Dial FDA: Marketers Face Added DTC Requirements

Under direction from Congress, FDA is examining whether television drug advertising can improve patient health and spur consumers to report adverse events. FDA's Risk Communication Advisory Committee—a new panel of social scientists that advises FDA on these matters—discussed these issues at a meeting last week.

Consumer advocates urged a speedy decision on the TV adverse event reporting policy, which FDA says will take two years to institute. But no one from industry stepped up with evidence that DTC advertising could be useful in accomplishing public health goals, or in educating patients about appropriate drug use—something that marketers regularly cite in fending off attacks on TV drug advertising.

The FDA Amendments Act (FDAAA) calls for FDA to study whether displaying an 800 number in TV ads will interfere with communication of important risk information. The legislation already requires such information to print ads, but the policy has been held off on broadcast ads pending further evaluation of how best to present the information.

"The typical 60 second spot in pharma, allowing for fair balance, has time for just five sentences of focused promotional copy," said Jay Carter, Sr. VP, director of client services at AbelsonTaylor in an interview on Tuesday. "Adding an 800 number for FDA would likely cut the promotional copy in a sixty-second spot to an average of four sentences from five. I am not arguing that we should not include fair balance, I am merely pointing out such additions distract from the central message of an advertisement, which is of course why marketers spend money to run ads."

The topic got plenty of discussion at the advisory committee meeting, with the consensus that displaying an 800 number would indeed reinforce the idea that drugs have adverse events, and that there is a way to report problems to FDA. While the call-in information may clutter up commercials, marketers could gain credibility by testing various approaches for including this information in ads, rather than waiting for FDA to rule on the issue.

Similarly, marketers probably know much more than academics and members of Congress about just how effective TV commercials are at communicating important health information to target patient populations—such as the elderly, children, blacks, Hispanics and other minorities. Congress is interested in reducing disparities in health problems for these groups, and has instructed FDA to assess how DTC advertising can prompt these target populations to seek information, and whether there is any health improvement as a result.

The advisory panel learned that there is scant data available on these issues, providing industry with a prime opportunity to gather that information or disclose some of its proprietary data documenting those kinds of values to DTC advertising.