Frequently
Asked Questions About Generics
What
are generic drugs?
If
generic drugs are the same as brand drugs, why are they sometimes
different shapes, sizes and colors?
What kind of savings can generics generate for American consumers?
How
are generic companies able to offer a product that is much
less expensive than the brand product?
Generic
drugs may save consumers money, but are they as safe and effective
as their brand counterparts?
Do
brand companies have more modern manufacturing facilities
than generic companies?
Why
isn’t there a generic version available for all brand
drugs?
Importation
seems to be a perfect answer to lowering prescription drug
costs. Why do the brand and generic pharmaceutical industries
oppose this initiative?
When
should a generic drug not be substituted for the brand name
drug?
Who
can the consumer turn to for more information about the benefits
of generic products?
What are generic drugs?
Generic drugs are versions of brand drugs whose patent terms
have expired. Generics are referred to by their chemical or
generic name. For example, fluoxetine is the generic name for
Prozac.
If generic drugs are the same as brand drugs,
why are they sometimes different shapes, sizes and colors?
All pharmaceutical products, whether brand or generic, vary
slightly. Sometimes a brand company patents the appearance of
the drug or the brand drug may be protected by trademark or
common law. This may prohibit a generic manufacturer from adopting
the appearance of the brand drug. However, the same testing
that assures batch to batch consistency for a brand product
is used to ensure equivalence of generics. Any cosmetic differences
between the generic and the brand product in no way impacts
the sameness or safety of the generic version.
What kind of savings can generics generate
for American consumers?
Generic pharmaceuticals can cost 30 - 80 percent less than the
equivalent brand product. For every healthcare dollar spent
on medicines, American consumers spend less than eight cents
on generic drugs versus 92 cents on brand drugs. This is despite
the fact that generic drugs are dispensed for nearly half of
all prescriptions.
In 2004,
the average price of a prescription filled with a generic drug
was $28.74 and the average price of a prescription dispensed
with a brand drug was $96.01. When substituting an equally effective
generic drug for the brand product, American consumers saved
an average of approximately 70 percent. With healthcare costs
rising exponentially, that is a savings every American can use.
Generics offer these savings without sacrificing quality, safety
or effectiveness.
How are companies providing generic products
able to offer a product that is much less expensive than the
brand product?
Generic companies spend little money on marketing generic products.
Because there are often multiple generic competitors for each
product, and because generics are sold under the same chemical
name, what limited advertising and marketing activities occur
are used to ensure that trade customers (drug store chains,
wholesalers and pharmacies) are aware that a generic is available.
In addition,
the expense of developing a generic product is much lower than
the typical expense of developing a brand product. This is why
brand companies receive market exclusivity; it ensures that
they can recoup their investment in new product development.
In order
to market a generic equivalent to a brand pharmaceutical company’s
drug product (once the market exclusivity on the innovator's
product has expired), a generic pharmaceutical company uses
the Abbreviated New Drug Application (ANDA) process of the Food
and Drug Administration (FDA).
Under this
process, the generic manufacturer uses the safety and efficacy
data supplied by the brand company, and must only prove to the
FDA that its generic product is equivalent to the branded product.
Generic drugs may save consumers money, but
are they as safe and effective as their brand counterparts?
Absolutely. To be approved, a generic must have the same active
ingredients, same dosage form, same standards for purity and
quality, same standards for manufacturing and same clinical
effect as the brand product. As far as safety, the FDA requires
all drug manufacturers and their facilities to adhere to specific
guidelines, called current Good Manufacturing Practices (cGMP),
no matter what the drug and no matter who the manufacturer.
Do
brand companies have more modern manufacturing facilities than
generic companies?
No. Generic companies have facilities comparable to brand firms.
The FDA requires both brand and generic companies to conform
to the same high manufacturing standards, known as current Good
Manufacturing Practices (cGMPs). To ensure compliance with these
standards, the FDA makes nearly 3,500 inspections a year of
both brand and generic companies.
Why isn’t there a generic version available
for all brand drugs?
When brand companies develop a new drug, they are granted patent
protection or another form of exclusivity for up to 20 years.
The patent protects the drug’s research, development and
marketing activities. When the patent expires, drug companies
may introduce generic versions but only after they are thoroughly
tested by the manufacturer and approved by the FDA.
Importation seems to be a perfect answer to
lowering prescription drug costs. Why do the brand and generic
pharmaceutical industries oppose this initiative?
The generic pharmaceutical industry opposes importation for
several reasons. First, data used to support importation considers
only a handful of top-selling brand name drugs and exaggerates
the potential savings. A more comprehensive representative sample
of drugs purchased by U.S. consumers found that average prices
in Canada, Germany, Sweden and Switzerland were comparable to
or higher than those when U.S. generic drugs are included in
the comparison.
The quality
of America’s prescription medicines is the highest in
the world. Importation would significantly undermine this quality
standard. There is no mechanism for assuring whether imported
drugs meet basic quality standards or whether they are expired,
sub-potent, properly labeled, contaminated or counterfeit. Importation
places consumers in the dangerous position of “buyer beware”
without any mechanism to protect their safety.
If importation
is allowed, consumers will be able to import medicines of questionable
quality, with no restrictions on the amount or frequency of
the importation. Foreign pharmacies and wholesalers will not
be subject to FDA or state oversight, there will be no assurance
of appropriate drug handing, and no ability to prevent shipment
of counterfeit or tainted drug products directly to consumers.
When should a generic drug not be substituted
for the brand name drug?
The simple answer to this question is: Never.
FDA-approved
generic drugs that are rated bioequivalent (AB-Rated) to the
brand drug must prove that they offer the same safety and effectiveness
as the brand name prescription drug. Although some groups would
suggest that certain drugs, such as mental health drugs, should
not be substituted, there is no scientific or clinical evidence
to suggest that the generic will not offer the same benefits
as the brand drug, at a substantially lower cost to the patient.
Who can the consumer turn to for more information
about the benefits of generic products?
The pharmacist plays a key role in explaining the quality, medicinal
comparability and financial benefits offered by generic products.
Recent surveys show that when consumers discuss generic pharmaceuticals
with their pharmacists, the overwhelming majority conclude that
generic products represent an important healthcare alternative,
one that is as safe and effective as the branded product. Physicians
can also help consumers decide if a generic alternative is available
for treating their illness.
The FDA
is also an excellent resource for information about generic
drugs. Visit the web site at www.fda.gov/cder/ogd/index.htm.
Product Guide 
