I don’t usually publish the scheduling of an AdComm with a blog posting. But this one merits one.
With fewer than the usual minimum of fifteen days’ notice, FDA has scheduled an FDA Advisory Committee meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss a new drug application (NDA) for terlipressin, lyophilized power for solution for injection for the proposed indication of the treatment of hepatorenal syndrome. The meeting will be held on July 15 from 8 AM to 5 PM and it will be a virtual meeting.
Normally before an advisory committee meeting, FDA opens a docket for the submission of public comment prior to the meeting at www.regulations.gov – and while they are opening one for this meeting, it will only accept comments until the end of day July 14, 2020, but only those comments submitted before July 10 will be submitted to the committee for review.
The reason for the lack of time between publication of the notice and holding the actual meeting was stated to be unspecified “technical problems”. The agency sates that it will make the background materials available no later than 2 business days prior to the meeting. Hopefully no technical problems there. These should be found on the FDA website at the Cardiovascular and Renal Drugs Advisory Committee meetings page.
The agency states in the Federal Register notice that the meeting will be conducted via an “online teleconferencing platform” but does not say which one. The notice refers people with questions to the standard FDA Advisory Committee webpage about in-person meetings. So you can find out how you get lunch in an in-person meeting, but there is no information about how to access the virtual meeting or how it will work. Bad show, FDA. Presumably this will become apparent in the meeting materials that will be posted prior to the meeting.
We are in the seventh month of this pandemic and it has been clear for at least five of them that virtual advisory committee meetings were likely. FDA needs to deliver a better product here for the sake of credibility in the approval process moving forward.
Photo by Philipp Katzenberger on Unsplash
