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TAGline 2015

NEWS ON THE FIGHT TO END HIV/AIDS, VIRAL HEPATITIS, AND TUBERCULOSIS

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.

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

 


TAGline Spring 2015: On Targets and Timelines

On Targets and Timelines
With growing recognition that science and discovery have forged the tools necessary to effectively diagnose, treat, and, indeed, eliminate three of the world’s most lethal infectious diseases—HIV/AIDS, tuberculosis, and hepatitis C—there is a need for greater mobilization and strengthened accountability among all stakeholders. Universal frameworks in which this can be achieved require time-bound targets: collaboratively developed, metrics-driven goals to optimize health outcomes among those living with the disease(s) and to minimize incidence among vulnerable individuals.
By Tim Horn

Ending the HIV Epidemic (ETE) in New York State
Not only is it the right thing to do for the health of New Yorkers, but a new analysis demonstrates that it is also cost-effective.
By Ginny Shubert, Housing Works; and Mark Harrington

Toward an Ambitious National HIV/AIDS Strategy
We won’t end HIV as an epidemic with anemic goals, delayed surveillance data, feeble support of state policies and resource needs, and an inadequate implementation science agenda.
By Kenyon Farrow

An HIV Cure and a Vaccine within the Next 15 Years?
Optimism is not without merit, but the science remains incredibly fragile.
By Richard Jefferys

C U L8ter: Hepatitis C Eradication
Hepatitis C is now curable. Now all we need is surveillance to monitor it, global funding to fight it, and targets set to address it.
By Tracy Swan

TB R&D’s Shift to the Left
As the Bill & Melinda Gates Foundation realigns its TB vaccine strategy to focus on early-stage candidate development, equitable access priorities must also be established before large-scale trials are conducted.
By Mike Frick