Agency asks for public comment on concernsIf the Internet can be compared to the Wild West, then the Foodand Drug Administration might be seen as the new marshal in town.The federal agency, long known for its no-nonsense approach todrug and
If the Internet can be compared to the Wild West, then the Foodand Drug Administration might be seen as the new marshal in town.The federal agency, long known for its no-nonsense approach todrug and device regulation, is concerned that violations may beoccurring as healthcare companies disseminate information abouttheir products over the Internet and World Wide Web. The agencyplans to hold a two-day meeting this month as part of its effortsto formulate a policy for regulating Internet-based promotions.
The rise of the Internet has created a host of new opportunitiesfor drug and device companies to distribute information to potentialcustomers, investors, and corporate partners. Chat rooms, newsgroups,and Web sites provide the means for launching information worldwideon virtually any topic relating to medical devices and drugs.
Web sites describing the wares of GE, Philips, Siemens, Picker,Toshiba, and many other radiology vendors are already up and running.Newsgroups such as sci.med.radiology, sci.med.telemedicine, sci.engr.biomed,and sci.image.processing generate dozens of comments daily aboutmedical products and research on new devices.
All that unregulated information has officials at Washington,DC's regulatory watchdog worried. Their biggest concern is thatsome users might violate the FDA's prohibition against inappropriatepromotion of medical products.
"How do you assure that someone searching the Internetknows that the material being read is meant to be an advertisementor if it's an educational piece?" said Ilisa Bernstein, asenior science policy advisor at the FDA. "There is a requirementthat advertisements for prescription drugs, biologics, and restrictedmedical devices have a brief statement to that effect."
How that statement would be incorporated, however, is the question.The FDA hopes to find that answer and others at a public meetingscheduled for Oct. 16-17, during which discussion groups madeup of 15 individuals will address a range of issues. The agencyis also looking for public comments on issues regarding FDA regulationof the Internet to be sent to the agency by Dec. 16.
Issues involving the Internet and World Wide Web fall primarilyinto several categories. One category focuses on the extent towhich information about products not approved or cleared by theFDA for marketing in the U.S. can be placed on a company-sponsoredWeb site. Many companies provide information, intended for stockholdersor potential investors, about products or uses of those productsthat are not FDA-approved or cleared.
Another area of concern is chat rooms and newsgroups. The agency'sinterest revolves around whether FDA-regulated companies maintainor sponsor such chat rooms or newsgroups about their productsand, if so, for what reasons. In that context, the FDA hopes toexplore whether parameters should be established for company participationin or sponsorship of such chat rooms or newsgroups.
Although the FDA's effort appears benign, any guidance or rulesdeveloped as the result of this month's fact-finding effort couldbe interpreted as constraining the free exchange of information.The danger inherent in a government agency doing so purposefullyor inadvertently is recognized by FDA officials, who are tryingto develop criteria to distinguish between the presentation ofthis information for economic or educational purposes versus promotion.
The gray area is increased by the unique features availablethrough the Internet, particularly the ability conferred by hypertextlinks that allow visitors to jump from one site to another. Companiescan provide links from their corporate page to other sites containinginformation about diseases, possibly creating the implicationthat one or more of the products featured on the home page mightbe effective in diagnosing or treating those diseases. The FDAis trying to determine whether these links should be permittedand, if so, what parameters should be established so as not toviolate prohibitions against promoting medical products for unapproveduses.
Perhaps the most difficult issue pertains to the internationalcharacter of the Internet and World Wide Web. Under the FederalFood, Drug, and Cosmetic Act, companies may not advertise or otherwisepromote products in the U.S. unless those products have been approvedor cleared by FDA. The question becomes especially troublesomewhen multinational medical companies centralize Internet serviceson a single server within the U.S. Technically, doing so putsthe Web site within the authority of the FDA.
"Does the fact that the server is inside or outside theU.S. make a difference in terms of whether a company is intendingto promote a product for use that is not approved by the agency?"Bernstein asked. "We don't really have an answer for that,which is why we want to hear people's opinions."
The meeting will be held at the Quality Hotel at 8727 ColesvilleRoad, Silver Spring, MD. For more information, call the FDA at301/827-3380, or log on to the FDA's Web site at http://www.fda.gov.