FDA's Reversal of Drug Kit Policy

On Jan. 21, the Food and Drug Administration gave official approval for over-the-counter drug testing kits. The test kits can be used to test for marijuana, PCP, amphetamines, cocaine and opiates, including heroin. The agency has allowed previously unauthorized sales of home drug kits since October, succumbing to political pressure to release the product.In last year's political campaign, the Clinton Administration, already sensitive to charges that it was soft on drugs, pushed the FDA to alter its position regarding the approval of over-the-counter testing kits. The FDA and the Health and Human Services department came under fire not only for being soft on drugs, but also violating the rights of parents to test their kids. The combination had the potential for political disaster, so the Clinton Administration moved to squelch the controversy.The catalyst for this latest skirmish in the drug war began with, Sunny Cloud, a single mother living in Newt Gingrich's Atlanta suburb of Marietta. In early 1994, she had come home early from work to find her 15-year-old son smoking pot. The incident led Cloud to market Parents' Alert, an at-home urine kit."I started this program as a single mother to help my kids," Cloud said in a phone interview. "I found out later that two or three times, other companies had tried to do this. Every time, they were denied [by the FDA]. They would only give approval to doctors, and said that parental access would cause family discord."Cloud's Parents' Alert $40 testing kit comes in a box with two different tests -- one for urine collection and another that tests saliva for the presence of alcohol. Also included are instructions that tell the parent, among other things, to "accompany the child to the collection site (usually a bathroom)." Further down it reads, "Child is given the specimen bottle and instructed to produce about 1 1/2 fluid ounces, or 30-40 ml of urine." The contents are then mailed to a lab for analysis.A second enclosed brochure instructs parents what to do if dissatisfied with a negative result. "A negative test result does not guarantee drug abstinence. If you notice continuing behaviors of concern, you should re-test."Cloud says she was first contacted by the FDA in April 1995, and was initially cooperative."I was willing to bend over backward for these people because I thought we shared the same goals. I didn't hear from them again for eight weeks, [then] I got a letter saying I created a Class 3 medical device. The letter was almost impossible to understand, and I didn't know what to do." Cloud later found out that a Class 3 medical device meant it could be administered only by certified professionals -- the Class 3 rating puts in in the same category as CAT scanners and heart pacemakers.That the FDA would presume to know what would cause family discord was jumped on immediately by members of Congress who wanted to make the Sunny Cloud case a symbol of high-handed liberalism in the Clinton Administration. Cloud, who describes herself as "nonpolitical," refused to obey the FDA and continues to sell her kits.This was hailed by conservative groups as a blow for parental rights. An investigation was called in September 1996 by Rep. Thomas Bliley (R-Va), chairman of the Commerce Committee. Several top FDA officials were called to testify. At the hearing, Dr. D. Bruce Burlington, FDA Director of the Center for Devices and Radiological Health (CDRH), testified that properly reading drug test results requires training."[When] there are adequate directions for lay use, and we are satisfied that the tests can produce consistently accurate results, we believe the products should be available OTC. Unfortunately, to date such systems for drugs of abuse have not been shown to meet these criteria," he said. His testimony was met with ridicule by both Republican and Democratic lawmakers, according to both Cloud and Rodney Hoppe, a spokesman for Congressman Bliley."The FDA's response is that these tests are going to cause family discord and tension. But if your kid is doing drugs then drives off a bridge, that's discord right there" Hoppe said.The political furor was enough to prompt Secretary of Health and Human Services Donna Shalala to issue a memo informing the Commerce Committee that Cloud could continue to market her product.Allen St. Pierre, of the National Organization for the Reformation of Marijuana Laws and an advocate against home urine testing, was critical of the FDA's decision. "The FDA made an exception for Sunny Cloud because it's drug-war rhetoric. They'd probably have her in chains otherwise."Even as the FDA backpedaled, agency spokesman Donald McClearn defended the agency's concerns about the product creating family discord. "We had, six or seven years ago, a similar situation with home AIDS tests. We were concerned because there was little hope for a cure. Just because we could sell these, didn't necessarily mean we should. We worried about adequate counseling for positive tests. Is that overly Big Brotherish?" Sunny Cloud maintains that she "respects" the FDA and says that the labs used by Parents' Alert meet FDA requirements. She also says that all positives are screened a second time.A second test could cost up to $100, but Cloud says she got a "great price" from the lab and is able to sell her kits at $40 per unit. Now that the FDA has finally given official approval to market the kits, Cloud is concerned with competition as well as saving children from drugs. She criticized new rival Personal Health and Hygene for announcing that their kits will go for $30. "I don't know how they can say that. There's not a lot of room for markup on these," she said.


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