Myths and facts of generic drugs

Myths and Facts of Generic Drugs

"Generic drugs' is the term for prescription drugs that are the same as brand-name drugs. (There are generic versions of nonprescription drugs, too, but this article is concerned only with prescription medications.) As with any new type of product, most brand-name prescription drugs are developed under a patent. This patent serves to protect a drug firm's investment in developing the drug by giving the company the sole right to sell the drug while the patent is in effect. Thus, generic versions of that drug may be sold by competing drug companies only after the patent expires--generally about 17 years after the original drug was discovered.

Because competition enters the picture when a patent expires, generic drugs usually sell for less than the brand-name product from the original manufacturer. The fact that generics generally sell for less has led many people to believe that generics are in some way inferior to brand-name products. That's not true; generic drugs contain exactly the same active ingredients as the brand-name drug and must be just as safe and effective.

Here's some more information to clarify the record on generic drugs:

MYTH: A new law permits the Food and Drug Administration to ignore safety and effectiveness requirements for generic drugs while brand-name drugs still must meet these rigid tests.

FACT: The new law, the 1984 Drug Price Competition and Patent Restoration Act, does not lower any standards for generic drugs. Previously, generic manufacturers had to perform their own tests to prove that the active ingredients in their products were safe and effective. But since that had already been proven when the equivalent brand-name drug was first marketed by the original manufacturer, there was really no need to test all over again. However, generic drugs must go through scientific testing to show that they work just as well as the original drug. Although the law is new, generic drugs are not. They've been around for many years. The new law just makes them available for many more drugs.

MYTH: Generic drugs just won't do the job as well as brand-name drugs.

FACT: Under the new law, generic drugs must be bioequivalent to their brand-name counterparts to gain FDA approval. That means that the generics must contain the same active ingredients and must be identical in strength, dosage form (tablet, solution, etc.), and route of administration (for example, taken by mouth or through injection). Further, they must release the same amount of drug into the body as the brand-name drug.

MYTH: Generic drugs are not as potent as brand-name drugs.

FACT: Generic drug manufacturers have to ensure that their products are of the same quality, strength, purity, and stability as the brand-name products.

MYTH: Generics take longer to act in the body.

FACT: In seeking FDA approval for their products, generic makers must submit evidence that their drugs will have the same therapeutic effect as the brand-name counterparts. This means that a generic product can be expected to deliver to the bloodstream, or other site where the drug does its work, the same amount of active ingredient as the original product.

MYTH: Generics are not as safe as brand-name drugs.

FACT: FDA requires that all drug products be safe and effective. Since generics use the same active ingredients as their brand-name counterparts and work the same way in the body, generics are as safe and effective as their brand-name equivalents.

MYTH: FDA requires that brand-name manufacturers test new drugs in thousands of patients, but it lets generic firms get by with tests in only 20 or 30 healthy volunteers.

FACT: Generic drugs are duplicates of products that have already been tested for safety and effectiveness. Therefore, generic manufacturers need only prove to FDA that their drug behaves the same way in the body as the original version. That requires only small-scale tests. In fact, the same small-scale testing is done for brand-name drugs whenever they are reformulated.

MYTH: Generic manufacturers only have to prove that the active ingredients in their products get to the bloodstream. That doesn't mean that their products are used by the body in the same way.

FACT: When the same amount of the active ingredients of the generic version gets into the bloodstream at the same rate as the brand-name version, there is no scientific reason to believe that the effects of the two drugs will differ.

MYTH: Most drugs are tested for bioequivalence in healthy young volunteers, yet 25 percent of all prescription drugs are taken by the elderly who don't react the same to drugs.

FACT: While the elderly may often absorb and process (metabolize) drugs differently than younger people, there is no proof that drugs will perform differently in them. Further, it isn't ethical to force already weakened or disabled patients to give blood samples and face the other discomforts of bioequivalence testing. Further, such patients cannot be used in bioequivalence testing because they are virtually always taking other drugs concurrently.