Last week, the FDA launched its new ‘Request to Connect’ portal, an initiative developed by the agency to encourage greater understanding of, and participation in, the FDA’s regulatory work. The online portal invites patients, their support groups, advocates and caregivers, and health care professionals and organizations to submit questions about drugs and medical devices and/or to request meetings with agency officials.
Co-developed by the FDA’s Patient Affairs Staff and the medical product centers, the new portal is intended to receive inquiries and route them to the appropriate office or medical product center to ensure they are reviewed and responded to.
The aim is to keep patient interests and perspectives at the heart of agency efforts. The FDA recognizes that patient populations and their needs are constantly evolving, and, as such, their opinions and insights must continuously be taken into consideration. Agency representatives have said that, “as a science-based agency, we continue to develop and engage programs that help FDA understand the patient perspective and advance the science of patient input.”
However, the FDA has made it clear that the meetings and question responses that come from this new initiative will not establish binding agreements pertaining to medical product development programs. The agency has also said that it will not discuss proprietary information pertaining to any drug or device development programs under FDA review.
Although FDA Commissioner, Scott Gottlieb, has since stepped down from office, he was integral in the development of this portal. He took to Twitter last week to say, “I’m excited that my vision for a single, central entry point for patients and caregivers to submit questions and meeting requests to the #FDA has come to fruition via our new web portal, ‘Request to Connect’.”
Click here to access the Request to Connect portal and submit a question or meeting request.