Drugs

PhRMA Wants Quality Metrics Transparency

Pharmaceutical Research and Manufacturers of America (PhRMA) says that FDA should provide transparency on how it plans to process, interpret, and use quality metrics data to be reported by industry. A PhRMA Catalyst blog post on the quality metrics proposal says that agency sharing of information “is critical so that stakeholders can weigh in and provide feedback on whether such plans will generate unnecessary or unintentional additional burdens.”

The association also asks FDA to clarify that it will continue to protect manufacturers’ confidential commercial information when it collects quality metrics data. “Such information must continue to be protected in order to avoid unintended consequences if the data were taken out of context, misinterpreted or misused,” it says. “PhRMA has requested that FDA explicitly state it will protect biopharmaceutical companies’ confidential commercial information when used as part of the quality metrics program.”

The quality metrics program goal, which PhRMA says it strongly supports, is to provide the agency with data to help calibrate its risk-based approach to inspections. “Under a risk-based inspection paradigm,” the post says, “high-risk facilities would be inspected and monitored more often than high-performing facilities that have a reputation for producing quality products for patients. Such an approach facilitates efficient use of agency resources while keeping patients safe.”

PhRMA calls on FDA to phase-in the program to make it possible to incorporate lessons learned by stakeholders over time. “A phased-in approach … would help to balance the potential benefits with any unnecessary burden for both the agency and industry so that we can both continue to meet our shared goal of protecting and promoting patient health,” the post concludes.

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