Drugs

Intarcia Raises NDA Advisory Committee Issues

Having accepted a proposal from FDA chief scientist Namandjé Bumpus for an advisory committee to review and address a 2021 CDER refusal to approve a company NDA for ITCA 650 (exenatide in DUROS device), Itarcia is expressing concerns about the committee’s composition and functioning. Minutes of a 4/3 virtual meeting to discuss the advisory committee meeting indicate that on behalf of the company, Hogan Lovells attorney David Fox raised concerns relating to (1) a request for more oversight by the chief scientist or others in the Office of the Commissioner to act as a neutral party to adjudicate any disagreements on the composition of the committee, the scope of the meeting, or other issues that may arise; (2) CDER’s stated intention to add ad hoc members, especially with medical device expertise, to the committee that the company fears could influence the committee’s fairness; and (3) narrowing the meeting scope to questions surrounding clinical risk for the drug/device combination.

Intarcia representatives voiced concerns about the fairness of an advisory committee meeting if the company is not included in formulating the issues for the meeting.

Bumpus said she trusts CDER to conduct a fair and open advisory committee meeting while following its usual procedures as it has said it will do. It was indicated that Bumpus and her team will consider the issues that were raised and respond to them in writing.

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