FDA, Industry Assess Best Way To Communicate Risk in DTC Ads

ATLANTA - When designing direct-to-consumer television ads, FDA would "prefer that you have the major risks in the audio," Amie O'Donoghue of FDA's Division of Drug Marketing, Advertising and Communications advised industry at the Drug Information Association annual meeting June 19.

"If you reinforce it ... somehow having a visual element without grossing people out, that would be preferable," she added. However, she pointed out, "There are many ways you can successfully do it, so we wouldn't want to say you must do it this way."

How audio, visual and textual elements of a TV ad interact and either support or distract from each other is the subject of a major study being launched by the agency. The audio is the benchmark of the study because of its importance in communicating risk, O'Donoghue said.

The importance of presenting risk information without distracting visuals was stressed in the recent report from an outside panel convened by the Pharmaceutical Research and Manufacturers of America to assess DTC ads in the wake of the group's advertising principles, which were released two years ago (¹ , p. 9).

Ultimately, FDA wants "to develop a DTC metric to assess the extent to which ads are accurately communicating the right risk and benefit information," DDMAC's Kathryn Aikin said.

This would include a method to objectively examine risk information in an ad and "a tool that would be used to apply that standard across all ads to assess the quality of the risk information, possibly the benefits," she said.

In the meantime, the agency is conducting several studies on how consumers perceive information in ads. Early results from a study of how viewers interpret eight frequently-used phrases found that understanding can differ depending on education level, O'Donoghue reported.

At one test site, for those with less education, the phrase "individual results may vary" indicated the sponsor was trustworthy, she said. For those with more education, it indicated the company would not stand behind its product.

"You can't take very much from a couple of focus groups, but that was interesting," she commented.

PhRMA's guiding principles on DTC require changes in the way companies advertise, and Pfizer is doing extensive research on their impact and how best to implement them, Director of Marketing Analytics Jon Richter reported during a separate session on DTC from industry's perspective.

One of the principles calls for ads to include the message that alternative treatment options are available. A key finding of Pfizer studies, Richter said, is that alternative treatment language "doesn't deter from any of the other messages in the ad. It doesn't deter or significantly lower understanding of risk information, understanding of benefit information, what the medication is for. It really has no impact on the other things in the ad."

In fact, it can be beneficial for the advertiser, he noted. "For those who saw it, it engendered a sense of trust in the company."

Pfizer has evaluated "many, many different formats" for redesigning the brief summary in line with the trade association's principles and conversations with FDA, Richter said.

The result is a brief summary that is "more usable. ... People have better recall of side effect information. They get whether these are serious side effects or not serious side effects."

Developing guidance on how to present risk information "is a high priority" for DDMAC, Director Tom Abrams said. Guidance on putting "important information from the brief summary into really understandable language" is being prepared as well.

While companies and FDA were discussing the mechanics of DTC advertising, the House Energy and Commerce Committee Health Subcommittee was removing provisions from its FDA reform legislation that would have allowed the agency to ban DTC ads during the first three years after launch of a new product (see ² (Also see "Risk Disclosure In Drug Ads Will Be FDA’s Focus After House Defeats DTC Ban" - Pink Sheet, 25 Jun, 2007.)).

Unaffected is a user fee program negotiated by FDA and industry to fund DDMAC review of TV ads.

Expanding the scope of user fees to include advertising, particularly given the increasing demand for preclearance of DTC material, was one of the agency's priorities going into PDUFA IV negotiations.

In anticipation of the user fees, the division already is developing systems to manage and track submissions, working to fill the 15 positions that would be funded, and drafting guidance on how to submit the ads, Abrams said.

If FDA reform is enacted as expected, the program would go into effect Oct. 1, "which is coming up very, very quickly, especially with all the work we have to do."

The user fees are "critical," Abrams insisted. DDMAC faces a growing workload as more products are promoted and the promotional materials become more complex, he pointed out. Promotional Web sites have contributed to the complexity, he said, "and there's more risky drugs being promoted directly to consumers" as well as "complicated indications ... which years ago would not have been presented."

"It's hard to keep up. It's hard to prioritize when we have increasing workload and limited resources." The agency recently shifted two positions to the DTC program, he said, calling it a "balancing act."

For its part, industry will receive "timely and predictable review" of its draft television ads - 45 days for a first submission and 30 days for a resubmission, Abrams noted. "Being timely is critical to industry. We realize that and we want to provide comments in a prompt manner."

FDA carefully monitors DTC ads, he pointed out, because "it's not in the public health interest to have misleading promotion occur in the marketplace, and we'll take action when we see it. I truly believe it's not in anybody's interest to have misleading promotion. It's not in industry's interest either. It tarnishes, it really does. Image is too important to throw away."

- Cathy Dombrowski ([email protected])