Congress Considers Bill That Extends FDA’s Foreign Inspection Power

Posted on May 15, 2012

A seeming inability of the Food and Drug Administration to properly police pharmaceutical factories in other countries has led some lawmakers to offer up a solution.

A Pennsylvanian Congressman has put forth a bill that would provide critical funding to allow the FDA to conduct more inspections in drug factories abroad.  The bill, known as H.R. 3988, would accomplish this by placing a fee on United States-based makers of generic drugs.  The Congressman said that drug makers are behind him on the plan, so long as it means that inspections can be carried out and drugs can make their way onto shelves quicker.

To that end, the bill also aims to speed through the long line of generic drugs currently trying to get approved by the FDA.  It does this by putting money toward the backlog.  If passed, the proponent of the bill thinks that the 30 month approval process could be made more expedient.

The Congressman touting the bill referred to the recent contaminated heparin situation making headlines as the type of thing that could be prevented if the FDA were given more foreign inspection power.  According to him, just shy of $300 million would go to the FDA by instituting the new fee on domestic generic drug producers.

The House Energy and Commerce Committee passed the bill last week.

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