Council on Aging Answers 2016 - 37

COUNCIL ON AGING - ORANGE COUNTY

ance company's rules and the medication involved. This
"Prior Authorization" process may take days and even
weeks to complete.

Why Are Generic Forms of a Drug Less Expensive
Than The Brand Name Version?
First, there are usually many manufacturers making
and marketing generic versions of a drug. Competition
tends to drive prices down. Secondly, manufacturers of
generic versions of a drug do not have to spend billions
of dollars performing the detailed, extensive and expensive clinical trials the brand name drug companies went
through.
Generic forms of drugs are widely dispensed in the
U.S. The FDA states that 8 in 10 prescriptions filled in
the United States are filled with generic drugs. In addition, the FDA states that (1) research shows generics
work just as well as brand name drugs (2) that cheaper
does not mean lower quality and (3) the FDA monitors
adverse event reports for generic drugs in order to maintain and to improve safety.
To check if there is a generic equivalent for a brand
name drug ask your pharmacist or visit: Drugs@FDA.
As with taking any medication, should you experience
any adverse events when switching from a brand name
drug to its equivalent generic or when switching from
one generic to another generic manufactured by a different drug company, notify your physician and pharmacist immediately and seek their advice.
During Medicare's annual enrollment period, (Oct.
15 - Dec. 7) it is important to review your medications
for continued coverage on your insurance plan. This is
essential if you had new prescriptions added during the
year. You can do this by contacting the Council on Aging's HICAP counselors at 800-434-0222 at no charge.
By taking an active role in your health management,
you will not hear those dreaded words: "Sorry, that drug
is not covered by your insurance."

Council On Aging-Orange County | 714-479-0107 | www.coaoc.org Answers Guide 2016

HEALTHCARE

Brand Name vs Generic: What's The Difference?
A drug is given a "brand" name by the drug company that owns the exclusive right to market that drug.
That drug company had applied for and was awarded a
patent. With that patent, the drug company is awarded
exclusive rights to market the patented drug. A patent is
usually for 20 years. A drug company, however, does not
have the full 20 years to market a patented drug because
on average, the first 5 to 8 years of a patent period will
be spent on clinical trials. Clinical trials are the studies,
research and experiments conducted on a drug's activity, efficacy and safety, first in computer models, then in
animals and finally in humans. Not only is this process
labor intensive but indeed, costly as well. A drug company can easily spend upwards of a billion dollars to
conduct clinical trials. All the data and results from the
clinical trials are submitted to the U.S. Government's
Food and Drug Administration (FDA) for review and
approval. Marketing of the drug can only begin when
the drug manufacturer receives final approval from the
Food and Drug Administration.
At some time into the marketing period of a brand
name drug, the patent will expire. At that time, any
drug manufacturer licensed by the FDA and meeting
the FDA's requirements can start manufacturing and
marketing that drug. The brand name, however, cannot
be used by any manufacturer other than the manufacturer that made that original drug. Other drug companies therefore can only use the "generic" name for that
drug. The "generic" name for a drug is also known as
the common name or non-proprietary name.
Example: The drug manufacture Pfizer discovered
a chemical for lowering cholesterol levels in humans.
They applied for and were awarded a 20 year patent
to exclusively manufacture and market that chemical.
The patented brand name for the chemical is Lipitor.
Pfizer then notified the United States Adopted Names
Council (USAN) for the need for a generic name for
this chemical. The USAN assigned Atorvastatin as the
generic name. When the patent for Lipitor expired,
many licensed drug companies applied to the FDA for
permission to manufacture and market Atorvastatin.
Atorvastatin, the generic version of Lipitor can only be

manufactured and marketed after meeting rigorous
standards and tests established by the FDA with respect
to strength, quality, purity and potency. The manufacturers of Atorvastatin also have to prove to the FDA
that their Atorvastatin has the same"bioequivalency" as
Lipitor, the brand name. Bioequivalency means that the
generic version of a drug must be the same as the brand
name drug regarding the amount of absorption from
the stomach into the blood stream and eventual elimination from the body.

http://www.coaoc.org

Table of Contents for the Digital Edition of Council on Aging Answers 2016