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Prescriptions for Drug Safety: Reforming U.S. Prescription Drug Regulations to Protect Consumers

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Abstract:

Protecting American consumers from the potentially fatal side effects of prescription drugs already behind pharmacy counters should be one of the top tasks of the U.S. Food and Drug Administration. Yet the FDA today has little authority and even less money to police prescription drugs after it has given final approval for a new drug to be prescribed by doctors across the country. Under current rules and regulations approved by Congress most recently five years ago, the presumption was that the FDA’s rigorous testing of prescription drugs prior to approval for sale to the public offered enough protection to consumers. That presumption is wrong.