FDA CLOSE TO EASING LIMITS ON RX TV ADS

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A Food & Drug Administration official said the agency is "very actively and very seriously" considering allowing marketers to name both a prescription drug and the ailment it treats in consumer advertising.

Such a change in the FDA's 28-year-old guidelines for advertising could bring a flood of direct-to-consumer TV spending, though FDA also is considering further restricting allergy product ads.

Already, DTC advertising totaled $595.5 million in '96, according to Competitive Media Reporting, though the lion's share is spent in print, with $67.1 million going to TV.

FIXING 'BROKEN' SYSTEM

"The [FDA] is clearly looking for ways to reform a broken system that confuses as many people as it informs," said John Kamp, senior VP of the American Association of Advertising Agencies.

So far, marketers have been frustrated by current FDA guidelines that prevent TV ads from being more than "reminder" advertising: permitting only a brand name or the condition-such as diabetes-but not both.

Though it never actually has, FDA now theoretically allows both parts to appear on TV if there is an "adequate provision" for what is ironically known as the "brief summary," the long list of contraindications that in magazine ads brings them up toas much as three pages.

"Recently, we've seen a number of creative ideas [around the restrictions] that we're seriously considering," said Nancy Ostrove, FDA public health analyst.

CASE-BY-CASE REVIEWS

It's believed the FDA won't yet establish overall rules, but will review ads on a case-by-case basis.

Industry watchers said the FDA is reviewing submissions from several pharmaceutical companies for 60-second commercials that devote 20 seconds to satisfying legal requirements and may also include 800-numbers leading to additional information.

Ms. Ostrove said the FDA is now "more and more experienced [with DTC] and likely to get more comfortable with making changes, if necessary."

The Coalition for Healthcare Communication, which includes the Four A's, has pushed for FDA to adopt a disclaimer for print or TV advertising-similar to the surgeon general's warning on tobacco ads-to replace the brief summary requirement (AA, Jan. 13).

Despite current restrictions, an increasing number of pharmaceutical marketers have added TV, including allergy drugs Claritin from Schering-Plough Corp., Zyrtec from Pfizer and Allegra from Hoechst Marion Roussel.

But some say the result has been confusing to consumers and question the value of spending up to $30 million on TV-as top DTC spender Claritin does-without being able to say what condition the brand treats.

PONDERING CURRENT WORK

At the same time, FDA is looking at the TV effort for Allegra; it stopped running in mid-May for unknown reasons.

The spot shows a windsurfer in a sea of wheat, and an executive with a competing brand said that when similar creative was submitted by his company it was turned down for being too representative of an allergy product.

"We're currently looking into that," Ms. Ostrove said. "Reminder advertising is very restricted. It is not permitted to make any suggestions or representations." The Allegra ads "appeared to suggest to a fairly large segment of the population that it treats allergies."

Hoechst and its agency, Medicus Group International, New York, declined comment.

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