To get products approved, firms had to create applications to prove that medicines were “safe and effective,” meaning more effective than doing nothing at all. That standard was never refined to include the more modern question: Is the product more effective than the dozens of other treatments for a particular condition that are already on the market? Equally important, the FDA yardstick for approval did not include any consideration of price or measure of cost-effectiveness—a metric that virtually all other countries now use as they consider admitting new drugs to their formulary.
