Drug makers seek looser rules for online ads
Firms to press FDA on requiring list of side effects
WASHINGTON - As federal regulators take their first tentative steps toward policing the wild west of medical information online, pharmaceutical companies are pressing their case to market drugs via Google, Twitter, and other websites.
The Food and Drug Administration will convene a two-day meeting beginning today to hear the drug industry’s position on Internet marketing. The agency has agreed to consider developing rules for online advertising after companies complained that the current guidelines for traditional media - which require a detailed list of possible side effects - have left them hamstrung on the Internet.
An estimated 83 percent of Internet users search for health information online, according to a recent survey by the Pew Research Center.
A few drug makers have begun trying to reach patients via social networking sites such as Facebook and YouTube. But overall, the industry’s online presence trails those of other sectors, including retail, financial services, and computer makers.
In the first half of 2009, pharmaceutical companies represented just 4 percent of the $10.9 billion spent on online advertising, according to a report from PricewaterhouseCoopers.
Industry observers say companies have largely steered clear of the Internet for fear of running afoul of FDA regulators, who have not defined the rules of operating online.
In a public statement announcing the meeting, the FDA acknowledged that “emerging technologies may require the agency to provide additional guidance.’’ But some specialists worry the FDA’s rule development process - which often takes years - cannot keep pace with online innovation.
“What’s happening is these new media are emerging at an increasingly rapid rate, and are being regulated by an agency that moves very slowly,’’ said attorney Mark Senak, who advises drug companies as a consultant for communications firm Fleishman-Hillard. “In essence, you have a regulatory communication crisis developing.’’
The vast majority of the pharmaceutical industry’s roughly $4.5 billion in annual marketing is still spent on TV and magazine advertising, where the rules are clear: All ads that mention a drug must provide a balanced picture of its risks and benefits.
The requirement to disclose risk information demands those long lists of side effects heard during TV and radio spots, as well as the large blocks of small print seen in magazine ads.
When drug companies have tried to adapt such ads to the abbreviated language of Google and Yahoo, they have run into trouble. In April, the FDA fired off warning letters to Pfizer Inc., GlaxoSmithKline PLC, and a dozen other drug makers for search engine ads that did not mention drug risks.
The ads, called sponsored links, appear on the screen margins of websites when users search for certain key words. With a maximum of just 25 words, the links did not include information about potential side effects, making them illegal, according to the FDA.
The Pharmaceutical Research and Manufacturers of America group will argue at today’s meeting that the FDA should relax its standards to accommodate new online approaches to marketing.
