Get the Facts on Generic Drugs
Learn all you ever wanted to know about generics from this easy-to-read, question-and-answer article.
What is a generic drug?
A generic drug is a chemically equivalent, lower-cost version of a brand-name drug. The generic version becomes available when the brand-name drug's patent protection expires, and at times costs only half the price of the brand-name version.
All drugs have a generic name. When a pharmaceutical company first develops a new drug, it gives the drug a generic name (or 'chemical name'). The company then gives the drug a brand-name as part of its marketing plan.
If generic drugs are just as good as brand-name drugs, why do generics cost less?
It's less expensive to make and sell generic drugs, so these savings are reflected in a lower price.
Unlike the manufacturers of brand-name drugs, the makers of generics don't have to spend money on research and development, marketing, and advertising. A brand drug manufacturer can spend about $800 million to discover develop and produce a new drug. Research and development on a generic is not needed because the active ingredient has already be studied and shown to be safe and effective. Advertising in particular has become a huge cost of doing business, therefore when a generic drug product is not marketed the savings are passed along to the consumer in the form of lower priced generic drugs. However, the opposite is true for the highly marketed brand-drugs that have to be compensated for the cost of advertising.
As for quality, the U.S. Food and Drug Administration (FDA) makes sure that generic drugs are equivalent to brand-name drugs. By equivalent, the FDA means that generics must contain the same active ingredients and work the same way in the body.
Why aren't all prescription drugs available in a generic version?
The laws regarding the length of time a patent on a brand drug has just recently been increased from 17 to 20 years. Therefore, this means that a brand drug manufacturer has exclusive rights to production of that drug until the patent runs out.
In some cases, a drug is on the market for only a few years before the generic is available. This is usually because the original testing period required by the FDA took many years - so by the time the drug was approved, there were only a few years left on the patent.
Are generic drugs tested as thoroughly as the brand-name versions?
Yes and no. Generic drugs are tested thoroughly to make sure their performance and ingredients meet the FDA's equivalency standards. However, as discussed earlier the generic drugs are not tested regarding the efficacy of the active ingredients because this has already been done.
In addition, FDA scientists sometimes visit the laboratories of the company that has applied to manufacture a generic drug. The scientists check the purity of the ingredients and the quality of the processing. The generic version must also be labeled with the same information as the original drug, including warnings and side effect information.
But the generic drug does not have to complete the clinical trial process applied to the original drug. To be considered a generic version, the drug must behave chemically identical to the brand-name version, which was already subjected to years of testing.
What about the companies that produce generic drugs? Are they as trustworthy as the companies that make the brand-name drugs?
That's a common concern, but you can trust generic drug manufacturers. Many times the same company that developed the brand-name drug releases a generic version when the patent expires. Other companies specialize in making generic drugs and are subject to FDA regulation and oversight.
Many drugs are difficult to make, even when their active ingredients are known. In fact, some drugs never become available as generics because they are too difficult or costly to make.
How can I know when a generic drug is available?
Ask your doctor to allow for generic substitution when he or she writes your prescription. The pharmacist can supply the generic, if there is one, only when your doctor indicates that option.
Managed healthcare programs encourage doctors to prescribe generics because they are less expensive, but some doctors (and patients) still choose higher priced brand-name drugs. In general, you'll be charged a higher copayment for brand-name drugs than for generics. You might even pay additional costs if you request a brand-name instead of its generic version.
Are there reasons to stick with a brand-name drug even if there is a generic on the market?
In some cases, the generic version might not be right for you. Remember, the FDA regulates the equivalency of active ingredients in generic drugs. But there are also tiny amounts of inactive ingredients, which may give the drug its bulk or a specific shape or color. For some people these inactive ingredients may have an unanticipated effect.
For example, suppose you're allergic to wheat. If a drug has some added fiber to help it pass through the gastrointestinal system quickly, that fiber doesn't affect how the drug works on your arthritis pain. However, if the bulking agent is wheat fiber, you may experience a slight allergic reaction.
If you have a specific allergy, ask your pharmacist about the ingredients in your medicine and remind your doctor of your allergies. There are sometimes several generic versions of a drug, with slightly different inactive ingredients, so there may be one that is right for you.
Why do some generic drugs look different from their brand-name versions?
All drugs - brand-name and generic - have inactive ingredients such as dyes, fillers, and preservatives. These ingredients often determine the size, shape, and color of the drug.
Generic drugs may have different shapes, colors, or packaging than their brand-name versions, but they are equally effective.
What is 'generic substitution?'
Generic substitution occurs when a prescription is written for a brand-name drug but is filled with a generic version. Most prescription plans offer less expensive copayments for generics.
What if my doctor prescribes a brand-name drug, but my plan requires generic substitution?
The pharmacist will contact your doctor and request the generic version.
What's the bottom line on generics?
You can use generics with confidence. Although they sometimes look different from their brand-name versions, equivalent generics are just as safe and effective.
References:
Abbreviated new drug application (ANDA) process for generic drugs. Center for Drug Evaluation and Research (CDER). Available at: http://www.fda.gov/cder/regulatory/applications/anda.htm.
An inside look at generic pharmaceuticals. Mylan Institute of Pharmacy. Available at: http://jbdc.vwh.net/mylanweb/overview/inside_generics.htm.
FDA approval process for generic medications. Teri Wagner, PharmD, Stadtlanders Pharmacy. Available at: http://www.stadtlander.com/general/generics.html.
FDA ensures equivalence of generic drugs. FDA Consumer, special report, January 1995. The Food and Drug Administration Web site. Available at: http://www.fda.gov/fdac/special/newdrug/generic.html.
Generic drugs. Merck Manual Home Edition. Available at: http://www.merck.com/pubs/mmanual_home/sec2/12.htm.
Generic drugs: saving money at the pharmacy. April 1998, Federal Trade Commission Web site. Available at: http://www.ftc.gov/bcp/conline/pubs/health/generic.htm.
More info on generics from the FDA. Available at: http://www.fda.gov/cder/handbook/bioequiv.htm and www.fda.gov/cder/handbook/andabox.htm.
Therapeutic equivalence of generic drugs. Response to national Association of Boards of Pharmacy. Available at: http://www.fda.gov/cder/news/ntiletter.htm.
A New Front in the Ongoing Battle Between Generic and Brand Name Drugs. Available at: http://www.cagw.org/site/PageServer?pagename=reports_davidgoliath.
Generic Drugs, Small Molecule. Available at: http://www.wikinvest.com/concept/Generic_Drugs_(Small_Molecule)
Last Updated: February 2008
This content was created by members of the DrugDigest team of experts and is solely under DrugDigest's editorial control.
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