FDA Acknowledged Study Sites (FAST!)

Executive Summary

Many Americans cannot afford healthcare that can provide vital but expensive prescription drugs. Instead, many must wait until a generic drug is approved: an average approval time of 16 months. At the FDA, we are proposing to shorten this approval time by connecting pharmaceutical companies with service providers who do the best work.

Our proposal: the FDA Acknowledged Study Sites, or FAST is to develop a public database that publishes company profiles, including on-site inspections that evaluate the quality of a firm. The benefit is two fold: provide up front information for pharmaceutical companies to select the best firms and to increase efficiency of the drug approval inspection process by lowering the inspection frequency on compliant sites.

Recent growth in generic drug submission has overwhelmed FDA. Each year, on average about a 1000 new applications is received, and despite the GDUFA act, which is passed by US Congress in 2012 to reduce the backlog of application, there are still about 1500 application backlogs as of November 2014.

There are various factors in play contributing to this backlog, such as application of new technologies in the clinical studies, and a major shift to using large numbers of foreign study sites, and manufacturing facilities. These delays cost millions to industry, consumers, and ultimately hurt the public

A project supported by the: HHS Ignite Accelerator

Team Members

Hasan Irier (Project Lead), FDA
Brian Folian, FDA
Chase Bourke, FDA
Kara Scheibner, FDA

Milestones

May 2014: Project selected into the HHS Ignite Accelerator
June 2014: Time in the Accelerator began
September 2014: Time in the Accelerator ended

Project Sponsor

Sam H Haidar, Supervisory Pharmacologist, Director of the Division of Generic Drug Bioequivalence Evaluation, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)