Me-Too Drug

A me-too drug, also known as a copycat drug, is a new drug which is very similar to one or more already-exist-ing drugs. The term is generally used in discussions of research and discovery expenditures at pharmaceutical manufacturers: while representatives of the pharmaceutical industry claim that they invest heavily in research which leads to the discovery of new drugs which benefit the public's health, critics of the industry say that much of that research is devoted to the development of me-too drugs which are not significantly different from drugs already on the market, and thus do not improve human health. According to Marcia Angell, MD, a former editor of the New England Journal of Medicine, about 75 percent of the drugs approved by the Food and Drug Administration in a year are me-too drugs.

The creation and approval of me-too drugs has been criticized on many grounds. One is that each new drug is required to be more effective than a placebo, but not more effective than existing drugs on the market, so a me-too drug could be approved for sale in the United States that is known to be less effective than similar, al-ready-available drugs. Second, me-too drugs are sometimes used to extend patent protection by creating a new drug that is a minor variation on a drug whose patent is about to expire. Third, the high profitability of me-too drugs for common conditions such as high blood pressure discourages pharmaceutical manufacturers from devoting research money to clinically important but less lucrative ventures such as developing orphan drugs (drugs to treat rare conditions). Representatives of the pharmaceutical industry counter that the development of competing drugs lowers costs and gives physicians and consumers more therapeutic choices.