Brought to you by...
National Association of Pharmaceutical Manufacturers
The facts are that every year retail and hospital pharacists fill more than 400 million per-
scriptions with generic drugs. These include tavlets, capsules, liquids, injections, creams
and ointments and other forms. This represents about one put of every three perscriptions
dispensed to American consumers. Generic drugs are as safe and effective as brand name drugs.
They are fully regulated by the U.S. Food & Drug Administration (FDA) as well as by government
agencies in every state. They also are priced a lot lower, anywhere from 40% to 60% less than
brand-name drug equivalents.
After you have compared fact with fiction, we are sure you will fel confident about purchasing
generic drug products. Your choice will save you money, while providing you and your loved
ones with pharmaceutical products that are as safe and effective ass higher pricwed, brand-name
Fiction Versus Fact
FICTION: Compared to brand-name drugs, generic drugs are unsafe. NOT TRUE!
FACT: No drug is allowed on the market if it is known to be unsafe. It is also important to
know that during the past thirty years physicians have perscribed, and consumers have safely
taken, over twenty billion dollars worth of genetic drugs! In fact, today, approximately one-
third of all perscription are filled with generic products.
FICTION: Ther are no official rules for determining drug bioequivalence. NOT TRUE!
FACT: The FDA has published, and enforces, very specific rules onbioequivqlence. The rules for
bioequivalence are that two drug products--a generic adn its brand-name equivalent --are tested
and, basicxally, that --within a range set by the FDA --the generic tablet or capsule product and
the brand-name produce must be shown tohave the same amount of active ingredient/drug delivered
to the body at the same time, and used by the same body in the same way.
FICTION: Health-care professionals generally do not encourage the use of generic drugs. NOT TRUE!
FACT: Health-care professionals strongly support the use of generic drugs. In fact, in many states,
pharmacists must dispense a generic drug, if it is avalible, unless the pharmicist is specifically in-
structed not to do so by by the physician who has written the perscription. Here are just a few of the
many statments made recently on behalf of generic drug use:
"Generic drug products have been used in hospitals setting safely and effectively for decades."
" . . . .generic drugs have sereved the public's needs for more that 30 years without documented thera-
"During the three to four years we've promoted generic use --a span covering hunderds of thousands of
patients --I haven't heard any complaints about generics not being effective."
"We've encouraged generic use for years without any problems."
FACT: In 1989, generic drugs accounted for an estimated seven billion dollars in U.S. sales. It is
predicted that by 1993 annual sales of generic drugs in U.S. may reach nin billion dollars.
FACT: According to information taken from the highly respected Annual Perscription Survey, two generic
products are now the top #1 and #2 perscribed drugs: amoxicillin and penicillin VK. in addition, thirty-one
generic drugs appear on the list of the 200 most frequiently perscribed drugs.
FACT: Generic drugs have saved the American public more thatn 40 billion dollars, both directly --through
prices 40% to 60% below those of brand-name drugs --and indirectly --through taxes saved due to reduced federal
and state spending, including VA and military hospitals, Medicare, Medicated and other programs that require
perscriptions to be filled with low-cost generics, whenever possible.
FACT: Within the next five years, senior citzens, many on fixed incomes, will represent one-third of the pop-
ulation. given inflation, many senior citizens --as well as people of all ages on fixed or limited incomes -- as
will not be able to afford to pay brand-name prices for medications, espesially those that must be taken
everyday for the rest of their lives. If low-cost generic medications are not available, some of these people
will be forsed to make a difficult choice: whether to buy food or their medication.
FICTION: Some generic drugs are not as effective as they should be because the tablets or cap-
sules dissolve incompletely, or they dissolve in the wrong area of the digestive tract. NOT TRUE!
FACT: Drugs that fit either of these description would not be considered bioequivalent and would
not be allowed on the market. On the other hand, a tablet or capsule product is considered bio-
equivalent, and eligible for marketing, if it is tested and found present in the proper amounts in
the blood and/or urine (same as brand-name drug) at different points in time after it has been taken.
In late 1989 and early 1990, the FDA inspected a large number of generic drug manufactures and testing
firms. They tested more than 2,800 samples of widely used generic drug products for strength, uniformity
and rate of dissolving. Only a very small percentage of the samples tested--similar to what was seen in
the testing of generic and brand-name* products in the past--differed form standard values.
"Generic Pharmaceuticals" A Matter of Dollars and Sense" --will, we hope, serve as a reminder that choosing
generic drugt products makes sense --not only because they are conciderably less expensive than brand-name
drugs --but also because they are as safe and effective as their brand-name counterparts.
*Brand-name pharmaceutical products also deviate, within allowable ranges, from standard values.
FICTION: Perscription generic drugs are not regulated by the givernment as strictly as brand-name drugs. NOT TRUE!
FACT: The federal government, through the Food & Drug Administration, has the same rules governing quality
for generic drugs that it has for brand-name drugs, and these rules are as strict for generic drugs as they are for
brand-name drugs. Many years ago, hunderds of thousands of dollars are spent by a generic drug manufacturer
on research, development and testing before the FDA allows the drug on the market, generic drugs are regulated by
the same government rules as brand-name drugs. State agencies also help regulate the use of all drugs, including