Suitability petitions and Pediatric Research Equity Act evaluation—Basic understanding and recent case studies

Abstract

Prior to Pediatric Research Equity Act’s enactment, Food and Drug Administration had approved several suitability petitions to permit abbreviated new drug applications to be submitted for drugs that had a different active ingredient, dosage form, or route of administration than their reference-listed drugs. Pediatric Research Equity Act does not impose pediatric assessment requirements on abbreviated new drug applications for generic drugs. However, abbreviated new drug applications submitted under an approved suitability petition under section 505(j)(2)(C) of the Act and the said difference from the reference-listed drugs are subject to the pediatric assessment requirements that Pediatric Research Equity Act imposes. In the federal notice dated 23 February 2007, Food and Drug Administration explained that the approval of 128 suitability petitions was being withdrawn because abbreviated new drug applications were never submitted and Pediatric Research Equity Act requires that all applications submitted on or after 1 April 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration containing an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred. Underlining information in this article helps in understating the Pediatric Research Equity Act, pediatric assessment for suitability petitions, pediatric review committee and its role, types of pediatric waivers, and its importance in suitability petitions. Also there are several examples provided for the Pediatric Research Equity Act assessment in recently filed suitability petitions by the various firms.