Analytical Reports on Teva Pharmaceutical Industries Limited and Forest Laboratories Inc. - Regulatory Changes Pending for Ge...
September 07 2011 - 8:25AM
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The proposed Generic Drug User Fee Act (GDUFA) still needs
Congressional approval, but both the generic drug industry and the
Food and Drug Administration appear close to a deal.
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Teva Pharmaceutical Industries Limited, Forest Laboratories Inc.
and other companies within the Drug Manufacturers - Other industry.
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Typically, only branded-drug makers had to pay to accelerate
approval processes at the FDA. Passage of the GDUFA will change
that and require generic drug manufacturers to pay as well. Since
getting generics to market is already time sensitive, drug makers
will likely have little choice but to pay for quicker
timetables.
Initially, it seems that fees will have a negative impact and
only eat at margins. While this is true, generics should be able to
pass along some of the costs to consumers because all drug makers
in the market will be subject to the same fees. The fees may
actually have a positive influence on competition. Smaller
companies may now be hesitant to compete over a drug with multiple
companies already producing a generic version of it.
Moving forward, investors in established, leading generic drug
manufacturers like Teva Pharmaceutical Industries Ltd. and Forest
Laboratories Inc. will want to track the status of the GDUFA.
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Teva Pharmaceutical Industries Limited and
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http://signalwatcher.com/FRX/September072011.php.
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