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FAQ
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What is a generic drug?
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How does the FDA ensure that my generic drug is as safe and
effective as the brand-name drug?
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Are generic drugs as strong as brand-name drugs?
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Do generic drugs take longer to work in the body?
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Why are generic drugs less expensive?
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Are brand-name drugs made in more modern facilities than generic
drugs?
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If brand-name drugs and generic drugs have the same active
ingredients, why do they look different?
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Does every brand-name drug have a generic counterpart?
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What is the best source of information about generic drugs?
1. What is a generic drug?
When a brand-name drug's patent protection expires, generic versions of the
drug can be approved for sale. The generic version works like the brand-name
drug in dosage, strength, performance and use, and must meet the same quality
and safety standards. All generic drugs must be reviewed and approved by the
FDA.
2. How does the FDA ensure that my generic drug is as safe and
effective as the brand-name drug?
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. The FDA also conducts periodic inspections of the manufacturing
plant and monitors drug quality — even after the generic drug has been
approved.
3. Are generic drugs as strong as brand-name drugs?
Yes. The FDA requires generic drugs to have the same quality, strength, purity
and stability as brand-name drugs.
4. Do generic drugs take longer to work in the body?
No. Generic drugs work in the same way and in the same amount of time as
brand-name drugs.
5. Why are generic drugs less expensive?
Generic drugs are less expensive because generic manufacturers don't have the
investment costs of the developer of a new drug. New drugs are developed under
patent protection. The patent protects the investment including research,
development, marketing and promotion by giving the company the sole right to
sell the drug while it is in effect. As patents near expiration, manufacturers
can apply to the FDA to sell generic versions. Because those manufacturers
don't have the same development costs, they can sell their product at
substantial discounts. Also, once generic drugs are approved, there is greater
competition, which keeps the price down. Today almost half of all prescriptions
are filled with generic drugs.
6. Are brand-name drugs made in more modern facilities than
generic drugs?
No. Both brand-name and generic drug facilities must meet the same standards of
good manufacturing practices. The FDA won't permit drugs to be made in
substandard facilities. The FDA conducts about 3,500 inspections a year to
ensure standards are met. Generic firms have facilities comparable to those of
brand-name firms. In fact, brand-name firms are linked to an estimated 50
percent of generic drug production. They frequently make copies of their own or
other brand-name drugs but sell them without the brand name.
7. If brand-name drugs and generic drugs have the same active
ingredients, why do they look different?
In the United States, trademark laws do not allow a generic drug to look
exactly like the brand-name drug. However, a generic drug must duplicate the
active ingredient. Colors, flavors, and certain other inactive ingredients may
be different.
8. Does every brand-name drug have a generic counterpart?
No. Brand-name drugs are generally given patent protection for 20 years from
the date of submission of the patent. This provides protection for the
innovator who laid out the initial costs (including research, development and
marketing expenses) to develop the new drug. However, when the patent expires,
other drug companies can introduce competitive generic versions, but only after
they have been thoroughly tested by the manufacturer and approved by the FDA.
9. What is the best source of information about generic drugs?
Contact your physician, pharmacist or insurance company for information on your
generic drugs. You can also visit the FDA Web site for more information.
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