Denton County Living Well Magazine Fall 2015 | Page 43

The Making of a Generic Drug
By Tucker Thompson

P

rescription drug patents, generally
lasting 17 years, begin when a
pharmaceutical company files to
market a drug with the Federal Drug
Administration (FDA).
Pharmaceutical companies must run
medical trials to show what the medical indications are, the side effects that
may occur, the drug’s half life, and
how effective the drug is for the medical conditions the drug is going to be
used for. The half-life of a drug indicates the average time a drug should
be at its peak performance in a person’s blood.
Before a drug can get FDA approval,
a pharmaceutical company spends
millions of dollars performing lab
studies on it; first the drug is tested

on animals, followed by clinical trials
with patients administered the drug’s
real formulation, while other patients
are administered placebos. Patients in
these trials agree to not know which
they will be given during the studies
(called double blind studies). The paperwork, including all the lab studies
and results fills, on average, two 40foot trailers that are 6 feet high.
The cost of prescription brand-name
drugs includes the money a company
spent on research, scientific development, all studies and clinical trials,
any added expenses to meet all FDA
requirements, the manufacturing, and
the continuous monitoring of a drug
throughout its patent protection. Usually the drug has a patent left for about
seven or eight years after FDA approval to help pharmaceutical companies

recover the costs incurred to research
and develop their drugs.
Once patent protection expires, generic companies can apply for FDA
approval to market a generic version.
Initially only one generic company is
approved. While they aren’t required
to prove how the drug works, the FDA
does regulate the labeling and manufacturing of the generic version. A generic drug can, however, have a 20%
variance in their formulation compared
to the original brand-name drug. Example: a generic 100-milligram drug
can have an 81- to 120-milligram variance. This is one reason why some generics work better than others and the
cost of the first generic is usually close
to the brand-name drug. Once the
FDA approves the drug to several generic drug companies the price drops.

Tucker Thompson, CSA, has worked in the insurance field for over 23 years in Long-Term Care, Medicare
Supplements. Medicare Advantage Plans, Prescription Drug Plans and Life Insurance policies.

New

Medicare choices in 2015
could mean better coverage for less money!

You can apply to change a Medicare supplement policy
anytime during the year!

Senior Life Division

Medicare Plans
Medicare Supplements
Health Insurance
Long-Term Care Policies
Life Insurance

Benchmark Financial Services is a local company with a Senior Life Division dedicated
to helping seniors review & find Medicare healthcare and prescription plans that best
fit each individual’s needs. With a strong commitment to offer independent,
unbiased advice, we are licensed with over 30 national companies and are not
“employed” by any of these companies whose plans we might recommend.

local [phone] or toll free [phone]

Your Local Agent:
Tucker Thompson

Certified Senior Advisor

DENTON COUNTY Living Well Magazine | FALL 2015

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