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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




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