The FDA vows to decrease backlogged applications

The U.S. Food and Drug Administration (FDA) has made a commitment to work on the backlogged list of generic drugs currently awaiting approval.

The announcement was made during last week’s Senate HELP (Health, Education Labor & Education) hearing by FDA Director of Drug Evaluation and Research Dr. Janet Woodcock. The hearing covered the Generic Drug User Fee Amendments (GDUFA): Accelerating Access to Generic Drugs.

The Generic Pharmaceutical Association (GPhA) was pleased by this announcement as well as the FDA’s recognition to limit obstructions that prohibit generic competition. This includes the mismanagement of the shared Risk Evaluation and Mitigation Strategies (REMS), which are in place to protect patient safety.

The FDA has more than 3,800 backlogged applications for generic drugs. The FDA must start by distinguishing which applications have had actions taken on them and the subsequent approval of that application. The actions taken on an application are important because they are what progresses it toward acceptance. The GPhA is very eager to see the number of backlogged applications decrease.

When the GDUFA began in 2011, the median approval time for applications was 30 months. Between 2011 and 2014 it jumped to 42 months and the current estimated approval time is 48 months.