post-title Generic vs. Trade name prescriptions. Are they the same? 2013-03-27 13:26:25 yes no Posted by

Generic vs. Trade name prescriptions. Are they the same?

by Dr. Don McNeil, M.D. There is no one answer to this question. Sometimes they are the same and other times, they are not. To understand this more completely, some background information is necessary. A pharmaceutical product (drug or device) is rigorously studied in preclinical trials in non-human and human volunteers long before approval by […]

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DonMcNeil-300x278by Dr. Don McNeil, M.D.

There is no one answer to this question. Sometimes they are the same and other times, they are not. To understand this more completely, some background information is necessary.

A pharmaceutical product (drug or device) is rigorously studied in preclinical trials in non-human and human volunteers long before approval by the FDA. During these trials, any adverse effects are thoroughly documented and if considered serious, a decision to discontinue the study is  possible. The cost to conduct studies such as these is substantial and the company developing the product must “factor in” these costs to continue. Hence, the final cost to the insurance company and/or the patient may seem excessive. Once on the market, the company has a limited amount of time to market the product to the prescribing physician before patent expiration and loss of exclusivity. Additional costs of marketing during this time add to the final price.

A company producing a generic equivalent drug is not required to undertake the same scrutiny by the FDA. All that is required is proof that the product is similar. The up front cost of drug development is a fraction of the initial start up costs of the original product. As a result, the cost to the public is quite often much less. A consumer who is not aware of the reason for the difference in price is often under the misconception that the trade name product is being sold at an exaggerated price.

This is not to say that an equivalent benefit would or would not occur with a generic drug. It is probably fair to say that this is often the case but there are notable exceptions. A consumer may be content to use a store brand aspirin vs. a Bayer aspirin but feel less comfortable taking a generic equivalent of a heart or cancer treatment. The health care provider is usually a good source of information in a situation like this because of their impartial opinion.

If an adverse effect should occur from a generic equivalent product, the protection afforded the consumer may not be the same as the original product.  The major burden of liability often falls on the back of the original manufacturer. If the consumer chooses to use a generic equivalent, it is also assumed that the choice is an informed one and that the benefit vs risk ratio has been carefully considered.

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