"You bet," said J. Patrick Anderson, VP-business development for Stryker Corp., which makes orthopedic implants. "One thing we've taken from the pharmaceutical companies and direct-to-consumer [advertising] is that it has spurred an awful lot of interest and demand that wasn't there before."
"The new guidelines are going to fuel a DTC medical-device revolution," said Marc Scheineson, a former associate commissioner with the FDA who now heads the food-and-drug practice for Washington law firm Reed Smith.
Stryker could be a perfect example. Prior to 2003, the company advertised only in medical trade journals. But then Jack Nicklaus had hip-replacement surgery using Stryker's innovative ceramic device instead of a traditional steel hip, and the legendary golfer began raving about the product. Last September, Mr. Nicklaus began appearing in late-night cable TV ads for Stryker, whose ad budget jumped to $670,000 and could go even higher this year.
So as pharmaceutical companies ponder their own new draft guidelines, what is fueling the medical-device community? The very fact that, for the first time ever, there are guidelines.
"Now that the FDA has showed us where the lines are, you bet we're going to advertise more," said an executive for a hearing-aid company. "In some cases, people held off on advertising because there wasn't a sense of what kind of fair balance was needed in this industry."
The draft guidlines ask manufacturers to present a "major statement" of product risks, and by identifying alternative means for consumers to obtain complete risk information.