Sick and tired of high drug costs? You're not alone. Americans spend more than 150 billion dollars per year on pharmaceuticals, and with costs rising all the time, many are looking to generic alternatives. These products promise the same benefits as their name-brand equivalents, but at a fraction of the cost. When considering something as important as your personal health, do generic drugs measure up?
Consumers sometimes hear the term “bioequivalence” when describing generic prescription medicines. Bioequivalence means that the generic medicine must have the same effect on the body as the brand name drug.
Bioequivalence studies are conducted with human volunteers. In most cases, single doses of the generic and brand drugs are administered and blood or plasma levels of the drug are measured over time. These studies are used by both the brand and generic companies to test their products.
The generic medicine must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the brand drug. FDA also applies statistical measures to further assure the accuracy of the bioequivalence data. These strict criteria must be met for the FDA to approve a generic medicine.
In addition to bioequivalence, FDA scientists use many other complex tests and methods in their thorough review and approval of generic medicines. They work hard every day to ensure that brand and generic medicines are safe and effective for the millions of patients who rely on them for better health. That’s why FDA is recognized around the world as having the gold standard in reviewing and approving prescription medicines.
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