DDMAC PRAISES PHRMA'S DTC AD GUIDELINES

PhRMA's recently approved code of conduct for direct-to-consumer (DTC) advertising is a step in the right direction for the drug industry, according to the head of the FDA's drug advertising oversight arm.

The agency's Division of Drug Marketing, Advertising, and Communications (DDMAC) "applauds PhRMA" for developing the code, said its director Thomas Abrams. "We're hopeful that this first step by PhRMA represents a growing commitment by the industry to raise the quality of DTC," he said at a recent Food and Drug Law Institute (FDLI) conference on advertising and promotions.

PhRMA issued the voluntary guidelines this summer in the face of strong criticism over DTC advertising practices by drug manufacturers. The trade group's board of directors has unanimously approved the guidelines, but the principles won't formally take effect until all of PhRMA's member companies sign off on them.

So far, 25 of the association's approximately 31 member companies have agreed to the guidelines, said PhRMA President and CEO Billy Tauzin. "We'll get the rest of them," Tauzin said in a separate speech at the FDLI conference.

Among other things, PhRMA's 15-point code calls on drugmakers to target their DTC ads at age-appropriate audiences; provide a balanced presentation of risks and benefits; submit all television ads to the FDA before airing them; and stop running "reminder ads" that mention the drug's brand name but not the condition that it treats.

Abrams said DDMAC plans to hold discussions with PhRMA about the process for firms to voluntarily submit DTC ad proposals for comment before airing them. It is important to submit proposals in the proper format, and provide adequate time to have them reviewed, he added. "If your timeframe is too short, we can't provide comments and you need to know that up front, so there is no holding up the processes," he said.