FDA Looking To Speed Review Of Generic Drug Applications.

by Friedman & Ranzenhofer, PC on April 9, 2012

in Buffalo Injury Questions and Answers

Buffalo personal injury victims quickly become aware of the high cost of medical treatment.  Even when the cost of medical treatment is being paid by insurance, individuals who have suffered a personal injury frequently receive copies of medical bills and can see how fast the cost of treatment adds up.  The cost of prescribed medications can also be quite expensive.  Fortunately for those who have suffered personal injury, the Federal Food & Drug Administration is taking steps to speed the processing of applications for much cheaper generic drugs.

In a recent interview on CNBC, FDA Commissioner Margaret Hamburg acknowledged that a large backlog of generic drug applications awaiting approval has developed over the past few years, with the current number of generic drug applications in limbo currently standing at approximately 2,500.  Given this problem, she indicated that the FDA is working with manufacturers of generic pharmaceuticals on revamping the system for approval.

The system currently being discussed involves a user fee program that would provide funding to bring additional staff on board and increase the speed of review.  The median review time for generic drug applications currently stands at approximately 30 months.  The goal is to bring it down to 10 months.  

Generic drugs usually cost from 50% to 70% less than brand-name drugs.  They account for a significant saving in medical expenses for both personal injury victims and the general public.  It is, however, unclear how the proposed user fee program would impact the final cost of generic drugs.

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