ATTORNEY GENERAL FILES JUDGMENT
AGAINST MERCK RESOLVING INVESTIGATION
INTO MARKETING OF VIOXX
New Jersey among 30 states sharing record $58 million settlement
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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