Generic Medications - The Truth Behind The Myths - By Richard Clement

These days the subject of generic medications troubles many "anxious about our
health government minds ".Generic drugs are unsafe, not helpful as brand names for
your diseases , they are made in unauthorised facilities and so on . Is this the truth or
is it just an attempt to favour some American drug manufacturers and pharmacies?
Drug products sold in the United States are approved by the FDA whether they are
brand name or generic. "Most people believe that if something costs more, it has to
be better quality. In the case of generic drugs, this is not true," says Gary Buehler,
Director of FDA's Office of Generic Drugs. "The standards for quality are the same for
brand name and generic products." Health professionals and consumers can be
assured that FDA approved generic drugs have met the same rigid standards as the
innovator drug. To gain FDA approval, a generic drug must:

x contain the same active ingredients as the innovator drug (inactive

ingredients may vary)
x be identical in strength, dosage form, and route of administration
x have the same use indications
x be bioequivalent
x meet the same batch requirements for identity, strength, purity, and quality
x be manufactured under the same strict standards of FDA's good
manufacturing practice regulations required for innovator products

So we can make the conclusion that: The Generic Drug is a drug which is
bioequivalent to a brand name drug with respect to pharmacokinetic and
pharmacodynamic properties.

Generic medicines must contain the same active ingredient at the same strength as
the "innovator" brand, be bioequivalent, and are required to meet the same
pharmacopoeial requirements for the preparation. By extension, therefore, generics
are identical in dose, strength, route of administration, safety, efficacy, and intended
use.

Thus, in some cases, the "generic" product is actually the brand product but inside a
different box.

The principal reason for the reduced cost of generic medicines is that these are
manufacturered by smaller pharmaceutical companies which do not invest in
research and development into new drugs. The significant research and
development costs incurred by the large pharmaceutical companies in bringing a
new drug to the market is often cited as the reason for the high cost of new agents -
they wish to recover these costs before the patent expires. Another reason for high
prices is that every year pharmaceutical companies spend billions to market their
products.

Developed by Marg Tolliday for OETWorkshop 1 June 2010 ©

When a pharmaceutical company first markets a drug, it is usually under a patent
that only allows the pharmaceutical company that developed the drug to sell it. This
allows the company to recoup the cost of developing that particular drug. It will
frequently cost millions of dollars to develop and test a new drug before it is
approved for use. After the patent on a drug expires, any pharmaceutical company
can manufacture and sell that drug. Since the drug has already been tested and
approved, the cost of simply manufacturing the drug will be a fraction of the original
cost of testing and developing that particular drug.

So despite the strict standards imposed by the FDA for approval of generic drugs,
and their enforcement of these standards, a number of misconceptions about
generic drugs persist that we must disprove:

MYTH: Generics take longer to act in the body.

FACT: The firm seeking to sell a generic drug must show that its drug delivers the
same amount of active ingredient in the same timeframe as the original product.

MYTH: Generics are not as potent as brand-name drugs.

FACT: FDA requires generics to have the same quality, strength, purity, and stability
as brand-name drugs.

MYTH: Generics are not as safe as brand-name drugs.

FACT: FDA requires that all drugs be safe and effective and that their benefits
outweigh their risks. Since generics use the same active ingredients and are shown
to work the same way in the body, they have the same risk-benefit profile as their
brand-name counterparts.

MYTH: Brand-name drugs are made in modern manufacturing facilities, and generics
are often made in substandard facilities.
FACT: FDA won't permit drugs to be made in substandard facilities. FDA conducts
about 3,500 inspections a year in all firms to ensure standards are met. Generic firms
have facilities comparable to those of brand-name firms. In fact, brand-name firms
account for 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.

MYTH: Generic drugs are likely to cause more side effects.

FACT: There is no evidence of this. FDA monitors reports of adverse drug reactions
and has found no difference in the rates between generic and brand-name drugs.
And finally what we can conclude is that the only "unsafe and unhealthy" thing
about generics is the financial loss for the big pharmaceutical companies that want
to protect their monopoly on our health, despite the necessity of some low income
households for effective medical care.

It takes knowledge & understanding to make wise decisions about the prescription
medications that we take.

Developed by Marg Tolliday for OETWorkshop 2 June 2010 ©

QUESTIONS - Generic Medicines

Q1 Generic pharmaceuticals (circle the correct option)

a. have continued to soar in price
b. are another way to get one’s required medications
c. are the same price as regular medications
d. save the consumer money

Q2 The author reports that: (circle the correct option)

a. generic drugs are safe
b. buying from online pharmacies is safe
c. generic drugs are safe because they must meet strict quality control standards
d. generic drugs are safe creating a huge demand for them

Q3 The author asserts the following about generic drugs, except for:
(circle the wrong option)
a. the law requires them to look different to their brand name counterparts
b. must have the same vital element
c. colours used in generic drugs must be the same as in their brand name
counterparts
d. must be of the same strength as their brand name counterparts

Q4 The author sets out some common beliefs: (circle the correct option)
a. generic drugs are not as safe as brand name drugs
b. generic drugs are more potent than brand name drugs
c. the quality of brand name and generic pharamaceuticals are the same
d. generic drugs are made in substandard facilities

Q5 The article sets out why we should not be afraid to use generic drugs, except for:
(circle the wrong option)
a. generic drugs are manufactured according to strict standards
b. brand name drugs are manufactured according to strict standards
c. both must have the same potency
d. share the same inactive ingredient properties

Q6 Any pharmaceutical company can manufacture and sell a drug that (circle the
correct option):
a. has been tested and approved
b. has a patent which has now lapsed
c. has been patented to the new / more recent pharmaceutical company
d. yet to be tested

Q7 Standards for generic drugs

a. are the same with respect to quality standards, as for brand name drugs
b. are more stringent
c. need to meet the same high standards as innovator drugs
d. all of the above

Developed by Marg Tolliday for OETWorkshop 3 June 2010 ©