FDA OKs 1st Over-Counter Home Test for Drug Use

The Food and Drug Administration Tuesday approved the first over-the-counter home test kit designed to permit parents to determine whether their children are using drugs.

The product can detect in urine the presence of marijuana, PCP, amphetamines, cocaine, heroin, codeine and morphine. It will be sold in drugstores and other outlets.

The decision came several months after congressional Republicans harshly criticized the FDA for what they called its infringement of parental rights by refusing to sanction a home kit being marketed by a Georgia woman. The woman, Sunny Cloud, has sold the kit by mail order from her home and has refused to seek FDA licensing through regular channels.

The kit approved by the FDA on Tuesday, however, is not the same one touted by GOP lawmakers last fall. The new product, which will be marketed as Dr. Brown’s Home Drug Testing System, was developed by Personal Health and Hygiene Inc., a Silver Spring, Md., firm that chose to undergo the agency’s review process.

The FDA regards home test kits as medical devices under its jurisdiction. In the past, the agency had expressed serious concerns about how parents, acting without the aid of a physician and untrained in drug counseling, would interpret and react to results. Those reservations were overcome with Dr. Brown’s test.

Rep. Thomas J. Bliley Jr. (R-Va.), chairman of the House Commerce Committee, who had championed Cloud’s cause, criticized the FDA’s handling of the issue, saying that “there is considerable doubt over whether the FDA has jurisdiction over these kits in the first place.”

He said that he has asked the Commerce oversight and investigations subcommittee to conduct more hearings on the FDA’s handling of the matter.

Representatives from drug treatment programs pointed out that the use of such home drug test kits would require cooperation from youngsters.

“The ideal situation is one where parents and teenagers are communicating with each other,” said Chris Policano, a spokesman for Phoenix House, a drug abuse treatment and prevention organization with centers in New York and California, including Los Angeles, San Diego and Santa Ana. “It’s not enough to know if a child is using drugs. You have to know what to do with those results.”

The product provides three elements: a special kit for urine collection, storage and mailing; a federally approved laboratory testing service and a telephone system for obtaining results and referrals for additional services, such as counseling.

It works like this: The collection kit--a paper cup for collecting urine and two plastic tubes with screw-on lids into which the urine is poured--is placed into a plastic pouch that is inserted into a bubble bag for mailing to a designated laboratory.

Each kit has an identification number, which is placed on the urine specimen, making it possible to obtain the results anonymously.

The designated lab has been certified by the Substance Abuse and Mental Health Services Administration, the College of American Pathologists and the Health Care Financing Administration, the FDA said.

The FDA has cleared the screening tests.

The lab performs confirmation testing--to minimize the possibility of false positives perhaps caused by certain medicines and foods--and then sends the results via computer to the company’s results center. They will be available one to three days after the lab has received the sample.

For results, callers use an 800 number and identify themselves using the code number attached to the urine sample and instruction booklet. The callers are informed of the results by a representative of Personal Health and Hygiene, who also provides information about the meaning of the results and can give referrals for drug abuse counseling and additional medical services.