By Lisa Seachrist

Washington Editor

WASHINGTON * While the information age is clearly upon us, the FDA monitors and approves the vast majority of information that pharmaceutical companies provide about their products.

That control of information served as the topic for a panel discussion at the Food and Drug Law Institute's meeting last week, Pharmaceutical Update '97.

"We need to consider whether the environment has changed sufficiently to warrant completely rethinking the role of restricted access to information," said panel member Deborah Steelman, an attorney specializing in health care and employee benefits.

Clay Patterson, an attorney with Johnson & Johnson who previously served in the General Counsel's office at the FDA, noted that in the midst of an information explosion, the agency is trying its level best to keep a tight rein on information. "FDA views its jurisdiction as very, very broad. They have a desire for ironclad control over drug promotion and communication."

Patterson detailed for the audience what he views as the agency's overarching control of all types of drug promotion, from examining the materials the company intends to use to launch the drug to the promotional pens and coffee cups handed out at medical meetings.

"The agency really maintains a very jaundiced view of industry," Patterson said. "You can see that in the guidances like the Industry Supported Scientific and Educational Activities. It assumes that if a company is involved the meeting becomes a drug promotion."

Patterson noted that even though the agency can't require industry companies to submit their launch materials for review, they usually do. That practice, according to Patterson, lengthens the time it takes to launch the product and is something that he believes "the industry should rethink."

In addition, Patterson argued that the agency should loosen its grip on promotional material like pens, notepads and coffee cups.

"Trust me, our competitors will bring anything that is misleading to your attention," Patterson said.

Permission To Release Articles Is Notable Progress

While Patterson considers the recent guidance permitting pharmaceutical manufacturers to disseminate journal articles containing the results of pivotal trials still too narrow, he noted, "It is remarkable progress for the agency to allow the dissemination of information that it has considered labeling in the past."

That guidance on reprints, treatment guidelines and textbooks allows for mention of off-label uses as long as the purpose of the mention is to disseminate information and not to promote the use. However, should a company wish to disseminate reprints, the studies must include information from pivotal trials only.

Patterson said he hopes the agency will expand the guidance to include articles detailing smaller and earlier- stage trials. "I see no reason why it should just include pivotal trials," he said.

For example, Patterson noted that for drugs which are off-patent or soon to be off-patent, companies are unlikely to sponsor or perform trials they will expand the drug's indication if they will immediately face competition from the generic drug sector. In such cases, studies performed by academic centers could play a very important role in providing information on off-label uses of a variety of drugs.

Steelman pointed out that the managed care revolution has created new consumers of health care that no longer assume they will receive quality health care, but focus on making sure they are receiving quality health care.

"The changes to managed care forced patients to choose from a limited number of providers and products," Steelman said. "Tomorrow's patient will have growing expectations and a fuller understanding that knowledge is power."

Steelman noted that in the quest for better treatment knowledge, disease and advocacy groups will build from the social service functions and public advocacy to providing comparative evaluations about treatment options in cooperation with health care systems.

"What happens if these groups don't have the best access to the information that research has brought to bear?" Steelman asked.

Regulate The Internet?

Steelman maintained that already patients use the Internet as their library. However, that information is completely unregulated and much of it is false.

"FDA views labeling as a danger. I am not an advocate of turning over FDA authority," Steelman said. "But, what are the implications of FDA's restriction of company communications in a milieu brimming with unregulated bad information?"

Steelman noted that the plethora of junk science and the advent of alternative and folk therapies could threaten Western medicines should the agency continue to restrict the types of factual information that companies may provide in print, broadcast and electronic media.

Ilisa Bernstein, a senior science policy advisor in the office of the commissioner at the FDA, noted that the agency is concerned about the free-wheeling nature of the information found on the Internet. Last fall the agency held a conference to discuss how it should regulate the Internet. Several letters of violation were issued to companies for information found on their web pages, but Bernstein noted that they were violations that would have caused problems in print advertising as well.

However, Bernstein said the Internet is very different from a print advertisement. "Where else can you read about a study, click on an icon and have the study in front of you?" she asked. "I am not saying that we need to regulate it differently, I am just saying that we need to acknowledge that the ability to link to other sites makes the Internet much different from any other medium."

Bernstein said the agency currently is working on a guidance for Internet advertising and that she expects a draft guidance to appear in the Federal Register in the late summer. *