Drugs

FDA Strengthening Essure Post-Marketing Study

FDA commissioner Scott Gottlieb says the agency is taking steps to strengthen a mandated post-marketing study for Bayer’s Essure permanent birth control device that was withdrawn from the market 12/31/18. In a statement, Gottlieb says the agency worked with Bayer to see that it implements several approved study modifications to strengthen the evidence collected.

First, he writes, women in the study will be followed for five years, rather than the three years that was initially required. “This extension will provide us with longer-term information on adverse risks of the device, including issues that may lead women to have the device removed,” he explains.

A second change is to require additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation. Gottlieb says the testing could help better evaluate potential immune reactions to the device and whether the findings are associated with symptoms that patients have reported related to Essure.

The agency also is requiring the company to enroll patients who might have opted to receive Essure in advance of its full discontinuation from the U.S. market and to continue to submit more frequent reports to FDA on the study’s progress and results.

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