Schering-Plough Letter - Refunds to 340B
Covered Entities
May
15, 2008
Jimmy Mitchell, R.Ph., M.P.F ., M.S.
Director
Office of Pharmacy Affairs
Health Resources and Services Administration
Department of Health and Human Services
5600 Fishers Lane, Parklawn Building
Mail Stop 10C-03
Rockville, Maryland 20857
Re: Refunds to 340B Covered Entities for
Certain 2006-2007 Purchases
Dear Mr. Mitchell:
I am writing on behalf of the Schering-Plough
Corporation (Schering-Plough) concerning
the refunds we are providing to Section
340B program covered entities that purchased
certain products of Organon BioSciences
N.V. (Organon) in 2006 and 2007. Schering-Plough
completed the acquisition of Organon in
November 2007. Schering- Plough has learned
that Organon's ceiling prices to 340B
covered entities were overstated in three
of the four quarters predating the acquisition.
Consistent with Schering-Plough's commitment
to compliance, we have made a disclosure
regarding this matter to the Department
of Health and Human Services Office of
Inspector General and arc making refunds
to covered entities for the Organon 340B
ceiling price overstatements. The refunds
will involve the following products and
quarters: (1) purchases of Desogen®
in the fourth quarter of 2006; (2) purchases
of Zemuron® in the first quarter of
2007; and (3) purchases of NuvaRing®,
Cyclessa®, and Desogen® in the
second quarter of 2007. Schering-Plough
is currently processing refunds, which
we will be sending to all entities we
identify as having purchased one of the
affected products for outpatient use that
did not receive the correct ceiling price
during a relevant quarter in which the
entity was registered with the Health
Resources and Services Administration
(HRSA) as a 340B covered entity. We expect
to have this process completed by August
of 2008.
If you have any questions about this matter,
please feel free to contact me at 908-
298-2292. While Schering-Plough will be
independently contacting covered entities
that we identify as eligible for refunds,
please feel free to post this letter on
HRSA's website to help us inform eligible
340B covered entities of the refunds.
Covered entities may direct any inquiries
they may have about refund processing
to Barry Schnepf at 908-629-3430. We value
our relationship with HRSA and our 340B
customers and appreciate your cooperation
and assistance.
Sincerely
/David L. Ralston, J.D, M.P.H./
Senior Legal Director |
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