FDA Policy/General

Speed Access to Drugs and Cut Drug Use: Makary

FDA commissioner Martin Makary says that while he wants to speed patients’ access to needed drugs, he also wants to reduce the need for pharmaceuticals by addressing the root causes of diseases. In an interview with Yahoo Finance, Makary said he has been focused on ensuring quicker access to drugs, questioning why it takes 10 years for a drug to reach the market, and calling for more transparency about drugs when they are approved.

“We’re releasing the FDA decision letters so the public can see them, drug developers can see them,” he said. “We can give more predictability. We’re modernizing the agency. We’re trying to cut some of the idle time,” saying this would help restore people’s trust in FDA.

Much of the interview was devoted to Makary’s views on the role food plays in causing chronic diseases.

“No one has been talking about the fact that food has been designed to be addictive,” he said. “So when we have a crisis in our nation’s children, that is, 40% have a chronic disease and 11% have prediabetes or insulin resistance, it’s not their fault. We don’t think that our childhood obesity epidemic is a willpower problem. We think this is something adults are doing to kids. We’ve got to talk about school lunch programs, not just putting every six-year-old on Ozempic. We’ve got to talk about sleep medicine and the quality of sleep, and not just antihypertensive after antihypertensive. And we’ve got to talk about environmental exposures that cause cancer, not just the chemo to treat it. We’ve got to talk about food as medicine and the microbiome.”

Makary said he intends to redraw the food pyramid that hasn’t been updated in more than a decade, and believes that also will go far in restoring trust in the agency.

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