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Worried about generics?

Last updated: March 2009

Recent news reports about improper manufacturing of certain prescription generic drugs may have made some people question the overall safety of generics. Nearly half of the people in our January 2009 survey, for example, said they had reservations about such medications. They shouldn't—though the recent cases do underscore the need for greater scrutiny of manufacturing processes by both generic and brand-name drug makers as well as by the Food and Drug Administration.

In February, for example, the FDA announced it was taking regulatory action against the generic drug maker Ranbaxy Laboratories for falsifying data and test results at one of its manufacturing plants in India. But brand-name drugs aren't immune to problems. For example, in February the FDA sent Genzyme Corp. a warning letter noting "significant deviations" in the manufacture of three branded drugs. And in 2008 Baxter International Inc. recalled certain branded versions of the blood-thinning drug heparin due to increased reports of adverse reactions. An FDA investigation found that the drug's active ingredient, which was manufactured in China, had been contaminated.

Overall, generic drugs appear no more likely than brand-name drugs to pose risks, according to our review of available data and interviews with experts. From 2004 through 2008, for example, generic drug companies received slightly fewer FDA "warning letters" about problems complying with good manufacturing practices than did brand-name ones, according the Generic Pharmaceutical Association (GPhA), a trade group based in Arlington, Va. That's particularly notable, since there are far more generic than brand-name drugs on the market.

"The vast majority of drugs are safe, but it is critical that the FDA expands its oversight to ensure adherence to safe manufacturing standards for both branded and generic drugs," says John Santa, M.D., director of the Consumer Reports Health Ratings Center.

Here are our answers to questions you may be asking about generic drugs and drug safety in general.

What makes a drug 'generic'?

A generic drug is simply a copy of a brand-name medicine whose patent has expired. By law, a brand-name company loses its right to be the exclusive maker of a drug after a certain period, usually about 10 to 14 years. Companies that specialize in making and distributing generic versions of drugs can then get FDA approval to manufacture and sell a copy. Much of the time the same company that makes a brand-name drug also makes its less-expensive, generic version in order to sell to both markets.

Are generic drugs as safe and effective as brand-name drugs?

Yes. A generic is a copy that is the same as a brand-name drug in dosage, quality, strength, intended use, and how it performs. Each generic must demonstrate it is bioequivalent with its brand-name counterpart by showing that it delivers the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug.

Generic drugs that do so should have the same therapeutic effect and therefore the same benefits and risks as their brand-name counterparts, but at less cost. Generics are available for about half of all prescription drugs. When they're not, as in the case of many newer brand-name drugs, doctors or pharmacists can substitute with the generic version of an older drug that has equivalent effectiveness (and often a longer safety record).

Is that true for generic over-the-counter-drugs?


Yes. Over-the-counter generics, which are often sold under the house brand of large retailers, such as CVS or Walgreens, have to meet the same manufacturing standards as the name brands with which they compete. In fact, there are only two ways in which any OTC drug can make it to the market. Many conform to the FDA's monographs, a set of rules specifying what ingredients may be used in a drug and for what purpose. But other drugs, such as prescription drugs that go "over the counter," or drugs that introduce new ingredients or dosages, must get FDA approval in a separate application process. Any changes in labeling must also be approved.

Why do generic drugs look and taste different?

Trademark laws prohibit a generic drug from looking exactly like other drugs on the market. After all, brand-name companies have made distinctive colors, shapes, and sizes part of their sales strategy. (Think of the ads urging consumers to take the "purple pill" for heartburn.) Also, brand-name pills and generic pills often have different inactive ingredients, such as flavorings, that affect taste. Keep in mind, though, that the shape, size, and taste of the pill have no effect on how well it works.

How much can you save with generic drugs?

Generics can cost up to 80 percent less than their brand-name versions and save consumers an estimated $8 billion to $10 billion a year. They're less expensive because generic manufacturers don't have the investment costs of the developers of new drugs, and rarely spend much on advertising, so they can sell their products at lower cost. Even if you have insurance, the co-pay for a generic drug is often less than for the branded version.

Why hasn't my doctor prescribed generic drugs?

Some doctors write a prescription for a brand-name medicine and leave it to the pharmacist to substitute a generic when applicable. Pharmacists in every state can legally switch you to an approved generic drug without your doctor's permission, unless the prescription contains the phrase "Dispense As Written" or "Medically Necessary." To avoid confusion, talk with your doctor about your prescription as it's being written. Ask whether the prescription is for a brand-name or generic drug and why the doctor has prescribed one or the other. It makes sense to let the doctor know that you would prefer the less-expensive choice as long as safety and effectiveness are equivalent.

How do I know if a drug has been recalled?


To find information about recalls and other medical safety alerts for generic as well as brand-name drugs, go to the FDA's Web site. If you're concerned about a drug you're taking, or if you've experienced problems that may be related to your medications, speak to your physician, pharmacist, or other health-care provider.

How often does the FDA inspect drug manufacturing facilities?

The FDA inspects the nation's approximately 3,000 domestic drug plants about once every two and a half years, according to a U.S. Government Accountability Office report published in September 2008. But the agency inspects only about 8 percent of foreign facilities in a given year, so that it would take more than 13 years to get to that group of plants, the GAO estimates. Overseas plants make ingredients for generic and brand-name drugs. An FDA spokeswoman says that the agency's recently opened offices in India and China will "over time allow greater access for FDA inspections." The FDA is beginning to collaborate with European countries and Australia to share inspection responsibilities.

Do U.S. drug makers inspect their foreign facilities?


Some do. The two U.S. trade groups representing brand-name and generic drug makers—the Pharmaceutical Research and Manufacturers of America and the GPhA—say that their member companies work closely with foreign and domestic manufacturers to help ensure that pharmaceuticals meet the FDA's safety requirements before entering the U.S. drug supply. That includes programs to inspect and perform audits of suppliers, followed by periodic re-inspections, as well as testing for safety and purity.

Where can I get more information?

You can check out our free CR Best Buy Drug reports on more than 20 classes of drugs to find out whether a low-cost generic is available for your health problem. For more on generic drugs in general, go to the FDA's Center for Drug Evaluation and Research Web site.

   

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