Abstract
To the Editor.— The equivalence of drug products containing the same active ingredient is being actively debated in connection with topics such as brand name vs generic products, repeal of antisubstitution laws, and national health insurance programs with maximum allowable drug product cost (MAC) provisions. The argument most often advanced to support the equivalence of the vast majority of the drug products available in the United States is that relatively few recent studies have actually demonstrated significant differences between competing products. Digoxin tablets are frequently cited as an example of a drug product that is prone to bioavailability problems. 1,2 We wish to call attention to our recently completed evaluation of 14 nitrofurantoin products. 3 These studies were conducted under the sponsorship of the Tennessee Department of Public Health as part of an ongoing effort to develop a drug formulary system that will provide an assurance of drug product quality
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More From: JAMA: The Journal of the American Medical Association
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