FDA outlines plans for generic drug competition

FDA said on Wednesday that it plans to take steps this quarter to make it difficult for branded drug companies to adopt tactics that attempt to delay generics from coming to market. The agency said the measures will address "potential abuses of the citizen petition process, companies that restrict access to testing samples of branded drugs, and abuses of the single, shared system REMS negotiation process."

FDA also issued two documents regarding the submission and review of ANDAs. In a draft guidance, the agency outlined common, recurring deficiencies in generic drug applications that it hopes applicants will avoid in order to reduce the number of review cycles and delays. FDA also unveiled a manual for FDA staff that is intended to streamline the ANDA review process. If an ANDA cannot be approved in its current form, reviewers are to provide generics sponsors with details of the application's deficiencies and with additional information needed to support an approval decision in the next application cycle...