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dated 23 February 2007, Food and Drug Administration explained that the approval of 128 suitability petitions was being withdrawn because abbreviated new drug applications were never submitted and Pediatric Research Equity Act requires that all applications submitted on or after 1 April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.

Keywords

505 Suitability petition ANDA PREA NDA pediatric rule

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References

Guidance for industry—how to comply with the Pediatric Research Equity Act—draft guidance. US Food and Drug Administration (FDA), US Department of Health and Human Services (HHS), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), September 2005 – Procedural.

Retrospective review of information submitted and actions taken in response to PREA 2003. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM197636.pdf.

Federal Register—the daily journal of the United States Government, a notice by the Food and Drug Administration on 23 February, 2007. http://www.federalregister.gov/articles/2007/02/23/E7-3043/withdrawal-of-approval-of-128-suitability-petitions#p-6.

OGD Suitability Tracking Report (Sorted by Drug Name). http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm283497.htm.

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Regulations.gov—your online source for U.S. government regulations. http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=10;po=0;D=FDA-2011-P-0186.

Regulations.gov—your online source for U.S. government regulations. http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=10;po=0;D=FDA-2011-P-0558.

Regulations.gov—your online source for U.S. government regulations. http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=10;po=0;D=FDA-2011-P-0166.