As of 2009, 46 percent of the drug products listed in the electronic Physician’s Desk Reference (“ePDR”) contained information for pediatric use. While this is a substantial increase from the mere 22 percent of labels that included this information in the 1970’s, more than half of all drug labels still lack pediatric-use information. This scarcity of pediatric data in drug labels was recognized at least as early as 1968, when Dr. Harry Shirkey coined the term “therapeutic orphans.”
In 1975, Dr. John Wilson performed a research study on the availability of medicines for children (and pregnant or breast-feeding women). Dr. Wilson studied the labeling of approximately 2000 drugs found in the 1973 print Physician’s Desk Reference (“PDR”) and found that only 22 percent of these drugs included adequate pediatric labeling. For the labeling to be deemed adequate, it had to contain effectiveness and safety data in children as well as dosage information for all pediatric age groups. Regarding the 78 percent of labels that were inadequate, 16 percent contained a disclaimer for the drug’s use in children (a contraindication, a “use with caution” or a “use restricted by age”), while 62 percent either did not list a pediatric dose, or only included a dose for a single age group.
Dr. Wilson published an update in 1999 which demonstrated the continuous presence of the therapeutic orphan dilemma. Between 1973 and 1991, little had changed with the PDR — while 22 percent of drugs in the 1973 PDR had adequate pediatric labeling, the 1991 PDR had only 19 percent (most having age disclaimers). As further validation for the dilemma, Dr. Wilson presented an analysis of off-label use of various drugs that had pediatric age restrictions. Drugs such as Albuterol, Ampicillin, Zoloft, and Prozac were frequently prescribed off-label to children despite the age-disclaimer present in the label.