Originally Published IVD Technology April 2005
INDUSTRY NEWS
FDA monitoring Internet sales of illegal tests
Richard Park
FDA issued a warning to consumers not to use unapproved home-use diagnostic test kits that have been marketed via the Internet by Globus Media (Montreal). The illegally sold kits included rapid HIV, drugs-of-abuse, and pregnancy tests.
Such actions by FDA are nothing new. The agency has been actively involved in monitoring Internet sales of IVDs and other medical devices for the past five years. FDA knows that with the proliferation of e-commerce, the Internet has provided unscrupulous companies immense opportunities to promote and sell illegitimate devices unlawfully to unsuspecting patients.
“FDA has been aware of the practice of marketing and selling medical devices over the Internet for some time and has taken a variety of public and nonpublic compliance actions,” say FDA officials. “FDA’s Office of Compliance (OC) has issued a number of warning letters and untitled letters for a variety of devices being promoted on the Internet. In addition, there have been import alerts and civil money penalty cases directed against firms selling over-the-counter products via the Internet without premarket review.”
While there is no formal working group assigned to monitor Internet marketing, FDA officials said that staff members at OC and the Office of In Vitro Diagnostic Evaluation and Safety (OIVD) surf the Internet regularly. FDA also responds to trade and consumer inquiries and complaints. In addition, considering the global nature of the Internet, FDA recognizes the need to watch closely Web sales of test kits coming from overseas.
“FDA works through its Office of International Affairs to coordinate enforcement activities with the U.S. Customs Service (Washington, DC) and other foreign government regulatory agencies,” say FDA officials. “FDA also works with the Federal Trade Commission (FTC; Washington, DC) and in some cases the Office of Criminal Investigations to address these issues.”
FTC has proven to be an effective partner in FDA’s efforts to block sales of illegal test kits over the Internet. During the past few years, FTC has taken strong actions against companies that are found to be selling illegal tests via the Internet. For example, in 1999, FTC settled charges with Cyberlink Marketing Inc. (Las Vegas) for falsely advertising on the Internet that its HIV home-test kits accurately detected HIV. FTC alleged that Cyberlink violated federal law when it represented on its Web site that its HIV tests detected HIV infection in human blood.
FDA testing of Cyberlink’s HIV home-test kits confirmed that the products were not reliable in detecting the presence of HIV. Under the stipulated final order settling the charges, Cyberlink received a lifetime ban from marketing or selling any HIV home-test kits in the future. In addition, Cyberlink had to transfer to FTC the money they received from the sales of its HIV tests.
FTC also charged another company, Medimax Inc., for fraudulently representing on the Internet that its HIV tests accurately detected HIV. Medimax agreed to a preliminary injunction and discontinued marketing its HIV test kits. Soon afterward, Medimax’s supplier, Alfa Scientific (San Diego), was also charged with making false claims regarding its HIV tests. Alfa agreed as well to a stipulated preliminary injunction, which halted all sales of its HIV test kits.
FDA officials recognize the negative effect that illegal sales of IVDs via the Internet can cause the IVD industry. The agency has encouraged IVD manufacturers to report any selling or marketing of illegal tests over the Internet.
“Illegal Internet sales divert from legitimate sales of IVD products and can be harmful to the reputation of manufacturers of legitimate products,” say FDA officials. “IVD manufacturers can assist FDA by calling our attention to problems they identify. The IVD industry has been very helpful in identifying devices that they believe are suspect to the agency.”
Additional information on reporting false claims to FDA may be accessed through its Web site at www.fda.gov/medwatch/.
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