Rockville, MD - A two-day US Food and Drug Administration (FDA) public hearing on direct-to-consumer (DTC) advertising of regulated medical products heard from 38 stakeholders with diverse views. While a few speakers recommended banning DTC drug ads altogether, others pointed out their value in prompting physician visits. Most speakers identified major weaknesses, such as misleading information, and some presenters advocated ad preapproval.

The US and New Zealand are the only two Western countries that allow DTC medical ads, but there is currently a moratorium on the practice in New Zealand.

Since the FDA guidance of 1997 that allowed identification by product name, there has been a tremendous growth in DTC spending—from $791 million in 1996 to an estimated $4.1 billion a year today. In 2002, Merck spent $160 million for rofecoxib (Vioxx) DTC advertising, more than the marketing campaigns of Pepsi or Budweiser that year.

The current hearings were an exercise in gathering public comments before developing new FDA guidances.

A few presenters maintained that the current system does serious harm and should be stopped.

Dr Rima Laibow (National Coalition of Organized Women) said she considered DTC advertising dangerous. "I think $4 billion could be spent giving real information."

Other speakers identified major weaknesses in the current system.

DTC drug ads bear little relation to public-health needs, said Dr Peter Lurie (Public Citizen Health Research Group, Washington, DC). Consumers are being misled, doctors are being coerced, and the price of healthcare is being driven up as drug utilization increases. FDA enforcement for misleading advertising is lackadaisical, and recidivism is common. "If the genie can be let out of the bottle, then it can be put back," he concluded.

DTC drug ads are a major contributor to the country's healthcare crisis, said Richard Samp (Washington Legal Foundation, Washington, DC). They create unrealistic expectations, promote brand-name drugs over generics, drive up costs, and skew research priorities. For instance, some patients who didn't fit the needs requirements for COX-2 inhibitors took these drugs and suffered heart attacks.

Many speakers pointed out how current DTC ads are misleading and unbalanced. Dr Diane Zuckerman (National Research Center for Women & Families, Washington, DC) displayed a Vioxx magazine ad that looked like a Norman Rockwell scene. In the ad, a young-looking grandmother is on her knees with her grandchild, and the message to consumers is how great life could be without arthritic pain. This powerful image should be regulated, she said. "Who are we kidding when we say this is an educational ad? They're designed this way for a reason—to sell a product. The image is that the drug is 100% effective, but it actually works in [fewer cases]. Even if Vioxx didn't have risks, shouldn't there have been information/images to tell us about the level of effectiveness?"

Who are we kidding when we say this is an educational ad? . . . Even if Vioxx didn't have risks, shouldn't there have been information/images to tell us about the level of effectiveness?

Dr Joseph Cranston (American Medical Association, Chicago, IL) mentioned how a Journal of Family Practice article found that while ads were informative, they lacked educational information. A Lancet article reported that print ads make an emotional appeal and leave readers with the perception that the benefit is large and everyone will enjoy this benefit.

Many other speakers identified a real problem in how side-effect information was being presented.

Dr Ruth Day (Duke University, Durham, MC) presented research showing that from a print ad, a drug's benefits could be identified by 80% of subjects, but its side effects were named by only 20% of subjects, partly because of the higher reading skills required—grade 6 for the benefits and grade 9 for the risks. Also, a drug's benefits are presented by separating similar information into chunks, which enhances recall. Side-effect information, however, is often quickly mentioned in one long sentence at the end of a TV ad, often with distractions such as fluttering wings in the background. "There is currently an unfair balance," Day summarized. "Risk information is physically present but functionally absent."

Despite all these drawbacks, several speakers argued that DTC ads do get patients to visit their doctors. "We are convinced DTC is here to stay," John Kamp (Coalition for Healthcare Communication, New York, NY) said. "It helps patients become more aware. . . . Advertising is best used to begin a conversation with a doctor."

"We have such a level of underdiagnosis in this country that it is important to get [people] to see a doctor," James Davidson (Davidson & Company, Washington, DC)said. "DTC advertising has motivated millions to seek advice."

Similarly, Scott Lassman (Pharmaceutical Research and Manufacturers of America [PhRMA], Washington, DC) told the audience that DTC ads can be a powerful tool, ultimately resulting in better-educated patients and increased compliance.

Several speakers noted that with or without DTC ads, consumers will find information on the internet or hear about it from various news sources. Physicians are the gatekeepers, however, since prescribing decisions rest with them.

"The cyber cat is out of the bag," said Meg Columbia-Walsh (Faith Popcorn's BrainReserve, New York, NY). "Everyone goes to the internet. . . . Even if doctors get annoyed when a person walks in with a stack of printouts from the internet, it starts the conversation at a higher level."

Even if doctors get annoyed when a person walks in with a stack of printouts from the internet, it starts the conversation at a higher level.

"DTC should remain a catalyst and not be viewed as a comprehensive information source," J Patrick Kelly (Pfizer, New York, NY) said."The decision to prescribe a medicine ultimately rests on one person—the physician."

Similarly, William Person (50 Plus WebHealth) said, "The doctors are key. They still play a vital role. You have days or weeks to educate the doctors. Consumers will hear about a new drug from the Wall Street Journal or Reuters."

John Calfee (American Enterprise Institute, Washington, DC)described how DTC drug advertising in New Zealand differs from that in the US. In New Zealand, DTC drug ads are prescreened, simpler, and less confusing. The philosophy is that risk information will come from physicians. The ads are self-regulated by the media. Response to complaints is very rapid: the media will refuse to run the ad.

To overcome the current problems in DTC drug advertising, several speakers recommended solutions such as mandatory preapproval of FDA ads, which would require adequate FDA staffing.

PhRMA supports the need for major reforms, said spokesperson Lassman. All new TV ads should be preapproved by the FDA's Division of Drug Marketing and Communication (DDMAC). The brief summary should be more patient friendly.

Samp urged the FDA to first increase enforcement and ensure that it has enough employees to do this. Currently, 40 people review 53 000 drug ads a year, which translates into 1300 ads per year (or 5.5 ads a day) per person. The FDA should ask Congress for power to impose severe monetary penalties. It should require prebroadcast ad submission, prohibit reminder ads, regulate disease-awareness ads (eg, those that refer the consumer to a promotional website), prohibit both coupons and drug ads aimed at children (eg, with messages such as get free music, fight acne, stay cool), and return to the pre-1997 DTC ad requirements.

Currently, 40 people review 53 000 drug ads a year, which translates into 1300 ads per year (or 5.5 ads a day) per person.

William Vaughan (Consumers Union, Yonkers, NY) said his group found a range of misleading drug ad messages and false superiority claims; repeated warnings from the FDA did not seem to have much effect. "The Consumers Union urges the FDA to make major reforms such as adopting a two- to three-year moratorium for new drugs and requiring ad preapproval."

In addition to hearing from the 38 speakers, the FDA also received written testimony. As explained in a press release, AstraZeneca's written submission proposed mandatory FDA review of all DTC advertising, but only where DDMAC has the necessary resources to conduct its review within a specific timeframe.