Drugs

House Passes Cures Act, Sans Device Reporting Measure

The day before the House approved (see related coverage) it 11/30, the Rules Committee denied a request by Rep. Louise Slaughter (D-NY) to add an 11th-hour amendment to the 21st Century Cures Act (see earlier story) that would have added an extra layer of adverse event reporting in order to improve medical device safety. Reps. Michael Fitzpatrick (R-PA) and Slaughter introduced the Medical Device Guardians Act earlier this year as advocates for patients allegedly harmed by power morcellators and the Essure birth control implant. Under the measure, the Food, Drug, and Cosmetic Act would be amended to require physicians and physician’s offices to be treated as covered device users that are required to report on certain adverse events involving medical devices. As such, a covered user would be protected from having their reporting to the agency used against them in a civil case.

During a discussion on the amendment, (watch the proceedings of the Committee here – at 8:30-11:30 minutes), Rules chairman Pete Sessions (R-TX) obviously dismisses the amendment and seems more interested in talking about the weather in Texas and Washington. Responding to Slaughter’s request, Rep. Fred Upton (R-MI) said it was too late to add the amendment because it was not added to the bill in earlier negotiations. He also appears not to understand the amendment, stating: “FDA has the authority to withdraw the device from market.” He noted that the agency has already has put a Black Box Warning on power morcellators because of their potential risks.

“What Upton doesn't appear to grasp is that this device was harming women for over 20 years without having been reported to the FDA — and that the Fitzpatrick/Slaughter amendment sought to rectify that by encouraging expert physicians to self-report problems to public health officials, observes patient advocates Hooman Noorchashm and Amy J. Reed, who was harmed by a morcellator. “Sessions and Upton had a real opportunity to address a system-wide hazard to American lives, and this wasn’t the first time Upton has ignored Fitzpatrick on this issue,” they wrote in a Philadelphia Inquirer online post. “When powerful politicians are more interested in the weather and in budget allocation than in saving lives, unsuspecting Americans will remain in harm’s way.”

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