Food and Drug Administration



GAO: Generic Drug User Fees: Application Review Times Declined, but FDA Should Develop a Plan for Administering Its Unobligated User Fees

June 2017

Nearly 90% of the prescription drugs dispensed in the United States are generics. The Food and Drug Administration must approve these drugs before they are marketed.

In 2012, a law allowed FDA to collect fees from drug manufacturers to support the review process. FDA committed to improving its process and meeting specific performance goals such as decreasing review times.

GAO found that FDA's reliance on user fees increased and that it surpassed many of its performance goals. Report




HHS OIG: Early Alert: The Food and Drug Administration Does Not Have an Efficient and Effective Food Recall Initiation Process

October 2016

OIG found that FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply. Specifically, we found that FDA’s policies and procedures did not instruct its recall staff to prescribe to the firms a time and a manner in which to initiate the voluntary recall. OIG also found that FDA did not have policies and procedures to ensure that firms initiated voluntary food recalls promptly. Report