Under current FDA approval requirements, applicants must demonstrate that a new drug has “the effect it purports or is represented to have under the conditions of use prescribed, recommended
Under current FDA approval requirements, applicants must demonstrate that a new drug has “the effect it
purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed
labeling.” In most cases, this means that the drug must be shown to be better than a placebo. Should the law be
changed to require applicants to demonstrate the comparative effectiveness of new drugs?i.e., that the drug is better
then, or at least as good as, existing treatments already on the market? Why or why not?
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