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Fast facts on generic drugs.

The latest styles are always tempting. Buying new cars, clothes, or computer upgrades may hurt your budget, but buying the newest drugs could hurt both your wallet and your health. For prescription medicine, "classic" drugs may be the way to go. Here's why. New drugs have unknown risks. Of course, drugs are tested before marketing, but they may not be tested in elders, children, or people with chronic medical conditions like diabetes or asthma. Problems may be revealed after a drug is used in more people or in a more diverse population. A new drug may be tested for a few months, but prescribed for years. Long-term problems and drug interactions take a while to show up.

One way to protect yourself from the unknown risks of new drugs is to request generic drugs. About three-quarters of drugs approved by the Food and Drug Administration (FDA) have generic equivalents. Any drug available in generic form has been on the market for many years and is time-tested, so we know more about their risks and benefits.

WHAT ARE GENERIC DRUGS, ANYWAY?

Generic drugs are chemically identical to brand-name drugs in every way: dose, safety, strength, quality, intended use, etc. Only the price is different, and the fact that generics are sold under their chemical name rather than a brand name (think Viagra vs. the generic name, sildenafil). Generic drugs are less expensive than brand-name drugs because generic manufacturers don't bear the investment costs of new drug development.

New drugs are developed under patent protection. The patent protects a company's investment in research, development, and marketing by giving it the sole right to sell the drug while the patent is in effect (usually 20 years). The FDA is the U.S. agency responsible for protecting public health by assuring the safety of medical drugs for the conditions they treat. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Generics manufacturers haven't paid to develop a drug, so they can sell their product at reduced prices. Generic competition usually results in lower prices on the brand-name version as well. By the way, brand-name manufacturers make about half of generic drugs.

AREN'T GENERICS INFERIOR TO BRANDED DRUGS?

No. Generics are subject to the same FDA standards as all drugs and must be manufactured in factories that meet FDA regulations. Generic drugs must pass stringent "bioequivalency" tests in humans, which compare blood levels of the generic with the brand equivalent. The minor variability in drug levels allowed in these comparative tests is the same standard that different batches of a branded drug must meet. After a generic drug goes on the market, the FDA continues to monitor drug quality and investigates any reports of generic or branded drugs failing to meet standards.

Product failures are unusual, but have occurred with both branded and generic drugs. If you're sure that a drug you're taking is not working, tell the FDA through its Medwatch program website (http://www.fda.gov/medwatch), by phone (1-800-FDA-1088), or by fax (1-800-FDA-0178).

WHAT ARE THE MAIN DIFFERENCES BETWEEN GENERIC DRUGS AND BRAND NAME DRUGS?

On average, a prescription for a branded drug costs three times as much as a prescription for a generic drug. (1) Besides price, the main difference is in packaging--both the container's appearance and how the pills look. Due to trademark laws, generic and brand-name drugs cannot look identical, so generic pills are often a different color or shape from their counterparts. Excipients (an inactive substance used as a carrier for medication's active ingredients, which can include fillers, binders, colors, and coatings)., may differ in various versions of a drug. Individuals may be allergic or sensitive to a specific excipient, but that can be true of both branded and generic drugs.

WHAT IF A DRUG ISN'T AVAILABLE AS A GENERIC?

Some novel drugs are still under patent protection, and unavailable as generics. If your doctor feels that it is important for you to take a particular brand-name product, ask why. If the brand-name product has a proven added medical benefit for you, the extra cost and risk may be justified. If the only difference is something minor, like that the brand-name requires taking fewer pills, you may decide the benefits are not worth the extra money for a brand-name.

"New" drugs are not necessarily novel drugs. That's because many "new" drugs are just minor variations of older drugs, new drug formulations (for example, long-acting forms), or new combinations of older drugs. Buying the drug's original version or buying generics of the separate components of a branded combination drug is almost always less expensive. If a generic is not available, it may be worth asking your doctor, "I'd rather not use a new drug. Is there a generic available for this drug or another in its class?" A great source for information on generics is Consumer Reports' Best Buy Drugs at http://www.consumerreports. org/health/bestbuy-drugs.htm.

WHAT IS THE BOTTOM LINE?

Major drug companies want you to believe that the newest, brand-name drugs are best, and they use implicit and explicit tactics to discourage consumers from asking for generic and other classic drugs. Demanding older, generic drugs will not only save you money, but, on a broader level, it can also help reduce health care costs by lowering expenditures on drugs, particularly for large, public programs such as Medicaid. It may even decrease your chances of drug-related adverse effects. Taking a generic drug is a sound health care decision. Don't let fancy packaging and glossy ads tell you otherwise.

REFERENCE

(1) Kaiser Family Foundation, Prescription Drug Trends, May 2007. http://kff.org.

PharmedOut is an independent, publicly funded project that empowers physicians to identify and counter inappropriate pharmaceutical promotion practices. This fact sheet was originally developed as a collaborative project with NWHN; a longer version is available on-line, at www.Pharmedout.org.
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Publication:Women's Health Activist
Date:Mar 1, 2010
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