Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
Associated Press - Friday September 22, 2000
Lauran Neergaard, AP Medical Writer
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 (news - web sites) 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 adequately protect their own citizens. Once overseas, 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. He could not elaborate on ongoing probes.
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.
The FTC's complaint came Thursday as it announced a settlement with Sovo Tec Diagnostics of Novato, Calif., forbidding misleading advertising. Sovo Tec, which brokers overseas sales of the products, had promoted unapproved HIV tests as "the most accurate technology available."
But the FTC declared faulty some tests - the "HIV 1/2 Stat-Pak Ultra Fast" brand - that were resold here by a Sovo Tec customer who was supposed to export them. The FTC stopped sales by that company,
Nevada-based Cyberlinx, but the FDA does allow other companies to export those tests.
Sovo Tec says it did nothing wrong and it has no complaints about its exports.
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