Agency Alleges Rapid Tests Produced Inaccurate Results
Two manufacturers of Food and Drug Administration unapproved rapid HIV tests have settled Federal Trade Commission charges that, in some instances, their tests did not accurately detect the presence of HIV antibodies. Under the terms of the settlements, Chembio Diagnostic Systems, Inc. and Alfa Scientific Designs, Inc. will be barred from making, or assisting others in making, any false or misleading representations concerning the accuracy of any unapproved HIV test or other unapproved device. The two settlements are the latest in a series of FTC enforcement actions against marketers of unapproved rapid HIV tests, and the first cases against manufacturers of the devices.
Chembio is based in Medford, New York. Alfa is headquartered in San Diego, California.
In its complaint against Chembio, filed in the Eastern District of New York last week, the Commission alleged that the company represented that its tests were more than 99 percent accurate in detecting the presence of HIV antibodies in human blood, serum or plasma. According to Commission allegations, however, Chembio's tests failed to detect the presence of HIV in some instances.
Under the stipulated final order settling the charges, Chembio is prohibited from making false or misleading representations in connection with the advertising or sale of any HIV test, or any other medical device not approved by the U.S. Food and Drug Administration, including any claims regarding the accuracy of the tests. The settlement also requires the defendant to notify the Commission of any complaints or refund requests in the future and allows the Commission, for a period of five years, to randomly select and test any HIV test or other unapproved device for accuracy.
In a separate matter, the Commission settled its lawsuit against Alfa Scientific, and amended its complaint to name as additional defendants Alfa Scientific's President, Naishu Wang, M.D., Ph.D., and the company's Chief Executive Officer, David F. H. Zhou, M.D., Ph.D. The Commission alleged in its amended complaint that Alfa, Wang and Zhou violated federal law when they represented on their Internet site that their "Alfa HIV-1/2 Rapid Tests" accurately detected HIV infection in human blood. According to the FTC, independent tests showed that Alfa's HIV tests produced false negative results when tested with HIV-positive whole blood samples.
The settlement prohibits Alfa, Wang and Zhou from making false or misleading representations in connection with the advertising or sale of any HIV test, or any other medical device not approved by the U.S. Food and Drug Administration, including any claims regarding the accuracy of the tests. The settlement also requires the defendants to notify the Commission of any complaints or refund requests in the future and allows the Commission, for a period of five years, to randomly select and test any HIV test or other unapproved device for accuracy.
In November 1999, the FTC settled similar charges against Cyberlinx Marketing, Inc., and its President, Jeffrey S. Stein, of Las Vegas, Nevada. Cyberlinx had obtained its rapid HIV tests from a San Francisco distributor, Sovo Tec Diagnostic Designs, Inc. Sovo Tec, which settled similar charges with the FTC last September, had purchased its HIV tests from Chembio, the subject of one of the actions announced by the Commission today.
In March 2000, the Commission settled another case against a Florida distributor of rapid HIV tests, David M. Rothbart, President of Medimax, Inc. According to the FTC, Alfa manufactured the HIV tests distributed by Medimax.
Rapid HIV tests use a simple finger prick process for blood collection or a special sponge device for saliva collection. The sample is applied to a plastic testing device and a developing solution, or diluent, is added to determine if the sample is positive for antibodies to HIV. Results are generally available in fifteen minutes. Currently, just one rapid HIV test is approved for sale in the U.S. and is available only to medical professionals. The rapid HIV tests both Alfa and Chembio manufactured and distributed cannot be sold in the United States but under federal law can be exported without FDA approval. Most unapproved rapid HIV tests are distributed in developing nations. In November 1999, the FTC and FDA issued a joint statement warning consumers that unapproved HIV tests can give inaccurate results.
The Commission vote to approve the settlement with Chembio was 4-0, with Commissioner Thomas Leary not participating. The vote in the Alfa matter was 5-0, with Commissioner Orson Swindle issuing a separate statement.
Commissioner Swindle issued a statement praising both settlements as "a tremendous public service," but cautioned that "enforcement of the FTC Act cannot systematically address the export from the United States of potentially faulty HIV tests." Referring to his statement in a related case, Sovo Tec Diagnostics, Inc., in which he raised questions about the treatment under current U.S. law of exports of unapproved rapid HIV tests, Swindle expressed concern that "there may be unanticipated gaps . . . that allow the export of some U.S.-manufactured HIV tests and test kits without independent scrutiny of their effectiveness, whether by the FDA or by a foreign government that authorizes the marketing of such devices. A system designed to prevent wasteful, duplicative review may have led to the unintended consequence of ineffective review." He urged the FDA and Congress to "take a hard look at the export regime to be sure that it is not inadvertently undermining U.S. and international efforts to combat the AIDS pandemic."
NOTE: A stipulated final judgment and order is for settlement purposes only and does not constitute an admission by the defendant of a law violation. The judgments have the force of law when signed by the judge.
Copies of the complaints, the stipulated final judgments, Commissioner Swindle's separate statement, related statements of Commissioners Swindle and Leary in the Sovo Tec matter, and the joint warning issued by the FTC and FDA are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The FTC works for the consumer to prevent fraudulent, deceptive and unfair business practices in the marketplace and to provide information to help consumers spot, stop and avoid them. To file a complaint, or to get free information on any of 150 consumer topics, call toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form at www.ftc.gov. The FTC enters Internet, telemarketing and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies worldwide.
(FTC File No. 992-3269 (Chembio))
(Civil Action No. 00CV 0081 BTM (NLS)
Claudia Bourne Farrell
Office of Public Affairs
Darren A. Bowie or Karen Jagielski
Bureau of Consumer Protection
202-326-2018 or 202-326-2509