title: Pediatric exclusivity: evolving legislation and novel complexities within pediatric therapeutic development.
abstract: OBJECTIVE
  To review the successes and omissions of the Food and Drug Administration (FDA) pediatric exclusivity incentive.
  
  
  METHODS
  Pediatric drug development receives less attention and funding than drug development targeting adults resulting in fewer appropriately labeled pediatric drugs. Newly introduced legislation aims to correct this deficit using market exclusivity incentives. Under the Food and Drug Administration Modernization Act (FDAMA, 1997), the FDA established the exclusivity principle. This legislation was renewed and amended in 2007 under Food and Drug Administration Amendments Act (FDAAA) allowing drug companies to receive a 6-month patent extension for initiating clinical investigation in pediatric populations. Fostering improved knowledge in pediatric indications and dosing is the motivating force behind this program.
  
  
  METHODS
  We examined drugs granted exclusivity through FDA published database as well as relevant drug labeling and postmarket safety studies. Our examination shows that studies conducted in support of patent protection are often not designed to meet current pediatric needs.
  
  
  CONCLUSIONS
  Amendments to FDAAA are needed to ensure that studies approved for exclusivity strive to meet the following requirements: relevant pediatric clinical indication ; disease addressed should represent a significant disease burden to the appropriate population; important age ranges should be covered; studies should not be allowed when a safety signal is identified prior to initiation of the study; and trials where endpoints are successfully achieved providing considerable contribution to pediatric dosing knowledge or result in labeling changes may gain an additional incentive.
authors: University of Florida, Gainesville, FL, USA.
authors: Donna R
authors: DR
authors: Rivera
authors: Abraham G
authors: AG
authors: Hartzema
mesh_terms: D000293:Adolescent; D002648:Child; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D004358:Drug Therapy; D064420:Drug-Related Side Effects and Adverse Reactions; D015507:Drugs, Investigational / Q000191:economics*; D006801:Humans; D007880:Legislation, Drug; D010330:Patents as Topic; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational
keywords: FDA Amendments Act of 2007; labeling change; patent extension; pediatric drug efficacy; pediatric drug safety; pediatric exclusivity