IVD Technology Magazine | IVDT Article Index
Originally published May, 1997
OTC drug tests go to market
In February, FDA announced adoption of an interim policy that removes the requirement that premarket approval (PMA) applications be submitted by companies that want to sell nonprescription drug-test kits. In the controversy leading up to that decision, companies such as Parent's Alert (Atlanta) and Dr. Brown's Home Drug Testing System (Silver Spring, MD) gained headline exposure for their over-the-counter urine tests. Meanwhile, researchers at the National Institute of Standards and Technology (NIST) have been busy confirming the accuracy of what some scientists and federal officials believe to be the wave of the future: hair-sample analysis.
None of this comes as a surprise to executives at Psychemedics Corp. (Cambridge, MA), which offers a drug test that relies on hair samples. The company just reported a record-smashing sales quarter, and recent trials indicate that hair-strand testing results compare favorably with those of urine tests.
In a study involving 14 laboratories, researchers at NIST's division of analytical chemistry found "consistently good results" from labs using gas chromatographymass spectrometry to detect cocaine and other illegal drugs (J Anal Toxicol, 20:242247, 1996.) Drug-testing of hair "seems very reliable," affirms Lorna Sniegoski, PhD, senior author of the study. "All you'd really need in order to do this kind of testing would be some strands from a hairbrush or comb."
NIST's research results arrive at a time when FDA is grappling with the entire issue of home-use drug-test kits. Earlier this year, that matter became so highly politicized it eventually involved congressional hearings.
Initially, FDA seemed to favor requiring PMAs for such home-use test kits. Then, in a turnabout that occurred under intense public scrutiny, the agency adopted an interim policy that includes only three criteria: that the companies use only FDA-approved tests, that they adhere to special labeling rules, and that test results be obtained through certified laboratories. Thus far, lab certification is defined as meeting the standards of the Clinical Laboratory Improvements Act or passing muster with the Substance Abuse and Mental Health Service Administration.
What does this mean for manufacturers of other diagnostics down the road? Probably nothing, says Carolyn Jones, director of technology and regulatory affairs for the Health Industry Manufacturers Association (Washington, DC). "I don't think we can assume that this policy will apply to anything like it that comes down the pike." The circumstances surrounding home-use drug-test kits are singular and "of a political nature," she points out.
Transcripts of congressional testimony confirm that the debate over approval of home-use drug test-kits was indeed a unique event. The hearings were filled with the kind of bickering that seemed to signal departure from the field of science and movement into the realm of public sentiment. FDA's deputy commissioner for public policy, William Schultz, found himself answering claims that the decisions of agency officials had been influenced by personal values. Alluding to a memo that purportedly indicated that some at FDA were worried about interfering with "parent-child relationships," Schultz said, "Concerns about the effect of a product on the parent-child relationship or family discord have no place in the agency's determination."
According to an FDA official in the policy office, it will probably take about two years to complete the rulemaking process and put into effect a final regulation that is likely to cover home testing as well as workplace testing, athlete screening, and drug checks by health insurers.
As a field, "home diagnostics are growing very rapidly," observes Gwyneth Munn, senior consultant at Kline & Co. (Fairfield, NJ), which tracks sales data for drug stores and private health institutions. Topping several years of increasing sales, for example, sales of home test-kits for blood glucose monitoring have grown 15% in the past year alone.
But whether sales of OTC drug-test kits will match that trend is debatable. Robert Koda, PhD, professor of pharmaceutical sciences at the University of Southern California (Los Angeles), is uncertain whether these test kits will make much difference at larger centers.
Athletes who undergo drug testing use labs with "a very fast turnaround time," says Koda. "These kits aren't likely to improve on that. But I could see how rapid sales growth might happen in areas where there is no lab close by."
"One of the potential problems is that you have to make sure the test is really reliable," adds attorney David Johnson, who specializes in health-care liability issues and heads the law firm of Thomson, Rhodes & Cowie (Pittsburgh).
Still, the convenience of using a nearby restroom or simply clipping a lock of hair may be enticing to many employee drug-testing programs. In terms of liability, "I can't think of a whole lot of distinction between that" and sending workers off to a collection site, Johnson says.
For hair testing, however, there are a few potential drawbacks. Mike Welch, PhD, a research chemist at NIST, says some studies show that drugs are incorporated more readily into dark hair. Theoretically, blonds could more easily escape detection. And some hair treatments may also affect drug detection, he notes.
But Welch expects all of these issues to be addressed. Such problems have a lot in common with early urine screens, which had to overcome such challenges as false-positive readings due
to contaminants like poppy-seed bagels. "Remember, there was a real mess with urine testing at first, too," he stresses. --Anne Scheck
