CA issues statement on pediatric rule.

Consumer Alert and the Competitive Enterprise Institute issued a joint statement regarding the current debate on the Food and Drug Administration's "Pediatric Rule." The U.S. Senate is currently considering a bill (S. 2394) that would codify FDA's rule.

The new bill would allow the FDA to require pediatric testing by pharmaceutical companies of adult-labeled drugs that have significant therapeutic potential for children. Proponents argue that it is necessary because many drugs prescribed for children have not been formally tested on them. Children often react differently than adults to medications, and therefore adult tests of such drugs are an inadequate basis for their "off-label" use for children.

In its statement CA warns that the proposed mandate ignores the inevitable trade-off between drug testing and drug availability. Expanded testing requirements will almost certainly result in a longer, more expensive drug development and approval process. This process is already too long and costly as it is. Pharmaceutical companies must already weigh a huge array of factors in deciding whether to proceed with a new candidate drug. If the possibility of mandatory off-label pediatric testing is added to that list, then it becomes even more likely that certain candidate drugs will be dropped from consideration. The result will be fewer available drugs for adults and children alike.

FDA's ultimate sanction against a company that declines to undertake mandatory pediatric testing is to disapprove it or remove it from the market.

But as one pediatrician has noted, "there are many drugs that are tremendously useful for children even though they are not labeled for pediatric use. The possibility that the FDA might remove these drugs from the market is unimaginable."

At heart, off-label use is an issue of how medicine is practiced. Physicians may well vary in how much information they require before undertaking such use; that is a matter best left to individual doctors. Once off-label testing mandates are imposed, this issue is taken out of the hands of individual physicians, because no doctor at all will have access to drugs that do not meet these standards. Congress should carefully consider whether it wishes to venture down this path.