FDA Policy/General

WSJ ‘Apologizes’ for Supporting Califf

[Commentary by Jim Dickinson] In an unusually strident critique of FDA’s 4/29 final rule to regulate laboratory developed tests (LDTs) as medical devices, the Wall Street Journal’s editorial board 5/3 accused the agency of “usurping and end-running Congress. We supported Dr. Califf’s nomination [for commissioner], but we apologize to readers. His lab-test rule serves no one’s interest but the FDA’s.”

Dripping with scorn, the editorial says “FDA’s 528-page rule snatches authority” from a Congress that seemed paralyzed by the technical complexities LTDs presented. It contended that the labs doing the tests “already overseen by the Centers for Medicare and Medicaid Services (CMS), as if that ought to be enough before going on to object, “but the FDA says lab inspections might not detect unreliable tests,” implying that CMS conducts inspections for reliability, which it does not.

The editorial then drapes the albatross of the 2016 Theranos fraudulent lab test scandal over FDA’s shoulders, pointing out that the agency had cleared the LDT in question. “The FDA believes its own experts are superior to doctors, states and third-party lab accreditors that play a role in regulating lab tests,” the editorial sneers.

It’s all conservative politics at the WSJ, as the editorial’s first sentence seems to confess: “We’ve been chronicling how Biden regulators are dusting off old laws to seize more power over the private economy.”

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