Drugs

Mixed Views on FDA Mifeprex Monitoring

A Government Accountability Office (GAO) review says that stakeholder organizations have mixed views about FDA monitoring of Mifeprex since its 2000 approval with an indication for the medical termination of early pregnancy. Members of Congress asked GAO to review FDA’s 2016 relabeling of Mifeprex with a revised indication and the agency’s subsequent monitoring of the drug and its safety.

FDA followed its standard review process when it approved the application and revised labeling reflecting certain changes to the indication and dosing regimen, GAO found. The report outlines a variety of monitoring activities the agency has used and says the monitoring has not identified significant concerns with Mifeprex safety and use.

GAO found that the views of stakeholder organizations were mixed about FDA Mifeprex monitoring, It says that positive comments included that the agency has a comprehensive monitoring program and a robust adverse event reporting system. Criticisms included that adverse events may be under-reported and that FDA may only be aware of a fraction of them.

On the drug’s safety, the report says, positive comments included that the mortality rate associated with Mifeprex is extremely low. Safety concerns included that the revised labeling no longer requires patients to have a second visit with a healthcare provider and that certain safety issues may be exacerbated by the increased gestational age limit approved by FDA.

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