Drugs

FDA Extending REMS to IR Opioids

FDA commissioner Scott Gottlieb says the agency is extending Risk Evaluation and Mitigation Strategy (REMS) requirements that now apply to extended-release/long-acting (ER/LA) opioid formulations to cover immediate-release (IR) formulations as well. Writing in an FDA Voice blog post, Gottlieb says FDA notified 74 manufacturers of IR opioids intended for outpatient use that their drugs will be subject to the more stringent ER/LA REMS requirements, including that training on safe prescribing practices and consideration of non-opioid alternatives be made available to healthcare providers who prescribe IR opioids.

He also says the agency will soon publish a final guidance to assist potential applicants who plan to develop and submit to FDA an application to seek approval of a generic version of abuse-deterrent formulations of opioid drugs.

Once the REMS requirement is finalized, Gottlieb says, an additional 277 IR opioid analgesics will be subject to the requirements. He says the training content also is being changed to add information on pain management, including non-opioid alternatives. And for the first time, training will be made available to other healthcare professionals, such as nurses and pharmacists, who are involved in managing patients with pain.

“FDA believes that all healthcare professionals involved in the management of patients with pain should be educated about the safe use of opioids so that when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving an opioid analgesic, they can help ensure that the product is properly indicated for the patient and used under appropriate clinical care,” the commissioner writes.

Finally, he says, FDA’s new Opioid Policy Steering Committee is considering whether there are circumstances when FDA should require some form of mandatory education for healthcare professionals, and how the agency would pursue such a goal. “The agency’s purpose,” he says, “is to reduce overall exposure to opioids by making certain that prescribing doctors are properly informed about appropriate prescribing recommendations, that providers understand how to identify the risk of abuse in individual patients, and know how to get addicted patients into treatment.”

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