Clinton, FDA Criticized for Limiting Sale of Drug Tests

The Clinton administration, already stung by Republican charges of complacency in the face of rising drug use, has come under a fresh round of fire for restricting sale of home drug tests designed for parents to administer to their children.

Although GOP presidential candidate Bob Dole has been responsible for most of the drug policy criticism so far, the latest salvos are coming from Republican lawmakers who accuse the Food and Drug Administration of denying parents a potent weapon for fighting drug abuse in the home.

Led by House Commerce Committee Chairman Thomas J. Bliley Jr. (R-Va.), Republicans cite the FDA’s actions as a prime example of what they characterize as a heavy-handed approach to regulation in an area where they believe parents’ rights should be paramount.

At issue is whether “Parents’ Alert,” a home drug test marketed by a one-woman firm in Georgia, should be commercially available without going through a lengthy FDA approval process.

Priced at $40, the test kit consists of a widely used, FDA-approved, urine-collection cup, an envelope for mailing it to a government-approved laboratory and a pamphlet explaining the meaning of the lab results, along with phone numbers of drug-abuse hotlines in the event of a positive result.

Since the mid-1980s, the FDA has treated home drug test kits as “Class 3 Medical Devices.” The designation puts Parents’ Alert in the category of medical devices presenting the most serious risks if misused by the intended consumers, in this case, parents.

Other Class 3 devices include X-ray machines (which are intended for use by trained medical clinicians), cardiac pacemakers, extended-wear contact lenses and anti-snoring devices placed in the mouth during sleep.

So far, the FDA has not approved an application for an over-the-counter test for illegal drugs, although in one case it approved the marketing of a home drug test by a physician’s prescription.

In deliberations on past submissions and in a recent Capitol Hill hearing, FDA regulators have questioned whether parents, acting without a physician’s assistance, can understand the results of a test and respond appropriately. Of particular concern is the possibility of a false-positive result, they said.

In notes taken during a 1995 meeting with FDA attorneys, one firm seeking the agency’s approval for a home test cited the agency’s concern that such tests could cause “family discord” and subject children to “coercion” from their parents.

Sunny Cloud, a Marietta, Ga., parent who began marketing Parents’ Alert after she caught her son smoking marijuana three years ago, never has applied for FDA approval of the test. Defying the agency’s warnings that she could be held liable for steep civil penalties if she continues to market the tests for home use, Cloud said that she has sold slightly more than 1,000 of the kits. Bliley’s office, citing provisions in criminal law, said that Cloud could be subject to a year in prison for every kit she has sold.

Cloud, however, is adamant. Arguing that a virtually identical drug-test package has been used by major employers for years, she has refused to subject her product to the FDA approval process and is still selling the kits by mail order from her home.

Government regulators and their allies see the case as a commercial dispute started by a businesswoman who does not want to submit her product to government scrutiny intended to ensure its safety, reliability and benefit to consumers.

Cloud says that the dispute involves government regulation that is arrogant, bureaucratic and hostile to small businesses. But she contends that it involves a grander principle as well: the right of parents to rear their children free of government interference. Cloud is furious that the FDA would deny parents a tool for managing their children’s affairs that corporations routinely use in managing their work forces.

“FDA was concerned about these tools because they said it would cause divisiveness and friction within the family,” Cloud said in an interview. “Well, I didn’t realize that FDA had powers that could extend into the living room. I thought parents could make those choices. My personal opinion is that [FDA’s stated concern on the] efficacy of the test is really a red herring. This is about parents’ rights.”

The wrangle over Parents’ Alert already has caused the FDA to modify its initial position and initiate a “review” of its policy that most home drug tests should be regulated as Class 3 devices. But in a recent hearing before Bliley’s committee, agency regulators defended their earlier statements that parents might not have the ability to respond appropriately to test results.

For President Clinton, the issue presents a potentially tricky political dilemma. It pits the president’s popular advocacy of “family-friendly” initiatives against the arguments of a regulatory agency charged with protecting consumers from the marketing of drugs and devices whose safety or effectiveness have not been proved.

In recent months, Clinton has championed a number of initiatives--from the V-chip to school uniforms--designed to help parents cope with society’s negative influences on their children. Many would consider support for a home drug test consistent with the president’s past actions. The FDA’s decision to maintain regulatory obstacles to sale of the test kits--all with the administration’s implicit assent--strikes some as a bad political move in the crucial final weeks of his reelection campaign.

Already, cracks in the administration’s unity have appeared: In an interview last week, Gen. Barry McCaffrey, director of the White House Office of National Drug Control Policy, said that he believes families “ought to make up their own minds” about whether the test is right for them.

“We have home pregnancy tests, home AIDS tests,” McCaffrey told the Christian Science Monitor. “Maybe we need a home drug test.”

McCaffrey’s comments prompted Bliley to fire yet another shot across the Clinton administration’s bow.

“Parents might disagree whether to test their own children, but that’s a decision that ought to be made by them--not by Washington bureaucrats,” Bliley said. “Maybe Gen. McCaffrey can get on the phone with the Food and Drug Administration and give them the same message.”

According to FDA spokesman Jim O’Hara, such a call would be unnecessary.

“The administration wants parents to have the tools they need to fight drug abuse,” O’Hara said. “The only question is how to make certain in this case that drug tests provide reliable and accurate information and that people know how to use it.”