FTC Says U.S. Exporting Faulty AIDS Tests

A government crackdown on unapproved AIDS tests sold to Americans over the Internet has uncovered another complaint: Such tests routinely are exported to other countries with no guarantee they work, officials say.

The Federal Trade Commission this week announced its fourth legal action against unapproved HIV tests, a small settlement forbidding a California distributor from misleading advertising.

The regulatory agency also complained about exports of the very HIV tests it seeks to keep from Americans.

“Defective test kits may contribute to the spread of AIDS,” FTC Commissioner Orson Swindle said in a statement accompanying the latest settlement.

A law governing the Food and Drug Administration permits export of such products “without regard to their accuracy,” Swindle wrote in a complaint echoed by a second FTC commissioner. “The gravity of this disease and its devastating impact on the world’s population warrant a hard look at whether current export laws and practices adequately address the export of devices that, if faulty, may contribute to the spread of AIDS.”

A 1996 law permits medical devices not approved for U.S. sale to be exported to countries that have FDA-style health regulators, assuming those nations can protect their citizens. The products can be reshipped to developing nations. Countries must understand the products are not FDA-approved, and companies must meet certain manufacturing conditions.

The FDA and FTC last summer began a crackdown on HIV tests sold illegally here.

The FTC has discovered faulty tests made or distributed by three companies, and went to court to successfully stop their sales here and abroad.

The FDA has received “a small number” of complaints from other countries about exported HIV tests and “there are a number of investigations going on,” compliance chief Steven Masiello said Friday.

How many unapproved HIV tests are exported? Masiello said he didn’t know. But the agency has cited 11 makers or distributors of unapproved HIV tests between 1997 and July for illegal exports. Most didn’t follow conditions in that 1996 export law, such as having quality manufacturing facilities. Some were allowed to resume exporting once they fixed such problems; the FDA did not evaluate the HIV tests’ accuracy.