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Turning point for medicine on the Net?

FDA decision on Internet drug ads may boost medical Web sites

From the September 1997 ACP Observer, copyright 1997 by the American College of Physicians.

By Deborah Gesensway

In a move that may boost the quality and quantity of health care information on the Internet, FDA officials now say they will not promulgate new rules regulating how drugs are promoted in cyberspace.

Internet advocates, who have long decried the quality of medical information available online, hope the decision will usher in a new era of medical content on the World Wide Web. In the past, many have complained that the threat of new regulations concerning the Internet was scaring away drug companies—and the valuable content they could bring to the Internet. Many of these companies, the argument went, were afraid to put drug information on the Internet until the FDA ruled whether such activities were in fact legal.

Now that the FDA has promised to refrain from creating any new rules to regulate how drugs are promoted online, many hope that drug companies will purchase advertising on the Web and give educational grants to top-notch sites. They also hope that publishers of medical books and journals, which have been seen as slow to embrace the new medium, will follow suit and begin making their rich archives of books and journals available online. Ultimately, analysts say, the FDA's decision might allow the Internet to finally become an integral part of drug promotion and health care publishing for both doctors and patients.

Technically, the FDA oversees the marketing efforts of companies that manufacture drugs, biologics and medical devices. Nonetheless, its edicts affect medical sites on the Internet, particularly those that seek financial sponsorship from drug companies.

For now, the agency has said that the same marketing rules that apply to broadcast and print drug ads will be used to regulate promotional materials on the Internet. In addition, the agency is currently revising guidelines that would possibly loosen rules for ads aimed directly at consumers. (See How looser rules for consumer advertising may affect the Web)

The agency's position on Internet drug advertising follows a long and heated debate about whether the agency should be in the business of regulating drug promotion specifically on the Internet. Until the FDA announced plans not to create any new regulations, there was what many described as a "chilling effect" on medical content on the Web. Rather than advertise their products on the Internet and attract the attention of regulators, many drug companies decided to simply stay out of the medium until the government issued guidelines.

Industry analysts say that this stance affected more than drug companies' individual Web sites. According to Dan McKillen, senior sales vice president for HealthAnswers, a Web site specializing in health care, drug companies were also reluctant to advertise on independently produced, commercial Web pages. Now that the agency has clarified its intentions, he said, analysts are more optimistic about the Internet's future as a medium for delivering health care information.

Not everyone claims that the pharmaceutical industry's generally unenthusiastic response to the Internet has to do with just the fear of FDA regulations. Some analysts say an even bigger problem is that too few people, including physicians, use the Web as a source of medical information. And since Web sites can't accurately attest to their readership, they can't guarantee a drug company's ads would reach the right audience, raising questions about the point of putting advertising dollars on the Net.

"The Holy Grail will be when we can guarantee [drug companies] that physicians are coming and seeing their ad banner," said Alex Martin, vice president for sales and marketing at the large health information Web site, Medscape.

Medscape, for example, is about to hire independent auditors to count viewers so it can guarantee potential advertisers a certain number of people who will be exposed to an ad on the Web site. The thinking goes like this: If Medscape can attract more advertising support because it can prove it is among the largest medical Web sites, then it can help set the standards of what constitutes acceptable medical content on the Web. That, in turn, will force others to ratchet up the quality of the content they post online also. "If you do that, you avert the FDA stepping in and taking control," Mr. Martin said.

FDA 'guidance'

So far, that's exactly what has happened. The FDA has said that it intends to stay away from writing regulations that specifically limit drug marketing on the Internet. In fact, the only action currently in the pipeline, according to Ilisa Bernstein, PharmD, JD, senior science policy advisor at the FDA, is a "guidance"—a policy that doesn't carry the legal clout of a regulation—that deals with Web-specific technology.

The FDA's guidance, which is expected to be released by the end of the year, will most likely refer the industry to other policies or guidances the agency has issued in the past, such as rules that govern direct-to-consumer drug ads. The new guidance is also expected to contain specific advice about linking a drug company's site to medical journals on the Web, patient support groups or chat rooms that discuss off-label uses of an advertised product.

This relatively laissez-faire attitude marks a change in the tone of the debate over how to regulate Internet-based drug ads. A year ago, when FDA officials invited dozens of medical Internet publishers, drug companies, consumer advocates, advertising agencies and physicians to a two-day conference to debate issues relating to advertising and promotion on the Internet, few would believe that this relatively small amount of special oversight would be case. It was the hearing, after all, that prompted many in the field to fear a crackdown was around the corner.

"There definitely was the fear of overregulation," said John Mack of VirSci Corp. of Levittown, Pa., publisher of PharmInfoNet, a drug information Web site. "People felt that if the FDA acted too quickly, it would make regulations that would be inappropriate as the Internet developed. Even if the regulations only applied to pharmaceutical companies, we thought that would have a chilling effect throughout the Internet."

During that meeting, participants hotly debated a number of issues. For instance, many questioned whether drug companies should be allowed to link drug ads to journal articles at another site that described off-label uses of their drug. Others wondered whether giving readers the opportunity to click on prescribing information would be adequate to meet fair balance requirements, or if that information would have to appear alongside the ad. And others debated how the global nature of the Internet would affect ads for drugs that had been approved in one country but not another.

Since that meeting, however, the climate for drug companies on the Net has warmed considerably. "To a large extent, I think the issues that were raised have turned out to be much ado about nothing," said Wayne L. Pines, a former FDA official who is now an industry marketing consultant with APCO Associates Inc. in Washington.

Mr. Pines said that the FDA realized that "the information is going to be out there anyway, so it might as well come from a drug company that knows what it's talking about and contains appropriate disclaimers." Besides, he explained, simply prohibiting drug ads on the Internet would only pave the way for less accurate information to appear. But perhaps most importantly, Mr. Pines said, "Most of the issues are easily resolvable within the context of existing FDA guidelines."

The FDA seems to agree. Dr. Bernstein, the agency's senior science policy advisor, said that the agency refrained from creating drug ad regulations just for the Web because the agency believes that there are relatively few problems. Since last fall's meeting, she said, many Web sites and drug companies have answered questions they had about drug ads on their own.

Take, for instance, the FDA requirement that drug ads include detailed information about side effects and contraindications. "We had been getting a lot of questions about how to do that on the Web," Dr. Bernstein said, "but they figured it out." How? Companies that mention a drug's benefits now offer a hypertext link to the full text of an FDA-approved packet insert that comes with the drug. With the click of a mouse, readers have access to those details.

What about the issue of linking ads to a journal article describing off-label uses of the advertised drug? Mr. Pines said drug companies have decided that if they provide a link to the electronic journal's homepage—but not the page that contains the description of the off-label use—they conform to existing FDA rules that let drug company salesmen distribute textbooks or print journals to doctors, even if the materials contain some mention of an off-label use of one of their products.

And to address concerns about non-health professionals or people in other countries seeing information aimed specifically at American physicians—or vice versa—the few drug companies advertising online have used disclaimers. Some have readers click through questions asking where they are from or what their profession is before they grant access to product information; others ask doctors to register with the site using their DEA number before providing any information.

To address another potential problem—the topic of international issues of cross-border advertising and the sale of medical products on the Internet-the FDA has agreed to participate in a World Health Organization meeting this fall. Dr. Bernstein said that for now, the agency has declined to issue any of its own regulations on the subject.

Just because new regulations covering online drug advertising aren't forthcoming, FDA experts stress that the agency is not completely backing off of the subject. Recognizing the importance of its actions in this field, FDA officials say they will continue to monitor promotion on the Internet and penalize drug companies who step over the line of fair promotion.

For example, the agency has been issuing warning letters as it discovers product promotional claims on the Internet that violate federal rules, such as advertisements for unapproved products. Recently, the agency sent a warning letter to a company selling "home abortion and self-sterilization kits" on the Internet; another challenged press releases posted on a company's Web site that the FDA says made unapproved claims about a diagnostic test for diagnosing heart attacks.

The message: 'Police yourself'

The word on the street, therefore, is police yourself. Even without the threat of immediate regulation, a number of medical Web sites are cleaning up their acts to make sure the FDA doesn't feel the need to get involved. In other words, the mere threat of FDA action has spurred a self-regulation movement. Consequently, medical Internet providers have been scurrying to come up with voluntary standards for their operations. Their aim has been to stave off demands of disgruntled consumers for government action to clean up the Web.

Many of those in the business say that the trend toward self-regulation is good business. In June, PharmInfoNet's Mr. Mack convened a group of medical Webmasters—the people who run Web sites-to establish voluntary industry guidelines for the medical use of the Internet. "From my own self-interest I felt I needed to have my advertisers know that we have certain standards, to help them to decide which sites to do business with," explained Mr. Mack.

The Geneva-based Health of the Net Foundation, whose "HON" symbol is now displayed at Web sites that follow an eight-point code of conduct, is also working to standardize medical content on the Internet. The group requires that affiliated Web sites clearly disclose who has provided "funding, services or material for the site," that advertising on the site be clearly distinguished from editorial material and that any medical advice offered be given by "medically trained and qualified professionals" or clearly identified as coming from someone without medical qualifications.

In addition, the International Committee of Medical Journal Editors, which includes Frank Davidoff, FACP, Editor of Annals of Internal Medicine, is just one of a half dozen or so groups involved in Internet publishing that in the last year have attempted to define voluntary standards and policies for their online operations.

Lingering doubts

But in the absence of any official word from the FDA, whether or not these strategies are enough to keep the agency out of regulating drug ads on the Web remains up in the air. Most drug company sites still contain only information about the company. A few have added disease-specific information for consumers, and fewer still have posted online any details about specific drugs.

In a highly conservative industry, some are questioning what effect the FDA's decision not to create new regulations will really mean. "For the most part, the internal regulations departments of pharmaceutical companies are much tougher than the FDA would ever be," noted Janet Carlson, a Brooklyn, N.Y.-based Web designer who specializes in sites for pharmaceutical companies. But a handful of companies, she said, are now starting to push the envelop on these issues—trying to see how much of a disclaimer is adequate for the FDA, for instance, or how much drug information is enough.

"We are seeing more a movement toward putting product information out there, because the bottom line is that they are trying to sell product," she said. She described the kinds of Web sites her company has created this way: "We refer to 1996 as the year of the company and 1997 as the year of the disease. 1998 will probably be the year of the product."

Physicians may be less than thrilled about the prospect of seeing more electronic ads cluttering up their screens and slowing down their access, but many concede that resolving the question of what drug companies can do online can only improve the general caliber of medical information online.

Laurence E. Widman, MD, PhD, a Texas cardiologist, for one, thinks the competition for advertising dollars is helping drive the quality improvement effort on the Web. "I'm encouraged now because the first people to show up [online] were the flakes and the amateurs. But now, professional societies and conservative companies are slowly coming into this and some people are putting a lot of energy into developing very high quality sites in the hope of attracting advertisers."


How looser rules for consumer advertising may affect the Web

Forget regulations aimed specifically at the Internet. New rules permitting easier-to-read consumer advertising of prescription products may have the greatest effect on the amount and type of drug information found online.

The FDA surprised industry watchers last month when, without warning, it suddenly released the first of a set of proposed directives to clarify and loosen existing regulations for direct-to-consumer (DTC) drug ads; in sum, they will give drug companies more freedom in making claims about their products in consumer ads, reducing the amount of small-print details required that spell out side effects, contraindications and effectiveness. The new "proposed guidance" clarifies requirements for prescription drug advertising specifically on television and radio. Another guidance is in the works that will pertain to DTC advertising in print media. The Internet is viewed as closer to a print media than it is to broadcast because it does not have the space and time limitations of a 60-second TV spot.

"If the FDA makes print ads more sensible for consumers too, I think the usage by [drug] companies of the Internet will be significant," said Jack Angel of the Coalition for Healthcare Communication, which represents advertising agencies, medical publications and health care marketers. Although his organization thinks the new FDA ruling does not go far enough-it was proposing as adequate for consumer protection a one-line disclosure such as is found on cigarette packages and ads—Mr. Angel agreed with other drug company analysts that the new DTC rules are likely to unleash a flood of drug ads on television, in magazines and eventually on the Internet.

"Any new drug that's coming out nowadays has to consider DTC advertising as a primary vehicle for introducing the new product," said Wayne L. Pines, a former FDA official who is now an industry marketing consultant with APCO Associates Inc. in Washington. "Now, new drugs will have to have their own Web pages."

And, since most people who use the Internet are consumers, "the same rules that apply to DTC promotion are very likely going to be easily applicable to the Internet," Mr. Pines said. As proof of the pent-up demand for DTC drug advertising, only hours after the FDA announced the relaxation of its broadcast rules, one giant drug company rushed onto the air a new 60-second ad for its genital herpes drug. It mentioned the drug, its benefits and, in terms of counterbalance, only warned people with certain diseases to inform their doctor. This ad would never have aired previously because it doesn't contain all the fine-print warnings.

According to the new FDA guidance, TV and radio ads promoting prescription drugs need only include information about any major risks and then instruct viewers on how they can easily obtain more detailed information about the drug's approved uses and risks. For instance, the guidance states, drug companies can meet the requirement for "adequate provision" for dissemination of the product's approved labeling by mentioning a toll-free telephone number patients can call, listing an Internet Web page address (known as a URL) that contains full access to the approved label details or referring to print ads that contain the full text of the drug's package insert that warns of side effects and contraindications, known as the "brief summary." FDA officials say they plan to reevaluate the new policy after two years.

Before this new guidance, the FDA forced drug advertisers targeting consumers to take one of two approaches. They could either be extremely vague and provide few if any details—think of Claritin's "a clear day is here" campaign—or they could be deliberately wordy and print the brief summary.

Drug marketers have long complained that forcing advertisers to print such disclosures overloads patients with extraneous information. But consumer advocates, such as Ralph Nader's Health Research Group, have complained that leaving the information out might lead to patients demanding more drugs they don't need or that cost more. The United States remains one of only a few countries in the world that permit DTC drug advertising.

The stakes are high in changing the DTC rules. In financial terms, consumer advertising already eclipses promotion to physicians. According to Advertising Age magazine, drug companies spent about $700 million on DTC advertising in 1996; in 1989, that same figure stood at about $12 million.

Ad agency and drug company officials quoted last month in the Wall Street Journal said they expect the FDA's ruling will prompt them to increase spending on TV ads, but they said they expect to cut in other places-such as in how much they spend on direct mail and for ads in medical journals.

Meanwhile, analysts caution, the effects of any new regulations may not hit cyberspace immediately. "One of the reasons that more has not been spent on the Internet is not because of the FDA but because money is being spent elsewhere, in what advertisers think will be more productive," said Mr. Pines. "A lot [of drug companies] could put more information on the Web sites that would be completely within FDA regulations, but they just haven't done it because they don't view the Internet as being a primary medium for target marketing their products. Right now, I think, they're viewing commercial television and magazines as the places to spend their money."

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