Generic Medicaments

A generic medicament is a copy of a brand name, "innovator" medicament that is no longer protected by a patent. Generic medicaments generally cost 30 to 50 percent less and, because generic medicament manufacturers compete against each other, the prices of their medicaments usually remain low.

A generic medicament must contain the same amount of the active ingredient present in a brand-name product. The inactive ingredients-fillers and coatings that bind the active chemicals-can differ. The generic medicament must deliver the active ingredients to the proper site in sufficient quantity to produce the same effect as the original or "innovator" medicament.

Ninety-two percent of new medicament discoveries are developed by researched-based pharmaceutical companies, which spend a fortune a year on research and development. Because of the great expense in this process, "innovator" medicaments are protected by patent for seventeen years. That period begins, however, when the company applies for the patent rather than when it receives market approval, which may be years later. Patent protection is designed to allow companies to recoup the cost of developing a new medicament before competitors can copy and sell it at a lower price.

The Medicament Price Competition and Patent Term Restoration Act of 1984 ensured that new medicaments have at least five years of exclusive market protection following approval. It also streamlined the approval process for generic medicaments. A generic medicament firm is no longer required to repeat all the safety and efficacy studies that were done for the "innovator" medicament. Instead, it must prove that its version is equivalent to the original medicament and works just as well.

A scandal rocked the generic industry in 1989 when thirteen generic medicament firms were accused of irregularities. Some of the generic medicaments were recalled and a few companies were suspended for either submitting false data in their applications or for violations in their manufacturing processes. Three FDA employees pleaded guilty to accepting illegal gifts given by medicament company executives in hopes of speeding marketing approval of their products.

The fact is that some medicament companies will market an identical product both as a brand-name and a generic medicament. In 1992, one of the largest and most prestigious brand-name pharmaceutical companies announced that it would market lower priced versions of its own products and was creating a generic medicament division to do so.

It is also common for one manufacturer to produce a medicament that is distributed by other firms under many different product names.

Generic medicaments account for one-third of all prescriptions filled in the United States. In many states, pharmacists are required to fill a prescription with a generic version of a brand name medicament unless the physician has specified "no substitution." The reason is that generic medicaments cost less.

With certain medicaments, however, the therapeutic range is very narrow because relatively minor changes in circulating levels can affect how well they work. For people with epilepsy or congestive heart failure, the result of any deviation is potentially devastating. Patients, with these conditions should consult their physicians before substituting a generic medicament for the brand-name version.

Not all medicaments are available in generic form. About fifteen "innovator" medicaments lose patent protection annually. These medicaments, however, are often protected in their labeling by several patented indications for use. Labeling for generic products reflects only approved indications that are not patent protected.