The Truth About Generic Drugs
Given the brainpower and the billions of dollars the pharmaceutical industry
devotes to developing new medicines, you’d think the latest brand-name drug is
always the best for whatever ails you, despite the higher price
tag.
Studies say it isn’t necessarily so.
In July 2007 the
nonprofit Consumers Union published an analysis of 11 diabetes drugs. It
reported that newer products, which aren’t yet available as generics, are no
safer or more effective than older medicines, although they “cost many times
more.”
The study shored up the U.S. Food and Drug Administration’s
vigorous support of generics. It also generated new heat in the conflict between
the pharmaceutical giants that make newer, branded drugs and the government,
public-interest groups and insurers, which recommend generic drugs as a
cost-saving measure.
Read on to learn more about generic and branded
prescription drugs so you and your physician can make the best
choices.
The Rise Of Generic Drugs
It’s hard to believe, but
aspirin, introduced in 1899, was once a trademarked product. In the 1920s the
maker of Bayer Aspirin fought unsuccessfully to prevent generic aspirin from
going to market.
Until the Food and Drug Act was passed in 1906,
consumers had no assurance that any medicine – branded or not – was pure, safe,
correctly labeled or effective. Legislation passed in the 1930s through the
1950s toughened the requirements that companies prove their drugs were safe. And
in 1962, Congress passed laws that required manufacturers to prove their
medicines safe and effective before they were sold. Both branded and generic
drugs now had to undergo extensive testing.
In 1980 the first edition of
what’s called the Orange Book was published. Updated monthly and now available
online, the Orange Book lists all approved prescription and nonprescription
drugs and indicates the availability of all generic equivalents.
Four
years later the Hatch-Waxman Act eased the introduction of non-branded drugs by
allowing generic manufacturers to use and reference the original drug-maker’s
research when they file with the FDA to sell a generic copy, making it much
cheaper to produce generics.
Generics accounted for 63 percent of U.S.
prescriptions filled in 2006, according to drug research firm IMS Health
Inc.
More than 13,000 prescription drugs are currently available, reports
the U.S. Office of Personnel Management, and about 50 percent have generic
equivalents.
What’s The Difference Between Generic And Branded
Medicines?
The short answer is virtually none.
By law,
generics must be identical copies of innovator drugs (the original branded
versions, also called pioneer drugs) in terms of safety, effectiveness, quality,
dosage and performance.
As the National Institute for Health Care
Management (NIHCM) Foundation put it in a 2002 report, each generic drug
“contains the identical active ingredient or ingredients as the innovator drug
in the same amount and behaves in the body in the same way. For all practical
purposes they are the same drug.”
The FDA says generics are:
-
Safe
-
Equally potent and effective
-
As quick to act in the body
-
Made in factories with identical safety and
manufacturing standards
In fact, about half of all generics are
made by the same companies that produce and sell the branded version.
But
despite having the same active ingredients, generics and branded medicines will
look and even taste differently because different colors, flavors, binders and
other inactive ingredients are used. U.S. trademark laws don’t permit generics
to look like their branded equivalents.
The stringent FDA drug-review
process for generics is “much the same as new, brand-name drug review,” says the
agency.
Among other things, makers of generic drugs must:
-
Prove that generic drugs are bioequivalent, which
means that the active ingredient works just as it does in the brand, and as
quickly
-
Provide detailed documentation of a drug’s
chemistry, manufacturing process and quality-control procedures
-
Show that the raw materials and finished drug meet
the standards of the U.S. Pharmacopeia
-
Meet all federal regulations for manufacturing
practices, with proper facilities for making, testing, packaging and controlling
the medicine
In addition, as with the makers of branded drugs,
generic manufacturing sites are inspected before drug approval and periodically
afterward, and the quality of the product is monitored.
Manufacturing
facilities for brands and generics must meet the same standards, and the FDA
conducts nearly 300 inspections each month, on average.
What’s The
Cost Difference Between Generic And Branded Medicines?
Generics are
usually 30 percent to 60 percent cheaper than branded drugs, according to
Caremark, a national mail-order pharmacy.
The Congressional Budget Office
estimates that generics save consumers $8 billion to $10 billion
annually.
Here are some sample price comparisons from the online pharmacy
drugstore.com:
-
30 pills of Celexa, a popular antidepressant, in
20-mg strength, cost $86.39; the same prescription filled with generic
citalopram hydrobromide costs $39.99
-
Glucophage, the most popular diabetes drug in the
U.S., runs $139.97 for 180 pills, 500 mg; the generic equivalent, metformin HCl,
is $85.99
-
Zocor, a statin drug used to treat high
cholesterol, is $404.97 for 90 pills, 20 mg; simvastatin, the copy, costs
$73.97
We cite drugstore.com’s prices merely as examples from a
large retailer – not to recommend that you order from it or any particular
company. The cost of drugs varies greatly from one pharmacy to another.
Comparison shop before filling a script, especially one you’ll be taking for an
indefinite time.
Why Is There Such A Price Discrepancy Between Brands
And Generics?
According to the U.S. Office of Personnel Management,
discovering and developing just one new medicine costs an average of $500
million and takes 12 to 15 years.
Drug pioneers are rewarded with patents
that enable them to be the sole suppliers of a new drug for a period of 17
years, with possible extensions of one to six years. Naturally, being the only
seller of a drug means a company can charge more, and not until the patents
expire can manufacturers make and sell generic copies.
When you buy a
branded drug, you’re also paying for the company’s investment in marketing. In
2006 alone drug companies spent $5 billion in direct-to-consumer advertising,
Nielsen Media Research says.
Which Should You Choose – Branded Or
Generic?
In almost all cases, generic is your best bet – but there’s
one caveat.
Of the thousands of generic drugs listed in the FDA’s Orange
Book, 96 percent are considered bioequivalent and therapeutically equivalent. In
other words, they’re considered to work just like the brands they
replace.
What about the other 4 percent? In most cases, these are “older
drugs on which modern tests have not been conducted,” says the NIHCM
Foundation’s 2002 primer on generic drugs. A few of those drugs are considered
nonequivalent because the body is extremely sensitive to minuscule variations in
the dose – in other words, they have what’s called a “narrow therapeutic
index.”
Over time, stricter FDA rules and better testing have
significantly reduced the percentage of nonequivalent drugs. It was 10 percent
in 1990, says the NIHCM primer.
If you know the name of a drug, you can
look it up in the online version of the Orange Book to see whether the available
generics have been found bioequivalent and marked with a “therapeutic
equivalence evaluation code” beginning with the letter A. That means there are
no known or suspected bioequivalence issues or that any actual or potential
problems with bioequivalence have been resolved.
If a drug’s code begins
with a B, it means “actual or potential bioequivalence problems have not been
resolved by adequate evidence,” according to the Orange Book. After completing
its investigation and review process and being satisfied, the FDA may change a
drug’s B code to an A.
In a handful of cases, the FDA and certain
scientists disagree about whether generics are truly bioequivalent. A few
examples include clozapine, used to treat schizophrenia; procainamide
hydrochloride, for irregular heartbeat; warfarin, a blood thinner; and
phenytoin, used to prevent seizures.
When Should You Ask Your Doctor
About Generics?
Whenever your doctor prescribes medicine, it’s smart
to have a brief discussion about brand versus generic.
Talk with her
about whether there’s any reason not to choose a generic. She may be familiar
with new research on a given drug or she may have preferences based on her
clinical experience. If she recommends a brand, ask why and whether the drug is
one with a narrow therapeutic index.
All 50 states now have laws
regulating when generic drugs can be substituted. And in many cases a pharmacy
is required to substitute a generic unless the physician has specified that the
brand must be dispensed. If you’re in doubt about what’s been prescribed or
whether a substitution is appropriate, talk with your doctor, pharmacist or
both.
Bottom line: Today’s drugs, both generics and brands, are safer and
more rigorously tested than ever. In almost all cases there’s an effective and
less expensive generic available – but it’s up to you to work with your doctor
to make an informed decision.
For More Information
To learn
more, check these government-sponsored sites.
The online Orange Book
(Approved Drug Products With Therapeutic Equivalence Evaluations), updated
regularly by the FDA:
http://www.fda.gov/cder/orange/
The home page for the
FDA’s Office of Generic Drugs: