Drug Makers Set Voluntary Curbs on TV, Other Ads

Hoping to head off tighter federal regulation, the pharmaceutical industry announced voluntary curbs Tuesday on consumer advertising, particularly television ads that critics say are skewing medical decisions, glossing over risks and helping to drive up the cost of prescription drugs.

The 15-point plan, announced in Dallas by the main drug industry lobbying group, calls for making sure doctors are fully informed about a new drug’s risks and benefits before a public advertising campaign is launched. It would also eliminate one type of commercial -- the brief, so-called reminder ad that mentions a drug by name but makes no reference to possible risks. And, responding to complaints that children are inappropriately exposed to ads for erectile dysfunction drugs such as Viagra, the plan effectively would keep such commercials off programs most likely to be watched by children.

It was not clear, however, whether the industry’s relatively modest steps would be enough to hold off growing complaints by some lawmakers, consumers and physicians. The Food and Drug Administration said it was beginning a review of the effect of drug advertising, but it set no timetable for completing it. And some members of Congress have urged stronger measures.

The plan stopped short of setting a specific waiting period before a new drug can be advertised to consumers, a step many consider to be a crucial reform. Experts say that would allow more time to detect rare but dangerous side effects that might not emerge in limited pre-approval clinical trials. Some critics, including Senate Majority Leader Bill Frist (R-Tenn.), have called for a voluntary two-year waiting period.

In a statement Tuesday, Frist said he hoped individual drug companies would seriously consider adopting such a policy. And he refused to rule out congressional intervention.

Defending the industry plan, Karen Katen, a Pfizer Inc. vice chairwoman who was closely involved in drafting the advertising code for the Pharmaceutical Research and Manufacturers of America, an industry group, said, “The heart of the [matter] is that the public wants to see some changes in our ads while preserving the educational benefit of engaging the consumer.”

One frequent industry critic, Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group, a consumer advocacy organization, dismissed the plan as an industry ploy, saying: “When I saw these guidelines, what it brought to mind was a misleading direct-to-consumer ad. The guidelines appear to be more effective than they really would be.”

Though less dismissive than Wolfe, some academic specialists said they were disappointed. “My own view is that it hasn’t gone far enough,” said Dr. Brian Strom, chairman of the biostatistics and epidemiology department at the University of Pennsylvania School of Medicine.

“I say to my patients, ‘You see those drugs on TV? Those are the ones you don’t want,’ ” Strom said. “If you needed them, I’d be prescribing them to you. You don’t want them if they’re not absolutely critical for you and they’re demonstrably better than the older drugs.”

Drug ads on television are a relatively new phenomenon. Traditionally, the pharmaceutical industry pitched its products primarily to the medical profession. Ads meant for consumers were published mainly in magazines, with a section in fine print covering possible risks. In 1997, the FDA eased rules that required detailed listing of side effects, opening the way for broadcast commercials.

The industry’s promotional budget took off, and it has risen almost fivefold since the late 1990s, to more than $4 billion. The growth in spending on advertising outpaced steady increases in the companies’ research budgets.

“I think this is a huge issue that gets right at the roots of our society,” said Dr. Raymond Woosley, president of the C-Path Institute, an Arizona nonprofit organization that seeks to improve the process for developing drugs. “We are a science-based nation, and we should have more respect for the science of pharmacology and medicine than to think we can peddle it over the airwaves. I’ve been in medicine for 35 years, and I still find it very difficult to answer questions about risks and benefits. Try putting it in a 30-second spot.”

Research has shown that doctors are more likely to prescribe medicines if patients ask for them by name as a result of advertising.

Beyond purely medical considerations, that trend raises economic concerns among federal officials responsible for huge health programs such as Medicare, which is adding an outpatient prescription benefit next year.

“Drug advertisements fuel America’s skyrocketing prescription drug costs,” Frist, a heart surgeon by training, said in a speech last month. “They influence consumer behavior. And they influence physician behavior. They cause more people to take prescription drugs. They create an artificial demand.”

But they also represent a form of speech that may be protected under the Constitution. Government-imposed advertising bans will probably be struck down in court, said Marc Scheineson, a former senior FDA lawyer who now represents industry clients.

In the past, voluntary efforts by the industry have succeeded in curbing improper promotional payments to doctors, Scheineson said. The new advertising policy “represents a platform on which you can build.

“You have to start somewhere with principles that can get industry consensus and compliance.”

Said W.J. “Billy” Tauzin, a former congressman who is now the drug industry’s top lobbyist: “We are in a free-speech area. Voluntary codes tend to be the best way to handle these things. So what we’ve done is set up a good, strong voluntary code.”

More than 20 major manufacturers have endorsed the policy. Although it is not scheduled to take effect formally until January, Tauzin said, consumers should start to notice changes in advertising right away.

Generally speaking, he said, ads will be more balanced and informative.

PhRMA, as the industry trade group led by Tauzin is known, will enforce the code by setting up a compliance office to act on complaints from consumers and doctors. But the main responsibility will rest with individual companies.

There will be no list of programs for which ads for sexual-enhancement drugs would be inappropriate. Instead, companies will have to research audience data and limit such ads to programs “reasonably expected” to draw an audience of which 80% are adults, the trade group said.

The policy also calls for companies to submit ads to the FDA with sufficient lead time for the agency to review them, but it’s not clear how that would work, given that the agency is short-staffed.

The FDA received about 40,000 ads for review in 2002 but has only 40 people to scrutinize them, Frist said.

Tauzin said the key to the new approach was that companies would now take enough time to fully inform doctors about the benefits and risks of a drug before promoting it to the public. The length of time will vary with the kind of drug that’s involved; one manufacturer has committed to an advertising moratorium for new drugs of at least one year.

Strom, the University of Pennsylvania doctor, said restrictions on advertising should be lifted not when companies have educated doctors about a new drug but only after they have conducted follow-up studies to detect rare side effects.

He has proposed a system of conditional approval, under which advertising restrictions would be eased based on patient safety data.

“Right now, we have major incentives for industry not to do [post-approval] studies,” Strom said.

“If you had conditional approval, and the conditions are not lifted until the data is complete, suddenly the financial incentives would be reversed.”