FDA Adopts System To Speed Application Review Of Generics

Armen Hareyan's picture

Generic Drug Review Process at FDA

The Food and Drug Administration said Friday that it has adopted a new information technology system to improve the efficiency of the review process for generic drug applications, which are growing significantly.

Although chemically identical to branded equivalents, generic drugs are much cheaper. They save consumers an estimated $8 billion to $10 billion a year at retail pharmacies, according to the Congressional Budget Office.


The FDA said the new system will allow electronic archiving of documents for better tracking and searching. It will also enable reviews to become part of the official electronic record for a specific generic drug application.

"FDA has seen a significant growth in the number of generic applications received and we expect even more growth in the future," said Steven Galson, director for FDA's Center for Drug Evaluation and Research, in a statement.

"Modernizing the tools we use internally to review these applications will help ensure a more efficient review and approval process," he said.

In a report earlier this year, pharmacy benefit manager Medco Health Solutions Inc. (MHS) said that, during the next five years, nearly 70 brand-name drugs are expected to become available as generics.