State Health Lawmakers' Digest: Psychotropic Drug Use among Children (Vol. 3, No. 3), On the Horizon

ON THE HORIZON

Prescription drug use is rising faster in children than in any other age group. Nearly one in two children took at least one or more prescription drugs last year, and more than 5 percent of all children were using some sort of psychotropic medication. Although prescription drug use among children is rising, most drugs have not been specifically tested and approved for the treatment of childhood disorders. Nearly three-quarters of all drugs prescribed to children are prescribed "off-label" because they have not been sufficiently tested. Growing concern exists about off-label drug use by children and the lack of available data relating to pediatric use. In response, several steps have been taken recently to encourage more pediatric drug research.

Historically, drug companies have not undertaken pediatric research for most drugs. Instead, they follow the Food and Drug Administration's (FDA) guidelines requiring them to insert warning labels specifically stating that the drugs have not been proven safe and effective for pediatric use. Children make up a small section of the market for pharmaceuticals and, until now, companies have had little financial incentive to develop drugs for them. Pediatric research is important, however, because children's bodies may react very differently to drugs. Without labeling for pediatric use, physicians often lack sufficient data on the appropriate dosing levels and potential side effects.

In recent years, there have been several initiatives aimed at encouraging the study of pharmaceuticals used on children. In 1997, Congress passed the Food and Drug Administration Modernization Act (FDAMA). The act, which was reauthorized in 2002, encourages pharmaceutical companies to conduct studies with pediatric patients of on-patent drugs that currently are not labeled for their use. The law provides a financial incentive for companies to conduct the studies by offering to extend the market exclusivity of the drug for an additional six months. The law also allows the FDA to develop a list of drugs for which pediatric studies are needed, and the Department of Health and Human Services (DHHS) will sponsor pediatric clinical trials for those drugs. The department has already announced its intention to study 12 drugs-including lithium, lorazepam, and dopamine, three psychotropic drugs-that are commonly prescribed for children.

The General Accounting Office (GAO) has found a substantial increase in pediatric drug research since the enactment of the FDAMA. The agency also found that more than half the drugs that were granted six extra months of patent protection provided more specific guidance regarding the effective dose or additional warnings about adverse events in children. The study concluded that the increase in pediatric research has laid the foundation for future clinical trials that benefit children.

In addition to FDAMA, the FDA instituted the Pediatric Rule in 1998. This rule required pharmaceutical companies to study new and marketed drugs in children to determine their safety, efficacy and dosing if the drug held a substantial promise of being a "meaningful therapeutic benefit" over current treatments or if more than 50,000 children were affected with the illness. The rule was overturned in 2001 by the courts, which stated that the FDA did not have the authority to force manufacturers to test for uses for which they were not seeking approval. Since then, however, the Bush administration has decided to push for legislation establishing FDA authority to enact the Pediatric Rule, and Congress is expected to consider it this year. Passage of the legislation, coupled with incentives provided in the FDAMA, could lead to increased pediatric drug research and provide more data on drugs that are currently being prescribed off-label. One commonly prescribed psychotropic, Prozac, has already been tested and approved for use in children between the ages of 7 and 17, and pediatric testing and approval of other drugs could soon follow.

TO NEXT SECTION (DIGGING DEEPER)

BACK TO MAIN