House Bill Gives FDA More Inspection Power, Creates New Fees

Posted on June 21, 2012

Changes are in the works over at the Food and Drug Administration.

That’s because the United States House of Representatives just passed a bill on Wednesday that will provide for a number of changes that would hopefully allow the FDA to conduct their business more successfully.  The bill aims to reconcile differences in two separate bills previously passed by the House and the Senate.  Should the newly passed bill be passed by the Senate next week, and many expect that it will, then it’s up to the White House to sign it.

One of the main things that the new bill does is allow the FDA to conduct more inspections overseas in areas like India and China.  The hope is that imported products, the number of which have increased over time, will be made safer through the new legislation.

The new bill also permits the FDA to gain $6.4 billion in fees from drug companies over the next half decade.  Some of those fees will now come from generic drug makers, the first time that such manufacturers have had to pay those costs.  The hope is that the new fees will allow the FDA to more quickly slog through the backlog of 2,700 generic drug applications currently awaiting review.

The bill also calls on manufacturers to alert authorities to drug shortages earlier in the process and increases penalties that must be paid by counterfeiters.

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