It's happened again. The pharmacist has asked that benign little
question and you don't know what to say. Last week, you were buying
a prescription drug for your baby. Then, the answer rolled easily
off your tongue: No. Now, though, you're getting a prescription
filled from your dermatologist and the matter seems somewhat less
serious. Yes, you'll take the generic, you say, knowing that the
medicine will cost you less.
And so you make a decision - choose the generic or the brand
name - almost every time you visit the prescription counter at your
pharmacy. Generic substitutes are available for about half the
drugs in wide use.
Generic versions of brand-name drugs have been available to
consumers in Texas for almost 20 years. Generic drug use in Texas
has skyrocketed from about 18.6 percent of the prescription market
in 1994 to almost half of all drug sales today, according to one
estimate. Nationally, generics captured about 46 percent of the
$121 billion prescription drug market last year.
Generic drugs save consumers an estimated $8 to $10 billion a
year at retail pharmacies, the Congressional Budget Office
estimates. Even more billions are saved when hospitals use
generics.
Most of the time, consumers know that the generic is cheaper,
providing savings for both them and their health-care providers.
But often, that's the only information a buyer has, leaving him or
her to make an important decision without much guidance.
Are generic drugs exactly the same as the brand-name drugs? Are
they as strong as the brand-name equivalent and do they act as
quickly? Do they have different side effects? In what ways can they
differ from brand-name drugs? What standards do generic drugs have
to meet to gain FDA approval?
The answers to these questions are complex, but they also seem
to be clear. Here, 10 things every consumer should know about
generics to answer your pharmacist's question with confidence.
1. Generics are chemical clones.
A generic drug is a chemical clone of a drug sold under a brand
name.
Pharmaceutical companies get a 17-year patent on any new brand
drug they develop through their own research. These patents usually
have only a seven-to-eight-year market value since it takes
eight-to-10 years to bring a new drug to the market. When a patent
expires, other companies are free to market the generic versions.
There are generic versions of both prescription and
over-the-counter medicines and often several brand names for the
same drug. For example, ibuprofen is the generic name of the
anti-inflammatory drug sold under the brand names Motrin and Advil.
2. To be approved by the FDA, generic drugs must be
bioequivalent and therapeutically equivalent to their brand-name
counterparts.
Under provisions of the Food, Drug and Cosmetic Act, the FDA is
required to publish a detailed list of approved generic drugs each
year with monthly updates. ``Approved Drug Products with
Therapeutic Equivalence Evaluations,'' also known as ``The Orange
Book'' is used by doctors and pharmacists in making generic
substitutions.
These products are considered pharmaceutical equivalents if they
contain the same active ingredient or ingredients, are of the same
dosage form and route of administration, and are identical in
strength or concentration to the name-brand. 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.
The FDA requires generics to have the same quality, strength,
purity and stability as brand-name drugs. The firm seeking to sell
a generic drug also must show that its drug delivers the same
amount of active ingredient in the same time frame as the original
product.
One way scientists demonstrate bioequivalence is to measure the
time it takes the generic drug to reach the blood stream in 24 to
36 healthy, normal volunteers. This gives them the rate of
absorption - called bioavailability - of the generic drug, which
they then compare to that of the pioneer drug. The generic version
must deliver the same amount of active ingredients into a patient's
bloodstream in the same amount of time as the pioneer drug.
Using bioequivalence as the basis for approving generic copies
of drug products was established by the Drug Price Competition and
Patent Term Restoration Act of 1984, also known as the
``Waxman-Hatch Act.''
``FDA-approved generic drugs are bioequivalent and
therapeutically equivalent to their brand-name counterparts,'' says
Doug Sporn, former director of the Food and Drug Administration's
Office of Generic Drugs.
``We have no interest in approving generic drugs that are not
therapeutically equivalent,'' says Dr. Janet Woodcock, director of
the FDA's Center for Drug Evaluation and Research.
``To date, there are no documented examples of a generic product
manufactured to meet its approved specifications that could not be
used interchangeably with the corresponding brand-name drug,'' says
Dr. Stuart Nightingale, associate commissioner for health affairs
for the FDA.
3. A generic may, however, differ from a brand-name drug in
several ways, and one company's generic version of a drug might be
slightly different from another's.
Pharmaceutically equivalent drug products may differ in
characteristics such as shape, scoring (grooves on the surface of
some tablets), packaging, colors, flavors and preservatives,
expiration date, and within certain limits, labeling.
In addition, though generic drugs are required to contain the
same active ingredients in the same amounts as their brand-name
equivalents, the original and copycats may contain different
preservatives and dyes that can cause problems for some people.
In a few cases, a patient may actually do better with a generic
that contains a different preservative from the original, or he may
not be able to use the generic at all because the preservative
causes an allergic reaction or irritation.
The FDA monitors reports of adverse drug reactions and has found
no difference in the rates between generic and brand-name drugs. In
other words, there is no evidence to show that, in general, generic
drugs are more likely to cause more side effects.
Because there may be more than one company producing a generic
for a brand-name drug, if you find one that works for you without
causing side effects, you may want to request that same company's
generic when getting a refill or new prescription. Do not assume
you will get the exact same drug.
4. Generics are not subject to the same extensive clinical
trials as the brand-name drugs in seeking FDA approval.
Generics are not required to replicate the extensive clinical
trials that have already been used in the development of the
original, brand-name drug, according to the FDA.
Brand-name tests usually involve a few hundred to a few thousand
patients. Since the safety and efficacy of the brand-name product
has already been well established in clinical testing - and
frequently in many years of patient use - it is scientifically
unnecessary and would be unethical to require that such extensive
testing be repeated on human subjects for each generic drug.
5. They're made by pharmaceutical companies that must meet FDA
standards.
Generic firms have facilities comparable to brand-name firms.
The FDA conducts approximately 3,500 inspections a year to ensure
standards are met.
Often several pharmaceutical companies make their own generic
versions of a drugs.
In some cases (but not often because it doesn't make financial
sense) when its patent expires, the company making the brand-name
drug begins making its own generic version.
You can always check with the pharmacist to find out who makes a
particular generic or, if you like the generic you are taking, to
make certain your prescription is refilled with the same
substitute.
7. When generic drugs were introduced in the 1970s, Texas
doctors seemed reluctant to use them.
``Texas was the second from the last state in the nation to pass
legislation allowing generic drug substitution \Rin 1981\S,'' Dr.
Marvin Shepherd, professor and director of pharmacy practice and
administration at the University of Texas College of Pharmacy in
Austin. ``We were 10 years behind other states. Doctors wanted to
know specifically what their patients were taking. They wanted
control, and they didn't have a lot of faith in the generic drug
industry.''
8. Generic use declined after a 1989 scandal, but the FDA has
since taken strong steps to monitor the generic drug industry.
The generic drug scandal of 1989 shook public confidence in the
FDA.
Some generic drug companies gave the FDA false data to win
approval for their products and offered illegal gratuities to FDA
employees. As a result, more than 200 products were removed from
the market, 36 generic drug makers were investigated, nine were
referred to federal grand juries, and five high-ranking FDA
employees, including Marvin Seife, once director of the agency's
generic drug division, lost their jobs.
No actual health threats were found, but officials involved were
referred to the Justice Department and charged with fraud and
reckless disregard for the health of consumers.
Then-commissioner Dr. Frank E. Young pledged to strengthen the
drug review system with a ``trust-but-verify approach.''
More recently, in a letter to health care practitioners
nationwide, Nightingale assured that any FDA-approved brand-name
drug can be interchanged with any FDA-approved therapeutically
equivalent generic product.
9. One factor influencing Texas doctors to accept generics is a
managed care system that emphasizes cutting costs.
``Managed care has forced them (doctors) to change,'' Shepherd
says.
Nationwide, 71 percent of HMOs now require generic substitution
whenever possible, he says. When insurance companies will cover the
brand names, the patient's co-pay is higher - often two or three
times higher.
10. There are certain classes of drugs that many physicians and
pharmacists believe should not be substituted, even when a generic
is available. A Fort Worth allergist and member of the American
Medical Association's House of Delegates, points to theophyline, as
an example.
The widely used oral asthma medication is manufactured under
many brand names as well as generic, but, someone doing well under
one brand should not be switched, Wynn says.
``Theophyline has been around for decades, and molecule by
molecule, there shouldn't be any differences,'' she acknowledges.
``But, it is chemically related to caffeine and can have the same
side effects - stomach aches, central nervous system disorders,
even seizures and comas. The generic theophylines are not as free
of side effects or as predictable. Absorption and blood-serum
levels may be eratic even though it's the exact same medication in
the exact same dose. I was taught in training never to substitute
theophyline. Most allergists will not allow generic substitution
for that drug,'' she says.
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(Carolyn Poirot writes on health issues for the Fort Worth
Star-Telegram. Visit the Star-Telegram's online services on the
World Wide Web: http://www.star-telegram.com) nn
