For the first time, a Food and Drug Administration advisory committee will focus on providing the perspective of patients in the review of medical devices.
The news comes as women who were adversely affected by a female sterilization device participate in an FDA hearing later this week.
The agency announced plans to create a Patient Engagement Advisory Committee in a blog post co-written by Dr. Robert Califf, FDA deputy commissioner for medical products and tobacco
Some of the topics under the panel's purview include FDA guidance and policies, the design of clinical trials and patient preference studies, device labeling, unmet clinical needs, and determinations of benefits and risk of a medical device's use.
However, Califf, who was recently named the White House's pick to become the next FDA commissioner, warned about the extent of the committee's influence.
“When assessing whether valid scientific evidence shows that a device's probable benefit outweighs its likely risks, FDA may consider rigorous, systematically gathered patient preference information as a part of the totality of the evidence from clinical and nonclinical testing,” the post read. “However, patient preference information will not be used to justify approval of unsafe or ineffective devices: If FDA determines the device would expose patients to an unreasonable or significant risk of illness or injury, or that the benefits do not outweigh the risks for a defined target population, FDA would not approve such a device.”
The FDA has been under fire for a device that was approved in 2002 but which thousands of women have said led to unintended pregnancies, organ perforation and pain.
Many of them are gathering this week in Washington, D.C., to review the safety and efficacy of Essure, a device that has generated more than 5,000 adverse-event reports.
Essure consists of a small flexible nickel coil that is inserted into each fallopian tube and causes tubal blockage. The implants are placed without a skin incision, through the vagina.
One major issue likely to be raised in the hearing is the sparse post-market studies evaluating the long-term and real-life experiences of patients and clinicians following FDA approval of products.
Those are the types of concerns likely to be addressed by the committee's members.
Nine voting members will be chosen from the areas of clinical research and primary-care patient experience, as well as one nonvoting member who will serve on the panel as an industry representative.
Committee members will be asked to stay on the body for up to four years. The commissioner will select the members. The group would meet approximately twice a year and those meetings would be open to the public.
Those interested in being considered for inclusion on the committees should apply by Oct. 21.