Prescription for Trouble FDA can finally preven
Post# of 2146
[b]Prescription for Trouble[/b]
[b]FDA can finally prevent narcotic drugs that can be widely abused from easily threatening patient safety. Will it seize the moment?[/b]
http://www.american.com/archive/2012/december...icle_print
But the Food and Drug Administration (FDA) may let the older, riskier versions back onto the market in the form of cheap generic drugs — reigniting the original problems. Ample evidence shows that criminal use will simply shift to the generic drugs, since these older pills are easier to abuse. It will undermine efforts undertaken by industry and policymakers to design the new tamper-resistant drugs as a way to combat the problem.
The FDA argues that its hands may be tied. In order to keep older drugs off the market, FDA has to declare that they were withdrawn for safety reasons after the tamper-resistant versions came along. FDA was asked to make this declaration when the tamper-resistant drugs were first introduced. But the Obama administration’s lawyers at the Department of Health and Human Services and FDA are wrangling over whether FDA has the proper authority.
As we’ll explain, FDA’s handwringing over what it calls “complex and novel legal issues”1 is partly a problem of the agency’s own making. FDA must decide one way or another. We think the agency’s delay only exacerbates the risks to public health.
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