Drugs

FDA Using National Academies Report on Opioid Prescribing

FDA says it will use information in a National Academies of Science, Engineering, and Medicine report it contracted on framing opioid prescribing guidelines for acute pain as it implements the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. That act requires FDA to develop evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain for the relevant therapeutic areas where such guidelines don’t exist.

The National Academies report recommends two frameworks—an analytical framework and an evidence evaluation framework—that medical professional societies, healthcare organizations, and state, national, and local agencies could use to develop clinical practice guidelines (CPGs) for prescribing opioids to manage acute pain.

“Rigorous evidence and CPGs based on that evidence help clinicians make the best possible decisions about patient care,” the report says. “Despite widespread efforts over the last five years to reduce opioid prescribing, opioids are commonly overprescribed for acute pain. In addition, the amount of opioids prescribed for acute pain varies by provider, hospital, and geographic region.”

The report identifies priority surgical procedures and acute medical conditions for which evidence-based CPGs for opioid prescribing would be desirable. The procedures and conditions were selected based on their prevalence or frequency and evidence of inappropriate prescribing of opioids. The report also identifies important gaps in current CPGs for opioid prescribing in acute pain and recommends additional research to address four issues.

FDA says one of the ways it can work with medical professional societies is to develop a framework that can assist them in creating and evaluating evidence-based guidelines on appropriate opioid analgesic prescribing to treat acute pain caused by specific medical conditions and common surgical procedures for which the drugs are prescribed.

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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’

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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

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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