Should the FDA consider cost-effectiveness when approving new drug applications?
If incorporated appropriately, the review of economic factors by the Food and Drug Administration could help facilitate a new drug’s entrance into the market. A new drug isn’t going to get far in the marketplace if managed care organizations and other payers are unwilling to cover it. And these payers want to see cost-effectiveness data. The problem is that cost-effectiveness claims are difficult and time consuming to evaluate. If payers had an independent evaluation of cost-effectiveness from the FDA, it could make coverage decisions easier and faster–allowing cost-effective drugs a smooth path to the marketplace. Economic data could be collected by drug companies during phase III drug trials and forwarded to the FDA as part of a new drug application (NDA). The FDA already has some experience in evaluating cost-effectiveness claims. For example, the agency evaluates the promotional material for drugs on the market, and at least some of that review involves evaluation of cost-effectiv
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