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Drug-Testing Law Gives Kids Their Due

Posted on: Saturday, 24 December 2005, 00:00 CST

THE FOOD AND DRUG ADMINISTRATION AND pediatric-health advocates observed a milestone this

week as they noted approval of the 100th medication specially tested for safety and effectiveness on children.

What's most remarkable is that prior to 1997 drug-approval laws and rules didn't require testing of a proposed medicine's effects on children. The omission left pediatricians to make educated guesses on whether a drug that was effective in the treatment of adults also would help their patients.

In a very real sense, manufacturers' failure to conduct -- and regulators' failure to require -- separate testing amounted to institutionalized medical malpractice.

Children were relegated to the status of clinical guinea pigs. Doctors, meanwhile, were left to puzzle over dosages in the absence of advice from manufacturers or testing that might show risks unique to children.

That changed with enactment of the Food and Drug Administration Modernization Act. Also crucial was subsequent legislation that was intended to achieve good regulation without eliminating incentives for the industry to attempt advances.

For example, drugmakers who voluntarily perform testing and who include pediatric information in their labeling get an extra six months to market the drug without generic competition. Critics -- especially so called "freemarket," anti-regulation zealots -- claimed pediatric testing requirements would slow development of drugs that would benefit adults. The fears proved to be unfounded, as regulations included many common-sense exceptions to prevent such delays.

U.S. Sen. Mike DeWine, R-Ohio, has made pediatric drug testing a leading personal cause. And, for good reason, he considers it one of his best accomplishments. The new rules have resulted not just in drug safety for children, but in greater insights into many childhood conditions -- including asthma, HIV, hyperactivity and leukemia.

These efforts advanced good policy and were among the too-few instances of genuine bipartisanship in Congress in recent years.

As late as 2003, 75 percent of drugs on the market were not tested or labeled for pediatric use.

Sen. DeWine worked with Sens. Christopher Dodd, DConn., and Hillary Clinton, DN.Y., to resurrect and expand the new rule after it had been struck down by a court on technical grounds. The legislation passed the Senate unanimously.

The Senate's commitment to children has since apparently dimmed. It passed budget legislation this week that was designed to pay for tax cuts with reduced support for student loans, childsupport enforcement and foster care -- legislation Sen. DeWine, along with just four other Republicans, voted against.

Source: Dayton Daily News

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