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