Drugs

AAM Issues with FDA Quality Metrics Program

The Association for Accessible Medicines (AAM) says FDA’s proposed potential new direction for a quality metrics reporting program may not align with five principles the association described in a 3/10/21 white paper submitted to FDA. In a 6/3 comment letter, AAM says it’s concerned that the agency’s proposed direction “may still lack appropriate statutory authority, may incorporate metrics that have not been validated and that may not be relevant to quality, and would incentivize the submission of metrics that are not meaningful and that would not advance public health.”

In its response to an agency request for comments on the metrics proposal, Vizient says it uses quality metrics as a factor in strategic sourcing decisions. “To enhance quality metrics,” it says, “information on each measure, per facility, per product, would be most needed. Vizient provides various suggestions for the agency’s consideration as it further develops the quality metrics reporting program.”

Finally, AstraZeneca responded to questions posed by FDA in its request for comment.

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