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FDA Wants More Time to Study Cold Meds for Kids
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Page: << Prev | 1 | 2 | 3 One of the most provocative issues is that of testing: What types of studies, if any, should be conducted in children and how should these studies be designed and powered?
"Testing in children is intensively debated," said Spigarelli. "It is felt by the FDA and most regulatory authorities that it is unethical to test in children, which means that pediatricians and family medicine doctors are left prescribing off-label, because it's equally unethical to let a kid suffer."
According to Spigarelli, 150 or so drugs have been tested in children since the Best Pharmaceuticals for Children Act, passed in 2002. The act extends the amount of time a pharmaceutical company has exclusive rights to market a drug if that company conducts studies in children of drugs the FDA thinks might be useful in younger age groups, he said.
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But the reality remains that few drugs have actually been tested in pediatric populations, Spigarelli said.
"The world [notably, the European Union] has shifted to doing more testing on children, but most of the medications used on children have not been tested, and cough and cold medicines are in that category," he said.
More information
Visit the FDA for more on its recommendation regarding over-the-counter cough and cold medications for young children.
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Copyright © 2008 ScoutNews, LLC. All rights reserved.
Last updated 10/2/2008
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SOURCES: Michael Spigarelli, M.D., Ph.D., assistant professor, pediatrics and internal medicine, division of adolescent medicine, Cincinnati Children's Hospital; Chanin Wright, Pharm.D., pediatric clinical specialist, Scott & White, and assistant professor, pediatrics, Texas A&M Health Science Center College of Medicine; Sept. 25, 2008, U.S. Food and Drug Administration notice; Associated Press; Oct. 2, 2008, news release, Public Citizen, Washington, D.C.
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