OIG: FDA takes too long to review generic drugs
Pharma Compliance Alert, June 18, 2008
The FDA exceeded the mandated review period for almost half of the Abbreviated New Drug Applications (ANDA) submitted for generic drugs in 2006, according to an OIG report.
Federal law requires the FDA to approve or disapprove original ANDA within 180 days of submission. The OIG examined 989 original ANDAs under review during 2006. OIG also surveyed FDA’s Office of Generic Drugs (OGD) division reviewers assigned to a sample of 105 ANDAs with review times greater than 180 days in at least one OGD division. Three OGD divisions review all ANDAs: Chemistry, Bioequivalence, and Labeling.
The OIG found:
- FDA disapproved 96% of original ANDAs under review in 2006 because they did not meet FDA review standards
- Almost half of Chemistry review times exceeded 180 days.
- Many review times in other OGD divisions exceeded 180 days
- In a sample of ANDA reviews exceeding 180 days, most reviews did not begin before the 180-day periods expired
- FDA prioritization practices affect ANDA review times
The OIG recommended the FDA:
- Identify common ANDA deficiencies
- Offer more guidance to the industry to decrease the percentage of disapproved original ANDAs
- Increase the percentage of original ANDAs reviewed by all divisions within 180 days
- Implement new prioritization practices
Comments
0 comments on “OIG: FDA takes too long to review generic drugs ”
Related Products
-
ePharm5 InDepth
EPharm5 e-mail newsletter delivers the top 5 developments in pharma business innovation, with original research, interviews...
-
Big Pharma Performance Before, During and Beyond the Global Recession
This report assesses the performance of the leading 15 pharmaceutical companies up to, during and beyond the recent global...
Most Popular
- Articles
-
- Q/A: Volume requirement for reporting hydration services
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- Catch up on what's new with injections and infusions
- Topic: CMS, OESS post new security compliance review information, checklist
- What does case-mix index mean to you?
- QA:Coding multiple initial infusions
- Capturing all necessary codes for IUD insertion and removal can be challenging
- News and briefs: Oklahoma Osteopathic Association against residency bill change
- OB services: Coding inside and outside of the package
- HIPAA Q&A: Level of encryption needed for email
- E-mailed
-
- Q/A: Volume requirement for reporting hydration services
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- Catch up on what's new with injections and infusions
- New conflicts of interest create new challenges
- Joint Commission Center announces handoff communication solutions
- Inside best practice: Reduce patient falls with a stoplight
- Identify modifiable risk factors to prevent patient falls
- Hospitalist-surgeon comanagement has no effect on outcomes
- HIPAA Q&A: Level of encryption needed for email
- Case Management Monthly, June 2012
- Searched