Drugs

Improve HHS Oversight of Pathogen Research: GAO

The Government Accountability Office (GAO) says HHS could improve its oversight of research involving enhanced potential pandemic pathogens. The GAO report faults a six-year-old HHS oversight framework that requires funding agencies to refer proposed research that is reasonably anticipated to create, transfer, or use enhanced potential pandemic pathogens to the department for additional review of associated risks and benefits. GAO says this does not fully meet the key elements of effective oversight identified in past work.

For example, it says, the framework does not provide a standard to help funding agencies interpret what “reasonably anticipated” means, thus allowing for subjective and potentially inconsistent interpretations of the requirement.

GAO recommended that:

HHS work with funding agencies to develop and document a standard for “reasonably anticipated;”
HHS work with funding agencies to identify and share non-sensitive information with researchers; and
the Centers for Disease Control director assess and document the risks posed by the limitations of the existing DSAT (Division of Select Agents and Toxins) exemptions for public health emergencies and seek legislative authority as needed.

GAO says HHS neither agreed nor disagreed with the first two recommendations and concurred with the third recommendation.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome