Merck/Schering Vytorin Settlement Shows New Trend: Government Control of Drug Ads

(MoneyWatch)  In Merck and Schering-Plough's settlement with the state attorneys general over Vytorin contains a set of provisions that are fast becoming the new normal for large drug companies: Government control of drug advertising, including pre-approval of ads and years-long compliance reviews.

Most people focused on the tiny sum that the two companies will have to pay: Just $5.4 million. The settlement was indeed miniscule. Arizona will receive just $300,000 from it; Idaho got $100,000. (Don't spent it all at once, Idaho!)

The settlement came after allegations that the companies failed to protect consumers by delaying for two years the results of a trial that showed Vytorin was no more effective than a generic at preventing carotid artery plaque.

Merck must now submit "all new DTC television advertising campaigns for any Merck Product to FDA for pre-review, wait until Merck receives a response from FDA prior to running the advertising campaign," the settlement says. The provisions last for seven to 10 years.

Sounds harsh? Get used to it -- it's coming to a company near you. Merck is at least the fourth major pharmaceutical company whose advertising is controlled by government officials. Consider:

• In February, Bayer agreed to submit all future advertising for Yaz to the FDA for pre-approval, following an off-label TV campaign. Bayer was also required to spend $20 million on FDA-ordered "corrective" advertising.
• In 2008, Cephalon signed a five-year agreement under which the company submitted to a "corporate integrity agreement" written by the Department of Justice, covering its advertising. The agreement came after Cephgalon promoted its painkillers off-label.
• In 2005, Eli Lilly's marketing of Evista came under DOJ control. You can read the details on Lilly's compliance agreement here.

Of all the agreements, Merck's is the strictest -- it covers all Merck products, not just the offending one. Which goes to show, the consequences of the Vioxx scandal were not merely financial for the company -- they crimped its marketing strategy options too.

• Previously:
• "Pain Is Pain": Cephalon's Marketing Comes Under DOJ Control
• Why the Bayer-Yaz Settlement Will Not Change Drug Advertising Forever