Generic Drugs: What You Need to Know

Many people still question the quality of generic medications. Perhaps people believe that generics are inferior because the generic version of a shampoo or a laundry detergent that they purchsed was inferior. Confusion exists regarding the potency and quality of generic medications compared to brand name drugs. According to the US Food and Drug Administration (FDA), a “generic drug is a copy that is identical to a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use.”

The only difference is the lower cost. It is estimated that eight to ten billion dollars per year is saved by the consumer though the use of generic medications. Billions more are saved when hospitals use the generic form.

The definition of an identical generic to a brand name is reassuring to the consumer. However, the myth of an inferior quality in relation to generic drugs persists. An examination of the facts should alleviate this concern.

What is a generic drug?

A generic drug by definition is “bioequivalent and therapeutically equivalent to its brand name counterparts,” says Gary Buehler, director of FDA’s office of Generic Drugs. Bioequivalent means that the drug performs in the same manner. Because generics have the same active ingredients, they also have the same risks and benefits.

Testing standards for a generic drug

One way to test a generic is to measure the time it takes the generic drug to reach the bloodstream. This is the rate of absorption (bioavailability). The generic drug by FDA standards must deliver the same amount of active ingredients into the blood stream in the same amount of time as the brand name. Bioequivalence is the standard measurement for approving generic drugs. This standard was established in 1984 with the Drug Price Competition and Patent Term Restoration Act also known as the Hatch-Waxman Act.

It is reassuring to note that production of generic and brand name medications must meet standards of good manufacturing process. The generic manufacturing facilities must be comparable to those of brand name facilities. About 50% of the brand name firms manufacture a generic drug. These companies make a generic for their own brand name drug but sell them without the brand’s label.

The FDA requires the manufacturer of the generic form to assure that the finished product meets certain specifications regarding sterility. The company must prove that the generic maintains its stability meaning that the container will not affect the drug. Each step of the manufacturing process must document the chemistry and quality control measures that meet FDA standards.

The FDA regulates not only the drug but also its labeling. It periodically inspects manufacturing plants and continually monitors drug quality after approval.

Why do generic drugs cost less?

Since a generic drug is not made from scratch, it costs are reduced. A new brand name drug is developed under patent protection. This is quite costly. The patent allows the drug company to recoup money spent in development including marketing, research, and promotion for as long as the patent is in effect which is approximately seventeen years. The patent protects the company and does not permit other companies to manufacture the medication. When the patent expires, other corporations can begin to use the active ingredients to manufacture the generic version of the drug. FDA requires the generic drug to be approved. Once the generic is approved, there is more competition and the price goes down.

Why do the generic and the brand name drugs look different?

A generic drug looks different from a brand name drug because US trademark laws do not permit generics to look exactly like the brand name. The active ingredients in a generic must be the same. However, colors, flavors, and other inactive ingredients may be different. These do not affect the manner in which the drug works only how the drug looks.

In conclusion, generic drugs are equivalent to its brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. The difference is you will save money by purchasing the generic form. Generic drugs not only save you money but encourage the drug manufacturing companies to continue research for newer and better medications that have the patent protection. As always, consult your physician regarding the medication you take.

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