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NEWARK
–Attorney General Anne Milgram and
the New Jersey Division of Consumer Affairs
today filed a stipulated judgment with Merck
and Company, Inc. resolving a three-year
investigation by 30 states into the company’s
deceptive promotion of the “Cox-2”
drug Vioxx.
New
Jersey’s share of a $58 million settlement
will be $1.8 million, Milgram said. The
judgment filed in State Superior Court in
Mercer County will largely restrict Merck’s
ability to deceptively promote any Merck
product.
“This
is the largest money settlement a consumer
protection multi-state group has ever received
in a pharmaceutical case,’’
Milgram said. “It will also tighten
standards for television advertising of
prescription drugs.”
Today’s
judgment requires Merck to submit all “direct-to-consumer”
television drug advertisements to the Food
and Drug Administration, wait for approval
and comply with FDA comments before running
the advertisement.
Merck,
based in Whitehouse Station, N.J., also
must comply with any recommendation made
by the FDA to delay direct-to-consumer advertising
for new Merck pain relieving drugs. The
states’ Attorneys General expressed
concerns regarding the negative effect of
direct-to-consumer advertising that commences
immediately with the release of a new drug
before doctors have a chance to gain experience
with the drug and understand its potential
side effects.
“Merck’s
aggressive early promotion of Vioxx drove
hundreds of thousands of consumers to seek
prescriptions before Vioxx’s risks
were fully understood,” said Acting
Consumer Affairs Director Larry DeMarzo.
“This action gives the FDA clear discretion
and authority to make just such an assessment
on all new Merck pain drugs and requires
Merck to submit television ads to the FDA
for suggested revisions and acceptance of
the final product before running the ads.”
Other
concerns of the states are either prohibited
or curtailed in the judgment including:
- deceptive
use of scientific data when marketing
to doctors
- “ghost
writing” of articles and studies
- failing
to adequately disclose the conflict of
interest of Merck promotional speakers
when these speakers present supposedly
“independent” Continuing Medical
Education
-
Conflicts of interest in Merck sponsored
Data Safety Monitoring Boards
Assistant
Attorney General James Savage represented
New Jersey in this multi-state investigative
effort.
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