Performance Improvement 2009. Does the Food and Drug Administration Give Timely Review and Approval of Generic Drugs?


This study examined timeliness of generic drug application review and approval. Federal law requires that the agency approve or disapprove original Abbreviated New Drug Applications (ANDA) within 180 days of receipt. Pharmaceutical companies must submit the applications to the agency’s Office of Generic Drugs and receive approval before marketing new generic drugs. Based on reviewers’ survey responses, the Office of Inspector General conducted in-depth analyses of review times for the sample and structured interviews with agency officials to determine factors affecting drug application review times throughout the review process.

FDA disapproved 96 percent of original drug applications under review in 2006 because they did not meet FDA review standards. Nearly half of Chemistry review times exceeded the 180 days required by Federal law. Moreover, many review times in other agency divisions exceeded 180 days. In addition, for a sample of ANDA reviews exceeding 180 days, most reviews did not begin before the 180-day periods expired. Reviewers found that the agency prioritization practices affected drug application review times. The agency has taken actions that address recommendations by providing guidance to assist industry in submitting more easily reviewed applications, developing a focused hiring program to increase staff and decrease review times, and prioritizing some applications based on potential market entry date.

Report Title: The Food and Drug Administration's Generic Drug Review Process
Agency Sponsor: OS-OIG, Office of Inspector General
Federal Contact: Erin Lemire, 202-205-9523
Performer: Staff; Office of Inspector General
PIC ID: 8992

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"PerformanceImprovement2009.pdf" (pdf, 1.26Mb)

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