FDA Policy/General

GAO Weighs in on FDA Inspections Priority

The U.S. Government Accountability Office (GAO) says FDA should make reducing its inspection backlog caused by the Covid-19 pandemic a high priority. In a recent letter to HHS, GAO says “FDA should, as inspection plans for future fiscal years are developed, ensure that such plans identify, analyze, and respond to the issues presented by the backlog of inspections that could jeopardize the goal of risk-driven inspections.” FDA previously stated that it is actively tracking the list of sites that need to be inspected. “To fully implement our recommendation, FDA should provide documentation that its inspection plans identify, analyze, and respond to the issues presented by the backlog of inspections,” GAO says.

Additionally, HHS says that another priority that has been lingering since 12/2016 is for the agency to “assess the effectiveness of its foreign offices’ contributions to ensuring the safety of imported products... FDA reported developing new performance measures for these offices as well as a monitoring and evaluation plan in 2018, but as of March 2021 has not reported additional progress.” GAO emphasizes that the “systematically track information to measure whether the offices’ activities—such as inspections, import alerts, and warning letters—specifically contribute to drug safety-related outcomes. In addition, as part of our ongoing work in this area, we will continue to obtain updated information on the role of FDA’s foreign offices in ensuring the safety of drugs entering the United States.”

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