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Published June 13, 2011, 12:36 AM

Generics Cost Less Than Name-brand Drugs, But Are They As Effective?

You pause before picking up that over-the-counter remedy and ask yourself: Grab the brand name or go with the generic version? Generics cost less than name-brand drugs, but are they as

By: Patrick Springer, Forum Communications

You pause before picking up that over-the-counter remedy and ask yourself: Grab the brand name or go with the generic version?

It’s a question that often arises, as prescription drugs lose their patent protection and as consumers continually are bombarded with ads for brand-name drugs.

The Food and Drug Administration requires generic drugs – both prescription and over-the-counter – to meet stringent standards in order to be sold as generic equivalents.

The savings from buying generic drugs can be significant, especially for prescription drugs.

For instance, the average generic drug claim paid this year by Blue Cross Blue Shield of North Dakota is less than $26, compared to $209 for the average brand-name drug.

So why do brand-name drugs cost so much more?

Pharmaceutical companies selling newly approved drugs get patent protection for a certain period of time – generally around 10 or 12 years – in order to recoup their research investments, said Tom Miller, a professor of pharmacy at North Dakota State University.

Also, manufacturers of generic equivalents don’t have significant expenses for marketing and promoting a brand.

Typically, once a prescription drug loses its exclusivity and becomes generic – opening the door to price competition among multiple manufacturers – the price of a prescription drug drops in the range of 60 percent to 70 percent, said Tom Christensen, director of pharmacy management at Blue Cross Blue Shield of North Dakota.

To contain costs, health insurers encourage their members to choose generic drugs – and most do.

During the first quarter, 73 percent of all drug claims paid by Blue Cross Blue Shield of North Dakota were for generics, Christensen said.

“In 2003, that number was 44 percent,” he added.

Also, if a generic equivalent is available, 96 percent of the North Dakota Blues’ members opt for it over the brand name.

“About 4 percent will stay with the branded product,” Christensen said.

Some doctors and patients are leery of generics. That tends to be the case when the difference between the therapeutic drug dose and a harmful drug dose is very, very narrow, Christensen said.

Also, some worry the generic equivalent might not perform the same as the brand-name drug when a “sustained release” dose is required, Wilson said.

In such cases, they said, some prefer to stick with the brand-name drug they have experience with rather than risking a new version – despite the strict FDA standards for equivalency and dosage, among other standards.

That’s been the case for warfarin, a blood thinner that goes by the brand name Coumadin, and for several drugs used to treat epileptic seizures, Wilson said, naming two examples.

Still others suspect that if a generic costs so much less that it must be of inferior quality.

Not so, the FDA insists in a fact sheet for consumers examining facts and myths about generic drugs.

The agency’s labs test for drug identity, strength, quality, purity and potency, allowing for slight variability in manufacturing. Generics must contain the same active ingredients as their brand-name counterparts, but not the same inactive ingredients.

The evidence of bioequivalency is found in the blood. Generics must produce the same blood levels as the reference drug; if blood levels are the same, so is the therapeutic effect, according to the FDA.

“The FDA standards are what they are,” Christensen said. “It’s not a matter of opinion. It’s the law.”

As for clinical performance, research shows generics perform as well as brand-name drugs, the FDA said. A recent study evaluated 38 clinical trials comparing cardiovascular generic drugs to brand-name versions.

The verdict, according to the study, published in the Journal of the American Medical Association: no evidence the brand-name heart drugs got better results.

Still, doubts about generics persist for some.

“It’s always something people wonder about,” Wilson said.

The reasons are partly cultural, Christensen said. “We’re a brand-orientated society,” he said, “and I think suspicions like that are natural.”

Meanwhile, a blockbuster prescription drug is scheduled to lose its patented exclusivity late this year. Lipitor, a widely prescribed cholesterol-lowering drug, will become generic.

The switch, anticipated by millions of patients, will translate into a substantial savings. The average Lipitor billing for Blue Cross Blue Shield of North Dakota is $197.97.

Consumers and insurers will appreciate the bargain, Christensen said, “Till they come out with the next thing,” he said.

Springer is a reporter at the Forum in Fargo

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