Copyright © 2002 The New York Times
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The Bush administration senselessly plans to abandon a farsighted regulation designed to ensure that all medicines used in children undergo proper testing for safety and efficacy. This is a bizarre abdication of responsibility for guaranteeing that society’s youngest and most vulnerable members are provided with the same safeguards that protect adults from unsafe or ineffective medicines. It is time for saner heads in both parties in Congress to press the administration to retain the rule it is trying to disown.
The need for the rule stems from injuries and ineffective treatments suffered by children taking medicines that have not been tested for safety and efficacy in young people. Drug companies generally test prospective products on adults and seek approval from the FDA to market them for adults. But once a drug is on the market, doctors are free to prescribe it for anyone they please. When they want to give a drug to children, they typically cut the dose and assume that it will work well and safely. But the doctors, alas, may guess wrong. They may prescribe too small a dose to be effective or too large a dose, causing harm. There also may be unexpected side effects in children. In 1999, seven newborns became seriously ill and required surgery after taking erythromycin, which had not been tested in their age group.
In 1997, Congress established an incentive program to coax manufacturers into conducting the desired tests by offering to extend patent protection on the products involved by six months. That voluntary program has spurred a flood of tests. The chief complaint is that it has given a windfall to some companies, yielding them hundreds of millions of dollars in added profits from the patent extensions and slowing the introduction of cheaper generics. The incentive has not worked for drugs that lack patent protection or have small markets.
In 1998, the Food and Drug Administration issued a Pediatric Rule that allowed it to require manufacturers to test their medicines in children, if the products were likely to be used by substantial numbers of pediatric patients. This mandatory approach seems to have been used less often than the incentives, but children’s advocacy groups believe that it is imperative for the FDA to retain the ability to require tests when needed.
Unfortunately, three conservative groups – the Association of American Physicians and Surgeons, the Competitive Enterprise Institute, and Consumer Alert – have filed suit challenging the FDA’s legal authority to require pediatric tests. Rather than fight, the FDA seems to be caving in. It has told the court that it may suspend all or part of the mandatory rule while determining whether it is still needed.
The FDA should not lightly abandon this potentially vital tool. The voluntary approach will leave unstudied many medicines and age groups that the manufacturers see no profit in testing. Congress has recently plugged part of this gap by authorizing payment for some pediatric studies through a new private foundation or through government contracts, but there is no guarantee that enough money will be available. At any rate, there will surely be circumstances where pediatric tests are needed and will not be conducted unless the FDA can order a company to do them. It makes no sense to abandon any weapon in the long uphill fight to obtain safe and effective medicines for the nation’s young people.