NEW YORK: A Food and Drug Administration panel has opened the door for the reintroduction of Vioxx, but Merck insists it has not yet begun any outreach for the controversial drug.
Jeanine Clemente, Merck's communications coordinator, noted that the company has been answering all media inquiries with the message that a re-launch is not set in stone.
"It's all speculation at this point," she said. "It would be premature to say anything."
She also could not confirm by press time whether Merck has retained its former agency to work on the Vioxx account.
The recall of Merck's blockbuster arthritis drug might have been the company's biggest crisis in recent memory, but industry experts insist that it would be possible to successfully bring Vioxx back to market.
Fleishman-Hillard SVP Mark Senak, who counsels clients on bringing drugs to market, noted that the public comment period drew what might have been an unprecedented number of attendees.
"Clearly between the doctors and the patients there is a devoted following," he said. "These drugs are useful for particular types of people who have particularly low risk."
But he noted that Merck and other manufacturers of arthritis drugs would need to invest in more safety studies.
The FDA panel has also proposed voluntary restrictions on direct-to-consumer (DTC) advertising for cox-2 inhibitors, the class of painkillers to which Vioxx belongs.
But healthcare communicators see an opportunity to deliver a more targeted message.
"You pretty much need to segment your audience. It's a much more refined effort," Senak said. "This takes PR to a new level."
Peter Pitts, SVP at MS&L and the former head of PR at the FDA, noted that patients get the majority of their health information from the media, not advertising.
"The public needs to be much more attuned to the fact that all drugs have risks," he said. "PR has to make sure that we're not selling hype."
If anything, the restrictions on advertising will position cox-2 manufacturers as "less of a huckster, more of a teacher," he said.
Merck's Clemente declined to discuss how the company would position the drug without advertising.
"We have had a lot of questions about the advertising restrictions," she said. "Right now it's still [just] a consideration."
Tara Olson, president of AllPoints Research, which tracks consumer perceptions for companies looking to launch a new product or DTC campaign, noted that cox-2 manufacturers will need to do significant physician outreach.
"I think what it comes down to is the support of the medical community. Certain consumers will be adamant ... but for the most part patients will trust their doctors," she said. "Most of the messaging is going to happen in the doctor's office."