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TAGline Fall 2015


October 2015

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.

The 21st Century Cures Act’s “Pathway to Crisis” in Drug Safety
Federal legislation promises a substantial increase in NIH funding—at the expense of a significantly weakened FDA
By Kenyon Farrow

The FDA’s Concession Conundrum
Can regulatory incentives promote responsible TB drug development?
By Lindsay McKenna and Erica Lessem

The Challenge of Defining HIV Remission
Supportive regulatory guidance for cure research requires a clear understanding of all possible outcomes, including remission
By Richard Jefferys

Improving Regulatory Systems to Address Global TB Drug Access Failures
Worldwide inefficiencies in drug approval processes are proving disastrous for people living with TB and other diseases
By Erica Lessem

PrEP: The Pathway to Global Access
Regulatory filing and review delays keep Truvada as pre-exposure prophylaxis out of reach of those who need it most
By Scott Morgan