US FDA Meeting Views Drug Data On The Internet

A public meeting held this month by the US Food and Drug Administration to discuss ways of regulating the exchange of drug information via the Internet heard from the Securities and Exchange Commission that when companies release investigational drug information through the Internet "they must speak consistently," regardless of whether the audience is the financial community, scientific and medical groups or consumers, reports the Pink Sheet.

SEC division of enforcement special counsel Al Rusch said the SEC regards the Internet as any other form of communication, but it provides unique problems in its provision of instant potential worldwide access of any statement made by a public corporation. "We've never had anything comparable to this form of communication," he said, and because of the declarant's and the audience's anonymity, "we (the SEC) don't know who's talking."

Internet links from company Web pages to sites containing independent information should be permitted, whether this data is on- or off-label, and whether or not it complies with FDA regulations, Glaxo Wellcome assistant general counsel David Vance told the meeting. GW has met with the FDA and told it that it was providing information with links to patient and professional groups, he said, but added that the patient groups to be linked to Web sites should be selected carefully, and regulations governing Web site links should be exactly the same as for continuing medical education.