Drugs

More ‘Rational’ Opioid Prescribing Needed: Gottlieb

FDA commissioner Scott Gottlieb says that opioid addiction often starts with a prescriber’s pen and the number of prescriptions being written is too high. “The doses of opioids being prescribed are also high, and we know that the higher the daily dose, the greater the chance of misuse, overdose, and death from opioids,” he said in a 4/4 speech to the National Rx Drug Abuse and Heroin Summit in Atlanta, GA.

Gottlieb said the agency is using its Sentinel database and other large datasets to assess opioid analgesic use in surgical and primary care settings. He said modeling suggests that for many common surgical procedures, one day of opioids is sufficient, but the mean prescription filled was for 30 tablets. He said variation in opioid analgesic use was found within surgical categories, suggesting differences at the patient level that are important to consider. “These findings suggest the need for regulatory flexibility even as we consider whether to impose requirements to reduce the morphine milligram equivalents that are prescribed,” he said.

The analysis will be expanded to the Medicare and pediatric populations, Gottlieb said. “There’s still a lot of data we need to develop to better inform policies,” he said. “It’s critical that we adopt a better framework for medical prescribing, one based on reliable evidence.”

Gottlieb also discussed ways to increase provider education about opioids, working with professional societies to develop evidence-based guidelines on the appropriate dose and duration for some common procedures, and better opioid labeling.

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