Copyright 2000 Newsday, Inc.
Newsday (New York, NY)
December 13, 2000, Wednesday NASSAU AND
SUFFOLK EDITION
SECTION: VIEWPOINTS; Page A46
LENGTH: 873 words
HEADLINE:
THE SOLUTION FOR LOWER RX DRUG COSTS IS GENERIC
BYLINE: By Robert S. Milanese. Robert S. Milanese is
president of the National Association of Pharmaceutical Manufacturers.
BODY:
REGARDLESS of who ultimately wins the
presidential election, one issue sure to weigh most heavily on the new
administration will be the high cost of prescription drugs.
Both Al Gore and George W. Bush campaigned on the
drug-price controversy, making it a cornerstone of their
election platforms. Unfortunately, neither of the candidates' proposals will
solve the crisis. The lack of affordable medication will continue to take a
major toll on the elderly, the poor and others who must make hard choices
between purchasing medication and everyday necessities.
But one sure way
to keep prescription prices down has been largely overlooked in the ongoing
public debate. And that is relying more on generic drugs than
on brand-name pharmaceuticals. Statistics show that when brand- name
drug patents expire, generic competition can lower prices of
these medicines by as much as 80 percent in the first 12 months -an annual
savings that can amount to nearly $ 10 billion for government, insurance payers
and consumers.
According to market research, generic
drugs make up 42 percent of all prescriptions filled at retail
pharmacies, but just 8.2 percent of total prescription sales dollars. If the use
of generic drugs is increased from 42 percent to 60 percent,
the public would save close to $ 20 billion per year, or more than $ 200 billion
in the next decade.
Generic drugs can play a
significant role in reducing the cost of many life-saving medications. But,
surprisingly, generic drug usage is actually declining. One
reason for this drop is the sophisticated and well-funded marketing machine by
the brand-drug companies. These manufacturers are now spending
more on advertising than they are on research and development of new
drugs.
They are also employing an increasingly creative
battery of tactics to ensure that more affordable generic drugs
never make it to market.
Just last month, for example, Bristol-Myers
Squibb Co. announced that it received a second patent on
BuSpar, a drug to treat anxiety. After the company's original
20-year patent expired in May, it won a six-month
extension from the FDA for conducting pediatric tests. When the
extension expired, Bristol-Myers secured a new
patent on the administration of the drug,
arguing that the process by which the drug achieves its
therapeutic goal is entitled to protection under U.S. patent
law. Bristol-Myers' ploy is representative of the well- funded exploits of the
brand-drug industry to keep generics at bay.
Equally
important are the misconceptions, misrepresentations and misunderstandings about
generic drugs that have kept them from being embraced by health
professionals and consumers. The brand drug companies have kept
alive the myth that generic drugs are somehow inferior.
But contrary to common belief, generic drugs have the
identical stamp of approval from the U.S. Food and Drug
Administration as their brand-name counterparts. In fact, both branded and
generic drug products undergo the same FDA scrutiny for
approval. In the eyes of science and government, brand name
drugs and generic drugs are interchangeable.
Most Americans willingly, even deliberately, pay a premium for
brand-name products. It's part of our national psychology. We are a brand
conscious, marketing driven society. If we are truly serious about bringing
pharmaceutical prices under control, we can no longer afford this luxury.
Scientific miracles have enabled pharmaceutical therapy to become our first line
of defense. New and better drugs that improve our lives in ways
previously unimaginable are being brought to market every day. The
pharmaceutical industry should, and is, being compensated for the research and
development that makes this possible.
But for many new brand-name
drugs, there are already established drugs
that are safe and effective, for which generic substitutes are readily
available. The cost savings that are possible with FDA-approved generic
alternatives must become a key factor in the decisions of consumers and
health-care professionals.
Health-care professionals should step back
from the onslaught of brand- drug advertising and marketing,
and consider the impact of drug costs on patients.
They
also need to help educate patients about the safety and effectiveness of
FDA-approved generics. Generic substitution should be the rule, not the
exception.
Brand drug companies have successfully
lobbied individual states to keep FDA-approved generics off their lists of
approved drugs. State review boards should not circumvent the
FDA standard for the benefit of individual drug companies. FDA
approval should preclude any attempt to black-list generic
drugs.
The average cost of a generic prescription
(adjusted for inflation) has remained steady for more than a decade, while brand
drug prices have climbed dramatically. At a time when many
Americans cannot afford prescription drugs, the U.S.
pharmaceutical industry has emerged as the single most profitable industry in
the history of the world. With so much at stake, the use of generic medicine can
be the decisive factor in reducing prescription drug costs.
LOAD-DATE: December 13, 2000