Regulatory Focus™ > News Articles > Reps Question Gottlieb on Bayer's Follow-Up Essure Studies

Reps Question Gottlieb on Bayer's Follow-Up Essure Studies

Posted 31 October 2017 | By Zachary Brennan 

Reps Question Gottlieb on Bayer's Follow-Up Essure Studies

Reps. Rosa DeLauro (D-CT), Jan Schakowsky (D-IL) and Louise Slaughter (D-NY) on Monday sent a letter to FDA Commissioner Scott Gottlieb regarding concerns related to Bayer's postmarket study for its permanent birth control device Essure.

A year and a half after Bayer's postmarket study was initiated, "It is unclear whether Bayer acted with urgency to enroll patients, or if the study results will be delayed. The FDA cannot continue to allow Bayer to drag its feet on this post-market study while women are continuing to suffer," the representatives wrote.

The letter comes as Bayer decided in September to halt all sales of Essure outside the US, though the company said that decision was a commercial one and not related to safety concerns.

The device has been linked to four adult deaths, 15 incidences of pregnancy loss and 631 reports of pregnancies in those using the device. And although FDA decided not to pull the device from the market, in February the agency required Bayer to add a boxed warning to the device and to conduct a surveillance study. 

According to the letter sent by the three representatives, there are currently 60 approved sites for the postmarketing study but, "Only one patient has been enrolled," though Bayer has said publicly that 100 patients have been enrolled in the safety study.

The representatives are seeking more information from Gottlieb on what FDA is doing to ensure that Bayer complies with the timeline for recruiting patients in its study, when the official number of patients enrolled will be released, how many trial sites are recruiting patients, how Bayer is ensuring that potential participants are informed of the new boxed warning and whether participants in the study will be tested for a nickel allergy prior to enrollment.

Letter


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