HHS Targets FDA's Generic Drug Reviews

June 19, 2008
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

With most deadlines missed for reviewing each abbreviated new drug application (ANDA) it receives, the US Food and Drug Administration is likely to take advice from the US Department of Health and Human Services (HHS) on how to speed up its process.

With most deadlines missed for reviewing each abbreviated new drug application (ANDA) it receives, the US Food and Drug Administration is likely to take advice from the US Department of Health and Human Services (HHS) on how to speed up its process. The HHS’ Office of Inspector General issued a report on the FDA’s generic-drug review process this month, advising the agency to better prioritize its review system.

By law, pharmaceutical companies must submit ANDAs to FDA’s Office of Generic Drugs (OGD) and receive agency approval before marketing new generic drugs. FDA has 180 days to review and approve or disapprove each ANDA. Current practice involves review by three OGD divisions: chemistry, bioequivalence, and labeling. The office’s microbiology division also reviews some ANDAs. All applications are reviewed on a first-come basis, except for those deemed to have no deficiencies by the chemistry division or those that have minor deficiencies, and are therefore fast-tracked through the other divisions. The chemistry division is the primary division to issue disapprovals based on chemistry deficiencies in companies’ applications, according to the HHS report.

The number of ANDAs has increased 158%, from 307 to 793, between fiscal year 2001 and fiscal year 2006, according to the report. During the same time period, OGD’s full-time positions increased by only 50%, from 134 to 201. The office’s funding increased by 74%, from $35.9 million to $62.6 million, between 2001 and 2006.

HHS looked at 989 original ANDAs under review in 2006 and interviewed OGD division reviewers and officials. Their findings show that, in 2006, FDA:

  • Approved or tentatively approved 4% of original ANDAs under review; the remaining 96% were disapproved

  • Exceeded the 180-day review requirement for nearly half of the original ANDAs under review because the chemistry division’s reviews exceeded 180 days

  • Microbiology, bioequivalence, and labeling division reviews exceeded 180 days

  • Nearly 70% of sampled division reviews exceeding the 180-day requirement did not begin before the 180-day review period expired.

Based on this information, HHS recommends that FDA:

  • Identify common original ANDA deficiencies and offer more guidance to industry to decrease the percentage disapproved

  • Increase the percentage of original ANDA reviewed by all divisions within 180 days

  • Identify new prioritization practices to reduce review times for ANDA close to approval.

In response, FDA has said it has already identified and is implementing portions of HHS’ recommendations, but it was not clear at press time whether the agency agrees with all of the report’s suggestions.

Read the full report by the HHS' Office of Inspector General.