Drug companies are beginning to favor unbranded direct-to-consumer ads over product-specific ads as a way to circumvent the fair balance warning statement requirement, PreTesting Company CEO Lee Weinblatt told a Strategic Research Institute DTC marketing conference in New York June 28.

Of the ads reviewed by the PreTesting company in 1999, many of which may not yet be on the air, "the majority of DTC ads outside of analgesics have stopped talking about name and what they're for so that they don't have to have the fair balance message," Weinblatt said. "Based upon some recent research, we're going to see more and more of this."

The Tenafly, N.J.-based advertising research firm performs advertising evaluations for 18 pharmaceutical companies, and has reviewed approximately 140-150 print and TV ads this year. Of the broadcast ads market tested by the firm, more than half have been unbranded.

PreTesting Co. has studied reactions of 3,200 subjects to branded TV drug ads that contain fair balance warning statements versus reactions to the same commercials with the statements "stripped out."

Subjects were less likely to remember the brand name of the advertised product with the warning (47%) than without (61%), more likely to change the channel before seeing the whole commercial (34% vs. 20%) and less likely to say they are "definitely willing to call their physician" (18% vs. 32%) after hearing the warnings, Weinblatt reported.

Weinblatt questioned whether TV is the optimal medium for DTC campaigns, noting that "in many cases we have found that print is superior to TV," because although branded print ads also carry fair balance statements, "we have found that in most cases...a good print ad for DTC will get more of its message across in a balance to the scare of a fair balance message."

"As long as fair balance warnings are being put in the way they currently are," companies are "simply going to start shying away from advertising on TV," Weinblatt predicted.

FDA's Division of Drug Marketing, Advertising & Communications is expected to issue a guidance clarifying its fair balance requirements.

DDMAC is "under a lot of pressure from a lot of outside agencies to generate a guidance document on fair balance," AstraZeneca Quality Liaison Leader Doug Dobak said. "From what I've heard in the last month, it's being generated, and there should be a draft guidance coming out...in the not too distant future."

Dobak suggested possible improvements in FDA's ad preclearance process for drug ads, noting that the current process can be lengthy and confusing.

He pointed to the preclearance process for AstraZeneca's currently running 45-second Prilosec broadcast ad featuring men and women dancing on the faces of clocks. This process included "12 telephone calls, 2 conference calls, 1 face-to-face meeting, 4 FDA letters, and 4 official submissions...in order to get this 45-second ad pre-cleared with FDA."

This process would be aided by a clearer understanding of how DDMAC comes to decisions about enforcement and of which guidances or regulations a specific decision is based upon, Dobak said. He also suggested "more team-type meetings" with FDA to better understand how the team comes to its decision.

He urged companies to "always anticipate further comments" from FDA, even after an ad has been pre-cleared, pointing to a Prilosec ad that had been running for over a year when DDMAC requested changes.

Dobak predicted that FDA's final DTC guidance will be out in mid-1999 with "only one minor change from the original document" which would eliminate faxing from the methods for providing labeling to consumers.

Attorney Phillip Katz (Buc & Beardsley, Washington, D.C.) agreed that the final guidance is likely to be similar to the draft, and predicted that pharmacy pamphlets will also be removed as a source of product labeling.

Katz also said that FDA will clarify its requirement for a concurrent print ad in a publication that reaches the same audience.

"FDA has been saying to people, 'your print component isn't good enough, you know you can't run this on Good Morning America and have broad exposure, and then run one ad in Men's Fitness, and say you've done a concurrent print ad that reaches the same audience.'"

Unbranded DTC Broadcast Ads Are Increasing As Way Around Fair Balance

More from Archive

More from Pink Sheet