Prescription Drugs: FDA Has Met Most Performance Goals for Reviewing Applications

United States. Government Accountability Office.

United States. Government Accountability Office.

关键词: Government accountability -- United States.;    health care;    prescription drugs;    letter report;   

RP-ID  :  GAO-12-500
RP-ID  :  589761

美国|英语

来源: UNT Digital Library

【 摘 要 】

A letter report issued by the Government Accountability Office with an abstract that begins "FDA met most performance goals for priority and standard NDAs and BLAs received from FY 2000 through FY 2010. FDA meets its performance goals by completing its review and issuing an action letter—such as an approval or a response detailing deficiencies that are preventing the application from being approved—for a specified percentage of applications within a designated period of time. FDA designates NDAs and BLAs as either priority—if the product would provide significant therapeutic benefits when compared to available drugs—or standard. FDA met the performance goals for both priority and standard NDAs and BLAs for 10 of the 11 fiscal years GAO examined; FDA did not meet either of the goals for FY 2008. Although FDA had not yet issued an action letter for all of the applications it received in FY 2011 and results are therefore preliminary, FDA was meeting the goals for both priority and standard NDAs and BLAs on which it had taken action. Meanwhile, FDA review time for NDAs and BLAs—the time elapsed between FDA’s receipt of an application and issuance of an action letter—increased slightly from FY 2000 through FY 2010. In addition, the percentage of NDAs and BLAs receiving an approval letter at the end of the first review cycle generally increased, although that percentage has decreased for priority NDAs and BLAs since FY 2007."