FDA's Regulation of Home Drug Test Attacked

DRUG TESTING November 1996

The FDA's effort to regulate a home drug test designed by a Georgia woman has prompted criticism (John Schwartz, "Home Drug Test Triggers Scuffle With FDA," Washington Post, October 7, 1996, p. A19).

After catching her son smoking marijuana, Sunny Cloud designed a home drug test containing drug screening tools similar to those used by businesses and athletic teams. Her $40 "Parents Alert" kit includes a plastic cup, a box addressed to a licensed testing laboratory and other materials. However, Cloud's attempt to market the kits directly to parents has brought warnings by the FDA. In 1995, the FDA informed Cloud that the kit she was marketing was considered a "Class III" medical device and that her company must go through the agency's medical device approval process (D. James Romero, "A Test of Love," Los Angeles Times, October 14, 1996, p. E1).

Some Republican lawmakers and conservative talk show hosts have cited Cloud's dispute with the FDA as an example of the agency's excessive power and Clinton's unaggressive drug policy. At a September 26 hearing, House Commerce Committee Chairman Thomas J. Bliley (R-VA) said he was outraged by the FDA's actions. The Committee's Republican staff members faxed a memo to radio talk show hosts, which read that the kit provided "the best excuse for kids to 'Just Say No.' But the Clinton FDA doesn't want them to have it."

FDA Commissioner David Kessler responded to the criticism in a letter to Bliley. Kessler said he pledged to allow the home drug test to stay on the market while the FDA completes its review of the public health issues raised by the device. All new medical devices not "substantially equivalent" to other devices already approved by the FDA for the same function must go through class III review, wrote Kessler. One former FDA official who works with the medical industry said, "If, in fact, the legal definition calls for making this a Class III device, then it's not the FDA's fault. Congress needs to change the law."

Cloud's Attorney, Larry Pilot, argues that the kit is not intended to diagnose a medical condition, and so "is not subject to the definition of the term 'device,' and therefore not subject to FDA regulation. Cloud, who still has not applied for FDA approval, said the agency's actions confounded her. "All the materials in this box have been commercially available for years. I just put it in a white box. You're trying to monitor a white box," Cloud recalled telling FDA officials.