2017 was another record-setting year for generic drugs

Kathleen Uhl, MD, FDA's Director, Office of Generic Drugs in the Center for Drug Evaluation and Research, notes the agency's generic drug program marked several major accomplishments in 2017. The Office of Generic Drugs (OGD) had another record-setting year for generic approvals at FDA with 1,027 new generic drugs, 214 more than the previous record of 813 set in 2016. Of those, 843 were full approvals and 184 were "tentative" approvals, that is, applications that are ready for approval from a scientific perspective, but cannot be fully approved due to patents or exclusivities on the brand-name drug. Also in 2017, the agency helped establish the first reauthorization of the Generic Drug User Fee Amendments (GDUFA II). GDUFA I, enacted in 2012, allowed OGD to hire additional staff, so that from 2012 to 2017 FDA had additional resources to approve the record numbers of generic drug applications. Reauthorization is helping facilitate continued advances in generic drugs, including complex drug products. In 2017, FDA approved 80 "first generic" drugs. The agency also updated its policy to prioritize the review of generic applications up to the third generic approval of a drug, helping to maximize savings for the public. OGD's regulatory science work and guidances helped advance scientific knowledge about generic drugs to assist industry. OGD's efforts provide the critical information needed to develop and meet FDA's standards for equivalence to the brand-name drug.