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Frequently Asked Questions
Courtesy of the U.S. Food and Drug Administration |
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- What is a generic drug?
- How does the FDA ensure that my generic drug is as safe and effective
as the brand-name drug?
- Are generic drugs as strong as brand-name drugs?
- Do generic drugs take longer to work in the body?
- Why are generic drugs less expensive?
- Are brand-name drugs made in more modern facilities than generic
drugs?
- If brand-name drugs and generic drugs have the same active ingredients,
why do they look different?
- Does every brand-name drug have a generic counterpart?
- 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 at http://www.fda.gov/cder/ogd/index.htm for more information.
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