$58 Million Merck Settlement To Change Deceptive TV Drug Advertisements
SAN DIEGO--California Attorney General Edmund G. Brown Jr. today announced a “groundbreaking settlement” with Merck & Co. which requires the pharmaceutical manufacturer to obtain Federal Drug Administration approval before running any television drug advertisements for new pain medications.
“Merck’s aggressive television advertising convinced hundreds of thousands of consumers to seek Vioxx prescriptions before the drug’s risk were fully understood,” Attorney General Brown said. “Today’s groundbreaking settlement prevents Merck from releasing new television drug advertisements without obtaining federal approval.”
Today’s settlement resolves 30 state lawsuits challenging Merck’s marketing practices for Vioxx, a non-sterodial anti-inflammatory drug used to treat symptoms of arthritis as well as chronic and acute pain.
In 1999 Merck launched an aggressive promotional campaign directed at both consumers and health care professionals in which the company allegedly misrepresented the cardiovascular dangers of Vioxx. In 2004, Merck admitted that Vioxx caused serious cardiovascular adverse events and withdrew the drug from the market.
California alleged that one of the problems with the Vioxx marketing campaign was that the direct to consumer advertising began when the drug was first released and before doctors had an opportunity to gain experience with the drug and its potential side effects. Under today’s settlement, Merck may not launch a television advertising campaign for a newly approved pain drug if the Federal Drug Administration recommends delaying such television advertising.
The settlement, which also requires Merck to pay $58 million in restitution to states, is the largest monetary settlement that a group of states have obtained in a pharmaceutical advertising case. California will receive $5.3 million of the settlement funds to pay attorneys’ fees, future enforcement and consumer education.
The settlement places other restrictions on Merck’s future conduct including:
• Prohibiting the use of deceptive scientific data when marketing new drugs to doctors
• Prohibiting Merck from “ghost writing” articles and studies for publication
• Requiring disclosure of conflicts of interest when Merck promotional speakers make presentations at supposedly independent Continuing Medical Education programs
• Requiring Merck to submit clinical trial results of FDA-approved Merck products to the National Library of Medicine
Merck’s principle place of business is One Merck Drive, Whitehouse Station, New Jersey. Merck advertised, sold, promoted and distributed the prescription drug rofecoxib, marketed under the name Vioxx, in California and nationwide.
Other states which participated in today’s settlement include: Arizona, Arkansas, Connecticut, Florida, District of Columbia, Hawaii, Idaho, Illinois, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, and Wisconsin..
Please contact the attorney general's press office for a copy of the complaint and settlement