Biologics

ICER Questions Diversity Action Plan Goal

The Institute for Clinical and Economic Review (ICER), a private, independent, nonprofit research institute, says that while it applauds FDA’s continued effort to create policies and guidance to enhance greater diversity in clinical trials, it is concerned about the stated intended goal of a draft guidance on diversity action plans to improve enrollment of participants from under-represented populations in clinical studies. The ICER comment letter says the guidance’s goal is to “increase the enrollment of participants from historically under-represented populations in clinical studies to help improve the strength and generalizability of the evidence for the intended population.”

ICER says the goal runs the risk of equating a lack of diversity in clinical trials to a lack of generalizability, when in many cases there is no heterogeneity in treatment effects based on factors such as race, ethnicity, and sex, that are evaluated in clinical trial diversity. “This intended goal may have a negative impact on how the evidence from clinical trials is perceived in practice,” the letter says. “Furthermore, while the target enrollment commonly set to achieve adequate clinical trial diversity may have some implications for assessing potential treatment differences between subgroups, these are often hypothesis-generating due to the small sample sizes and should not be the key goal of improving clinical trial diversity.”

The letter also has specific comments on sections of the guidance.

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