FDA sets voluntary drug ad guidelines

The Food and Drug Administration issued guidelines yesterday aimed at improving advertising by drug makers, but some who monitor the industry's marketing practices called the initiative toothless.

"This is the least they could have possibly done," said Meredith Rosenthal, a Harvard University School of Public Health professor and an expert on drug-industry advertising. "These things are extremely innocuous, but it makes them feel like they are doing something."

The FDA issued guidelines rather than mandatory rules, leaving it up to drug companies to follow them voluntarily.

An FDA official speaking on condition of anonymity said the agency stopped short of proposing mandatory regulations on consumer advertising because the procedure for adopting formal rules is cumbersome. When the FDA issues guidelines, the official said, they are generally followed by the drug industry.

The most significant suggestion urges manufacturers to stop putting the side effects and risks of their products in tiny type in print advertising. The blocks of scientific jargon that accompany the glossy photographs are ignored by 73 percent of readers, according to the FDA. By moving the risks into an easier-to-understand format -- with fewer sentences and written in plain English -- the FDA hopes more people will read the warnings.

The agency is making no new suggestions for changes in the risk disclosures in broadcast advertising by drug makers, which has exploded on the American airwaves since 1997 and consumes the majority of the $3 billion a year spent on drug ads. Critics have said the ads are sometimes misleading and have contributed unnecessarily to the nation's burgeoning drug spending.

The FDA said yesterday it is content with broadcast risk summaries currently in use. It is, however, encouraging greater use of general commercials to educate the public about illness without naming specific brands. It warned against juxtaposing such spots with other commercials that make specific mention of brand drugs without disclosing risks. The agency also said it would hold the manufacturers of medical devices such as hearing aids to the same broadcast advertising standards as pharmaceuticals.

Months in the making, the guidelines were drawn up after a study and public hearing by the FDA last year. FDA Commissioner Mark McClellan, in a news release, said the agency wants to maximize the beneficial effects of advertising on consumers. The FDA found through a survey that consumers and doctors believe that drug spots serve an educational purpose by raising awareness about disease and getting people to ask their doctors questions. The same survey found that a majority of doctors believe drug advertising obscures side effects and confuses the public.

"We intend to do all we can under the law to make sure that the information conveyed by prescription drug promotion is as useful as possible," said McClellan.

Reaction from the drug industry was favorable. Dorothy Wetzel, vice president for consumer marketing at Pfizer Inc., said the drug company has already launched initiatives to make risks more understandable in its print advertising. Full disclosure in advertising will drive people to ask questions of their doctors and lead to more people receiving treatment, she said.

"The more that you let the consumer know what the product is for and what the side effects are, the more they will pay attention to your ad," she said. "Direct-to-consumer advertising is effective at driving measurable health benefits."

Harvard's Rosenthal said the FDA action won't have much impact on drug industry ads. "I don't think there is much here," Rosenthal said. "This is not an administration that is going to be introducing new regulations."

"Given all the angst they caused in the industry, there's not a lot different here than what we've seen in the past," said Ed Slaughter, director of research for Rodale Inc., publisher of Prevention, Men's Health and other magazines.

Christopher Rowland can be reached at crowland@globe.com.