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FDA official outlines when companies must file a suitability petition before an ANDA
Summary
Karen Rothschild of FDA's Office of Generic Drugs described what a suitability petition is, when it is required before an abbreviated new drug application (ANDA), and the core documentation and docketing steps applicants must follow.
Karen Rothschild, regulatory counsel in the Food and Drug Administration's Office of Generic Drugs Policy, told attendees that companies must file a suitability petition when a proposed generic product differs from the reference listed drug (RLD).
"If you are developing a generic drug product ... you will need to submit a suitability petition before submitting your ANDA," Rothschild said, defining the petition as the mechanism by which a company asks FDA whether the ANDA pathway is appropriate for a proposed change.
Rothschild walked through the petition's procedural requirements: suitability petitions are a type of citizen petition filed to the docket referenced in 21 CFR and petitioners will receive a docket number to use in all correspondence to avoid delays. She said three citizen-petition sections typically apply to suitability petitions—action requested (A), statement of grounds (B) and certification (E)—and urged petitioners to include the RLD label and their proposed product label.
Rothschild also recommended including an Orange Book screenshot to confirm RLD status and cautioned that if an RLD was discontinued, petitioners should verify whether it was withdrawn for safety or efficacy, which requires a Federal Register determination. She emphasized that an approved suitability petition allows an applicant to pursue the ANDA pathway but does not guarantee later ANDA approval.
