US FDA Sets 'Low Bar' For Meetings With Patients
Executive Summary
New request system is intended to boost FDA transparency, allow patients to more easily gain access to agency staff.
The US FDA is taking a deliberately non-rigorous approach to one of its new data-gathering efforts – the a new online meeting request system for patients and other non-industry stakeholders to interact with staff.
John Whyte, director of Center for Drug Evaluation and Research's Professional Affairs and Stakeholder Engagement (PASE) staff said during an April 3 workshop on patient engagement at CDER that for meeting requests received through the website, "our goal is really to have a low bar for meetings, meaning we're trying to encourage engagement."
Whyte also said most of the meetings have or will be in-person at FDA's White Oak headquarters in Silver Spring, Md.
"The default in a way is to have a meeting," he said. "We also don't want to waste people's time to come in for a meeting on an area where we don't have regulatory authority, but … our goal is to honor those requests for meetings."
FDA in recent years has made communication and integration of patient comments a priority. As part of the 2012 prescription drug user fee reauthorization, the agency created the patient-focused drug development initiative, which included 24 disease-focused meetings allowing patients and advocates to voice their opinions about unmet needs and treatment options to FDA staff. (Also see "FDA Ends Regularly Scheduled Patient-Focused Drug Development Meetings" - Pink Sheet, 28 Sep, 2017.)
The agency now is working to more systematically include patient input into drug review and decision-making. (Also see "From Listening To Advising: The Maturation Of US FDA's Patient-Focused Drug Development Program" - Pink Sheet, 8 Jan, 2018.)
The agency also recently signed an agreement with the National Organization for Rare Disorders to allow reviewers to conduct listening sessions with patients and advocates on various diseases and issues. (Also see "US FDA/NORD Partnership Will Further Increase Patient Involvement In Drug Development" - Pink Sheet, 27 Feb, 2018.)
12 Meetings Granted So Far
The new meeting request system is one way to help patients find the proper staff to direct questions or comments.
The "Request a Meeting on Drugs" website, which launched Feb. 9, houses the application. Requesters enter their name, organization, email address, and phone number, as well as the proposed meeting topic, attendees and agenda.
When the system launched, there were concerns about it stoking confusion, especially among patients and groups new to navigating FDA. (Also see "Seeking A Meeting? CDER Wants Patient Advocacy Groups To Go Online" - Pink Sheet, 19 Feb, 2018.)
PASE staff expect to respond to meeting requests within seven business days with a phone call to the meeting requester to tease out the topic and best route for the meeting, said PASE Health Communications Specialist Christopher Melton.
Whyte said the call sometimes surprises people.
"Our goal is to call people," Whyte said. "Everything doesn't always have to be these long emails."
Whyte said there there have been 12 meeting requests since the system launched. However, that figure may have been tempered by technical problems that took the site down briefly.
Meetings for all the requests so far already have occurred or are planned, he said. None were denied.
Whyte said all the meetings have or will be in-person with FDA staff, but the agency also will offer alternative means to avoid scheduling and travel issues.
"Everyone likes to have a visible meeting," he said. "In many ways I think we can accomplish a lot by having Webex meetings or something of that nature or conference calls."
Indeed, FDA has experienced problems scheduling meetings with biosimilar sponsors within the time-frames mandated in user fee program commitments. When the user fee programs were renewed in 2017, the agency asked for more leeway in scheduling formal meetings. (Also see "Biosimilars Will Get PDUFA-Style Reviews Under New User Fee Plan" - Pink Sheet, 28 Sep, 2016.)
Better Than Industry Meeting Process?
Drug sponsors and industry stakeholders may be jealous of the patient- and advocate-focused system, given some of the complaints that have been received about the formal meeting process.
FDA is not as liberal in granting meetings to sponsors, whether they be for drug development or application-related issues.
The agency requires sponsors to submit extensive background packages as part of formal meeting requests for complex generics, which can be a substantial burden, especially if there is a chance the meeting may not be approved.
NDA sponsors also must submit a pre-meeting package, but it can arrive after the meeting has been granted and scheduled. (Also see "Unhappy With GDUFA II? Note It For GDUFA III, FDA Says" - Pink Sheet, 28 Nov, 2017.)