Pediatric Rule

In 1990, the Institute of Medicine sponsored a workshop to address the lack of pediatric labeling. This workshop produced recommendations that eventually led to the pediatric provisions of the FDA Modernization Act (FDAMA) of 1997, as well as to the 1998 FDA Pediatric Rule (FDAMA, 1999). Stimulated by FDAMA and the 1998 Rule, researchers have devel-... 

The 1998 Pediatric Rule was published in final form December 2, 1998 (FDA, 1998), and became effective April 1, 1999. Unlike the pediatric section of the FDAMA, which is voluntary, the Pediatric Rule gives... 

The 1998 Pediatric Rule gives the FDA authority under certain circumstances to require pharmaceutical sponsors who are developing new adult claims for drugs to conduct studies in pediatric patients having the same disorder. 

In four instances, the agency has invoked this rule at the time of approval of supplements for new indications for psychotropic drugs already approved for other psychiatric indications. It was noted in the approval letters for these supplements that, since the drugs in question would likely be used in children and/ or adolescents with the newly approved indications, the FDA required the sponsors of these products to conduct studies that would be pertinent to such use in the pediatric population. Since the products were ready for approval in adults, the FDA deferred the required pediatric studies to a future date. Alternatively, sponsors could make an argument for waiver of the requirement. The drug products and indications for which the FDA has required studies under the Pediatric Rule are as follows paroxetine for social anxiety disorder sertraline for post-traumatic stress disorder (PTSD) olanzapine for acute mania in bipolar disorder and fluoxetine in premenstrual dysphoric disorder (PMDD). 

The FDA has a pediatric page on its website (www.fda.gov/cder/pediatric) that provides a wealth of information about the implementation of the FDAMA 1997 and the 1998 Pediatric Rule. 

More studies are needed to address the insufficient evidence base for drug treatment of psychiatric disorders in pediatric patients. Recent initiatives, in particular the FDAMA 1997 and the 1998 Pediatric Rule, have provided the FDA with tools for stimulating research in this area. As a result of these initiatives, several clinical... 

Current guidelines have recently been updated, proposing new pediatric rules and actually encouraging to investigate the safety and efficacy of a medicinal product in children, and also elucidate cases in which the drug blood concentration will become the basis of subsequent determination of the dosage schedule. 

FDA chose to interpret the patent life extension as applying to all indications, not just to pediatric use. As might be expected, the generic companies continue to appeal this interpretation of the pediatric rule. 

The Pediatric Rule was finalised in 1998 and became effective on 1 April 1999. After the proposed Pediatric Rule was issued but before it was finalised, the Food and Drug Administration Modernisation Act (FDAMA) (Food and Drug Administration, 1997) was enacted by the... 

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