Paper1 Essay

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H E A LT H & MEDICINE With dual-tracking, patients can have early access to potential miracle drugs while the FDA maintains its testing regimen. Breaking the FDA Monopoly B Y B ARTLEY J. M ADDEN M DUAL TRACKING ost Americans rarely encounter the Food and Drug Administration and consequently are not alarmed by its significant growth over the last few decades. Congress has facilitated fda expansion by using wellpublicized episodes of unsafe products to promote pro-expansion legislation and by allowing a silent but inexorable proliferation of fda regulations. On top of that, the news media feed Americans a steady diet of examples that purportedly cry out for increased government regulation of unsafe products and environmentally damaging behavior. What does not get reported is that every expanded piece of the fda’s bureaucratic machinery is matched by a loss of consumer choice. The nature of the fda is to strive at any cost to prevent individuals from acquiring a drug that might cause serious harm or early death. Such occurrences generate widespread criticism and turn up the political heat on the fda. The agency has been largely successful in that effort, but the significant costs of that prevention have received only limited attention. One such cost is the economic loss to society in the form of higher prices, in order to offset the hugely expensive clinical trials (on both failed drugs and approved ones) and for new drug applications. A second significant cost to society is from time delay before useful drugs become available to those who would benefit from them. for consumers to access those products — a track that would allow informed consumers to purchase drugs that have undergone only the initial phase of the fda drug-approval process. By opening this second track, patients would have access to potential miracle drugs after those drugs

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