Drugs

REMS Can be Improved: Doc Survey

In a study funded by FDA, academic and FDA researchers who surveyed doctors about their experiences with Risk Evaluation and Mitigation Strategies (REMS) for eight REMS-covered drugs found that most doctors said the REMS certification process provided useful information about the drugs but wanted more information on their benefits and non-REMS-related risks. Writing in the Journal of Clinical Pharmacology & Therapeutics, the researchers say (purchase required) the survey responses “highlight how REMS programs contribute to risk mitigation by providing useful drug information to physicians and facilitating shared decision making. It is plausible that these benefits translate into reduced harm.”

They note the benefits were more often reported by older doctors, suggesting that perhaps younger doctors feel more confident in their abilities to work with patients to ensure safe use outside of additional regulatory requirements, while doctors who are more established in practice appreciate the additional support provided by the REMS materials.

“The responses to the survey questions raise the possibility of using the educational materials provided as part of the certification process to communicate more essential information about the study drugs, such as all clinically relevant risks and how well the drug is expected to work,” the report concludes. “Extracting such information otherwise from drug labeling is laborious and leads to gaps in communication. The provision of literature, including enrollment agreement forms, under the REMS program could help convey these data clearly, incorporating best practices identified from dissemination research. However, enhanced use of REMS programs in this way must be efficient to avoid placing a substantially increased burden on physicians.”

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