Generic Drug Safety

With the skyrocketing prices of health care, many individuals and organizations are seeking to reduce costs wherever possible. One way to do this is to change from branded drugs to generic drugs. By law, both the branded drugs and generic drugs must be exactly identical. However, because of the advertising campaigns of drug manufacturers who desire to instill trust in their brand, many people are unsure about the efficacy of generic drugs and, especially, generic drug safety, though they are technically chemically identical. How safe are generic drugs, anyway?

Generic Drugs are Identical to Branded

It should be emphasized that the only differences between branded and generic drugs is the name and the cost. Not only are the ingredients identical, but also all the other features of the drug: dosage requirements, how it is used, effects, potential side effects, and, importantly, safety. Thus, in theory there should be no difference between a branded drug and a generic drug in how safe it is to take. A generic drug could be just as dangerous or safe as a branded one.

FDA Approval

Like brand-name drugs, generic drugs undergo strict testing and regulation by the US Food and Drug Administration (FDA). They must undergo the same rigorous clinical trials, including double-blind studies, as any other drug. Furthermore, generic drugs must be as effective and must work as quickly as do the drugs it is purportedly equivalent to. Generic drug safety is thus tied directly to the same methods used to test brand-name drug safety.

Quality Versus Cost

The lower cost of a generic drug does in no way reflect on its quality, efficacy, and safety. Many people think that "higher price means better." For drugs, this is simply not true. The higher price of a brand-name drug lays specifically in the branding. A drug company spends millions of dollars on print, TV, and online ads, much of which is aimed directly at potential patient and consumer. Furthermore, the company making the branded drug often is the one responsible for producing it in the first place. They need to invest millions, even billions, of dollars into research and development, testing, and distribution and marketing. The patent on their drug will last for 20 years. When the patent expires, generic drug companies can move in and reproduce the drug more cheaply.

Regulation of Manufacturing

The manufacturing of generic drugs does not occur in lesser facilities than those that manufacture branded drugs. Some believe that the prices of generic drugs are lower because manufacturers in some foreign country take shortcuts in its production. This makes consumers fear that their generic drugs could be tainted, defective, or in other ways unsafe. This, again, is false. The FDA regulates the manufacturer of all drugs, generic and branded, and requires the same standards of safety and manufacture for all the drugs under its purview.

Difference in Appearance

Finally, for all its similarities, there is one rather significant difference between branded and generic drugs. Generic drugs will often look different then their equivalents, such as in color, size, or shape. Even the "flavor" of the drugs can differ. This has more to do with patent and trademark issues than in the actual efficacy or generic drug safety. The difference here, however, may be significant, as the differences in look of the drug depend on the inactive ingredients used in its manufacture. Thus, brand-name and generic drugs may contain different inactive ingredients. By definition, this should have no impact on generic drug safety or efficacy. However, in practice, certain people may be sensitive to certain inactive ingredients. Check with your doctor to make sure that the drug's inactive ingredients won't have any adverse effects with your body (due to allergies or other conditions) or with any other drugs you may be taking.