Marketers Blast Drug-Ad Study

NEW YORK Advertisers’ lobbying groups reacted with anger today at a study published in the Annals of Family Medicine that criticized direct-to-consumer prescription drug advertising.

The study was out of date and misconceived, the marketer advocates said.

The article, published Monday, concluded that “only 26 percent” of drug ads on TV made claims about “risk factors or causes of the condition” in question. It also noted that seven of the 38 ads captured in the study were “reminder” messages (promotions that tout the name of the drug but give no other information). Reminder ads are the subject of a voluntary ban among major drug marketers.

The results are flawed because the study was conducted two years before the reminder ad ban came into effect, said PhRMA, the drug industry-lobbying group.

“Unfortunately, the study . . . is based on a sampling of old advertisements broadcast in 2004, long before PhRMA’s Guiding Principles went into effect,” said PhRMA representative Ken Johnson in a statement. “The study does not reflect any of the positive changes in DTC advertisements over the past 12 months and therefore has little relevance to the current policy discussion on direct-to-consumer advertising.”

The study also makes the confusing distinction between whether ads mention “risk factors” associated with a disease and risk factors associated with taking the drug being advertised. Advertisers have no duty to mention a disease’s risks, but the Food and Drug Administration generally requires that marketers describe the drug’s risks—which is why drug ads are so frequently filled with boring disclaimers about “nausea” and “stomach upsets.”

Dan Jaffe, vp, government relations for the Association of National Advertisers, said today that he feared the study would be misunderstood in Congress, where proposals have already been floated for new legal restrictions on DTC.

“I really think those in the Congress in positions of power are going to go forward with proposals to restrict prescription drug advertising,” Jaffe said. Sen. Michael Enzi, R-Wyo., a former chair of the Senate health committee, proposed a bill co-sponsored by Sen. Ted Kennedy, D-Mass., “which would have empowered the FDA to ban prescription drug advertising for as much as two years for new drug products, or empower the FDA to require pre-clearance of all advertising,” Jaffe said.

The study is also a concern, Jaffe believes, because of moves to demand a “user-fee” payment of $392 million from the drug industry to allow the FDA to vet all DTC advertising prior to airing. The ANA has no problem with the user-fee being voluntary but opposes it becoming mandatory.

“To stop someone from truthfully advertising and saying ‘we won’t allow you to speak at all’ is very, very restrictive,” Jaffe said of mandatory fees. “Generally, prior restraints on speech are considered unconstitutional.”

When it was put to him that $392 million is a tiny sum when spread among all drug companies, whose profits frequently enter the tens of billions of dollars, in return for the peace of mind FDA approval would bring to the industry and the consumer, Jaffe said, “$392 million sounds like a lot of money to me. Once you’ve got the principle that we can take money out of advertising, here’s a golden goose that can lay a $392 million egg. [Politicians will say], ‘Let’s see if we can do it again here and here and here.'”