Devices

LDT Final Rule Legal Challenges Likely: Attorneys

Six Hogan Lovells attorneys say litigation challenging the FDA final rule asserting the agency’s authority to regulate laboratory-developed tests remains likely, based on longstanding industry claims that the rulemaking exceeds FDA’s authority. Writing in a comprehensive analysis of the final rule that will become effective 7/5, the attorneys note that throughout the lengthy final rule, FDA “explains its rationale for maintaining that it has such authority and that the final rule does not create new authority to enforce against violative test manufacturers because enforcement discretion is voluntary on the part of the agency and never represented a lack of authority to oversee these products.”

The attorneys say the likelihood of stakeholder success against the agency will be greater if the Supreme Court overturns the longstanding Chevron doctrine of deferring to an agency’s authority to interpret statutory ambiguity in cases currently before the court.

The Hogan Lovells analysis covers the final rule’s enforcement timeline and phaseout policy, changes from the proposed rule, and questions that remain unanswered.

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