ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Monday, September 30, 1996 TAG: 9609300107
SECTION: EDITORIAL PAGE: A-7 EDITION: METRO
COLUMN: George F. WIll
SOURCE: GEORGE F. WILL
HILLARY CLINTON'S epiphany, confided to the country during her speech to the Democratic convention, that it takes not only a village but also a president to raise a child, does not do justice to the scope of caring in her husband's administration. Sure, it takes a president, everyone knows that, but it also takes this president's Food and Drug Administration.
Evidently the FDA thinks it has a roving commission to prevent ``family discord.'' And it has acted to do so by issuing an edict designed to prevent parents from getting too intimately involved in raising their own children. Herewith a story melding many themes of today's political debate - drugs, families and whether the country's contempt for Washington is sufficiently severe.
When Sunny Cloud, a Georgia mother, found her son smoking marijuana, she took him to an emergency ward for a drug-screening test. She found the experience so disagreeable and expensive that she developed a kit that would enable parents to administer tests to their children. The mere possession by parents of such kits would give children a powerful reason to resist peer pressure for drug use.
Cloud's kit consists of a small plastic cup for a urine sample, a temperature-measuring strip to prevent the substitution of old urine, two saliva-sample strips, and a box and mailing label addressed to a federally licensed laboratory which tests for numerous drugs. Each sample is assigned a number, and the household that sent the sample is notified of the results associated with that number. The name of the person who gave the sample is not involved.
Cloud, a former teacher, started a business, Parent's Alert Inc., to manufacture this $40 diagnostic kit. Then on June 15, 1995, she received from Washington a bellow of reproach.
The FDA's ``warning letter'' stated that ``our investigator'' has revealed that the kit is ``a Class III device'' and does not have the FDA approval such devices require. The FDA darkly noted that ``this letter is not intended to be an all-inclusive list of deficiencies at your facility.'' (Imagine an all-inclusive list of deficiencies at FDA.) The letter commanded ``prompt action'' to correct ``deviations.''
CAT scan machines are Class III devices. So are MRIs, pacemakers and X-ray machines. And so, it seems, is Cloud's plastic cup. But only when used by parents to protect their children.
Another drug-testing kit is made for hair samples. This supposedly Class III device consists of aluminum foil for the hair and a labeled box. Such urine, saliva and hair kits are in legal commercial distribution. They are used for drug screening by many companies and governmental units, such as General Motors and the New York City Police Department.
After a meeting of FDA officials with one of the manufacturers, the FDA's policy was reported by an attorney for the manufacturer and seemingly corroborated by the FDA's own minutes of the meeting. The policy is to allow the sales of kits ``marketed exclusively for forensic purposes (e.g., law enforcement, employment).'' But over-the-counter sales ``indicated for teen-agers'' should be regulated, meaning prevented. The attorney's memorandum describes this as ``a deliberate policy decision that has been made at a high level within the'' FDA. According to the memorandum by the manufacturer's attorney, the FDA, whose minutes refer to ``ethical and social issues,'' has a capacious notion of its mandate and competence. It ``is concerned about issues such as anonymity, confidentiality, coercion, and family discord.''
Oh, so this tentacle of the nanny state really should be called the FDDA - the Food, Drug and Discord Administration. Perhaps some of the FDA's caregivers could drop by at breakfast time, when there are three pairs of hands reaching for the newspaper's sports section. Talk about family discord. And then there is custody of the television remote control.
The FDA's overreaching, overbearing busybodies merit derisive laughter. But the gargantuan presumptuousness of this federal bureaucracy elbowing its way into family matters is infuriating for many reasons, one of which is:
Children on drugs often are uncommunicative and in denial until confronted with undeniable evidence, at which point they become open to rehabilitation. Parents will be more inclined to seek evidence from home tests that preserve anonymity and confidentiality than from emergency-room or other procedures that generate medical records.
Of course this assumes that if parents say ``pretty please'' and ``mother may I,'' the FDA will give them permission to participate - as Washington's junior partners, naturally - in parenting.
- Washington Post Writers Group
LENGTH: Medium: 83 linesby CNB