Generic Drugs Save You Money
Generic drugs help save you money, but did you know that, overall,
the use of generic drugs helps to bring down the cost of medical
insurance and benefits for everyone? The Congressional Budget
Office (CBO) estimates that the use of generic drug equivalents
in the United States saved consumers an estimated $8-10 billion
in 1994?
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.
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.
Are generic drugs as safe as brand-name
drugs?
Yes. FDA requires that all drugs be safe and effective. Since
generics use the same active ingredients and are shown to work
the same way in the body, they have the same risks and benefits
as their brand-name counterparts.
Are generic drugs as strong as
brand-name drugs?
Yes. FDA requires generic drugs to have the same quality, strength,
purity and stability as brand-name drugs.
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.
Are brand name drugs and their
generic equivalents absorbed and used in the body the same way?
Overall, yes. However, concerns have been expressed about some
brand name drugs that require very close monitoring of blood levels
or outcome being switched to the generic form in the middle of
therapy. These types of drugs include anticonvulsants, blood thinners,
asthma drugs, and thyroid drugs, among others. The FDA has investigated
these concerns and, to date, no problems have been attributed
to the substitution of a generic product for a brand name product
(or vice versa). Even so, if you plan to switch to a generic form
of these types of drugs, please be sure to double-check with your
doctor first.
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. FDA won’t
permit drugs to be made in substandard facilities. 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.
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.
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.
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
website at http://www.fda.gov/cder/ogd/index.htm
for more information.
Are generic drugs made by legitimate
drug companies?
Yes, the manufacturers of generic drugs are legitimate companies,
and meet the same state and federal regulations as brand name
drug manufacturers. The generic drug company may be entirely independent
of the originator of the drug. However, the generic drug company
may be, and often is, a wholly owned subsidiary of the originator
of the brand name
drug.
Do all drugs have a generic
available?
No. Many drugs do have a generic available, but the newest drugs
approved by the FDA do not. Patents on new drugs expire after
17 years, at which point any company can manufacture a generic
version, providing they get permission from the FDA.
Why the 17-year exclusive patent?
Before any new drug is approved, the FDA requires many years
of research and testing to make sure that the new drug works,
and that it is safe. Many new drugs fail to win FDA approval.
For these reasons, every new drug that is approved has taken years
to develop and cost millions of dollars in research and testing.
The 17-year exclusive patent allows the originator to recoup their
expenses, and make a profit. This provides them with the incentive
to develop more new drugs in the future.
Once the 17 years is up, will
there automatically be a generic?
No, because:
- Sometimes the FDA extends the patent if the originator somehow
changes the formulation or the manufacturing process.
- The generic drug still must receive FDA approval before it
can be sold.
- The brand name drug may be too technically difficult to make,
or unique in some way. For these reasons even though it has
been on the market for longer than 17 years, a generic may not
be available. An example of this is the estrogen hormone replacement
drug called Premarin.
How do I find out if the drug
I take is available in a generic?
To find out if your drug has a generic equivalent, just type
the name of your drug into a Prescription Point search box. If
a generic is available, its name and price will appear in the
price list, near the name and price of the brand name drug.
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