249 (October 20, 2004) [PDF 51K]
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