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TAGline Fall 2015: In Defense of Stringency

In Defense of Stringency
By Tim Horn

In response to growing public concern with health risks posed by approved drugs, a 2006 landmark report by the Institute of Medicine (IOM) argued that the U.S. Food and Drug Administration (FDA) lacks the unambiguous authority necessary to ensure the safety and efficacy of the country’s medicinal products. The IOM emphatically recommended that Congress enact any legislation necessary to buttress the agency’s enforcement powers so that it may apply the strengths of the pre-approval process, including stringent data review, to postapproval monitoring and regulation. Nine years later, Congress and federal courts have followed a markedly different course. Instead of ensuring agency leadership and resources, they have continued assaults on the FDA’s regulatory powers—eroding not only its postapproval oversight, but also the safety and efficacy requirements for its approval of drugs and medical devices.

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