The following information will help answer your questions and concerns.

What Are Generic Drugs?
When an originating company develops a new drug, it gives the drug two names. One is its generic name - the name of the chemical compound that makes up the drug. The other is the brand name, which is what the manufacturer calls the product.

When the company believes the new drug is safe and effective, it obtains a patent, which lasts 20 years. This means that only that company - the originator of the drug - has the exclusive and legal right to manufacture and market the drug during the life of the patent. Also, the brand name of the drug cannot be used by any other manufacturer. Many drugs have several patents, which prolong the exclusivity period beyond 20 years.

Once the patent expires, the drug may be manufactured and sold by other companies under a different brand name, or under its generic (chemical compound) name. All manufacturing and marketing of the generic drug must be conducted in strict compliance with the guidelines established by the Food and Drug Administration (FDA). The FDA is a federal agency staffed with pharmaceutical and medical experts who approve safe and effective drugs for sale. No prescription drug may be sold without this approval.

How Are Generic Drugs Approved?
When applying for approval of a generic drug, a pharmaceutical company must supply a great deal of information about the product, its manufacturing process, and its quality control testing to the FDA. In addition, a listing of all ingredients, both active and inactive, must be provided. The FDA studies this information and determines whether the drug is acceptable.

The major difference between the review of a brand drug and the review of a generic drug is that the manufacturer of the generic drug is not required to duplicate the original medical studies proving the safety and efficacy of the chemical compound. Since medical usefulness of the brand name drug has already been determined, only bioequivalence/ therapeutic equivalence testing is required for a generic drug (see below, What Is the Quality of Generic Drugs?). The FDA approves only those generic drugs shown to be bioequivalent/therapeutically equivalent to their brand name counterparts.

What Are the Manufacturing Standards for Generic Drugs?
The manufacturing facilities of all pharmaceutical companies, whether they are makers of brand or generic drugs, must pass stringent, regular inspections by agencies of the federal government. There is no difference between the manufacturing standards set for generic pharmaceutical companies and those set for brand pharmaceutical companies. The approval for both manufacturers may take several years. Many pharmaceutical companies that make brand name drugs also make drugs sold under generic labels. Conversely, many generic companies manufacture drugs for brand name companies.

What Is the Quality of Generic Drugs?
To be considered "bioequivalent/therapeutically equivalent" to its brand name counterpart, a generic drug must not only have identical active chemical compounds, but the quantity and speed of absorption of its active ingredients into the bloodstream must also be the same or similar, within ranges designated and approved by the FDA. (Most oral medication must be absorbed into the bloodstream before it can produce the medical results your physician is trying to achieve.) If the FDA is satisfied with the tests submitted by the manufacturers for its review, the agency rates the generic drug as bioequivalent/therapeutically equivalent to the brand, recognizing it as equal to and interchangeable with it. Your pharmacist dispenses only products that have been approved by the FDA.

Sometimes the generic version of a drug may have a different color or shape from its brand name counterpart. These differences have no effect on the medical action of the drug. They are created simply to distinguish the appearance of one drug from another.

Why Are Generic Drugs Prescribed and Dispensed?
Sometimes your physician prescribes a specific brand of a drug, but other times he or she will either prescribe or agree to have your pharmacist substitute a generic drug. Before a pharmacist fills a prescription, he or she will generally offer you the choice of brand or generic. Federal, state and private health insurance programs will, in many cases, finance only cost-effective medication, thereby making generic drugs a desirable alternative. Generic drugs typically are less expensive than their brand name counterparts.

Your pharmacist recommends and dispenses generic drugs instead of brand name drugs for a variety of reasons. In a survey conducted by a leading professional journal, the majority of pharmacists agree that generics are better than brands in terms of price, and as good as brands in terms of therapeutic effectiveness, quality control, appearance, and packaging. Your pharmacist knows that today’s generic drugs have been thoroughly researched and tested to meet the same high standards set by the FDA for brand name drugs.

In Summary
Now that you have a better understanding of generic drugs, the reasons they are prescribed, their quality, and how they are approved and manufactured, you can see why your physician prescribes them and your pharmacist often recommends and dispenses them. Discuss any questions you may have about your prescription with your physician or pharmacist. They are experts, professionally qualified to determine whether a generic drug is in your best interest. They would not recommend or dispense a generic drug unless they were completely confident of its safety and effectiveness. When your prescription is filled with a generic drug, you can be sure that you’re getting the quality medication you need...at a more affordable price.