FDA Policy/General

Califf on FDA and the Clinical Community

FDA commissioner Robert Califf says the gap between FDA clearance or approval of a medical product and use of the product to treat patients “should be filled by an invigorated clinical research system that generates evidence that patients, clinicians, and health systems need to make well-informed decisions.” Writing in a New England Journal of Medicine Viewpoint, Califf says FDA programs can stimulate progress in evidence generation, but these programs will be more successful if leaders of academic institutions, health systems, and professional societies prioritize evidence generation as a professional activity.

Noting that the global information environment has been “contaminated by misinformation and disinformation,” Califf says FDA must be more proactive in preempting and countering misinformation, but the complexity of the issue requires collaboration across sectors to “create an information environment in which decisions about diet, testing, and therapeutic interventions made by consumers, patients, and clinicians are more likely to be informed by reliable information based on high-quality evidence from trustworthy sources.”

Turning to the agency priority for accelerating progress against cancer, rare diseases, and chronic conditions, Califf writes that regulatory models that stimulate innovation while detecting risks will require new systems for clinical evaluation to assess outcomes during the long interval needed to evaluate the benefits and risks of interventions with potentially life-long effects, often amid scientific and clinical uncertainty at the outset of treatment.

Other priorities addressed in the article are continuing major efforts against Covid-19, addressing drug use and overdose, reducing harm from tobacco, human and animal health, and reversing inequities in health outcomes.

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