Merck & Co. has agreed to pay $58 million as part of a multistate settlement of allegations that its ads for the once-popular painkiller Vioxx deceptively played down the health risks.
The agreement announced Tuesday also called for Merck to submit all new TV commercials for its drugs to the Food and Drug Administration for review before they can be aired.
The civil settlement ends a joint three-year investigation by 29 states and the District of Columbia into Merck's advertising practices involving Vioxx, Pennsylvania Atty. Gen. Tom Corbett said.
Vioxx was taken off the market in 2004 after research showed it doubled the risk of heart attacks and strokes. That triggered thousands of lawsuits against Whitehouse Station, N.J.-based Merck. A pending $4.85-billion settlement would end the bulk of those personal injury suits.
Thanks to aggressive marketing through direct-to-consumer television ads begun in 1999, hundreds of thousands of consumers demanded Vioxx prescriptions before doctors had a chance to understand the side-effects, Corbett said.
"Consumers need clear information about the risks associated with prescription drugs so that they can make well-informed decisions about their healthcare," Corbett said.
The FDA does not require drug companies to submit advertisements for advance approval except in cases where it has pursued enforcement actions over false and misleading claims, agency spokeswoman Rita Chappelle said.
The agreement calls for Merck to submit all new TV commercials for its drugs to the FDA for review and to follow through with any changes the agency recommends before airing them for seven years. Additionally, for a 10-year period Merck must comply with any FDA recommendations to delay TV advertising for newly approved pain medications.
Merck is also prohibited from "ghostwriting," a practice in which people who worked for the company or were otherwise connected to it allegedly wrote positive articles and studies about Vioxx, Corbett said.
Merck is not admitting wrongdoing under the settlement and defended its marketing of Vioxx on Tuesday.
"Today's agreement enables Merck to put this matter behind us and focus on what Merck does best, developing new medicines," said Bruce Kuhlik, Merck's executive vice president and general counsel.