Frequently Asked Questions about Generics
What are Generic Drugs?
A generic drug is the bio-equivalent version of a brand name
drug. Bio-equivalence, certified by the U.S. FDA, means a generic
drug has the same dosage form, safety, strength, route of administration,
quality, performance characteristics and intended use as the
branded version of the drug. Although therapeutically equivalent
to their branded counterparts, generic drugs are typically sold
at substantial discounts from the branded price.
Why is there a difference in cost between branded and generic
drugs?
New drugs, like other new products, are typically developed
with patent protection. The patent protects the investment a
company makes in investing in the drug's development by giving
the company the right to exclude others from selling the drug
while the patent is in effect. When patents expire, other manufacturers
can make and sell the FDA approved generic versions of the drug.
The ANDA process does not require the drug sponsor to repeat
the costly animal and clinical research on ingredients or dosage
forms already approved for safety and effectiveness. Since generic
manufacturers have plenty of competition, lower R&D costs,
and spend much less on advertising and marketing efforts, their
products are priced much lower than branded counterparts.
According to the Congressional Budget Office, generic drugs
save consumers an estimated $8 to $10 billion a year at retail
pharmacies. Even more is saved when hospitals use generics.
According to the Genetic Pharmaceutical Association (GPhA),
generics account for more than 51 percent of all prescriptions
filled but only eight percent of the dollars spent on prescription
drugs. Consumers, insurers and governments can save even more
through greater utilization of these safe, affordable generic
drugs.
Are generic drugs as safe and effective as branded drugs?
The U.S. FDA regulates all generic products under strict guidelines,
requiring the same testing as the branded product to ensure
that the generic version is interchangeable with its branded
counterpart.
For both brand name and generic drugs, the U.S. FDA works with
pharmaceutical companies to ensure that all drugs marketed in
the U.S. meet specifications for identity, strength, quality,
purity and potency. In approving a generic drug, the U.S. FDA
has tests and procedures to ensure that the generic drug is
interchangeable with the brand name drug under all indications
and conditions of use for which the branded product is approved.
Do generics differ at all from brands?
Generics may differ slightly from brands in regards to inactive
ingredients. The U.S. FDA allows generics to use different inactive
ingredients, from those used in the brand, as long as bioequivalence
is attained. Inactive ingredients, such as fillers and dyes,
do not affect the safety or performance of drugs or API.
Is the quality level the same?
The U.S. FDA states that an AB rated generic product can be
interchanged with its branded counterpart. The U.S. FDA also
continuously ensures that the companies test the quality of
products currently on the market, and regularly inspects the
pharmaceutical manufacturing facilities of generic companies
for quality control.
Health professionals and consumers can be assured that U.S.
FDA-approved generic drugs have met the same rigid standards
as the innovator drug. To gain FDA approval, a generic drug
must:
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Contain the same active ingredients as the innovator
drug (inactive ingredients may vary) |
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Be the same in strength, dosage form and route of administration
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Be therapeutically equivalent |
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Meet the requirements for identity, strength, purity
and quality |
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Be manufactured under the same strict standards of FDA's
good manufacturing practice regulations required for innovator
products |
How do you know which is right for you?
Physicians and pharmacists are the best sources of information
regarding prescription drugs since they have years of training
and experience, and are aware of the latest developments in
the industry. Speak to your physician and/or pharmacist about
whether a generic or branded product is the best course of treatment,
and always let them know of any changes you notice in your reaction
to your medication.
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