FDA Is “Writing Off” PDUFA Meetings Via “Written Response Only” Loophole
​[Thursday, September 27, 2018]

Over the last few years, FDA is increasingly refusing to meet companies, either in-person or via phone, and instead providing written responses to the applicant’s questions, a process called “Written Response Only (WRO)”. The WRO process which was originally created to make it easier to answer routine questions in certain meeting requests is now being used for all meetings, making it harder for companies to discuss with reviewers. Since the beginning of PDUFA, FDA and industry have greatly benefited from meeting each other to discuss issues related to pending and planned applications. Numerous independent studies have shown that meetings with FDA exponentially increase the odds of successful outcome for the applications under review. Meetings allow manufacturers to directly clarify issues with FDA prior to formal submissions, making the reviewers familiar with the content of planned submissions, in turn reducing review times and success rate. FDA has long touted its meetings as an invaluable free resource available to manufacturers. But over the years, the success of the FDA meeting process has become its own handicap. FDA is inundated with meeting requests receiving over 3000 meeting requests every year. In addition, several new programs launched in the last few years have required the FDA reviewers to prioritize meetings for certain products such as those designated as breakthrough therapies, or for other expedited approval pathways. And FDA has increased its public engagements with various other meetings, all of which take resources away from PDUFA meetings. Meetings take a lot of resources to execute. Not only does a typical FDA meeting involve ten or more FDA personnel, who need to find time on their schedules, the project managers must find a suitable meeting room on FDA campus and take care of the security processes. And having a meeting is taxing for the reviewers as well who must dedicate more than an hour for the meeting, in addition to the time needed for review and preliminary comments. Many FDA reviewers follow remote-work schedules adding to the challenge of either traveling to the office just for the meeting or trying to call into the conference lines. Over time, it was also seen that many questions from the manufacturers were satisfactorily answered with the preliminary response and did not need further discussion at the meeting. So, to meet the PDUFA goals for meeting most sponsor while at the same time deal with increased number of meetings, FDA “invented” the WRO process in 2012. Originally, the WRO process was intended to apply only to about a third of pre-IND meetings and Type C meetings. During the last PDUFA renewal in 2017, the WRO was expanded to all kinds of meetings. Reports indicate that more than 50% of meeting requests are granted WRO. While WRO process is needed since it is impractical to expect FDA to meet all requesters, these have limited use for the sponsors. A WRO eliminates a productive discussion with the reviewers the way a meeting or phone call would. In effect WRO literally pushes a sponsor to make formal submissions without substantive pre-submission discussion. It could be argued that getting a WRO is equivalent to getting a rejection for a meeting request as a rejection also involves substantive written response to the request as to why a meeting is not necessary. It would have been better if FDA made its process for granting a meeting more restrictive, so sponsors prepare better before requesting a meeting, rather than “writing off” a meeting request with a WRO. WRO should not become a “loophole” used by FDA to keep its numbers for meetings good, while not really doing the job. It would be deceptive for FDA to say that it grants 90% of the meeting requests when 50% of those were WRO. A WRO is not a meeting and should not be counted as one, period.