FDA Bill Pertaining to Foreign Inspections and Generic Fees Passed

Posted on November 1, 2012

A sweeping new bill that could radically alter the way that drugs are approved and inspected by the Food and Drug Administration only needs the President’s signature to officially become law.

The United States Senate approved the FDA bill almost unanimously, with only four members voting in disagreement with the law.  There are two main facets of the law that could lead to the most wide-ranging changes:  the FDA will have more ability to inspect foreign drug manufacturing facilities, and generic drugmakers will have to pay fees just like their brand name brethren.

Right now, foreign drugmaking facilities only have to submit to an inspection from the FDA every nine years, whereas those in the US have to face one every two years.  But with many manufacturing entities heading overseas in a bid to cut down on costs, this method had become somewhat problematic.  The bill passed instead tasks the FDA with targeting those plants with a history of possible safety issues, no matter what country those plants are in.

The second big facet of the bill is the extension of the Prescription Drug User Fee Act, which puts mechanisms in place wherein drugmakers pay fees for drug approval, in turn letting the FDA hire scientists who can facilitate that approval.  Now, generic drug manufacturers will pay fees so that the FDA can hire more scientists who can get through the some-2,700 drugs whose approval is currently pending.

Hopefully this measure will benefit consumer safety.

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