Drugs

Community Should Push AA Drug Studies: Califf

FDA commissioner Robert Califf says insurers and other stakeholders have a role to play in ensuring that studies on new drugs approved through the accelerated approval pathway are completed. Speaking 3/16 to the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum, Califf said completion of the required studies is not just a matter of the agency making sure the studies are done, according to an online MedCity News report. “This is a community issue where you all have a role to play,” he said.

Last year, the HHS Inspector General reported finding that more than one-third of accelerated approval drugs had incomplete confirmatory trials.

Califf said that despite more authority over the studies given to FDA through the recent Consolidated Appropriations Act, there are still barriers to getting the studies completed, including from insurers.

The commissioner said he was unaware of any major effort by insurance plans to help people get studies done. “It’s hard to assign value unless you’ve done the right studies,” he said. “Make it easier for health systems and clinicians to do the right study so we do get the outcomes,” he urged insurers.

Ultimately, he said, having complete research will rule out the drugs that don’t work and thus reduce costs.

“I really urge [insurers] to get beyond being a passive recipient of research and figure out what policies you can institute that actually make it easier to generate the evidence that we all need,” Califf concluded. “I believe, fundamentally as an amateur health economist, that if you spend more of your time generating evidence, you could stop paying for a lot of things because it would be clear that they don’t work. And ultimately, your costs will go down.”

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