FDA Policy/General

Trump Plan to Reorganize Government Would Nix Food Role

A Trump Administration government reorganization proposal would rename FDA the “Federal Drug Administration” and remove and reassign all food-related resources and activities to the U.S. Department of Agriculture (USDA). The proposal would merge about 5,000 FDA employees and $1.3 billion in budget authority with about 9,200 staff and $1 billion in resources in USDA. “In the long term, the Administration expects this proposal would result in improvements in food safety outcomes, policy and program consistency, and more efficient use of taxpayer resources,” the proposal (see p. 32) says. The new combined entity would be called the Federal Food Safety Agency.

Reacting to the proposal, the Alliance for a Stronger FDA notes that discussions in the past about consolidating food-related activities had “envisioned the single food agency reporting to the Secretary of HHS. Because CFSAN and FSIS operate under different laws and regulations and have different cultures, we are told this part of the reorganization is extremely unlikely to be adopted, although it is concerning. The Administration will have a chance to state its priorities when the totality of the reorganization plan is discussed at a 6/27 hearing of the House Oversight and Government Reform Committee (here).

An FDA observer, who discussed the proposal on background, told FDA Webview 6/22 that the “merger is based on a superficially good idea (one food agency), but the deeper you dig the more it becomes clear that such a transition would be difficult and disruptive and the putative gain small to non-existent.”

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