It's the most difficult question you've encountered at the store since the first time you were asked "paper or plastic?" You're at the pharmacy filling your prescription and the pharmacist turns to you to ask, "Is the generic version O.K.?" Your pulse quickens as you frantically weigh your options: generic drugs cost less, but are they really the same as the brand name version? Should you get the generic and save a few bucks?
The answer is a resounding 'maybe.' In most cases, generic drugs are considered safe due to the testing process used by the Food and Drug Administration (FDA).
Pharmaceutical companies invest big money into developing their drugs. In order to recover those costs, which can be in the hundreds of millions of dollars, the U.S. government issues a patent or exclusivity on the drug.
A patent is defined as "the right to exclude others from making, using, offering for sale, or selling". In other words, no other drug company can create the same drug in its laboratories and sell it. Patents can last for as long as 20 years, but each specific patent is different. A patent can be issued at any time during the drug approval process. Therefore, a drug may be patented, but not yet approved by the FDA for use by patients.
A similar right called exclusivity may also be granted to the pharmaceutical company. Exclusivity is defined as the "exclusive marketing rights granted by the FDA upon approval of a drug." Created to strike a balance between the creation of new drug and generic marketing, exclusivity may or may not coincide.
The length of exclusivity is dependent on the type of drug for which it is being granted, and can be anywhere from 3 to 7 years. When the patent and exclusivity have expired, other pharmaceutical companies can recreate the drug and market it themselves under a different name. This opens up the market for competition, and drives the cost of generics down.
Generic drugs must have the same active ingredients as the name brand, but the inactive ingredients could be different. Inactive ingredients may include colors, preservatives, or other fillers. However, just because a generic has the same inactive ingredients it is not automatically considered a generic equivalent.
A pharmaceutical company that wishes to market their generic drug must offer proof of bioequivalency to the FDA. In order to be bioequivalent, the active ingredients in a generic drug must be absorbed at a similar rate and in a similar amount as the brand name drug. The generic does not have to act exactly the same as the brand name drug, but it does have to fall within certain guidelines set by the FDA. These guidelines may vary from drug to drug.
To be sure that the generic drug you are offered has been established as bioequivalent to the brand name, check with your pharmacist. Your pharmacist has access to information about generic drugs from the FDA's Orange Book. The Orange Book contains listings of drugs and their bioequivalency status. The electronic version is searchable by active ingredient and proprietary (brand) name.
If your doctor has written a prescription for a drug using the brand name for that drug, the pharmacist must fill it with that specific drug. The pharmacist can call your doctor and talk about substituting a generic form of the drug. Or, you can talk with your doctor about generic vs. prescription drugs when the prescription is written.
If you are surprised at the drug counter with the question about brand name or generic, call your doctor's office. The doctor who prescribed the drug for you will know if you can get the desired results with the generic.
Sources:
U.S. Food and Drug Administration. "What are Generic Drugs?" FDA.gov 16 Oct 2008. 13 Oct 2008.
U.S. Food and Drug Administration. "Frequently Asked Questions on Patents and Exclusivity." FDA.gov 28 Apr 2006. 13 Oct 2008.
