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Questions and Answers on
Generic Initiative for Value and Efficiency (GIVE)
1. What are generic drugs?
A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use. When a pioneer (or brand-name) drug's patent protection expires, generic versions of the drug can be approved by the FDA.
2. How does FDA ensure that generic drugs are as safe and effective as the brand-name drug?
Health professionals and consumers can be assured that FDA-approved generic drugs have met the same rigid standards as the pioneer. All generic drugs are put through a rigorous, multi-step review process that includes a review of scientific data on the generic drug's ingredients and performance. Generic manufacturers must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner) to the pioneer drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream over the same amount of time as the pioneer drug.
3. What is FDA doing to help get more generic drugs on the market?
FDA has announced a program aimed at increasing the number and variety of generic drug products available to consumers and health care providers. The Generic Initiative for Value and Efficiency (GIVE) will use existing resources to help the FDA modernize and streamline the generic drug approval process.
4. What are the specific things FDA will do under the GIVE program?
As part of GIVE, FDA will hire and train new generic drug reviewers and focus on enhanced use of electronic programs for handling drug submissions and internal documents. When possible, resources from other FDA departments will be engaged in the effort and the agency will identify low-risk manufacturing changes that do not require an intense review. As well, FDA will look at possible changes to the application procedures that might help make the process more efficient.
5. How will GIVE benefit health care providers and consumers?
Generic drugs play an important role in keeping people healthy. FDA expects the initiative to have positive results in the near term. Anticipated benefits from GIVE include:
- Increased review and approval of generic drugs in FY 2008.
- Availability of more generic options for health care providers and consumers.
- More generic drugs and a greater variety of a generic drug will result in increased savings at the pharmacy for consumers on average, 30 percent to 80 percent less than brand name drugs.
- Generic drugs save consumers between 8 and 10 billion dollars a year.
- Program growth and additional career opportunities for review staff.
- Greater efficiency in document handling, storage, and retrieval.
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Date created: October 4, 2007 |
