FDA, drug firms talk online content

More than 300 law firms, advertising agencies, medical education groups, and pharmaceutical firms met today to discuss possible guidelines for medical and drug-related content on the Internet, addressing mounting concerns that drug companies are crossing the line in promoting products or services that aren't approved.

The Federal Drug Administration is holding the conference, called the first of its kind, in response to a barrage of inquiries that it has recently received regarding online issues. The meeting is yet another example of how the Net is moving government agencies to redraft many of the nation's oldest regulations and guidelines.

The conference covered topics including chat rooms and newsgroups, regulations, site links, and international issues. The FDA is also accepting written opinions from the industry until December 15. Guidelines and regulations will then be set based on discussions and opinions.

The FDA has a strict set of advertising guidelines for the pharmaceutical industry, but the laws were written before the industry began touting their products online.

As a result, pharmaceutical companies are confused about what they can and cannot post online: Can they link to related sites about drugs that have not yet been approved by the FDA? Can they host chats on medical products?

"The industry is more confused now because the FDA hasn't set down any specific guidelines regarding advertising on the Internet," said John Mack, online editor of PharmInfo. "That has kept the industry out of advertising on the Net and I think establishing some formal guidelines will improve the situation."

Some companies hesitate to advertise online because "nobody wants to be a test case," Mack added.

Dan McKillen, president of SoundSide Consulting, a firm that works with medical companies interested in having a presence online, agreed that advertising became a conference buzzword. Some companies could run a ten-page ad about a new drug, with eight pages of benefits and only two pages of warnings, but they must walk a fine line, he said. McKillen also moderated a conference session on general regulatory issues.

Current law doesn't allow companies to promote a product before it has been proven safe and effective by the FDA, and many say the same rules should apply to the Net.

"Companies live and die depending on the approval of the FDA for a new drug. If a company is too aggressive with a promotion, the FDA may just put their proposal in the back of the line," McKillen said.