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Most Prescription Drugs Not Approved for Children

Sep 22, 2008 | Parker Waichman LLP

Most parents surveyed believe that the prescription drugs their pediatrician prescribes is safe for their kids.  But according to a recent study conducted by doctors and researchers at the University of Michigan, 70% of all available drugs, which includes those used to treat children, have not been approved by the Food and Drug Administration (FDA) for use by children.

"It's business as usual, but it's not business the way you want it to be done," said Dr. Richard Gorman, a pediatrician and chairman of the American Academy of Pediatrics Section on Clinical Pharmacology and Therapeutics.  The academy's official position is that it's up to the pediatrician to prescribe off-label drugs to children if there's a scientific reason to expect they'll be helpful and when there is a lack of realistic alternatives.  Gorman says this occurs daily. "Right now, the FDA is reviewing cold medicine use in children ages two to 11.  Remember?  These drugs were taken off the market for children under two earlier this year following some accidental overdoses that led to deaths in children"

Finding child test subjects can be difficult and researchers report that there has not been much financial incentive for drug companies to test children.  Children may represent a small portion of the market for a particular drug, and finding parents willing to have drugs tested on their children can be difficult.  “That leaves parents and doctors in a tough situation," said Dr. Matthew Davis, U-M associate professor of pediatrics, a pediatrician at C.S. Mott Children's Hospital in Ann Arbor, and coauthor of the National Poll on Children's Health released in May.  The study surveyed over 2,000 parents and found 83% believe their child's last prescription was FDA-approved.

Meanwhile, about 30% of medicines have been approved for kids and some, like those to treat Alzheimer's, are really only beneficial to adults.  Children are not just small adults, said Dr. Esther Yoon a lecturer in the U-M division of pediatrics, a practicing pediatrician in Canton and the poll's coauthor. "They metabolize substances differently."  This doesn't seem to matter as parents end up unwittingly testing drugs on their children.

The FDA approves about 95% of all adult medications; however, receiving approval for children is problematic as approval is age driven:  Children over six months and two-, six-, and 12-year-olds.  Drug companies are not financially motivated to approve older medications or off-patent, or generic, drugs to children.  The majority of parents asked—60 percent—said they would not let their children participate in such tests.

The Best Pharmaceuticals for Children Act, passed in 2002, gives drug companies an extra six months of exclusivity on the market if they test their medicine for children at the FDA's request and the Pediatric Research Equity Act went into effect in 2003, requiring drug companies to put new medicines through pediatric testing unless they successfully won a waiver for their products.  Since last year, 100 applications for waivers were filed by drug companies and 50 more requested a deferral.


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