Lawmaker Asks FDA To Launch Criminal Inquiry Into Power Morcellators
This article was originally published in The Gray Sheet
Rep. Mike Fitzpatrick, R-Pa., is asking FDA's criminal office to investigate whether Ethicon and several East Coast hospitals fulfilled safety reporting requirements for power morcellators, which have been linked to a risk of spreading cancer in women undergoing treatment for uterine fibroids.
You may also be interested in...
Several US House lawmakers are drafting a bill in response to a Government Accountability Office report finding that FDA's Medical Device Reporting system has shortcomings that may have missed adverse events for laparoscopic power morcellators. The devices have been linked to an increased risk of spreading cancer in women undergoing fibroid surgery.
The 21st Century Cures bill passed on a 344-77 vote, attracting significant bipartisan support in the House. It includes multiple provisions supported by the device industry, including a priority review pathway for breakthrough devices. Attention now moves to the Senate, which is working on its own bill that could face budget barriers and calls for more safety protections.
The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.