Drugs

Problems Seen in Draft Pressor Effect Guidance

Public Citizen says that an FDA draft guidance on assessment of drugs’ pressor effects “is vague and will thereby fail to effectively identify the cardiovascular risk of drugs that have hypertensive effects.” The advocacy group’s comment letter lists several limitations of the draft and recommends several revisions.

Roche/Genentech say that while they agree with the spirit of the draft with respect to ambulatory blood pressure monitoring (ABPM), they believe that “a risk-based approach would better address the concern of potential drug-induced effects on blood pressure by reserving ABPM investigations ‘for cause’ (e.g., based on mechanism or action, high-risk population, or evidence of a blood pressure effect in early emerging data).” It suggests alternatives for FDA to consider.

In its comment, Novo Nordisk asks the agency to elaborate on use of home blood pressure measurements over three days as an alternative to ABPM. “In general, ABPM is challenging to use,” the company says, “due to expensive equipment, time consuming mounting and de-mounting, data analysis and interpretation, and effects of a patient’s every-day life during the measurement period. Serial in-office, resting cuff measurements during a trial visit or home BP measurements would not be sufficient in a large-scale study, which would be much more feasible for sponsors.”

Finally, Merck says it supports the overall aims of the draft guidance and wants further clarity on issues including the guidance’s scope, preclinical considerations, clinical threshold, study population, study sample size, study timing, and active control.

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