Popular at-Home Drug-Test Kit Runs Afoul of FDA 

Popular at-Home Drug-Test Kit Runs Afoul of FDA 
Posted by FoM on September 08, 1999 at 18:37:11 PT
By Christine B. Whelan, The Wall Street Journal 
Source: Star-Telegram
Back in May, radio psychotherapist Dr. Laura Schlesinger started steering troubled parent-callers toward a little-known line of instant drug and alcohol tests called First Check. By June, First Check was a paying advertiser, running a 60-second spot in which a pharmacist recommended the do-it-yourself kits "when the need to know . . . is now." 
"Every time that 60-second spot runs, every [phone] line we have lights up for 15 minutes," says H. Thad Morris, president of Worldwide Medical Corp., First Check's Irvine, Calif., manufacturer. "It shows us how concerned parents are."The Food and Drug Administration is concerned, too, and last month asked Worldwide Medical to pull the ads from radio, print and television. The First Check drug test isn't approved for consumer use, and Worldwide Medical is selling it illegally, the FDA says. The agency sent the company a letter informing it of "serious regulatory problems" with the First Check drug test that could result in a seizure of inventory, monetary penalties or a court injunction against selling the product.Worldwide Medical is fighting back, challenging the FDA's authority to regulate a product that is proving to be astonishingly popular. In the 18 months since introducing the at-home drug kits, Morris says, Worldwide Medical has sold 1 million of them. Since its December 1997 introduction, the product has helped fuel a more than sixfold increase in the company's revenue, to $6.5 million from $1 million, Morris says.First Check is convenient and fast, qualities that make it both popular with parents and controversial with regulators. Parents need just three drops of their child's urine to test for the presence of marijuana, cocaine, heroin and methamphetamines. They get results, on small plastic panels, in less than 10 minutes: Red lines indicate a negative result, and no lines mean a positive. Other tests, by contrast, require a wait of days or weeks for results from an outside laboratory.Since June, Kmart Corp. has been selling First Check tests, which range from $9.99 for the marijuana kit to $24.99 for marijuana, cocaine, methamphetamines and heroin. Spokeswoman Mary Lorencz says sales are strong. "Until there's some ruling that it can no longer be sold, we'll continue to carry it," she says.According to FDA regulations, any at-home drug test that gives immediate results is a medical device and requires clearance. The agency says Worldwide Medical hasn't adequately tested the First Check kit in home conditions. Worldwide Medical takes the position that its kits provide only "preliminary" results and that the FDA has already approved the technology, the "underlying panels."Rivals in the fast-growing market for at-home drug tests complain that Worldwide Medical has grabbed an unfair advantage by skirting the FDA's costly premarket approval process. "We'd love to do what they're doing, but we're following the FDA's rules," says Bruce Christie, chief executive of Drug Detection Devices Ltd., a closely held Georgia distributor of the At Home Drug Test, made by Phamatech, of San Diego.Phamatech's test is one of just a few consumer drug tests approved by the FDA for home use. It indicates whether any of five drugs is present in a urine sample: If some lines are missing from a dip stick, that indicates the presence of a drug. Consumers must send the sample to a lab and, within three to seven business days, obtain specific results by calling a confidential, toll-free number. It costs $29.95.The FDA approved Phamatech's home test in October, and Phamatech says its sales are approaching 100,000 units. "If [the FDA doesn't] discipline people like Worldwide Medical, I don't know why the rest of us should toe the line," Christie says.When instant-drug-test kits were introduced about 10 years ago, they raised eyebrows, mainly for privacy reasons. Some critics say because they don't involve a medical professional or counselor, they can be dangerous: Parents are usually emotionally distraught when they get the test results. "I fear the average parent won't know how to react to the information," says Peter Newland, director of the adolescent division for Phoenix House, a New York drug-treatment group.Still, the tests are proving to be popular with parents of teens.In 1998, 54 percent of high-school seniors reported having taken an illegal drug at least once, according to an annual study conducted by the University of Michigan. The recent rise in drug abuse, especially of heroin, among affluent white teens has sent the at-home-test market soaring.David Moore, a Lake Forest, Calif., single father, says both his teen-age children took the First Check test at his request. His 17-year-old son was indignant, Moore says, but the results were negative. Now, he says, they talk freely about drugs. "I am an old-school parent. I believe you have to question your kids," Moore says. He keeps two of the kits on his kitchen counter all the time, he says. "This test really works as a deterrent against drug use." Updated: Wednesday, Sep. 8, 1999 at 13:04 CDT  1999 Star-Telegram, Fort Worth, Texas 
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