According to the U.S. Food and Drug Administration (FDA), generics are “copies of brand name drugs that have exactly the same dose, intended use, side effects, route of administration, risks, safety, and strength as the original drug.” However, a generic version may have different colors, or inactive ingredients. The FDA estimates that 50% of generic drug production occurs in the same plants used to manufacture the brand name drugs (Office of Generic Drugs, FDA, 2009).
After a patent expires on a brand BCP, a drug company wanting to market a generic version must submit an abbreviated new drug application to the FDA. This process is streamlined so that the basic animal and then human studies do not need to be repeated since those studies were done when the brand name’s ingredients/doses were being approved (FDA, 2010). However, absorption of the generic compared to the brand name drug is studied. After reviewing 2,070 of these comparisons, it was found that the average difference in absorption was only 3.5%. When considering individual drugs, almost 98% of generics had absorptions (“area under the curve”) which were less than 10% off from the brand name (Davit, 2009). It is important to remember that there can also be similar variability between batches of the more expensive brand name drugs (FDA, 2009).
The American College of Obstetricians and Gynecologists published an opinion statement (number 375), “Brand versus generic oral contraceptives.” It supports patient or clinician preference in choice of BCPs as brand and generic are considered medically equal (ACOG, 2007).
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