FDA recently announced a public workshop to be held on September 18 – 19, 2013 on ways to incorporate patient perspectives on “meaningful benefits” and “acceptable risks” of new medical devices. The meeting is intended to solicit stakeholder input to discuss ways to collect and validate patient preference information and to inform the use of patient preference information in the agency’s review process for medical devices. FDA ultimately seeks to incorporate patient preference information into its pre- and post-marketing regulatory activities for a device.
FDA has historically included patients in advisory committee meetings, but the agency has recently taken additional steps to incorporate patient perspectives in its review process for medical devices. In March 2012, FDA issued a guidance, “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications.” The guidance set forth the principal factors FDA considers when making benefit-risk assessments during the review process for some medical devices. In that guidance, FDA noted that it would consider patient- centric metrics when assessing data in a premarket approval (PMA) application and a de novo petition. A few months later, Congress required FDA, in section 1137 of the Food and Drug Safety and Innovation Act (FDASIA), to develop strategies to solicit views of patient representatives during the medical product development process. In April 2013, Commissioner Hamburg announced the launch of a Patient Network Website to encourage patients to share ideas with the agency about the product development process.
FDA is encouraging stakeholders to comment on the following topics at the public workshop being held next month: (1) how to identify patients and their preferences, (2) what approaches should be used to collect patient preference information, (3) how to validate patient preference data and information, and (4) how to incorporate patient preference information in the regulatory process. One issue the agency will need to grapple with as it seeks to incorporate more patient perspectives is mediating any conflicts-of-interest that might arise with the use of patients in the regulatory decision-making process.
If you are interested in attending the workshop in person or via webcast, you must register online by September 11. FDA is accepting written comments until October 18, 2013. Comments that are submitted by August 19, 2013 might be included in workshop materials for discussion at the meeting.