Advertisers Weigh Impact of FDA Rulings

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A Federal Drug Administration ruling last August designed to open up the direct response market for prescription drug makers has done just that, but buyers and observers contend that the guidelines still inhibit effective use of direct response mechanisms.


While record numbers of branded prescription drug makers are turning to television for direct to consumer advertising, the addition of either an 800 number or Web site address as part of the FDA's overriding recommendation is not always translating to true direct response advertising.


In the period of August through December of 1997, drug companies jumped ad spending in direct to consumer on television by about 246 percent, to $96.8 million, compared to the same period in 1996, according to data by Competitive Media Reporting, which tracks media activity and expenditures.


"Obviously, prescription drugs have some fluctuations but even so that is a dramatic number," said Lynn Fava, a senior analyst with CMR, New York. "You can expect to see the same kind of increase by the time August hits and we can [evaluate] a full year."


But Fava, like others, contend that the jump in direct to consumer advertising does not necessarily correspond with a jump into true direct response advertising. Many of the spots resemble general brand advertising and are running during prime-time network dayparts rather than on discounted remnant time, usually the domain of DRTV advertisers.


"The new ruling has affected branded television, but is it general awareness or is it direct response TV?" said Bruce Houtman, direct to consumer manager, Pharmacia & Upjohn Co. "It is all direct response because they are required to have a response mechanism, but are you buying at DRTV rates and style, versus national general awareness?"


Before the FDA issued its "guidances" -- they are not permanent regulations yet -- companies were greatly restricted in their televised messages to consumers. Companies could either run unbranded ads in which the commercial could talk about a condition or symptom but not about an actual product, or they could run brand reminder ads in which the brand could be mentioned but the conditions and symptoms could not.


Now, companies can televise brand name and conditions if they provide references for more information in what is considered a "brief summary" on drug usage and its impact. Because ads must include one of four references that outline all the benefits and side affects of a certain drug, the commercials direct consumers to a corresponding print ad, web-site address, 800 number or to a doctor. Among the most notable to break since the ruling was Lamisil, a foot fungus treatment by Novartis.


The television guidances, which will be reviewed for 18 months by the FDA, aimed to generate greater consumer education. "Basically our goal in all of this is to make sure people get accurate, well-balanced information and this was one way we thought was a practical way of doing it," said Brad Stone, a spokesman with the FDA. "If it turns out in practice there are better ways of doing it, we are very open. But this indeed may work well."


While media buyers and advertisers favor some form of guidances, they contend the current ones are not achieving the goal.


"I support the somewhat unpopular view that the guidances are not bad," said Jim Sandino, managing director, Lowe McAdams Direct, a division of Lowe McAdams. "If you are truly creative, you will find a way to communicate effectively and to do good print ads and good, entertaining TV." But Sandino said the guidances have stymied the product message.


"A lot of people jumped into TV with both feet without thinking clearly," he said "What we have ended up with is a number of spots that are probably more confusing than before. Now, the spot has to carry a lot of baggage by requiring four calls to action. It muddies the whole creative. You end up with TV that neither educates adequately about the benefits nor adequately tells people what the real risks are."


Such baggage does not translate well to direct response. "When you put four things in ads you inhibits response and drive away interest and so you see a drastic reduction in phone calls and in the effectiveness of the communication."


Further, Sandino said clients are also paying too much. "A lot of them are doing more direct to consumer and a lot of them are doing direct response," he said. "But a lot of them do not know good direct response and as a result are not real, direct marketing efforts. A lot of the advertising is still being bought as general awareness so clients are paying more than they have to."


"Most of these drug companies put the bulk of ad dollars into print and network The lion's share of the pharmacy advertising continues to go into direct mail mass media," said Desiree Dumont, managing director, Media Direct, which handles such brands as migraine medication Imitrex and stomach drug Prilosec. The agency posted billings of about $200 million last year.


"There remains a lack of understanding for the business and how to utilize direct as a powerful weapon in the marketing arsenal," Dumont said. "There is a lack of knowledge for the power of direct response and how to harness the power. It is still an uphill battle."


Despite the FDA guidances other response issues regarding direct to consumer advertising for prescription drug products remain.


"You still have to do a lot to convince a client to do direct to consumer," Dumont said. "There is no retail store with shelf space and there are no sales goals to meet. And if doctors don't know about a drug and they are the ones writing the prescription it may not increase prescription sales. It is not as simple as 'go on TV or do direct response TV, there are a lot of steps in the process."


Part of the process for Upjohn is determining whether direct response is appropriate based on consumer needs. "We'll be looking at other products as we go forward because the new rule does make it easier to do branded rather than sticking to non-brand and brand reminders," Houtman said. "A lot of it is going to come down to informational needs and impact."
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