Gottlieb to Meet with Lawmakers on Essure Concerns
FDA commissioner Scott Gottlieb has agreed to meet with Rep. Rosa DeLauro (D-CT) and other members of Congress to discuss the safety of Bayer’s controversial contraceptive implant Essure (see earlier story). DeLauro says the meeting was granted on the condition that women who have been affected by Essure not be present. However, an agency spokeswoman disputes this account. “The FDA has communicated and met regularly with Essure patients over the years, and we welcome future meetings with them,” she told FDA Webview 12/4. “The formal request we received from Congress was for the commissioner to meet with Rep. DeLauro and a few fellow members of Congress, which the commissioner plans to do.”
The lawmakers requested an FDA meeting following Internet blog reports that Bayer has enrolled only one patient of the 2,400 needed for a post-marketing study of its controversial Essure birth control device. “Despite widespread safety concerns,” they wrote in a 10/30 letter to Gottlieb, “FDA has allowed Essure to remain on the market even while mandating that the manufacturer, Bayer, conduct an additional post-market safety study. However, a year and a half after the study was initiated, it is unclear whether Bayer has acted with urgency to enroll patients, or if the study results will be delayed. FDA cannot continue to allow Bayer to drag its feet on this post-market study while women are continuing to suffer.”
The letter cited a 2015 Government Accountability Office report requested by DeLauro finding that following a post-market safety study request by FDA, companies lack incentives to enroll participants and are slow to report findings. “The Bayer post-market study on Essure has held true to those GAO findings,” the letter said. “In the post-market study plan released by FDA in 3/2016, Bayer planned to enroll 78 patients per month when all approved sites were activated. According to the FDA Web site, there are currently 60 approved sites but only one patient has been enrolled in the study.”
Bayer vice president Steven Immergut disputed DeLauro's complaint, telling FDA Webview in an email: “Bayer is working closely with the FDA to meet all study requirements and deadlines. In fact, enrollment started three weeks early, on May 3, 2017, and is currently on schedule. According to FDA’s Web site, as of October 19, 2017, 136 patients were enrolled at 44 different sites. You can see this update here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=356&c_id=3854. Bayer provides an interim study report to the FDA every six months, and it is up to the agency to determine when updates to the FDA Web site are made.”