House Democrats Request Hearings on Metal-on-Metal (written by Lauren Uzdienzki @ HealthPointCapital)
Democrats from the House Energy and Commerce Committee have asked Republican leaders to hold hearings on metal-on-metal hips and brain stents. In a letter, Democrats said these devices have caused “significant harm to human health”. Bloomberg writes that the FDA has received more than 5,000 complaints about metal-on-metal hips, among about 500,000 patients who have received the devices; the backlash from the ASR alone is already expected to cost DePuy over $1 billion.
The hearings would be designed to offer insight into the FDA’s regulatory process. The agency is currently negotiating the terms of MDUFA III, its user fee authorization, so an understanding of how the agency makes regulatory decisions is relevant as legislators help determine how to augment the FDA’s funding. Prior hearings have focused on delays in getting products to market, according to Bloomberg’s report.
The FDA is conducting its own review of metal-on-metal, having requested post-market data from about 20 companies, including Johnson & Johnson, Zimmer, Biomet and Wright Medical. This represents an unprecedented request for data, with the CDRH’s deputy science director, Dr. William Maisel, noting, “This is the largest group of studies that we have asked for” post-approval.