The patent laws allow generic
versions of drugs to be created
20 years after first approval.
Any company that creates a drug is granted an exclusive patent for 20 years. It may spend up to 10 years on testing before getting the drug to market, limiting time to recoup costs. Once the patent expires, other companies can make a generic version.
Manufacturers of generics don't have to repeat the expensive and extensive clinical research done by makers of innovator drugs. However, "generic manufacturers need to prove that their drug is bioequivalent," says Gary Buehler, director of the Office of Generic Drugs for the Food and Drug Administration (FDA). That means the generic version must deliver the same amount of active ingredients into the bloodstream and in the same amount of time as the innovator drug. Generics also must be the same in strength, dosage form (pill or capsule), administration (oral or injection), and able to meet the same requirements for purity and quality.
Developing a medically acceptable generic drug is challenging, however. A noteworthy example is the estrogen-replacement drug Premarin, which millions of postmenopausal women take to help prevent osteoporosis and heart disease. Premarin, which is made from the urine of pregnant mares, contains a complex mixture of more than 100 different hormones. "Premarin is a naturally derived product, and the problem is making a product that has the same active ingredients," says Buehler. "We have had groups looking at this, but nobody has been able to do this yet."
A 1999 review in the Journal of the American Medical Association examined 127 generic drug applications approved by the FDA in 1997. Researchers studied the data used to evaluate the bioequivalence of generic and brand-name drugs, and found that in all 127 drugs studied, both would provide the same intended clinical benefits.
Because of inactive ingredients -- such as filler, flavoring, and color -- generic drugs do not resemble their brand-name competitors in appearance. This difference keeps patients from confusing them. And the bottle must identify a generic drug as such on the label.
Using Generics Safely
Take time to discuss your prescription with your doctor. Ask whether you're getting the brand-name drug or its generic version, and ask why it's the best choice.
Make sure your pharmacist confirms what prescription you've been given, and explains the medication's potential side effects and any special instructions for taking it. Also bring up any concerns about the price and quality of over-the-counter brand-name drugs versus generic versions. The pharmacist's experience will help you make wise decisions in giving your family effective products.
When consulting your doctor or pharmacist, make sure you have current records of drugs that family members are taking, including any over-the-counter medications.