The FDA takes on pharmaceutical companies in cyberspace...now what?

By Anne Federwisch, OTR

Deciding who can say what about pharmaceutical and medical products is a lot easier in print than in cyberspace, according to the Food and Drug Administration (FDA). The international, interactive, interconnected nature of the Internet creates situations unparalleled in conventional print media. And that means drug companies and consumers are asking questions about the best way to make sure online information is accurate, fair, and properly attributed.

The FDA faces the challenge of developing policies to guide companies creating sites on the World Wide Web. To gather comments on the matter, the agency held public meetings Oct. 16 and 17 in Silver Spring, Md., on using the Internet to advertise medical products. “We were soliciting information about what people were interested in doing [on the Internet], what their concerns are, possible areas where we might look into being more flexible in terms of how we approach things on the Internet than we have been with, for example, print advertisements,” said FDA spokesperson Brad Stone.

About 500 people attended, including representatives from pharmaceutical companies, consumer groups, the news media, and professional organizations such as the American Society of Health–System Pharmacists (ASHP) and the American Medical Association.

To encourage discussion, the FDA created Internet-related scenarios involving a fictitious company called ADF and its Web site. Attendees joined in ADF’s discussions about chat rooms, links to other Web sites, and putting information about company products still awaiting FDA approval on the Web site. Questions addressed included: How can an international drug company create a Web site that respects the laws of all countries? Does it matter where on a Web site information is presented? Can companies link to external Web sites that promote off-label use? Are companies responsible for what non-employees say about regulated medical products in a company-sponsored chat room?

The FDA does not regulate the Internet per se, but rather the promotion of prescription drugs and other medical products and devices, Stone said. “So the authority is there to regulate promotion, be it through more conventional media like TV, radio, or print or through things like the Internet. The question is how to tailor that authority to the particular need and attributes of the Internet,” he said.

The key elements of regulating information, according to Stone, are the same inside or outside cyberspace: Looking at who is presenting the information (the FDA has authority over only those with a vested financial interest in promoting the products), looking at the accuracy of the statement, and looking at whether the claim is approved. “But beyond that, there are certain nuances that come with the Internet that have to be explored,” Stone said.

For example, print advertisements for prescription drugs are required to include the full labeling text of the drug, including indications for use, contraindications, and warnings. “When you see an advertisement [in print], it will be one page that is the advertisement itself and then it will either be followed by another page or pages with the labeling information about the product,” Stone said. But Web pages can be accessed in so many sequences that no one page can be considered to “follow” another. So where should the labeling information be included on a Web site?

The Internet also makes it easier to obscure the origin of information. That means misinformation is more difficult to regulate, particularly when it’s posted to newsgroups or in chat rooms. “It’s hard to know who’s posting the information,” said Jackie Fishman, a spokesperson for the ASHP, a professional association representing over 30,000 pharmacists. People posting information on the Internet “can say they’re a doctor,” Fishman said. “They can say they’re a pharmacist. They can say they’re anybody, but we don’t really know who they actually are.” She said that the ASHP fears that people claiming to be pharmacists may present erroneous information as fact.

She said that the ASHP is also concerned that manufacturers may present advertisements on the Internet in such a way that consumers may not know that the information is from the maker of the product. “A particular pharmaceutical advertiser might be able to use this [Internet] for advertising in a way in which [it seems that] this is just a discussion group activity going on, that it was just somebody’s opinion,” Fishman said.

Mark Grayson, spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA), does not believe pharmaceutical companies intentionally mislead visitors to their Web sites. “I don’t think that anybody is hiding their connections at all. Our companies feel very good about the information they provide,” he said. Grayson agrees, however, that it’s important to discuss precisely how and where disclosure of who is posting information takes place.

Part of the problem is that Web sites do not have to be viewed in any particular order and are rarely viewed in their entirety. Companies may disclose their connection to the site on a Web page that consumers rarely access first.

The Allergy Relief Zone (http://www.allergy-relief.com) is an example of how a Web site’s origin may not be readily apparent. The site, which does not violate any regulations, contains information for allergy sufferers, including frequently asked questions, a pollen report, and a description of the prescription allergy medication Claritin (loratadine). Consumers could access the information without knowing that the site was developed by Schering–Plough Corp., the maker of Claritin, because not every page of the Web site discloses the connection to the company.

The Allergy Relief Zone is just one of several disease-related Web sites Schering–Plough has. “All materials on prescription medications on the Schering–Plough home page are consistent with product-related materials routinely submitted to the U. S. Food and Drug Administration,” said Ron Asinari, spokesperson for the company. He said that all information that the company puts on the Internet is reviewed for scientific accuracy, balance, and compliance with regulations.

Grayson thinks the location of the disclosure of a company’s connection to a site is less important than the validity of the information presented. “Our view is that there is certainly no place to go better than a pharmaceutical industry site to get information about most diseases and medications that you can take since our companies have spent the most money in developing and have the most knowledge available on those particular diseases,” he said.

Stone said that pharmaceutical companies are just as concerned as consumers about the possibility of false information being presented as fact on the Internet. “If you have a site that is sponsored by somebody who for whatever reason has a vested interest in bad-mouthing a particular product—what do you do in that instance?” Stone said.

Participants at last month’s public meeting raised many issues, but reached no definitive conclusions. “The meeting wasn’t designed to resolve anything,” Stone said. He expects the FDA will provide some kind of written guidelines on advertising and promoting medical products on the Internet in the upcoming months. In the meantime, he said that companies can continue to seek guidance from the FDA division of drug advertising and marketing on what is permissible on the Internet.

As the FDA seeks to develop guidelines, the Internet itself continues to evolve. Grayson said, “Whatever is done, we think that the FDA should look at the Internet as a medium of the future and not just look at trying to regulate it as it exists today, thinking about what it’s going to be like, so they don’t stifle the use of the Internet.”

According to Stone, the FDA does not intend to stifle anyone’s use of the Internet. “We see that the Internet has enormous potential for us and for companies and for consumer groups and for anyone who wants to use it,” he said. “In terms of trying to stifle the use of it, on the contrary—we have no problem with using the Internet, provided that the information that is provided to consumers is accurate, truthful, and in the full context.”

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