New FDA program will fast forward generic drug approvals

Oct 4 2007

The Food and Drug Administration (FDA) in the United States has a plan to fast forward it's approval process for generic drugs.

A new program will be introduced which should mean the approval for generic drugs will be expediated.

The program 'the Generic Initiative for Value and Efficiency' (GIVE) will implement some changes to the generic drug approval process in order to keep up with the increasing number of generic drug applications.

In 2007 the FDA has approved 682 generic drugs 30% more than in 2006 and each year the number of applications for generic drugs grows.

Gary Buehler, FDA director for generic drugs says the agency is already facing a backlog of 1,300 applications.

The FDA says GIVE will ensure applications for generic drugs that face no blocking patents or exclusivity provisions, will be reviewed immediately which will mean the generic drugs will reach consumers much quicker.

The FDA also plans to increase its current review staff of 215 and also increase the use of an updated electronic format for submissions, and use teams to review multiple applications for the same product.

There has been a dramatic rise in the use of generic drugs in recent years, as blockbuster drugs lose patent protection and healthcare costs continue to soar.

The Generic Pharmaceutical Association, which represents the majority of the industry, is not impressed by GIVE and says the generic review is weak.

They would like to see a rein placed on the lobbying activities of brand-name drugmakers which stalls approvals and they have also called for more resources.

They say giving an initiative a title will achieve little unless more resources are put in place.

However brand name drug companies pay to help fund the review of applications, whereas generic drug companies do not; the industry opposes such fees.

Major generic drug companies include Teva Pharmaceutical, Barr Pharmaceuticals, Mylan Laboratories, Watson Pharmaceuticals and Novartis.