Choice Between Branded And Generic Drugs

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Generic drugs offer many benefits over brand-name prescription alternatives.

Difference Between Branded and Generic Drugs

One of the most common choices American consumers face is between brand-name products and their lower-priced generic counterparts. When you consider abandoning a brand-name facial tissue or laundry detergent for a “no-frills” or supermarket brand, you weigh the assurance of quality provided by the familiar product against the lower price of the generic brand. But you don’t risk much by choosing a supermarket brand of facial tissue. If it’s not as soft as the name brand tissue, the worst that you’ll suffer is a sore nose.

A similar choice exists in the prescription drug marketplace. Physicians can prescribe either a brand-name drug or a lower-priced generic version to treat a growing number of conditions. And even if the doctor prescribes a brand-name medication, many states permit pharmacists to substitute a generic version of the drug if one exists, unless the prescribing physician has expressly indicated otherwise.

As a consumer, you can influence these decisions by talking to your doctor or pharmacist. Making an informed choice between a less-expensive generic drug and the more expensive familiar brand helps to know how generic drugs resemble and differ from their brand-name competitors.

What is Generic Drug?

A generic drug is a version of a brand-name drug with the same active ingredient in the same concentration as the brand-name product. Experts refer to the original, brand-name version of a drug as the pioneer. When a pioneer drug is developed, it is given a generic name—officially known as the United States Adopted Name—that refers only to its active ingredient and not to the particular product.

Typically, generic drugs are marketed entirely under the drugs’ generic names. For example, Valium is the brand name of an antianxiety drug containing the active ingredient diazepam. The generic counterpart of Valium is thus sold under the name diazepam. The generic version of diazepam may contain different inactive ingredients—such as flavorings or the compounds that hold the drug together—than Valium does.

Generic versions of a drug may not be sold until the patent on the original prescription has expired. In the United States, drug patents—which give the drug’s developer the sole right to market it—are generally granted 17 years. (Patents may be granted for up to 22 years in cases where regulatory delays have kept a firm from marketing a new drug.)

Generic Drug Must Prove Bioequivalence

Like pioneer drugs, generic drugs cannot be marketed until they have been approved by the U.S. Food and Drug Administration (FDA). However, generic versions of the medication must not undergo the same rigorous—and expensive—testing as the pioneer. In 1984, the United States Congress passed a law streamlining the approval process for generic drugs.

Previously, a company that wished to produce a generic drug had to prove that its product was safe (produced no undesirable side effects) and effective (worked as designed), just as the brand-name firm had shown in its original clinical trials.

Under the 1984 law, drug companies must prove only that a generic drug is bioequivalent to its brand-name counterpart. To be bioequivalent, a generic drug must behave biologically like its brand-name counterpart. Scientists test bioequivalence by giving various doses of the pioneer drug to one group of healthy volunteers and equal doses of the generic version to another group. Investigators then measure levels of the drug’s active ingredient in the volunteers’ blood after specific periods. If the generic and brand-name drugs enter the blood at the same rate and in the same concentrations, they are considered bioequivalent.

The safety of generic drugs came into question after a scandal shook the industry in 1989. That year, federal investigators found evidence of fraud, bribery, and other abuses by officials of the FDA and several drug manufacturing firms. In response to the scandal, the FDA tightened its inspection and approval procedures for generic medications.

It also tested thousands of samples of various generic drugs, including all those capable of posing a severe health threat when taken in incorrect doses. Only about 1 percent of the samples tested failed to meet federal standards for safety, strength, quality, and other characteristics—about the same failure rate as that for brand-name drugs. The FDA also found that none of the drugs posed a threat to public health.

Following the FDA’s actions, the American Medical Association (AMA) reviewed its policy concerning generic drugs. It determined that the substitution of generic for brand-name versions of a drug is acceptable as long as the products are bioequivalent.

Bioequivalence Testing Of Generic Drug

Some experts have expressed concern about aspects of bioequivalence testing. For example, they say that slight variations in the rate at which different brands of a drug enter the bloodstream might affect individuals with certain disorders but not the healthy individuals who serve as the subjects for bioequivalence testing. Critics also say that bioequivalence should not be used to determine the safety of drugs in which the difference between a safe dose and a dangerous dose is slight.

The FDA points out that brand-name drugs are no less vulnerable than generics to charges that bioequivalence testing is inadequate. Under United States law, pioneer drugs can be—and often are—reformulated between the time they are tested and the time they reach the pharmacy shelf. The reformulated versions, which may vary substantially from the original medication, are merely required to undergo bioequivalence testing before being sold, just as generic drugs are.

Why Doctors Avoid Generic Drugs

Most experts agree that requesting generic drugs is a safe way to keep down medical costs in most cases. However, there are times when physicians or pharmacists may hesitate to substitute generic for name-brand drugs.

Many generic drugs, for instance, look and taste different from their brand-name counterparts. This need not pose a dilemma for an adult, but when children must take the medication in a liquid form, it can present a significant hurdle—mostly when the brand-name drug tastes sweeter than the generic version. A physician may also avoid prescribing the generic form if a patient has been taking a particular medication for a long time and might resist a change.

Some physicians hesitate to change a patient’s medication because of the possibility that the patient will have an allergic reaction to one or more of the inactive ingredients in the generic drug. For this reason, most experts advise that physicians monitor their patients’ responses to any new brand of medication carefully. Experts also say that once patients and physicians are happy with the performance of a certain brand, whether brand-name or generic, they should stick with that particular manufacturer.

Staying with a particular product is especially important in the case of certain drugs, such as hormones and delayed-release products, where slight variations in the amount of drug released can be critical. In these cases, a pharmacist can’t automatically fill a prescription with the generic version. A physician must determine the best dose for each patient and prescribe the appropriate drug.

Generic Drug Is A low-cost Alternative

The main attraction of generic drugs, of course, is their cost. Manufacturers can sell generic medicines at a much lower price than that of the brand-name product. On average, analysts say, generic drugs sell for 30 to 50 percent less than their pioneer counterparts.

The lower cost of generic drugs makes them attractive to both consumers and insurance companies. In 1992, generic drugs made up 40 to 45 percent of all prescriptions filled in the United States, according to analysts. And brand-name companies play a major role in the generic business. According to FDA spokesman Mike Shaffer, as many as 75 percent of generic drugs are marketed by brand-name firms. Increasingly, manufacturers are selling generic versions of their pioneer drugs as a way of maintaining market share in a competitive industry.

In today’s world of skyrocketing medical costs, generic drugs provide an alternative to expensive brand-name medications—a way to treat your ailment without draining your bank account. Consulting with your doctor or pharmacist will help make sure your prescription is safe, within your budget, and right for you.

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