The guidelines now allow DTC commercials to name the product and what it does as long as the ad has a "major statement" mentioning serious side-effects and directing viewers to a print ad and Web site for detailed disclosures.
ALLEGRA AD IN QUESTION
The change came shortly after Hoechst Marion Roussel's "Wheat surfer" ad for Allegra antihistimine caused the agency concern -- it found consumers were figuring out the product was an allergy drug.
Back then, an ad with a brand name alone could not specify what its purpose was. The May letter FDA sent, inviting Hoechst to discuss the ad, became a turning point, and new guidelines were issued in August 1997.
The FDA will now wait to see how well the guidelines work over an 18-month period before formalizing them or making further changes.
The guidance has left some open questions about the print requirements. Magazine and newspaper publishers charge some pharmaceutical marketers aren't playing fair.
Recently, drug companies -- such as Glaxo Wellcome for antiviral drug Valtrex -- made network TV buys reaching millions of viewers but only ran the necessary print ads in limited circulation publications. In others, the drug marketers ran print ads that contained only the disclosure language -- without the colorful display ad.
Representatives of the Magazine Publishers of America and the National Newspaper Association, in a joint meeting with FDA officials, argued for a requirement of audience equity in both media.
MORE DISCLOSURES REQUIRED
Print media representatives say broadcasters have an unfair advantage because far more disclosures are now required in print ads than broadcast and that print disclosures should be more consumer-friendly.
Meanwhile, most prescription drug marketers tend to limit their print buys to a handful of the highest-circulating magazines, such as Reader's Digest and Time, without knowing if they can take alternative approaches to reaching their audience.
SKIP PRINT ALTOGETHER
In a letter to the FDA, Abbott Laboratories even questioned the need for print ads or brochures at all, saying they would add "no additional benefit to consumers" who could easily get the information by calling a toll-free number provided in a TV spot.
"Obtaining a printed advertisement may require purchase of a magazine or newspaper [and] the consumer will then be directed to the toll-free number [contained in the TV ad]. Both of these alternatives have the potential to be time-consuming and inconvenient for the consumers," writes Frank Pokrop, director of regulatory affairs for Abbott, in a letter to the FDA.
"There is no necessary concurrence between consumers who are apt to hear a broadcast advertisement and those who are apt to see or search for a print advertisement," says Pharmaceutical Research Manufacturers of America.
The Coalition for Healthcare Communication, which includes the American Association of Advertising Agencies and medical marketing groups, said the FDA went too far in suggesting that anything beyond a toll-free phone number is needed for disclosures.
"Our position is that is excessive and not necessary," says Jack Angel, executive director at the coalition. "If you have the 800-number, there is no need for the other stuff."
CLIMATE OF FEAR
More could change when a new FDA commissioner is appointed to replace David Kessler, who left in November 1996. Mr. Kessler was heavily criticized for being an impediment to modernizing DTC policy and fostering a climate of fear to challenge the situation.
Such concerns were due to the industry's contention that the agency has a murky dual role in approving both sale of prescription drugs and its advertising. Until the last few years, prescription drug marketers were wary of challenging the FDA's outdated ad guidelines as well as an unofficial "pre-clearance" of advertising, suspicious that doing so would cause the agency to retaliate when it came to approving their drugs.
FDA, which has since instituted reforms for speedier drug approvals, has denied being vengeful and that it requires pre-clearances, rather only "voluntary" submissions of advertising.
Advertisers say that when they do skip showing the FDA, however, they often hear from the agency through warning letters for changes. Since the agency relaxed its TV requirements, they agree that it is much more open to communication and seeking partnerships to establish more sensible guidelines.