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Forces persuade generic drug expansion in the United States

The United States (U.S.) Food and Drug Administration, as protectors of public health, encourages generic drug development and use so that patients can access affordable medications. The FDA, however, has limited mechanisms to encourage generic drug manufacturing.

Generic drug manufacturers make decisions regarding development of products based on expected profitability, influenced by market forces, features of the reference listed drug, and manufacturing capabilities, as well as regulatory restrictions. Barriers to the development of generic drugs include the challenge of demonstrating bioequivalence of some products, particularly those that are considered to be complex generics.

A generic drug is equivalent to it's brand name counterpart, but is usually much less expensive. A generic drug must have the same active ingredients, route of administration, dosage form, strength, and indications as the original brand product. Generic drugs are approved by the U.S. Food an…
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