FDA ANNOUNCES NEW DRUG AD GUIDELINES

Wants Marketers to Emphasize Risk Information in Print

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DETROIT (AdAge.com) -- The Food and Drug Administration this morning announced three new draft guidelines for the $2.6 billion direct-to-consumer advertising industry, telling pharmaceutical companies to revamp and reduce the brief summaries in print ads and encouraging more disease awareness spots on TV.

Less is more?
"This is a case of where less may be more,"

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said FDA Commissioner Dr. Mark B. McClellan, who suggested using bullet formats and breakout boxes that portray the most significant risks of taking prescription medications. "Technically, the brief summary is in compliance with the laws but it doesn't convey that information to consumers who find it too detailed and off-putting. Because the brief summary is the main tool designed to convey this information, we need to do better."

In the brief summaries, the FDA said the risk information was often overshadowed by the amount of information, and that it was communicated in difficult-to-read fine print. Mr. McClellan said the print guidelines should be reduced to a less-cluttered format and be more consumer-friendly.

But while the drug makers and their advertising agencies are generally pleased, some feel the new guidelines don't go far enough.

Congressman critical of plan
"The new guidance misses the crux of the problem, which is the FDA's abysmal failure to take strong action against the false and misleading claims in current DTC ads," U.S. Rep. Henry Waxman, R-Calif., said in a statement. Mr. Waxman has been critical of the FDA's oversight of DTC ads.

"While I agree that risk information in print ads needs to be presented in language that consumers can understand, the FDA's example demonstrates how this provision could open the door to abuse. The FDA says that it's OK for drug companies to replace a consumer warning that says a drug may cause 'acute liver failure' with a warning that the drug 'can affect your liver function.' That's consumer-misleading, not consumer-friendly."

Former FDA Associate Commissioner Marc Scheineson, an attorney who now heads the food and drug practice at Washington D.C. law firm Reed Smith, blasted his former agency. He said that a "less is more" philosophy may open pharmaceutical companies to greater product liability.

Like gasoline on an fire
"The goal was always to rein in DTC advertising. This is like throwing gasoline on a simmering fire," Mr. Scheineson, an associate commissioner with the FDA from 1990-92, said of the new draft guidelines. "If you're going to simplify, what do you take out [of the brief summary]? Even if you direct the patient to another periodical or a toll-free number or a Web site, will a court in the future say it wasn't sufficient enough notice?"

Peter Pitts, the FDA's associate commissioner for external relations, said, "What we're trying to do is make sure people have the information that they need. We think companies can still achieve legal protection and important public health benefits by doing that in a better way."

Bob Clark, director of regulatory relations for Pfizer, said there are many mechanisms and media to relay product information.

"It's going to be a balancing act, but we have internal practices and policies to make sure what we're doing is right," he said.

Broadcast rules not changed
Current TV broadcast advertising guidelines will remain the same. The FDA is asking pharmaceutical companies to utilize more "unbranded" messages, also defined as help-seeking or disease-awareness ads, and is putting guidelines in place for medical device broadcast advertising. Medical devices are considered to be items such as hearing aids and pacemakers.

As part of the request for more unbranded messages, the FDA did write into its draft several guidelines in which reminder ads -- 15-second brand spots that do not identify the disease -- are not be broadcast with help-seeking ads.

"We don't want a reminder ad placed next to a help-seeking ad that could imply to consumer that here's a drug used for that particular condition," Mr. McClellan said.

"We felt the top priorities [of the new guidelines] were getting more utility out of the brief summary," Mr. McClellan said. "Most promotion is in print, and it's an opportunity to give people more information about risk and benefit. We also heard a lot about the potential value about health-seeking ads, and we also heard concerns about broadcast ads for devices where no guidelines were in place."

Ad groups said they were pleased with the FDA action, but also said they were still reviewing the guidance.

Skipping the legalese
"I believe it is a welcome step to tell consumers about the risks in a way they can understand, rather than something that is long, legalistic and verbose," said Adonis Hoffman, senior vice president and counsel for the American Association of Advertising Agencies. "It is welcome for advertising agencies because it makes our job as creative people much clearer."

Dan Jaffe, executive vice president of the Association of National Advertisers, also praised the guidance, but said that they still have to be more thoroughly reviewed.

"This is just out, and it is a complex proposal," Mr. Jaffe said. "The information that is provided now is not helpful and is not consumer-friendly. There must be a way of providing information without inundating people with technical information, but have they hit the target? We have to really look. But the FDA is focusing on the right issue."

The new guidance, the first since 1999, had been expected since late last year. The FDA held a two-day public hearing last September in Washington, receiving input from pharmaceutical companies, advertising agencies and consumer health groups, among others, on the risks and benefits of DTC advertising. The FDA also conducted its own survey and used the results to shape the new guidelines.

In favor of DTC
Mr. McClellan and other FDA officials have generally been in favor of DTC advertising, saying, among other things, that the marketing and promotions have helped to get people to see their doctors and have de-stigmatized conditions that previously were not discussed in public.

The new guidelines should not affect pharmaceutical marketers or magazine publishers. Several drug makers have already told AdAge.com they will likely convert some branded spots into unbranded ones without increasing its ad budget. And a reduced brief summary probably won't hurt magazines since those pages are generally sold to pharmaceutical companies at a loss.

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