The Food and Drug Administration (FDA) is developing guidelines that will incorporate patients’ experiences with medical devices into the regulatory review process.
Working together, the Medical Device Innovation Consortium, a collaboration of the device industry, the FDA, and the National Institutes of Health, released a draft framework for device makers as they collect patient-preference information and submit the data to the FDA when seeking device approvals, Roll Call reports. The draft calls for the FDA to incorporate patient input in reviewing new device applications. The House Energy and Commerce Committee will consider this issue as it works on legislation called 21st Century Cures. The current FDA device approval process does not require the submission or consideration of patient-preference information, but Ross Jaffe of the venture capital firm Versant Ventures, calls such information an “enhancement” to a submission, according to Roll Call. Medical devices under FDA jurisdiction range from equipment used by physicians and nurses in testing and treatments, to devices like insulin pumps, joint replacements, and pacemakers worn on or implanted in the body.
In its guidance, the FDA said it will only consider certain kinds of patient-preference information in device applications. The new guidance builds on 2012 documents clarifying that the FDA would consider data on risk tolerance and perceived benefits as long as the data was validated by the agency. Research on patient preference is an emerging area of regulatory science and one of the greatest challenges lies in determining how to measure patients’ preferences in situations in which benefits do not clearly outweigh risks. The FDA says it can use patient-preference data in evaluating device applications and in designing trials, but the process is still challenging and unclear. Telba Irony, who is part of the agency’s Center for Devices and Radiological Health wonders how much benefit the FDA would need to see. “If we don’t approve the technology for the 40 percent [who are more risk tolerant], then nobody has access to it,” Roll Call reports.
In the new framework, the group describes quantitative methods device makers can use, But “[t]his is going to be fairly overwhelming to the industry,” said Diana Salditt, a regulatory affairs adviser at device maker Medtronic. Salditt noted the need for education; she feels people in the industry “will need to see and maybe even work though some case studies on how this will be applicable.” Device makers, Salditt says, “understand how to identify the attributes patients want,” but not “how to weigh attributes and measure the trade-offs.” Nevertheless, the industry said it welcomes the FDA’s readiness to consider additional data, according to Roll Call.
John F.P. Bridges, a professor at the Johns Hopkins Bloomberg School of Public Health and a researcher into patient perspectives in medicine said he never thought “anyone would pay attention to our research,” according to Roll Call. “Based on good science and justice, one day preference information will become ubiquitous,” Bridges said.