FDA To Strengthen Generic Drug Program Which Will Streamline Generic Drug Approval Process

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharma Industry / Biotech Industry;  Pharmacy / Pharmacist
Article Date: 05 Oct 2007 - 11:00 PDT

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The US Food and Drug Administration (FDA) will bolster its generic drug program which should raise the number and range of generic drugs available to health care providers and consumers. Generic drugs tend to be cheaper than brand name drugs - fierce competition among generic makers has helped bring prices down, explains the FDA.

The Generic Initiative for Value and Efficiency (GIVE) is aimed at streamlining and modernizing the FDA's generic drug approval business. According to the Agency, during fiscal year 2007, 682 generic drugs were approved, 30% more than during fiscal year 2006.

Gary Buehler, Director, Office of Generic Drugs, FDA, said "To keep pace with the increasing number of generic drug applications, FDA will implement some changes to the generic drug approval process. The GIVE plan outlines ways to maximize the use of our resources so that FDA can review and approve even more high quality generic drugs during the upcoming fiscal year than it did in 2007."

The FDA said it is improve the review order for some specific drug applications. For example, first generic drugs, for which there are no blocking patents or exclusivity protections on the reference listed drug, will be placed in the fast review ("expedited review") category. In other words, drugs for which there are no generic products on the market will reach the market earlier.

There are currently 215 full-time FDA employees working on the review of generic drug applications. Under GIVE, the FDA will take on and train new generic drug reviewers and concentrate on enhanced use of electronic programs for managing drug submissions and internal documents. When needed, and also when possible, other FDA department resources will be channeled into the effort.

The FDA added that it enhance its communications with generic drug makers and provide education on proper application submission to the industry via Web casts and meetings.

The FDA explains that generic drugs are subject to rigorous scientific scrutiny to make sure they are of the best quality, safe and effective. Generic drug makers need to demonstrate that said generic product has the same dosage form, strength, route of administration, and conditions of use as the approved brand name drug. The generic drug maker also needs to prove that its generic product delivers identical amounts of its active ingredient in the same time-scale as the brand-name counterpart - in other words, they must demonstrate bioequivalence. Bioequivalence is a fundamental stipulation for concluding that the brand-name and generic drug will produce identical therapeutic results.

-- Generic Initiative for Value and Efficiency (GIVE)
-- New Initiative to Improve Availability of Generics
-- Consumer Q and A: FDA's New Generic Drug Program
-- FDA's Office of Generic Drugs

Written by: Christian Nordqvist
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