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TRENTON
-- Attorney General Anne Milgram announced
today that New Jersey has entered into a multi-state
settlement agreement with Pfizer Inc. that
resolves allegations the pharmaceutical maker
improperly marketed its antipsychotic drug
Geodon.
In
addition to requiring that Pfizer make certain
changes in its approach to marketing Geodon,
the settlement also requires Pfizer to pay
New Jersey $943,230.
The participating states charged that Pfizer
engaged in unfair and deceptive practices
when it marketed Geodon for certain “off
label” uses. Off label uses are those
which have not been approved by the U.S. Food
and Drug Administration (FDA.)
As
part of the settlement, Pfizer has agreed
to change the way it markets Geodon and has
also agreed not to promote off label uses.
Geodon
is the brand name for the prescription drug
ziprasidone. Ziprasidone has been approved
by the FDA for treatment of schizophrenia
in adults, and for manic or mixed episodes
of bi-polar disorder in adults.
The
state’s complaint charges that Pfizer
improperly promoted Geodon for pediatric use
and for use at dosage levels higher than those
approved by the FDA. Both applications of
the drug are not approved by the FDA and,
as such, are considered off-label uses.
Although
a physician is allowed to prescribe drugs
for off-label uses, federal law prohibits
pharmaceutical manufacturers from promoting
and marketing their products for such uses.
The multi-state settlement announced today
requires that Pfizer not make any false, misleading
or deceptive claims regarding Geodon. Pfizer
has also agreed not to promote Geodon for
off-label usage.
In
addition, the settlement mandates that Pfizer:
- Post
on its Web site a list of physicians and
related entities who receive payments from
Pfizer until the year 2014
- Provide
product samples of Geodon only to health
care providers who have specialties that
customarily treat patients who have diseases
for which treatment with Geodon would be
consistent with the product’s current
labeling
- Register
and post on a publicly accessible Web site
certain Pfizer-sponsored clinical trials
- Require
its medical staff to be responsible for
the identification, selection, approval
and dissemination of scientific article
reprints containing off-label information
about Geodon, and also that such information
not be referred to or used in a promotional
manner.
The settlement also mandates that, for a nine-year
time period (which extends beyond the patent
term for Geodon), Pfizer must require its
medical staff – not its marketing staff
– to have ultimate responsibility for
developing and approving the medical content
for all medical letters concerning Geodon.
For a six-year period, Pfizer must:
- Disclose
on its Web site information about grants
it makes to health care providers, including
continued medical education grants
- Not
use grants to promote Geodon, or tie the
funding of continued medical education to
Pfizer’s approval of speakers and/or
program content
- Contractually
require continuing medical education providers
to disclose Pfizer’s financial support
of their programs, as well as any financial
relationship with faculty and speakers
In addition to New Jersey, 41 other states
and the District of Columbia are party to
the overall $33 million settlement with Pfizer,
including Maryland and Delaware, who led the
multi-state executive committee that negotiated
with Pfizer.
Deputy Attorney General Jennifer D. Dougherty
of the Consumer Fraud Prosecution Section
represented the State in this matter.
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