FDA Policy/General

FDA Shutdown Enters 3rd Week and Challenges Mount

As FDA enters the third week of the partial government shutdown, agency employees still on the job are facing challenges with fulfilling public health responsibilities, according to the Alliance for a Stronger FDA. The group has created an “FDA Shutdown Toolkit” that explains how agency operations are affected. During the shutdown, FDA is limited to activities necessary to address imminent threats to public health and safety, and those activities funded by carryover funds (mostly user fees).

Specifically, the agency during the shutdown will be permitted to:

monitor and respond to outbreaks related to foodborne illness and the flu
support high-risk food and medical product recalls when products endanger consumers and patients
pursue civil investigations when the public health is imminently at risk
pursue criminal investigations
screen food and medical products that are imported to the U.S. to protect consumers and patients from harmful products
address other critical public health issues that involve imminent threats to the safety of human life
conduct critical surveillance for significant safety concerns with medical devices and other medical products

Currently, about 60% of FDA’s employees are still working without pay. “Depending on the duration of the shutdown, account balances and burn rates, there may reach a point where funds to carry out user fee-funded activities are not available and employees are furloughed,” the Alliance notes. “This eventual phase-down will be different for each of the separate user fee programs. Additionally, about 1,100 members of the U.S. Public Health Service Commissioned Corps are not subject to the furlough and will be working throughout the shutdown."

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