FDA creates new division to speed up generic approval times

Generics/General | Posted 25/06/2010 post-comment0 Post your comment

As the FDA’s Office of Generic Drugs (OGD) struggles to keep up with its growing backlog of abbreviated new drug approvals (ANDAs), the office is creating a new chemistry division that it hopes will allow speedier generic drug approvals.


Mr Robert West, Deputy Director of OGD, reported that the FDA has already selected a director for the new Division of Chemistry IV, as well as teams to populate the division.

American consumers are waiting nearly a year longer for government regulators to approve new lower-priced generic drugs than they did in 2005. Five years ago, a new generic drug was approved on average within 16.3 months of the application’s filing. But by 2009, approvals for new generic drugs were taking 26.7 months.

Due to the increasing number of generic applications, the agency now has a backlog of nearly 2,000 pending generic applications — more than double the backlog in 2005.

There is no doubt that plenty of generic drugs have reached the market, as they now account for more than 70% of prescriptions filled in the USA. The generics industry has saved consumers nearly US$750 billion over the last decade.

While accounting for the majority of drug prescriptions in the USA, generics represent just a fraction of the total cost of drugs. Generics accounted for 70.4% of the 2.9 billion prescriptions in the USA last year, according to IMS Health. But they accounted for only about 15% of the US$300 billion spent on prescription drugs last year.

Since 2003, the agency has received around 800 applications a year, up from an average of 330 applications a year in the previous decade.

The delays, caused by a growing backlog of applications at the FDA, may be costing consumers and the federal government hundreds of millions of dollars a year as they continue in some cases to pay for branded drugs even after their patents expire.

As the number of generic applications continues to increase, it is hoped that the introduction of this new division will significantly reduce the time taken for an ANDA to be approved.

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