Merck agrees to TV ad pre-clearance

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Merck agreed to submit all TV ads to the FDA before running them and to adhere to agency recommendations on them as part of a Vioxx-related settlement.

Under the terms of the May settlement, Merck will pay $58 million to settle with 29 states over alleged deceptive advertising of Vioxx.

The company has also agreed to delay any DTC TV for pain medications if recommended by the FDA and to refrain from “ghostwriting” and using scientific data deceptively when marketing to doctors, according to Pennsylvania Attorney General Tom Corbett.

In a statement, Merck EVP and general counsel Bruce Kuhlik said: “Merck remains committed to communications that help patients and their physicians choose medicines based on accurate, fair and balanced information. Today's agreement enables Merck to put this matter behind us and focus on what Merck does best, developing new medicines.”

Many companies, including Merck, already voluntarily submit DTC advertising to FDA before it runs.
But industry advocates, voicing First Amendment concerns, have long feared that preclearance of advertising might be made mandatory. Early drafts of last year's FDA Amendments Act included language to that effect, though it was scuppered in later versions—in part because a short-staffed FDA couldn't cope with the extra workload such a policy would bring.

John Kamp, executive director of the Coalition for Healthcare Communications, called the agreement “ugly and unfortunate,” but said Merck probably saw little choice. “I'm guessing they were faced down by 30 state Attorneys General in effect saying , ‘Sign this or we'll smear your company's reputation in court in front of Washington, Wall Street and the press until you beg to die,'” said Kamp. “It's a terrible judicial precedent, and should be declared a per se violation of fundamental due process and the First Amendment. But that's the power in the hands of state prosecutors today.”
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