The cost of drugs in the United States can be very high. Finding ways to reduce costs is important and necessary for many Americans. Buying generic drugs instead of brand-name drugs is one way to save money. However, not all generic drugs are the same as their brand-name counterparts. Generic DrugsAccording to the Food and Drug Administration (FDA), Americans saved $158 billion in 2010 simply by purchasing FDA-approved generic drugs instead of brand-name drugs. . At the time, generic drugs cost on average 80-85% less than brand-name drugs, and eight out of ten prescriptions contained generic drugs. The reason generic drugs are less expensive than their brand-name counterparts is because the FDA does not require manufacturers to repeat clinical trials to test their safety and effectiveness, and these drugs are typically not advertised, marketed, or promoted (Food and Drug Administration, 2013). .Generic drugs must be the same as the brand-name drug. The FDA requires that generic drugs contain the same active ingredient, the dosage form must be identical, the concentration must be the same, and the route of administration must be the same as the brand-name drug to gain FDA approval (Food and Drug Administration, 2013). The manufacturer must also demonstrate that the generic drug provides the same amount of active ingredient as the brand-name drug. This bioequivalence helps draw the conclusion that the generic and brand-name drug will produce very similar therapeutic results (Food and Drug Administration, 2012). Bioequivalence Studies Bioequivalence studies required by the FDA are generally conducted on a small group of healthy individuals. These studies do not use individuals who have been diagnosed with the condition the drug is used to treat. Therefore, age- and disease-related factors and patient-related variables are not taken into account. Furthermore, these studies are only single-dose studies that do not take cumulative dosage effects into account (Johnston, Stafylas, & Stergiou, 2010). Recommendations are made by the FDA on bioequivalence using assessments. If the FDA rates a generic with an “A,” it means that the generic and brand-name drugs are interchangeable. A “B” rating means not recommending a substitution for the generic drug (Barrett, 2010). In a recent FDA review of more than 270 generic drugs, the average difference between the generic and brand-name counterparts was 3.5%. This percentage is very similar to that expected and found among batches of brand-name drugs (Food and Drug Administration, 2012).
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