The plan is still in development, but the foundation is set: Merck plans to bring in randomly selected consumers, expose them to the advertising and assess how well they can recall and understand the condition the drug is intended to treat; essential information about the drug's risks and benefits; and whether they felt the ads were false or misleading.
"We're a data-driven industry, FDA is a data-driven agency," said Ed Slaughter, manager-consumer marketing at Merck. "It carries with it the potential of facilitating the review process."
The $4 billion DTC industry has been under public and political pressure since late 2004 when Merck was forced to take its anti-arthritis drug Vioxx off the market after studies showed an increased risk of heart attacks. Critics charged that heavy advertising of Vioxx contributed to it being over-prescribed.
Drug makers must presubmit ads to the FDA's Division of Drug Marketing, Advertising and Communications under a code of conduct issued by the Pharmaceutical Research and Manufacturers of America.
Merck's consumer research "is not required under the code, but companies are certainly encouraged to provide additional information," said PhRMA VP-Communicatons Ken Johnson. Merck spends more than $400 million annually on advertising marketing such brands as Fosamax, Singulair, Zocor and Vytorin (co-marketed with Schering Plough). Mr. Slaughter said that if Merck's data showed an overwhelming amount of consumers were confused or didn't understand the risk/benefit information, the company would take the spots back to its ad agency before even submitting the campaign for review.
"Clearly we don't want to be putting things out that are non-communicative," he said. "But I hope it would be the rare case that we got to a final cut to find out that something wasn't working."
DDMAC agreed to provide technical assistance to Merck on developing the system. Once finished, Merck said it would make the protocol available to competitors.
Whether it expedites the review process remains to be seen. "While we don't know if development of this protocol will result in any changes to DDMAC's current review policies," said Thomas Abrams, director of DDMAC, "if successful the protocol could be a useful tool for facilitating review of ... advertisements."
Peter Lurie, deputy director of Washington advocacy group Public Citizen, disagrees. "The data would be far more convincing if it came from a disinterested party," he said.
Mr. Slaughter responded: "That's part of the reason why we went to FDA for technical assistance. It's not like we developed this on our own. We went to the people responsible for viewing the ads and asked their advice on how to put it together."