Drugs

Advisors to Review Fentanyl REMS

Members of the FDA Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products advisory committees will be asked 8/3 to review data from the most recent assessment of the REMS (Risk Evaluation and Mitigation Strategy) with Elements to Assure Safe Use for transmucosal immediate-release fentanyl (TIRF) products. FDA commissioner Scott Gottlieb says committee members will be asked to discuss the findings from the assessments conducted by manufacturers of these products, as well as additional data about their use patterns and adverse events.

“Asking the FDA’s advisory committees to take a closer look at this opioid-related REMS reflects our commitment to further evaluating this critical program and making sure we’re providing transparency around its effectiveness and whether any modifications may be necessary,” Gottlieb says. “These TIRF products are medically important but also pose serious risks. We’re seeking the advice of outside experts on the effectiveness of the REMS and whether changes to the REMS might be necessary.”

The statement says that since the REMS was implemented, there has been a significant decline in prescribing of TIRF products and currently they are prescribed to some 5,000 patients nationwide. Because surveillance data are limited and look at a relatively small number of patients compared to overall opioid analgesic prescriptions, it says, this affects FDA’s ability to evaluate REMS effectiveness. “One topic we’ll discuss is how to best evaluate the REMS program, including our methods for data collection and assessment tools,” Gottlieb says.

Another topic the advisors will be asked to consider is how the TIRF REMS has affected the prescribing patterns for TIRF products and how the TIRF REMS can better promote safe prescribing. “We’ll ask the advisory committee to evaluate the reliability of our current trend information, and how we can collect even more accurate data,” Gottlieb says. “We’re seeking expert input into whether the TIRF products are helping patients who most need these products, as well as whether there are adverse outcomes associated with the current prescribing patterns.”

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