The Antibiotic Pipeline in Pediatrics

  • George H. McCracken
Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 634)

The Approval Process

Before 1970, very few antibiotics prescribed for children had specific pediatric labeling. Pharmaceutical companies avoided testing these drugs in infants and children because of the stigma associated with the early history of clinical research, liability issues, and difficulty of working with infants and children as research subjects. As a result Dr Harry Shirkey, a pediatrician with a clinical pharmacy background, coined the term ‘orphan drugs’ for those essential drugs, like antibiotics, that were used commonly in pediatrics, but had not been thoroughly evaluated, especially for appropriate dosage and potential toxicity (Shirkey, 1968).

It was not until 20 years later that the Food and Drug Administration (FDA) initiated several labeling efforts to remedy this situation (Roberts et al., 2003).

Pediatric Labeling Efforts in the United States

In 1994 the Pediatric Rule was enacted to encourage companies to perform complete clinical pharmacologic studies of...


Acute Otitis Medium Molecular Entity Complicated Urinary Tract Infection Antibiotic Stewardship Antibiotic Stewardship Program 
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  2. Roberts, R, Rodriquez, W, Murphy, D, Crescenzi, T. Pediatric drug labeling. J Amer Med Assoc 2003; 290:905.CrossRefGoogle Scholar
  3. Shirkey, HC. Thearapeutic orphans. J. Pediatr 1968; 2:119.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Department of Pediatrics, Division of Pediatric Infectious DiseasesUniversity of Texas Southwestern Medical CenterDallas

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