Drugs

Rep. Fitzpatrick to Release Essure Investigation Findings

Just weeks away from CDRH completing a safety review of Bayer Health’s controversial Essure permanent birth control device, Rep. Mike Fitzpatrick (R-PA) now is planning to release investigation findings 2/17 to expose unreported deaths caused by the device and complaints alleging illegal kick-backs from the manufacturer to doctors. Fitzpatrick has been calling for removal of Essure from the market, and introduced the E-Free Act in November of 2015. When releasing his findings, Fitzpatrick will be joined by Device Events reporting expert Madris Tomes and two women allegedly harmed by the device, Amanda Dykeman and Angie Firmalino.

Late last year, CDRH said it will announce findings of its internal Essure safety review by the end of February, at which time it will identify appropriate next steps. In September, FDA and Bayer took major criticism from an advisory committee for not requiring or conducting a randomized clinical trial to allow the Essure contraceptive on the market 13 years ago. FDA’s Obstetrics and Gynecology Devices Panel heard from dozens of Essure patients who complained about pain and other serious problems following implantation of Bayer’s fallopian tube permanent sterilization coil. They called on the agency and the panel to recommend that the device be withdrawn from the market, but no such formal vote was taken.

During the meeting, FDA acknowledged that in the past two years it has seen a dramatic increase in the number of adverse events submitted in relation to the Essure device. A briefing document released in advance of the panel meeting said FDA had been exploring various tools for “social listening” as a means to expand its ability to identify and refine new safety signals.

A CDRH notice says the Essure evaluation is a “high priority issue for the agency, and we are working expeditiously to conduct an evidence-based review of the available information... Presently, we are reviewing information from the panel meeting, the public docket, as well as additional medical literature and adverse event reports which have been published or received since the panel meeting. In this review, we are focusing attention on the concerns identified by the public speakers and the feedback and recommendations provided by the panel (see advisory committee meeting summary and panel transcript).”

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