Drugs

Opioid Crisis Worse Despite Progress: Califf

While progress has been made in many areas of FDA’s four-part drug overdose prevention framework, the crisis has grown into an even more dangerous public health challenge. That’s the assessment of FDA commissioner Robert Califf, in an online FDA Voices 8/31 post to mark International Overdose Awareness Day.

Califf writes that the framework’s four priorities are primary prevention, encouraging harm reduction, advancing evidence-based treatments for substance use disorders, and protecting the public from unapproved, diverted, or counterfeit drugs. He says the agency has taken steps in each of the four areas:

supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing;
encouraging harm reduction through innovation and education;
advancing the development of evidence-based treatments for substance use disorders; and
protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

“I’m pleased that we’ve seen some important advances and policy changes addressing critical areas of need,” Califf concludes. “However, we have many important actions left to take, especially given the changing nature of the crisis. We seek collaborators to quell the shifting supply chain of illicit opioids and stimulants, while also supporting society-wide efforts to reduce the demand for illicit drugs. And we will continue to seek ways we can effectively embrace cutting-edge science and technology to support even more powerful advances to help bring an end to this crisis.”

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