The government could require drug companies to test medicines to assure that dosages were appropriate for children under legislation given final approval Wednesday by Congress.
The measure, passed by the House on a voice vote, is aimed at eliminating the guesswork for doctors who prescribe for children medicines that have been tested only for adults. The bill already had passed the Senate.
“Doctors were cutting adult pills in half, hoping they would work with children, often with life-threatening results,” said Rep. Anna Eshoo, D-Calif.
The bill “will have the effect of dramatically improving the health and well-being of our nation’s children,” said Rep. Deborah Pryce, R-Ohio.
The legislation was sponsored in the Senate by Sen. Mike DeWine, R-Ohio. It expands on 1997 legislation championed by DeWine and Sen. Christopher Dodd, D-Conn., that extended patent rights time periods for pharmaceutical companies that volunteered to carry out pediatric studies to develop labeling standards for children.
The Food and Drug Administration in 1998 issued what it called the “pediatric rule” giving the agency the authority to require tests for adult drugs prescribed more often for children. But last year a federal court struck down the rule, stressing that it was up to Congress to pass legislation giving the FDA the authority it needed.
The legislation would ensure that the FDA can require testing on children when drug companies lack the financial incentives to voluntarily conduct testing.
It applies to all medications, such as vaccines, whose intended use for children is the same as that for adults.
Sen. Hillary Rodham Clinton, D-N.Y., another co-sponsor of the Senate bill, said it was “important to ensure that no future administration and no court of law could stand in the way of a sensible measure designed to protect our children.”
Mark Isaac, vice president of the Elizabeth Glaser Pediatric AIDS Foundation, said the legislation was a major victory for children. “This is a law that will benefit every child and every family by finally guaranteeing children the same access to safe and effective medicines that we demand for ourselves as adults.”
Now only a fourth of the drugs on the market are tested and properly labeled for safe use by children. Because children and adults react to drugs in different ways, trying to calculate dosages on the basis of what is appropriate for adults can lead to overmedication and under-medication for children.
FDA Commissioner Mark McClellan and Health and Human Services Secretary Tommy Thompson, in a joint statement, welcomed passage of the bill. “Children are a unique population with special medical needs,” they said. “We are delighted that Congress has recognized this need, too.”