Patients Get More Access to FDA Via a New Formal Meeting Requests
[Thursday, March 14, 2019]

Last week FDA launched a new online portal for patients, physicians, patient advocates and support groups. They can formally and directly request meetings with the FDA to discuss their disease and ask about specific FDA regulated products. Over the last few years, patients have been able to interact with FDA directly and that has led to some major FDA decisions. Many years ago, the most common place for patients to interact with the FDA was during the public Advisory Committee meetings or public hearings. But in recent years, FDA created additional ways for patients to communicate their opinions such as through the Patient Focused Drug Development (PFDD program), the critical path innovation meetings and direct meetings. The newest initiative creates a simplified process for interested parties to contact FDA. These interactions will be led by the Patients Affairs Staff (PAS) and not by specific review divisions, but it can be assumed that the PAS will invite internal subject matter experts from the relevant review divisions to any meetings with the patients. It is also can be safety assumed that patients will generally be provided broad non-confidential suggestions. Although these meetings cannot be requested by industry sponsors for new products, but industry stakeholders can participate by coaching patients to contact FDA for areas of mutual interest. The new process for patient interactions seems to aim primarily for educational and public relations goals, however, it can be used by patients to advocate for specific products.