For immediate release - Thursday, May 13, 2004.
Contact Bob Brammer - 515-281-6699.
Warner-Lambert to Remedy Allegations
of "Off-Label" Marketing of "Neurontin"
States and U.S. alleged deceptive and unlawful promotion of the
prescription drug for "off-label" indications, even though scientific
evidence was lacking to support use of "Neurontin" for some indications.
Company is taking major steps to resolve allegations by state and federal
officials of deceptive "off-label" marketing of the prescription drug
"We alleged that Warner-Lambert promoted Neurontin in various ways that
dramatically increased doctors prescribing Neurontin for off-label indications
for which there was little or no scientific evidence of efficacy," said
Iowa Attorney General Tom Miller. "It is illegal for prescription-drug
makers to promote use of their drugs for 'off-label' indications that
are not included in the FDA-approved label, although doctors may prescribe
for other uses. Doctors must have fair and accurate information about
drugs in order to make effective prescriptions for patients."
Warner-Lambert is a wholly-owned subsidiary of Pfizer Inc., the world's largest
pharmaceutical company. Its U.S. revenues last year for Neurontin were
over $2.2 billion.
The states alleged their consumer protection laws were violated when Warner-Lambert
promoted Neurontin for various off-label indications, including bipolar
and other psychiatric disorders, back pain and other pain disorders, Lou
Gehrig's Disease, attention-deficit disorder, migraine, and monotherapy
treatment for epilepsy, even though scientific evidence was lacking to
support use of the drug for the indications. Neurontin has been approved
by the FDA as an adjunctive or add-on treatment for epilepsy, and treatment
of post-herpetic neuralgia (pain after shingles.) The States said that
about 90% of Neurontin prescriptions are for off-label purposes.
One study of Medicaid patients in Oregon who were prescribed Neurontin
has shown that 95% of the patients were prescribed the drug for off-label
purposes, and for many their condition did not improve after taking the
The "global settlement" today with Warner-Lambert resolves investigations
by the states, the U.S. Attorney's Office out of Boston, and the Association
of Medicaid Fraud Control Units. The states said there was extraordinary
cooperation among the officials. For
the states, the consumer protection investigation was led by Vermont,
Oregon, Florida, New York, Ohio, and Texas.
In total, Warner-Lambert will pay $430 million under the settlements, including
$38 million to the states. Most of the states' payment, $28 million, will
go for a nationwide "remediation" program consisting of advertising and
education programs aimed at prescribers and consumers to provide fair
and balanced information about drugs. The programs will aim to remedy
the "glide effect" of Warner-Lambert promotions in the past (the fact
that prescribing patterns might continue to reflect alleged misinformation
the company disseminated in the marketplace.) The states will receive
$10 million for costs, consumer education, and litigation. Iowa's share
The states alleged Warner-Lambert used various methods to deceptively
promote Neurontin for off-label indications, including continuing
medical education classes that lacked fair balance and misrepresented
the nature of the classes, and provided expensive "perks" to attending
physicians; a "publication strategy" that subsidized the production and
dissemination of anecdotal reports favorable to off-label use of Neurontin
and were of no scientific value; and payments to prescribers for "research"
that was, in effect, a kickback for off-label prescribing.
The 50-state settlement, by an Assurance of Voluntary Compliance or Discontinuance,
prohibits Warner-Lambert and its corporate parent, Pfizer Inc., from many
activities, including: making false, misleading or deceptive oral or written
claims about Neurontin and promoting off-label uses in violation of the
federal Food, Drug and Cosmetic Act; misrepresenting the nature of scientific
evidence relating to Neurontin; violating Federal anti-kickback laws;
and several other prohibitions.
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