The Health Gazette

Generic Drugs

Karl Hempel, M.D.

Patients frequently ask me whether it is okay to buy generic drugs instead of brand-names. In this article I will discuss the safety of generic drugs.

Pharmaceutical companies may produce a generic drug when the patent expires on the brand-name drug. Usually, generic drugs are much less expensive than the brand-name product. Some patients and physicians will hesitate to prescribe these medications because of concerns about the quality of generic drugs. In reality, the only differences between the brand-name product and the generics are the price and the name.

The Food and Drug Administration (FDA) is responsible for making sure that generic drugs are safe and effective. The approval process for generic drugs began in the late 1960s. Generic drug manufacturers were required to prove that their formulation is bioequivalent to the brand-name product.

Over the past several years there have been studies that have proven without a doubt that generic drugs are safe and effective. Generic drugs are always less expensive and can save patients and insurance companies thousands of dollars without compromising the quality of care. This ultimately will lower the premiums that we pay for health care. The FDA must approve generic drugs just as brand-name drugs must be approved. When a pharmaceutical company first markets a drug, it is usually under a patent that only allows the pharmaceutical company that developed the drug to sell it. This allows the company to recoup the cost of developing that particular drug. It will frequently cost millions of dollars to develop and test a new drug before it is approved for use. After the patent on a drug expires, any pharmaceutical company can manufacture and sell that drug. Since the drug has already been tested and approved, the cost of simply manufacturing the drug will be a fraction of the original cost of testing and developing that particular drug.

It is important to realize that many drugs do not have generics available because their patent has not expired. This means that you must pay the brand-name price if you are going to use this drug. The length of time before a patent expires varies for different drugs. About half of the current drugs have a generic equivalent. Ask your doctor to prescribe generics if at all possible.

In Florida, the law requires that the pharmacist give the least expensive generic that they have available. If they only carry the brand-name product, then it is legal for them to give you the more expensive brand-name. You may have to call several different pharmacies to find one that carries the generic form. This is well worth your time since the generic is usually much less expensive.

For more information, you can visit the Food and Drug Administration’s web site at http://www.fda.gov. Go to human drugs. You may also call 1-800-532-4440.

 

References

Generic Drugs: The Medical Letter, Vol. 41 (Issue 1053), May 21, 1999.

 

The information provided above is offered as a community service about health-care issues and is not a substitute for individual consultation. Advice on individual problems should be obtained from your personal physician. This information is based on research by the author and represents his interpretation of the literature.