Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

Reuters NewMedia, Inc. - Friday, 11 October 1996

If a multinational firm has information on its Internet pages about use in France of a drug that has not been approved in the United States, should and can the U.S. Food and Drug Administration keep U.S. patients from learning about and trying to get access to an unsanctioned product?

Currently U.S. regulations state that drugs can only be promoted for uses that have been demonstrated to be safe and effective to the satisfaction of the FDA.

But the regulations were written before drug makers began wide use of the Internet.

Now an Internet surfer can find sites such as Merck and Co. Inc.'s "Disease Infopark," which has information about maladies including AIDS, for which Merck offers the drug Crixivan, and osteoporosis, which can be treated by Merck's Fosamax.

Eli Lilly and Co., maker of Humalog and other diabetes treatments, has a page dedicated to extensive information about that disease.

But companies are uncertain what the FDA will and will not allow on the Internet, or if they will be liable for off-label drug use promoted by third parties, officials and industry spokesmen say.

"Some companies have asked us if can they sponsor a chat room or a news group," said Ilisa Bernstein, senior science policy adviser at the FDA. "Because on a chat room or news group there can be a host of discussions on unapproved uses of a product."

Consumer groups are concerned that quack remedies are being pushed by fringe sources, as well as legitimate drugs being promoted without balanced risk and benefit information.

"There has to be a policy decision that this is advertising, it's just a different form of advertising," said Linda Golodner, president of the National Consumers League.

In a bid to get feedback from the industry, as well as from information vendors, consumer groups and health care professionals, the FDA is sponsoring a conference next week, "FDA and the Internet: Advertising and Promotion of Medical Products."

The two-day conference in Silver Springs, Md., which starts Wednesday, may lead to written guidelines over how drug and medical device companies can use the Internet, Bernstein said.

But some who will attend the conference said they do not want the FDA to place rigid regulations on Internet use that would either add more confusion or sharply curtail its use for drug and medical information.

Health care reform is most likely to emerge from patients' gaining knowlege about diseases and their treatments in order to make more informed decisions about their own care, said Dan McKillen, who runs Sound Side Consulting in Bayville, N.Y.

"The Internet is a fabulous vehicle to do that if it's not overrregulated," said McKillen, whose firm advises healthcare companies about the Internet. He will moderate a discussion group at the conference on general regulatory issues.

A number of drug companies have limited their use of the Internet because of the uncertainty over regulations and also because they have not determined whether its benefits will outweigh its costs, said Mark Grayson, a spokesman for the industry trade group Pharmaceutical Research and Manufacturers of America.

In addition to disease and research information, companies could potentially use the Internet as a marketing tool, saving calls by their sales personnel by directing doctors to detailed drug information on their Web site.

"Eventually you'll start to see a lot of that kind of thing as long as the FDA doesn't regulate it out of business," Grayson said.
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