FDA Plans to Review More Generic Drug Applications


The Kaiser Daily Health Policy reported an FDA policy change that would speed-up the reviewing of generic drug applications. The agency plans to put generic reviews ahead of drugs awaiting patents. In the past, generic applications had to get in line behind other drugs awaiting patents, which took the FDA forever to process because of the extensive reviews given to unpatented drugs.

The FDA also plans to review other drugs that do not already have generic alternatives. This would call for an increase in staff and resources, and for improvement in the review process. The Senate Appropriations Committee has already provided the funds needed to hire more reviewers.

This waiting in line approach has cause the consumer to dig deeper into their pockets for many years to purchase badly needed medications at higher prices. Generic drugs are sold at about 60 percent less than patented drugs, but the key ingredient is exactly the same. They are also processed under the same strict conditions as patented drugs. The only difference… generic drugs are no longer patent protected.



2 Responses to FDA Plans to Review More Generic Drug Applications

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